Rami Sandoz is a drug for the treatment of hypertension and cardiac diseases. Amoxicillin Sandoz - instructions for use Use in children

Active ingredients: Amoxicillin trihydrate 0.574 g. Equivalent to amoxicillin 0.5 g.
Excipients: Magnesium stearate, polyvidone, sodium starch glycolate, microcrystalline cellulose.

Shell composition: Titanium dioxide, talc, hypromellose.

Pharmacokinetics. Suction
The absolute bioavailability of amoxicillin depends on the dose and mode of administration and ranges from 75 to 90%. At doses from 250 mg to 750 mg, bioavailability (parameters: AUC and / or excretion in urine) is linearly proportional to the dose. At higher doses, the absorption is lower. Absorption is not affected by food intake. Amoxicillin is acid-fast. With a single oral dose of 500 mg, the concentration of amoxicillin in the blood is 6-11 mg / l. After a single dose of 3 g of amoxicillin, the concentration in the blood reaches 27 mg / l. Maximum plasma concentrations are observed 1-2 hours after taking the drug.

Distribution
About 17% of amoxicillin is associated with plasma proteins. The therapeutic concentration of the drug is rapidly achieved in plasma, lungs, bronchial secretions, middle ear fluid, bile and urine. Amoxicillin can penetrate the inflamed meninges into the cerebrospinal fluid. Amoxicillin crosses the placenta and is found in small amounts in breast milk.

Metabolism and excretion
The main place of excretion of amoxicillin is the kidneys. About 60-80% of an oral dose of amoxicillin is excreted within 6 hours after ingestion in an unchanged active form through the kidneys and a small fraction is excreted in the bile. Approximately 7-25% of the dose is metabolized to inactive penicillic acid. The plasma half-life in patients with unchanged renal function is 1 - 1.5 hours. In patients with severe renal impairment, the elimination half-life varies from 5 to 20 hours. The substance is amenable to hemodialysis.

Amoxicillin is an aminobenzyl penicillin that has a bactericidal effect by inhibiting bacterial cell wall synthesis.

The MIC thresholds for different susceptible organisms vary.

In accordance with the NCCLS recommendations and when using the NCCLS-indicated methods, M. catarrholis (β-lactamase negative) and H. influenzae (β-lactamase negative) are regarded as sensitive at concentrations ≤1 μg / ml and resistant at ≥4 μg / ml; Str. pneumoniae are considered susceptible at MIC ≤ 2 μg / ml and resistant at ≥ 8 μg / ml.

The prevalence of resistant strains varies geographically, so it is advisable to rely on local information on resistance, especially when treating severe infections. With such a level of prevalence of resistant strains, at which it becomes doubtful the advisability of using the drug, at least in the treatment of some infections, it is better to seek the help of a specialist.

Gram-positive aerobes:

• Bacillus anthracis.
• Corynebacterium spp. §
• Enterococcus faecalis. §
• Listeria monocytogenes.
• Streptococcus agalactiae.
• Streptococcus bovis.
• Streptococcus pneumoniae # * 4.6-51.4%.
• Streptococcus pyogenes. # *
• Streptococcus viridans. §

• Bacteroides melaninogenicus. §
• Clostridium spp.
• Fusobacterium spp. §
• Peptostreptococci.

• Microorganisms resistant to amoxicillin
  • Gram-positive aerobes:
    • Staphylococcus (B-lactamase-producing strains).
  • Gram-negative aerobes:
    • Acinetobacter spp.
    • Citrobacter spp.
    • Enterobacter spp.
    • Klebsiella spp.
    • Moraxella catarrholis *.
    • Proteus spp (indol positive).
    • Proteus vulgaris.
    • Providencia spp.
    • Pseudomonas spp.
    • Serratia spp.
  • Anaerobes:
    • Bacteroides fragilis.
  • Other:
    • Chlamydia Mycoplasma.
    • Rickettsia.

A -% of β-lactamase production.

b -% penicillin resistance (including intermediate resistance).

# - To date, there are no reports of the emergence of β-lactazmase-producing strains.

§ - inconsistent sensitivity; sensitivity cannot be predicted without performing sensitivity tests

* - clinical efficacy has been shown for susceptible strains when used as indicated.

Bacteria can be resistant to amoxicillin (and therefore ampicillin) as a result of the production of beta-lactamases that hydrolyze aminopenicillins, changes in penicillin-binding proteins, impaired drug permeability, or due to the functioning of special pump pumps that pump the drug out of the cell. Several resistance mechanisms can be simultaneously present in one microorganism, which explains the existence of variable and unpredictable cross-resistance to other beta-lactams and antibacterial drugs from other groups.

For oral therapy of the following bacterial infections caused by amoxicillin-susceptible gram-positive and gram-negative pathogens:

Upper respiratory tract infections, including ear, nose and throat infections:

Lower respiratory tract infections:

Lower urinary tract infections:.

Gastrointestinal tract infections:. Combination therapy may be required for infections caused by anaerobic microorganisms.

Method of administration and dosage:

Application features:

Side effects:

Interaction with other medicinal products:

Contraindications:

Overdose:

Storage conditions:

Store at a temperature not exceeding 25 ° C. Shelf life is 4 years. Keep out of the reach of children. Do not use after the expiration date.

Vacation conditions:

On prescription

Package:

1 blister contains 12 tablets. In a cardboard box 1 blister.

Dosage form

Coated tablets from white to slightly yellowish, oblong, biconvex, with notches on both sides.

Compound

amoxicillin trihydrate 574 mg,

Which is equivalent to amoxicillin 500 mg

Excipients: magnesium stearate, polyvidone, sodium starch glycolate, microcrystalline cellulose.

Film shell composition: titanium dioxide, talc, hypromellose

Pharmacodynamics

Antibiotic of the group of semi-synthetic penicillins with a broad spectrum of action. It is a 4-hydroxyl analogue of ampicillin. Has a bactericidal effect. Active against aerobic gram-positive bacteria: Staphylococcus spp. (with the exception of strains producing penicillinase), Streptococcus spp; aerobic gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp.

Microorganisms that produce penicillinase are resistant to amoxicillin.

In combination with metronidazole, it is active against Helicobacter pylori. It is believed that amoxicillin inhibits the development of resistance of Helicobacter pylori to metronidazole.

Cross-resistance exists between amoxicillin and ampicillin.

The spectrum of antibacterial action expands with the simultaneous use of amoxicillin and a beta-lactamase inhibitor clavulanic acid. This combination increases the activity of amoxicillin against Bacteroides spp., Legionella spp., Nocardia spp., Pseudomonas (Burkholderia) pseudomallei. However, Pseudomonas aeruginosa, Serratia marcescens, and many other gram-negative bacteria remain resistant.

Pharmacokinetics

When taken orally, amoxicillin is quickly and completely absorbed from the gastrointestinal tract, it is not destroyed in the acidic environment of the stomach. Cmax of amoxicillin in blood plasma is achieved after 1-2 hours. When the dose is doubled, the concentration also doubles. In the presence of food in the stomach, it does not decrease total absorption. With intravenous, intramuscular and intramuscular administration, similar concentrations of amoxicillin are achieved in the blood.

Plasma protein binding of amoxicillin is about 20%.

It is widely distributed in tissues and body fluids. Reported high concentrations of amoxicillin in the liver.

T1 / 2 from plasma is 1-1.5 hours. About 60% of the dose taken orally is excreted unchanged in the urine by glomerular filtration and tubular secretion; at a dose of 250 mg, the concentration of amoxicillin in the urine is more than 300 μg / ml. A certain amount of amoxicillin is determined in the feces.

In newborns and the elderly, T1 / 2 may be longer.

In renal failure, T1 / 2 may be 7-20 hours.

In small amounts, amoxicillin penetrates the BBB during inflammation of the pia mater.

Amoxicillin is removed by hemodialysis.

Side effects

Allergic reactions: urticaria, erythema, Quincke's edema, rhinitis, conjunctivitis; rarely - fever, joint pain, eosinophilia; in isolated cases - anaphylactic shock.

Effects associated with chemotherapeutic action: the development of superinfections is possible (especially in patients with chronic diseases or reduced body resistance).

With prolonged use in high doses: dizziness, ataxia, confusion, depression, peripheral neuropathy, convulsions.

Mainly when used in combination with metronidazole: nausea, vomiting, anorexia, diarrhea, constipation, epigastric pain, glossitis, stomatitis; rarely - hepatitis, pseudomembranous colitis, allergic reactions (urticaria, angioedema), interstitial nephritis, hematopoietic disorders.

Mainly when used in combination with clavulanic acid: cholestatic jaundice, hepatitis; rarely - erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis

Selling features

prescription

Special conditions

Use with caution in patients prone to allergic reactions.

Amoxicillin in combination with metronidazole is not recommended for use in patients under 18 years of age; should not be used for liver diseases.

Alcohol consumption is not recommended against the background of combination therapy with metronidazole.

Indications

For use as monotherapy and in combination with clavulanic acid: infectious and inflammatory diseases caused by sensitive microorganisms, incl. bronchitis, pneumonia, tonsillitis, pyelonephritis, urethritis, gastrointestinal tract infections, gynecological infections, infectious diseases of the skin and soft tissues, listeriosis, leptospirosis, gonorrhea.

For use in combination with metronidazole: chronic gastritis in the acute phase, gastric ulcer and duodenal ulcer in the acute phase, associated with Helicobacter pylori

Contraindications

Infectious mononucleosis, lymphocytic leukemia, severe gastrointestinal infections accompanied by diarrhea or vomiting, respiratory viral infections, allergic diathesis, bronchial asthma, hay fever, hypersensitivity to penicillins and / or cephalosporins.

For use in combination with metronidazole: diseases of the nervous system; hematopoietic disorders, lymphocytic leukemia, infectious mononucleosis; hypersensitivity to nitroimidazole derivatives.

For use in combination with clavulanic acid: a history of indications of liver dysfunction and jaundice associated with taking amoxicillin in combination with clavulanic acid.

Drug interactions

Amoxicillin may decrease the effectiveness of oral contraceptives.

With the simultaneous use of amoxicillin with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin), synergism is manifested; with bacteriostatic antibiotics (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonism.

Amoxicillin enhances the effect of indirect anticoagulants by suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index.

Amoxicillin reduces the effect of drugs, in the process of metabolism of which PABA is formed.

Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs reduce the tubular secretion of amoxicillin, which may be accompanied by an increase in its concentration in the blood plasma.

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce, and ascorbic acid increases the absorption of amoxicillin.

Prices for Amoxicillin Sandoz in other cities

Amoxicillin Sandoz belongs to the drugs of a new generation of antibiotics of the penicillin group. It has a wide spectrum of action and activity in the fight against various coccal flora. It is resistant to acidic environment. This makes it suitable for oral administration. Produced by the Austrian company Sandoz.

Characteristics of the drug

The drug is a partially synthetic aminobenzyl penicillin that dissolves the cell wall of both gram-negative and gram-positive pathogenic microorganisms. The impact on the causative agent of the infection occurs at the stage of proliferation. The antibiotic inhibits the synthesis of the cell membrane, followed by its dissolution and death.

During drug therapy, it is important to take into account the geographical distribution of resistant strains, especially during epidemic outbreaks and with severe pathology. If the use of a medication becomes impractical due to the resistance of microorganisms, it is necessary to seek the help of a specialist. The action of the drug is detrimental to both aerobic and anaerobic flora, including:

• Pneumococci and streptococci.
• Enterococci and corynebacteria are prone to intermittent resistance.
• Listeria and Bovis.
• Anthrax pathogens.
• Cholera vibrios.
• Meningococci and Brucella.
• Shigella and Proteus.
• Salmonella.
• Gonococcal flora.
• Escherichia coli.
• Helicobacter pylori bacteria.
• Peptostreptococci and Clostridia.
• Fusobacteria and bacteroids.

Some pathogens have multiple drug resistance factors, resulting in variable and unpredictable behavior of infectious agents. Sulbactam and clavulanic acid are used to combat beta-lactamase-producing bacteria.

Composition and form of release

The dosage form is presented in the form of oval biconvex tablets, divided in the middle by a notch. The membrane is white or yellowish. Packed in containers made of plastic, metal or foil blisters.

One plate contains from 6 to 12 pills of 1 thousand and 500 milligrams. The capacity contains from one to nine thousand units of half a gram or 1 g of the antibiotic Amoxicillin Sandoz, instructions for use are in a cardboard box along with the drug.

The storage conditions for the medicinal product are to place the package with the medicine in a place protected from sunlight and moisture, inaccessible to babies. The term of use is four years.

The main element in the composition of the medication is amoxicillin trihydrate. Supporting components include:

• Microcrystalline cellulose - an analogue of natural fiber to retain moisture in tablets. Does not enter into a reaction with other components of drugs.
• Magnesium stearate - a combination of magnesium salts and stearic acid is a stabilizer and foam suppressor, helps to obtain a homogeneous mass.
• Sodium starch glycolate is a thickening agent with an oleophobic effect.
• Polyvidone has a detoxifying effect.

The casing contains food coloring titanium dioxide for bleaching. The second component is hypromellose, which has a good lubricating effect.

Pharmacokinetics of the drug

The bioavailability of a drug is in direct proportion to its dose and treatment regimen. With an increase in the dose to 1 thousand milligrams, the absorption of the drug decreases. During oral administration from 500 to three thousand milligrams, the content of the drug in the blood increases from 5 to 25 milligrams per liter. The maximum accumulation in plasma is observed within 1-1.5 hours after taking the medication.

Approximately 20 percent of the drug combines with a protein element, penetrates into mucous membranes and tissues. The drug is capable of overcoming the encephalitis barrier and the placental wall. A small amount passes into breast milk.

Almost all of the drug is excreted by renal tubular secretion five or six hours after administration. A small percentage of the drug is excreted from the body through the biliary tract. With the help of metabolic processes, 20 percent of the drugs become acidic penicillin, belonging to the inactive type.

In case of impaired renal function, the elimination of the medication takes much longer and reaches 21 hours after its introduction into the body. Extrarenal blood cleansing is allowed during treatment.

Compatibility with other medications

The use of Amoxicillin along with some medicines can lead to the development of complications and side effects. These drugs include:

• Vitamin C enhances absorption.

• Allopurinol leads to the development of allergic reactions.
• Aminoglycosides, glucosamine, laxatives and antacids slow down the absorption of the drug.
• Vitamin C enhances absorption.
• Indirect anticoagulants lead to a decrease in the prothrombin index and the synthesis of Vikasol (vitamin K), suppression of the intestinal flora.
• Methotrexate in combination with Amoxicillin becomes more toxic.

The use of Oxyfenbutazone, Allopurinol and diuretics leads to blocking of renal tubular secretion and, accordingly? an increase in the antibiotic content in the body. Taking the drug and contraceptives containing estrogens increases the risk of bleeding and decreases the effectiveness of hormonal contraceptives.

Concomitant treatment with an antibiotic and indirect anticoagulants should be closely monitored for prothrombin time. Interaction with cephalosporins can cause cross-allergic reactions. The use of drugs related to sulfonamides, tetracyclines, macrolides can lead to antagonism between them and the main antibiotic.

During treatment, it is necessary to exclude alcoholic beverages from the diet. When alcohol enters the body, an enzyme is produced in the liver that breaks it down into acetic acid and water to reduce toxic effects. Antibiotics suppress this function, which leads to toxic hepatitis, liver failure, necrotic changes in the tissues of the organ.

Incompatibility with alcohol is a negative effect on other important organs. The consequences of this combination are expressed in allergic reactions up to anaphylactic shock, vomiting, shortness of breath, malaise, increased risk of heart attack and stroke against the background of depression of the central nervous system.

The consumption of alcoholic beverages leads to a decrease in the concentration of the drug in the plasma, an acceleration of its excretion from organs and, as a consequence, the adaptation of pathogenic bacteria to it. In this case, the appointment of a stronger medication will be required.

After a long drinking period, the antibiotic is prescribed by a specialist based on the patient's condition and only after a long rehabilitation. After small doses of alcohol, it is necessary to pass at least a day before starting therapy.

Indications for use

Indications for therapy are infectious and inflammatory pathologies that are caused by microorganisms that are not resistant to antibiotics. These pathologies include:

• Pharyngitis and bronchitis.
• Pneumonia and lung abscess.
• Sinusitis, otitis media and tonsillitis.
• Infectious lesions of the genitourinary system.
• Bacterial infections in the gastrointestinal tract.
• Inflammation of the gallbladder.
• Leptospirosis and borreliosis.

Surgical operations that do not require general anesthesia include preventive measures at the risk of developing complications such as endocarditis. The medication is prescribed one hour before the operation. If necessary, it is used in the postoperative period, six hours after the intervention.

Contraindications and side effects

The main contraindication to the use of an antibiotic is the patient's hypersensitivity to the components of the drug. Before the appointment, you should carefully study the patient's history. Failure to observe precautions can lead to serious complications up to death caused by anaphylactic shock. During treatment, care should be taken if:

• Diathesis of allergic and bronchial asthma.
• Infectious mononucleosis.
• Viral infections.
• Acute lymphoblastic leukemia.
• Renal failure.

The ability of the drug to cross the placental barrier and be excreted in breast milk increases the risk of fungal colonies on the infant's mucous membrane or diarrhea. If it is impossible to cancel the medication, you should refuse to breastfeed.

Side effects are most often manifested in the form of headache, urticaria, nausea and vomiting, and drowsiness. In people with chronic pathologies and weakened immunity, the appearance of superinfection, characterized by vaginal or oral candidiasis, may occur.

Very rarely, taking an antibiotic can be accompanied by nervousness, tremors, irritability, sleep disturbances, depression, hypoglycemia. Serum levels of bilirubin may increase. In the gastrointestinal tract, there is discomfort in the epigastric region, the appearance of flatulence and loose stools. In isolated cases, granulocytopenia, leukopenia, anemia, thrombocytopenia are noted.

The medicine can inhibit psychomotor reactions, cause lethargy and drowsiness. In this regard, it is advisable to exercise caution while driving a car and during work that requires increased attention.

Method of administration and dosage

Therapy of infectious diseases with the drug is carried out by the oral or parenteral method. The introduction of injections is indicated for severe pathology or the impossibility of oral administration of Amoxicillin Sandoz. How to take and in what doses, only the attending physician decides according to the test results and anamnesis.

The course of treatment continues for two or three days after the symptoms of the disease disappear. Treatment of infectious pathologies caused by streptococcus of the beta-hemolytic group requires a ten-day continuous course.

Standard doses for adults and the elderly range from 750 milligrams to 3 grams per day. In the case of an uncomplicated infection, an adult patient may be limited to taking one and a half grams twice a day.

Patients with severe renal failure require dose adjustments based on renal clearance. At a blood flow rate of 30 milliliters per minute, the dosage decreases, and the interval between doses of the drug increases. With a clearance of 10 ml per minute, 500 milligrams are required once a day. Patients who are on extrarenal blood purification are prescribed 0.5 grams after hemodialysis.

V childhood the dosage of Amoxicillin sandoz 1 g is calculated in accordance with the weight of the child from 25 to 50 milligrams per 1 kilogram of weight and is divided into several times a day. If the disease is severe, the dose is increased to a maximum of 60 milligrams. For adolescents weighing more than 40 kilograms, adult therapy is prescribed.

A drug overdose is characterized by nausea, crystalluria, diarrhea, and nephrotoxicity. Treatment is symptomatic - with activated charcoal, gastric lavage and hemodialysis.

Pharmacological analogues

Preparations similar to Amoxicillin Sandoz, produced by both Russian and foreign manufacturers, contain the same components and have a similar effect.

Amosin is a domestic drug produced in granular, powdery and liquid form. Solutions are administered both intravenously and intramuscularly. Suspensions are prescribed for the treatment of children. When taken in large doses, it is concentrated in the gallbladder and liver. It has a high acid resistance, so it can be taken both before meals and after meals. Not recommended for children under three years of age. This is one of the cheapest substitutes for Amoxicillin, its average cost is from 26 to 54 rubles.

Ekobol has a tablet dosage form. Indications for admission are similar to the main medication, which is the main component in the composition of the product. It helps well with colitis resulting from antibiotic therapy. Long-term treatment requires monitoring of the patient's condition.

Patients with a history of bacteremia may develop endotoxic shock. The advantage of the drug is the presence of lactulose in the composition, which promotes the growth of beneficial flora, preventing the development of dysbiosis. Prices vary depending on the area and the dosage of tablets and are 50-125 in rubles.

Ospamox is a 4-hydroxyl base agent substitute. It is presented in the form of a powder, from which a suspension is prepared. Contains fruit flavors, anhydrous citric acid, trisodium citrate and precipitated silicon dioxide. For the treatment of exacerbations of gastrointestinal ulcers and chronic gastritis, the combined use of Ospamox and Metronidazole is shown. If the patient has liver disease, then such therapy is contraindicated. The minimum price is 145 rubles.

Flemoxin Solutab is presented in the form of dispersible oval tablets with the manufacturer's logo on one side and separating strips on the back. An advantage is considered the possibility of use in such a medical industry as pediatrics. Produced by the Dutch company "Astellas". The cost of tablets of 0.25 and 0.5 grams is from 300 to 400 rubles, respectively.

Amoxiclav - tablets with two different dosages of 500 and 125 milligrams, which allows you to regulate its intake according to therapeutic indications. The drug can be used in combination with other antibiotics belonging to different groups. The cost varies from 200 to 450 rubles.

Amoxicar is used to destroy staphylococcal and other pathogenic flora in children and adults. Suspensions are prescribed in childhood from birth to 12 years, and capsules and tablets for adolescents and adult patients.

Rapiklav is an Indian antibiotic containing potassium salt. It is used for the treatment of salpingitis, osteomyelitis, sinusitis, and also helps with purulent wounds and phlegmon. Due to its low toxicity, it is well tolerated by patients.

Augmentin - a drug based on clavulanic acid and Amoxicillin is used during lactation in the absence of such reactions in the child as diarrhea, conjunctivitis and candidiasis of the mucous membranes.

Clonacom X is a combination drug with Cloxacilin. Use for sexually transmitted diseases - gonorrhea, syphilis in the primary and secondary phases - is carried out along with monthly serological tests for four months.

Amoxicillin is the main component of all similar drugs. The difference between the medicine Amoxicillin Sandoz and Amoxicillin lies in the number of additional auxiliary elements in the composition of the latter. Besides, medicines are produced by different manufacturers and may differ in cost. For Amoxicillin Sandoz 1 g, the price ranges from 120 to 150 rubles. Amoxicillin costs 53 rubles per pack.

According to the reviews of patients and doctors, the antibiotic has proved to be an effective remedy in the fight against various ailments. In some cases, complete recovery is noted after antibiotic therapy. Affordable cost makes the drug popular with buyers.

I prescribe the penicillin antibiotic Amoxicillin Sandoz for staphylococcal, streptococcal and other infections. Shows good results in the treatment of sinusitis, tonsillitis, otitis media. The tablets are inexpensive, the suspension for children, which you have to prepare yourself, is a little more expensive. If the disease is treated in a timely manner, the drug copes well with pathologies.

Physician Nadezhda

The effectiveness of the drug has been proven in practice. Like other similar drugs, there are side effects and contraindications. It is known that antibiotics are harmful to beneficial microflora, therefore, before treatment, you need to take care of purchasing drugs that prevent its destruction. For the rest, it is a good remedy.

Doctor Nikolay

She was treated with Ampicillin for a long time, but there was no effect. The doctor advised to buy Amoxicillin. Thanks to him, she got rid of bronchitis and sinusitis. To avoid dysbiosis, I take prebiotics. I have never had any side effects, so I prefer to take this proven remedy.

Svetlana

Since childhood, my daughter's lymph nodes in the neck have become inflamed. With the help of the drug, it is possible not to bring the disease to complications. Symptoms disappear after three days. We continue the treatment for 10 days so that the microbes die completely. In parallel, we take various drinks with bifidobacteria. The whole family is treated with this antibiotic if necessary.

Amoxicillin Sandoz is a penicillin antibacterial agent. "Popularly about health" will present to your attention instructions for the use of the drug in tablets. How to take Amoxicillin Sandoz for adults, to whom it is contraindicated and from what it helps, you will learn from this article.

Composition of tablets

The active ingredient of the drug Amoxicillin Sandoz is amoxicillin trihydrate (0.574 grams), which is equivalent to amoxicillin at a dosage of 500 mg. Additives act as auxiliary substances - cellulose in microcrystals, magnesium stearate, polyvidone and other substances.

How Amoxicillin Sandoz works?

The active substance has a detrimental effect on various types of gram-positive and gram-negative bacteria, as well as on some anaerobic bacteria. The exception is pathogens that are able to synthesize the enzyme penicillinase. It protects the membranes of microorganisms from antibiotic action.

Amoxicillin sinks through the cell membranes of pathogenic bacteria, disrupting their integrity. As a result, they die. What microorganisms are affected by the active substance of the drug?

1. Some types of staphylococci.
2. Streptococci, including those that cause pneumonia.
3. Enterococci (with the exception of resistant strains).
4. Salmonella.
5. Treponema.
6. Chlamydia.
7. Helicobacter Hillary et al.

So, you have learned how the drug works and what bacteria it affects, and now let's consider what are the indications for its use.

Antibiotic indications

The indications for Amoxicillin Sandoz are the following diseases:

Respiratory system caused by active reproduction of bacteria resistant to Amoxicillin - tonsillitis, bronchitis, pneumonia.
ENT organs, for example, otitis media, sinusitis, sinusitis, laryngitis.
Genitourinary system - bacterial prostatitis, pyelonephritis, cystitis, endometritis, urethritis.
Bowel and gallbladder infections such as cholecystitis or cholangitis.
Skin bacterial infectious diseases, etc.
Peptic ulcer, gastritis, provoked by Helicobacter Hillary. In this case, therapy is also carried out with the drug Metronidazole.
Gonorrhea.

Antibiotic contraindications

Among the contraindications to Amoxicillin, Sandoz, the manufacturer especially emphasizes hypersensitivity or intolerance to penicillins. Children under five years of age are not prescribed the drug in the form of tablets; Amoxicillin granules are produced for them, from which a suspension is prepared.

Patients diagnosed with serious kidney problems should only take this drug with the permission of a doctor with caution. The same recommendation applies to people with asthma, as well as those with diarrhea or viral infections.

Pregnancy is not a contraindication for the use of Amoxicillin Sandoz, if necessary. But the doctor must sensibly assess what benefits the treatment will bring to the mother and what possible harm the developing fetus in the womb will receive. It is recommended for lactating women to stop breastfeeding during antibiotic therapy with this drug, since the active substance in small doses penetrates into milk.

How to take Amoxicillin Sandoz tablets for adults?

The medicine is taken orally with water. The absorption of active substances does not depend on food intake. It is recommended to continue therapy for about three more days after the complete disappearance of the symptoms of the disease in order to increase its effectiveness. Diseases caused by beta-hemolytic streptococci are treated for at least 10 days. It is important to note that with prolonged use of an antibiotic, antifungal agents should be prescribed in parallel with it. This is due to a violation of the microflora in the body, as a result of which the patient may develop fungal infections. In this case, along with Amoxicillin, the patient should take Nystatin or its analogue Levorin.

The dosage of Amoxicillin Sandoz for adults can range from 750 mg of active substance to 1500 mg per day. It is recommended to divide this dose into 3 doses with equal time intervals. More precisely, the dose is determined by the doctor, taking into account the severity of the course of the disease, the patient's weight, and also the anamnesis.

Children over 12 years of age weighing more than 40 kilograms are considered adults. Children under this age and with less body weight should be prescribed a dose of the drug, which is calculated based on their weight (from 25 to 50 mg of active substance per kilogram of body weight).

For patients with renal insufficiency, the dosage of the antibiotic is prescribed individually - the doctor takes into account the level of creatinine in the patient's blood.

Before starting antibiotic therapy, the doctor must determine whether the patient's pathogen is susceptible to Amoxicillin Sandoz.

Instruction Amoxicillin Sandoz defines the drug as an effective antibiotic for the treatment of infections caused by bacteria that are not resistant to it. Instructions for use for this medication are rather complicated for an ordinary user who does not have medical education. In this regard, you should not self-medicate - only a doctor is able to determine which bacteria are sensitive to an antibiotic and which are not.

Registration number: LP-002797-270515
Tradename: Escitalopram Sandoz®.
International patented name: escitalopram.
Dosage form: film-coated tablets.

Compound:
active substance: escitalopram oxalate - 6.39 / 12.77 / 19.16 / 25.54 mg (in terms of escitalopram - 5.00 / 10.00 / 15.00 / 20.00 mg); Excipients: lactose monohydrate - 68.49 mg / 91.23 mg / 136.85 mg / 182.46 mg; microcrystalline cellulose - 6.93 mg / 9.63 mg / 14.44 mg / 19.25 mg; croscarmellose sodium - 4.50 mg / 6.25 mg / 9.38 mg / 12.50 mg; hypromellose - 1.44 mg / 2.00 mg / 3.00 mg / 4.00 mg; magnesium stearate - 1.35 mg / 1.88 mg / 2.81 mg / 3.75 mg; colloidal silicon dioxide - 0.90 mg / 1.25 mg / 1.88 mg / 2.50 mg; shell: hypromellose - 2.07 mg / 3.45 mg / 4.49 mg / 4.83 mg; macrogol 6000 - 0.51 mg / 0 85 mg / 1.11 mg / 1.19 mg; titanium dioxide (E 171) - 0.27 mg / 0 45 mg / 0.59 mg / 0.63 mg; talc - 0.15 mg / 0.25 mg / 0.33 mg / 0.35 mg.
1 - removed during production

Description:
5 mg tablets: round biconvex film-coated tablets, white or almost white.
10 mg tablets: oval biconvex film-coated tablets, white or off-white, with a scored on one side. In cross section, the core of the tablet is white or almost white.
15 mg tablets: oval biconvex film-coated tablets, white or off-white, with two notches on each side. In cross section, the core of the tablet is white or almost white.
Tablets 20 mg: round biconvex film-coated tablets, white or almost white, with a cross-shaped line on each side. In cross section, the core of the tablet is white or almost white.

Pharmacotherapeutic group: antidepressant.

ATX code: N06AB10.

Pharmacological properties

Escitalopram is a selective serotonin (5-HT) reuptake inhibitor with high affinity for the primary active center. It is also associated with an allosteric center on the serotonin transporter with an affinity 1000 times lower.
Escitalopram has no or low affinity for a number of receptors, including 5-HT1A, 5-HT2, DA D1 and D2, α1-, α2-, β-adrenergic receptors, histamine H1, cholinergic muscarin, benzodiazepine, and opioid receptors.
Inhibition of 5-HT reuptake is the only possible mechanism of action that explains the pharmacological and clinical effects of escitalopram.

Severe depressive episodes
Escitalopram was found to be effective in the acute management of severe depressive episodes in three out of four double-blind, placebo-controlled, short-term (8-week) studies. In a long-term relapse prevention study, 274 patients who completed the initial 8-week open-label trial and took escitalopram 10 or 20 mg per day were randomized to receive escitalopram at the same dosage or placebo for a maximum of 36 weeks. Throughout this study, patients who continued to take escitalopram did not experience relapse for a longer period of time over the next 36 weeks compared to those who took placebo.
Social phobia
Escitalopram has been shown to be effective in both three short-term (12-week) studies and 6-month studies to prevent relapse in patients with social phobia. During a 24-week dose selection study, escitalopram was shown to be effective at doses of 5, 10 and 20 mg.
Generalized anxiety disorder
Escitalopram 10 and 20 mg daily has been shown to be effective in four of four placebo-controlled studies.
The pooled analysis of data from three similar studies, including 421 patients taking escitalopram and 419 patients taking placebo, included 47.5% and 28.9% of patients in whom treatment achieved the goal, respectively, and 37.1% and 20.8% of patients whose disease went into remission. A sustained effect was observed starting from 1 week.
Maintenance of the efficacy of escitalopram 20 mg per day was demonstrated in a 24-76-week, randomized, treatment-efficacy study in 373 patients who improved during the initial 12-week open-label study.
Obsessive compulsive disorder
In a randomized, double-blind clinical trial, the effect of escitalopram 20 mg daily was compared to placebo based on Yale-Brown obsessive-compulsive scores at 12 weeks. After 24 weeks, escitalopram at 10 and 20 mg per day showed better results than placebo.
Relapse prevention has been demonstrated with escitalopram 10 and 20 mg per day in patients treated with escitalopram in a 16-week open-label trial who participated in a 24-week, randomized, double-blind, placebo-controlled trial.
During a double-blind, placebo-controlled ECG study conducted in healthy patients, the difference between the QT and the isoline (correction according to the Fridericia formula) was 4.3 msec, (90% CI: 2.2, 6.4) at a dosage of 10 mg per day and 10, 7 msec. (90% CI: 8.6, 12.8) at 30 mg daily.

Suction
The drug is absorbed almost completely and does not depend on food intake (the average time to reach the maximum concentration (average Tmax) is 4 hours after taking in various dosages). As with racemic citalopram, the absolute bioavailability of escitalopram is assumed to be about 80%.
Distribution
The estimated level of distribution (Vd, β / F) after oral administration is 12 to 26 l / kg. Plasma protein binding does not exceed 80% for escitalopram and its main metabolites.
Metabolism
Escitalopram is metabolized in the liver to demethylated and didemethylated metabolites. Both substances are pharmacologically active. Alternatively, nitrogen is oxidized and forms an N-oxide metabolite. Both the parent substance and metabolites are partially excreted as glucuronides. After taking different dosages, the average concentration of demethylated and didemethylated metabolites, as a rule, is 28-31% and Withdrawal
The half-life (T1 / 2) after taking various dosages is approximately 30 hours, the plasma clearance (Cloral) when taken orally is approximately 0.6 l / min. T1 / 2 of the main metabolites is much longer. Escitalopram and the main metabolites are excreted mainly through the liver (by metabolism) and the kidneys, while the bulk of the dose is excreted as metabolites by the kidneys.
Pharmacokinetics is linear. A stable plasma level of the drug is reached after approximately 1 week. An average equilibrium concentration of 50 nmol / L (ranging from 20 to 125 nmol / L) is achieved with a daily dosage of 10 mg.
Elderly patients (> 65 years)
In elderly patients, escitalopram is excreted more slowly than in younger patients. The systemic exposure (AUC) in elderly patients is approximately 50% higher than in younger patients.
Patients with impaired liver function
In patients with mild to moderate hepatic impairment (mild or chronic alcoholic liver damage), escitalopram T1 / 2 was approximately twice as long and the exposure was approximately 60% higher than in subjects with normal liver function.
Patients with impaired renal function
In the case of racemic citalopram, patients with impaired renal function (creatinine clearance (CC) 10-53 ml / min) have a longer T1 / 2 and a slight increase in exposure. Plasma concentrations of metabolites have not been studied, but they can be increased.
Polymorphism
It was found that slow metabolizers of CYP2C19 demonstrate a twice higher concentration of escitalopram in blood plasma compared to rapid metabolizers. The slow metabolizers of CYP2D6 did not show significant differences in exposure.

Indications for use

Depressive disorders;
panic disorder with / without agoraphobia;
social anxiety disorder (social phobia);
generalized anxiety disorder;

Contraindications

Hypersensitivity to escitalopram or other components of the drug;
concomitant use with monoamine oxidase (MAO), monoamine oxidase-A (MAO-A) inhibitors (for example, moclobemide) or reversible non-selective MAO inhibitors;
patients with prolonged QT interval (congenital long QT interval syndrome); concomitant use of drugs that can lengthen the QT interval (for example, class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides);
pregnancy;
breastfeeding period;
children under 18 years of age;
lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully

Renal failure (CC less than 30 ml / min), manic disorders (including history), pharmacologically uncontrolled epilepsy, depression with suicidal attempts, diabetes mellitus, electroconvulsive therapy; old age (over 65 years), cirrhosis of the liver, a tendency to bleeding, simultaneous administration with drugs that lower the threshold of convulsive readiness, lithium, tryptophan, drugs containing St. John's wort; with drugs that cause hyponatremia, anticoagulants for oral administration and drugs that affect blood clotting; with drugs metabolized with the participation of the CYP2C19 system, ethanol.

Method of administration and dosage

Inside, 1 time per day, regardless of food intake.
The maximum daily dose is 20 mg.
Depressive disorders
The usual dose is 10 mg / day. Depending on the patient's clinical condition, the dose may be increased to a maximum of 20 mg / day.
The antidepressant effect usually develops 2-4 weeks after starting treatment. After the disappearance of the symptoms of depression for at least another 6 months, it is necessary to continue therapy to consolidate the effect obtained.
Panic disorder with / without agoraphobia
The recommended starting dose for the first week of therapy is 5 mg, with a subsequent increase to 10 mg / day. Depending on the patient's clinical condition, the dose may be increased to a maximum of 20 mg / day. The maximum clinical effect is achieved 3 months after the start of therapy. The treatment continues for several months.
Social Anxiety Disorder (Social Phobia)
Usually 10 mg is prescribed once a day. Relief of symptoms usually develops 2–4 weeks after starting treatment. Depending on the patient's clinical condition, the dose of the drug can subsequently be reduced to 5 mg / day or increased to a maximum of 20 mg / day. Since social anxiety disorder is a chronic disease, the minimum recommended course of treatment is 12 weeks. To prevent recurrence of the disease, the drug can be prescribed for 6 months or longer, depending on the clinical condition of the patient. It is recommended that you regularly evaluate your treatment.
Generalized Anxiety Disorder.
The recommended starting dose is 10 mg / day. Depending on the patient's clinical condition, the dose may be increased to a maximum of 20 mg / day. Long-term administration of the drug (6 months or longer) at a dose of 20 mg / day is allowed.
Elderly patients (over 65 years old)
The starting dose is half the recommended dose (5 mg). Depending on the patient's clinical condition, the dose of the drug may be increased to 10 mg / day.
Patients with renal impairment
No dose adjustment is required for mild to moderate renal impairment. When creatinine clearance is less than 30 ml / min, the drug should be used with caution under the supervision of a physician.
Patients with hepatic impairment
For patients with mild to moderate hepatic impairment (Child-Pugh class A or B), the starting dose for the first two weeks is 5 mg / day. Depending on the patient's clinical condition, the dose may be increased to 10 mg / day. In severe liver failure (class C on the Child-Pugh scale), the drug is prescribed under the close supervision of a physician.
CYP2C19 isoenzyme deficiency
For patients with CYP2C19 deficiency, the starting dose for the first 2 weeks is 5 mg / day. Depending on the patient's clinical condition, the dose may be increased to 10 mg / day.
Cancellation of the drug
Abrupt withdrawal of the drug should be avoided. Upon termination of treatment with escitalopram, the dose of the drug should be gradually reduced at intervals of 1-2 weeks in order to reduce the risk of developing a withdrawal syndrome.
In case of intolerance to dose reduction, it is possible to resume taking the drug in the same dose or to reduce the dose with a long interval.

Application during pregnancy and during breastfeeding

Application during pregnancy
The use of the drug during pregnancy is contraindicated due to the lack of clinical data on efficacy and safety.
There are limited data on the use of escitalopram during pregnancy. During reproductive toxicity studies of escitalopram in rats, embryophetotoxicity was observed, but an increase in the number of congenital defects was not found. If escitalopram was continued late in pregnancy, especially in the third trimester, the newborn should be monitored. If escitalopram continued until delivery or was stopped shortly before delivery, the newborn may develop withdrawal symptoms. If the mother uses selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors (SSRIs / SNRIs) in late pregnancy, the newborn may develop the following side effects: persistent pulmonary hypertension, respiratory depression, cyanosis, apnea, seizures , difficulties with feeding, vomiting, hypoglycemia, hypertension, muscle hypotension, hyperreflexia, tremor, increased neuro-reflex irritability, irritability, lethargic sleep, constant crying, drowsiness, poor sleep. These symptoms can occur due to the development of a withdrawal syndrome or serotonergic action. In most cases, these complications occur within 24 hours after birth.
The use of SSRIs / SNRIs in late pregnancy also increases the risk of developing persistent pulmonary hypertension in newborns with a frequency of up to 5 cases per 1000 and a frequency of 1-2 per 1000 in the general population.
Application during breastfeeding
The drug is excreted in small amounts into breast milk, therefore, when taking the drug during lactation, it is recommended to decide on the termination of breastfeeding.
Fertility
Animal studies have shown that citalopram can affect sperm quality. Medical cases involving the use of SSRIs have shown that the effects on sperm quality are reversible. Until now, no effect on human fertility has been found.

Side effect

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often (> 1/10), often (> 1/100, 1/1000, 1/10000,

1 There have been reports of cases of suicidal ideation and suicidal behavior while taking escitalopram or immediately after stopping treatment.
2 These events have been reported for the treatment class of SSRIs.

In epidemiological studies with patients aged 50 years or more, an increased risk of bone fractures has been reported in patients receiving SSRIs and tricyclic antidepressants. The mechanism leading to this risk is unknown.

Discontinuation of SSRIs / SNRIs (especially abrupt), as a rule, leads to withdrawal symptoms. The most common reactions are dizziness, sensory disturbances (including paresthesia and electric shock sensations), sleep disturbances (including insomnia and vivid dreams), agitation or anxiety, nausea and / or vomiting, tremors, confusion, sweating, headache, diarrhea, heart palpitations, emotional instability, irritability, and visual disturbances. As a rule, these phenomena are mild to moderate in severity and go away on their own, but in some patients they can be severe and lasting. Thus, when the need for escitalopram treatment disappears, it is recommended to cancel the drug by gradually reducing the dose.

Cases of prolongation of the QT interval and ventricular arrhythmias, including ventricular tachycardia of the "pirouette" type, have been reported, predominantly in female patients, with hypokalemia or pre-existing prolongation of the QT interval or other cardiovascular diseases.

Overdose

Toxicity
Clinical data on escitalopram overdose are limited, and many cases involve concurrent overdose of other drugs. In most cases, symptoms are mild or absent. Fatalities resulting from an overdose of escitalopram alone have been reported rarely; in general, there is also an overdose of concomitant medications. Doses of 400 and 800 mg of escitalopram without other drugs are tolerated without any serious symptoms.
Symptoms: overdose of the drug develops dizziness, tremor, agitation, nausea, vomiting, arterial hypotension, tachycardia, prolongation of the QT interval, hypokalemia, hyponatremia, in rare cases - serotonin syndrome, cardiac arrhythmias, convulsions and coma.
Treatment: the specific antidote is unknown. Symptomatic treatment: ensuring a constant supply of fresh air, supporting the function of external respiration, adequate oxygenation, monitoring cardiac activity, gastric lavage, prescribing enterosorbents. Forced diuresis, hemodialysis, hemoperfusion are not effective.

Interaction with other medicinal products

Pharmacodynamic interactions
Contraindicated combinations:
Irreversible non-selective MAO inhibitors
Cases of serious adverse reactions have been reported in patients receiving combination therapy with SSRIs and as well as patients who have recently discontinued SSRI therapy and started therapy with such MAO inhibitors. In some cases, patients have developed serotonin syndrome. Escitalopram can be prescribed 14 days after stopping treatment irreversible non-selective MAO inhibitors... At least 7 days must elapse after the end of escitalopram before treatment with irreversible non-selective MAO inhibitors can be started.
Reversible Selective MAO Inhibitors Type A (Moclobemide)
Due to the risk of developing serotonin syndrome, the combined use of escitalopram with reversible selective MAO inhibitors, such as moclobemide, is contraindicated. If there is a justified need for the use of such a combination, treatment should be started with the minimum recommended dose under close clinical supervision.
Reversible non-selective MAO inhibitors (linezolid)
Antibiotic linezolid is reversible non-selective MAO inhibitor and should not be used in patients receiving escitalopram therapy. If there is a justified need for the use of such a combination, treatment should be started with the lowest doses under close clinical supervision.
Irreversible selective MAO inhibitors type B (selegiline)
Caution is necessary in the case of joint use of escitalopram and irreversible selective MAO inhibitor type B selegiline due to the risk of developing serotonin syndrome. Selegiline in doses up to 10 mg per day has been successfully used in conjunction with racemated citalopram.
Prolongation of the QT interval
Pharmacokinetic and pharmacodynamic studies of escitalopram in combination with other drugs that prolong the QT interval have not been conducted. The additive effect of escitalopram and these drugs cannot be ruled out. Thus, the simultaneous administration of escitalopram with medications that prolong the QT interval, such as Class IA and III antiarrhythmics, antipsychotics (eg phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (eg antimalarial drugs, especially halofantrine), some antihistamines (astemizole, mizolastine), is contraindicated.

Medicines that lower the seizure threshold
Escitalopram may lower the seizure threshold. Care must be taken with the simultaneous use of escitalopram and other drugs that lower the threshold of convulsive readiness ( tricyclic antidepressants, SSRIs, neuroleptics - derivatives of phenothiazine, thioxanthene and butyrophenone, mefloquine and tramadol).
With simultaneous use lithium and tryptophan preparations cases of intensification of the action of escitalopram have been recorded.
Simultaneous use with St. John's wort preparations(Hypericum perforatum) may increase the number of side effects.

With the simultaneous use of anticoagulants and other drugs that affect blood clotting (for example, atypical antipsychotics and phenothiazine derivatives, tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs, ticlopidine, dipyridamole) a blood clotting disorder may occur.
Escitalopram does not enter with ethanol a pharmacodynamic or pharmacokinetic interaction. However, as with other psychotropic drugs, the simultaneous use of escitalopram and alcohol is not recommended.
Pharmacokinetic interactions

Escitalopram is metabolized mainly by the CYP2C19 enzyme. CYP3A4 and CYP2D6 may also be involved in metabolism, albeit to a lesser extent. Metabolism of the main metabolite, S-DCT (demethylated escitalopram), is partially catalyzed by CYP2D6.
omeprazole 30 mg once a day (a CYP2C19 inhibitor) resulted in a moderate (approximately 50%) increase in plasma concentrations of escitalopram.
Simultaneous administration of escitalopram and cimetidine 400 mg 2 times a day (a general enzyme inhibitor of medium strength) resulted in a moderate (approximately 70%) increase in the plasma concentration of escitalopram. Escitalopram must be combined with caution with cimetidine... Dose adjustment is recommended.
Thus, the drug must be combined with caution with CYP2C19 inhibitors (such as omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine... After monitoring the side effects caused by the simultaneous use of other drugs, it may be necessary to reduce the dose of escitalopram.

Escitalopram is an inhibitor of the CYP2D6 enzyme. Care must be taken with the simultaneous use of escitalopram and drugs with a narrow therapeutic range, which are mainly metabolized by this enzyme, for example flecainide, propafenone and metoprolol(for use in heart failure), or certain CNS drugs that are primarily metabolized by CYP2D6, such as antidepressants such as desipramine, clomipramine, and nortriptyline, or antipsychotics such as risperidone, thioridazine, and haloperidol... Dose adjustment may be advised.
Simultaneous administration of the drug with desipramine or metoprolol led to a twofold increase in the concentration of these CYP2D6 substrates in blood plasma.
In vitro studies have shown that escitalopram may also be a weak inhibitor of CYP2C19. It is recommended to use the drug with caution in conjunction with drugs metabolized by CYP2C19.

special instructions

Application with MAO inhibitors
Escitalopram should not be administered concurrently with MAO inhibitors due to the risk of developing serotonin syndrome. Escitalopram can be prescribed 14 days after stopping treatment with irreversible MAO inhibitors and at least 1 day after stopping treatment with reversible MAO inhibitors type A (moclobemide).
At least 7 days must elapse after the end of escitalopram before treatment with non-selective MAO inhibitors can be started.
The use of the drug in children and adolescents under the age of 18
Antidepressants are contraindicated in children and adolescents under the age of 18 because of the increased risk of suicidal behavior (attempts at suicide and suicidal thoughts), hostility (with a predominance of aggressive behavior, tendency to confrontation and irritation). In young people under 25 with depression and other mental health problems, antidepressants increase the risk of suicidal ideation and suicidal behavior compared to placebo. Therefore, when prescribing the drug and with any other antidepressants, young people under 25 years old should correlate the risk of suicide and the benefits of their use. If a decision is made to start antidepressant therapy, the patient should be closely monitored for early detection of violations or changes in behavior, as well as suicidal tendencies.
Paradoxical anxiety
When using drugs belonging to the therapeutic group of SSRIs, including escitalopram, it should be borne in mind that in some patients with panic disorder at the beginning of treatment with SSRIs, an increase in anxiety may be observed. This paradoxical reaction usually disappears within the first two weeks of treatment. Low starting doses are recommended to reduce the likelihood of an anxiogenic effect.
Epileptic seizures
Acceptance of escitalopram should be discontinued if the patient first has an epileptic seizure or more frequent seizures (in patients with a history of epilepsy).
SSRIs should be avoided in patients with unstable epilepsy, and patients with controlled epilepsy should be closely monitored.
Mania
Escitalopram is recommended to be used with caution in patients with a history of mania, hypomania. With the development of a manic state, escitalopram should be canceled.
Diabetes
In patients with diabetes mellitus, treatment with escitalopram may alter plasma glucose levels. Therefore, dose adjustment of insulin and / or oral hypoglycemic drugs may be required.
Suicide / suicidal ideation or clinical worsening of depressive conditions
Careful monitoring of patients taking antidepressants is necessary, especially at the beginning of therapy, due to the possibility of clinical deterioration and / or the appearance of suicidal thoughts and behavior. Clinical experience shows that an increased risk of suicide is usually observed in the early stages of recovery.
Other mental disorders for which escitalopram is prescribed may also be associated with an increased risk of suicidal behavior and manifestations. In addition, these diseases can accompany severe depressive disorder. Precautions for treating patients with severe depressive disorder also need to be followed when treating patients with other psychiatric disorders.
It is known that patients with a history of suicidal activity and manifestations, or those who showed suicidal tendencies before treatment, are at greater risk of suicidal intentions or attempts, therefore, they should be closely monitored during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressants in adults with mental disorders showed an increased risk of suicidal behavior with antidepressants compared with placebo in patients less than 25 years of age. Careful observation of patients, in particular those at high risk, should accompany drug therapy, especially at the beginning of treatment and after dose changes.
Patients and caregivers should be warned to monitor for any clinical deterioration, suicidal behavior or intentions, or unusual behavioral changes, and seek immediate medical attention if they notice such symptoms.
Akathisia / psychomotor agitation
The use of SSRIs has been associated with the development of akathisia, a condition characterized by an unpleasant, debilitating feeling of anxiety and hyperactivity and is often accompanied by an inability to sit or stand still. This condition most likely occurs during the first few weeks of therapy. Increasing the dose can harm patients who experience these symptoms.
Hyponatremia
While taking the drug, hyponatremia occurs, possibly associated with a violation of the secretion of antidiuretic hormone (ADH). Usually disappears when therapy is canceled.
Care must be taken when prescribing the drug to patients with a history or those at risk of developing hyponatremia: the elderly, patients with liver cirrhosis.
Bleeding
While taking escitalopram, skin hemorrhages (ecchymosis and purpura) may develop. It is necessary to use the drug with caution in patients at risk of bleeding, as well as taking oral anticoagulants and drugs that affect blood clotting.
Electroconvulsive therapy
Caution must be exercised with the simultaneous use of the drug and electroconvulsive therapy (ECT) due to limited experience.
Serotonin Syndrome
In patients taking escitalopram and other SSRIs concurrently with serotonergic drugs, in rare cases, serotonin syndrome may develop. The development of this disease may be evidenced by a combination of symptoms such as agitation, tremor, myoclonus and hyperthermia. In this situation, you should immediately stop taking SSRIs and a serotonergic drug and begin symptomatic treatment.
Withdrawal symptom after stopping treatment
Withdrawal symptoms when treatment is discontinued are common, especially if treatment is discontinued abruptly. In clinical studies, discontinuation adverse events were observed in approximately 25% of patients receiving escitalopram and 15% of patients taking placebo.
The risk of discontinuation of treatment may depend on several factors, including the duration, the dose during treatment, and the rate of dose reduction. The most commonly observed reactions are dizziness, sensory disturbances (including paresthesia and sensations of electric shock), sleep disturbances (including insomnia and vivid dreams), agitation or anxiety, nausea and / or vomiting, tremors, confusion, sweating, headache, diarrhea, heart palpitations, emotional instability, irritability and visual disturbances. These symptoms are usually mild to moderate in severity, but in some patients they can be severe.
They usually occur within the first few days after discontinuation of treatment, with similar symptoms being reported much less frequently in patients who accidentally miss a dose.
These symptoms are usually self-limiting and usually resolve within 2 weeks, although some people may have them for longer (2-3 months or more). Therefore, it is recommended to gradually reduce the dose of escitalopram after discontinuation of treatment for several weeks or months, depending on the needs of the patient.
Cardiac ischemia
Due to the limited experience of use, care must be taken when using the drug in patients with ischemic disease heart (ischemic heart disease).
Cases of prolongation of the QT interval
It was found that escitalopram causes a dose-dependent lengthening of the QT interval. Cases of prolongation of the QT interval and ventricular arrhythmias, including bidirectional tachycardia, have been reported during the post-registration period, mainly in female patients with hypokalemia, or with pre-existing prolongation of the QT interval or other cardiovascular diseases.
It is recommended to exercise caution when recommending the drug to patients with severe bradycardia, patients after recent acute myocardial infarction or with uncompensated heart failure.
Electrolyte disturbances such as hypokalemia and hypomagnesemia increase the risk of dangerous arrhythmias, and these diseases should be corrected before escitalopram is prescribed.
If the drug is prescribed to patients with persistent heart disease, an ECG should be done before starting treatment.
If signs of cardiac arrhythmia appear during treatment with escitalopram, the treatment should be discontinued and an ECG performed.
Escitalopram does not enter into pharmacodynamic or pharmacokinetic interactions with alcohol. However, as with other psychotropic drugs, the simultaneous use of escitalopram and alcohol is not recommended.
The medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, congenital lactase deficiency or malabsorption of glucose-galactose should not take escitalopram.

Influence on the ability to drive vehicles, mechanisms

During the period of use of escitalopram, one should refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form
Film-coated tablets 5 mg, 10 mg, 15 mg, 20 mg.
10 tablets in Al / Al blister.
1, 2, 3, 6 or 9 blisters in a cardboard box together with instructions for use.

Storage conditions
At a temperature not higher than 25 ° C.
Keep out of the reach of children.

Best before date
2 years
Do not use after the expiration date printed on the package.

Vacation conditions
On prescription.

Manufacturer

Sandoz dd, Verovshkova 57, 1000 Ljubljana, Slovenia;
Sandoz Private Limited, plots No. 8-A / 2 and 8-B, TTK industrial zone (Trans Thane Creek), Kalwe quarter, Dighe village, Navi Mumbai, Thane 400708, Maharashtra state, India.

Latin name: Amoxicillin Sandoz
ATX code: J01CA04
Active substance: amoxicillin trihydrate
Manufacturer: Sandoz Gmbh, Germany
Condition for dispensing from the pharmacy: On prescription

Amoxicillin Sandoz is a partially synthetic antibiotic of the penicillin group with bactericidal properties. Affects the pathogen in the polyferation phase. Has a wide range of effects on most cocci, gram-positive and negative types. The drug is resistant to acidic environment. With regard to resistant strains, they are guided by the territorial information on the spread of the virus, especially in severe diseases.

Indications

Amoxicillin Sandoz is prescribed to combat susceptible pathogens that cause the following pathologies:

• Acute and chronic respiratory infections: tonsillitis, abscess and pneumonia, pharyngitis, sinusitis, bronchitis
• Laryngotorinology: otitis media, neuritis, mastoiditis
• Meningeal syndrome
• Urethral and genital system: nephritis, cystitis, pyelitis, adnexitis, prostatitis, endometritis and gonorrhea
• Septic lesions after termination of pregnancy
• Digestive organs: cholecystitis, enteritis, salmonellosis, typhoid fever, peritonitis
• Leptospirosis
• Borreliosis
• Endocarditis
• Burns
• Epidermal infections
• Ulcerative manifestations of the stomach in the stage of exacerbation, caused by Helicobacter pylori.

Compound

Amoxicillin Sandoz contains 574 mg or 1148 mg of amoxicillin trihydrate, which is equivalent to 500 mg and 1000 mg of amoxicillinum (active ingredient), respectively. There are also several additional components in the tablets:

• The chemical combination of stearic acid and magnesium salt, insoluble in water, is white crystals. It is used as a foam damper and stabilizer. It is necessary to ensure a homogeneous mass without foreign inclusions and lumps.
• Polyvinylpyrrolidone with different degrees of polymerization for solid dosage forms- detoxifier.
• The sodium salt of carbonic acid imparts viscosity, acts as a thickener, and has a good oliophobic effect.
• Cellulose in small crystals is similar to natural fiber, retains moisture and tablet shape without reacting with drug enzymes.
• Titanium dioxide food coloring is added to the whitening casing.
• Hypromellose provides lubrication, makes the film hard.

Medicinal properties

Amoxicillin Sandoz delays the course of physicochemical processes during the formation of pathogenic membranes. Thus, under the influence of agents, peptidoglycan substances begin to dissolve, the cell is destroyed at the time of reproduction. The drug is active against most microorganisms, but the threshold of sensitivity for different viruses can be variable.

Enterobacteriaceae are inhibited when the concentration of the active ingredient is 6-8 μg / ml, they become resistant when the concentration is more than 30 μg / ml.

Moxarella catarhalis and Haemophilus influenzae, producing beta-lactamase enzymes, are susceptible at amoxicillin trihydrate content of 1 μg / ml, do not react at 4 μg / ml. Pneumococci are destroyed by the amount of amoxicillin 2 μg / ml, continue to grow at 8 μg / ml.

Some pathogens can be marked with certain symbols denoting the features of interaction with the drug (s - intermittent resistance, β - producing betalactamase, p - producing penicillinase):

Gram-positive

• anthrax
• Corynebacterium (s)
• Enterococci (s)
• Listeria
• Streptococcus agalactia
• Bovis
• Pneumococci
• Piogenes
• Viridans (s)

Gram-negative

• Brucella
• Influenza stick
• Gonococci (p)
• Salmonella (s)
• Proteus
• Meningococci
• Shigella (s)
• Cholera vibrio
• Colibacillus
• Helicobacter pylori

Anaerobes

• Bacteroids (s)
• Clostridia
• Peptostreptococci
• Fusobacteria (s)

The following strains are constantly resistant to Amoxicillin Sandoz:

• Staphylococci. (β)
• Citrobactras
• Klebsiella
• Moraxella
• Providence
• Pseudomonas
• Seration
• Fragilis
• Chlamydia
• Rickettsia
• Mycoplasma

Some pathogens are resistant to Amoxicillin Sandoz as a result of pumping mechanisms that pump out components from the core and due to the production of enzymes that violate the permeability of the membranes. Several resistance factors may be present in one cell of the pathogen, which explains the unpredictability and variable behavior of pathogenic bacteria towards antibiotics of other groups.

Bioavailability depends on the dosage and dosage regimen of the drug, on average it is about 85%. The indicator is directly proportional to the amount of medication when using 250-750 mg of the drug per day. Absorption decreases when 1000 mg tablets are taken.

For oral administration of 500 mg, the blood content is 5-10 mg / l. After 3000 mg of a single dose, the parameter reaches 25 mg / l. Maximum accumulates in plasma 60-90 minutes after the start of treatment.

About 20% of the drug combines with a protein element, penetrates well into tissues, mucous membranes, passes through the encephalitis barrier. In small quantities passes into breast milk.

Most, 80% is excreted by the kidneys, the rest is excreted through the bile ducts within 5-6 hours. Metabolic processes convert 20% of the drug into inactive acidic penicillin. In patients with impaired renal function, partial removal takes 7 to 21 hours. Hemodialysis is possible.

Forms of issue

Average price: 130 rubles

Amoxicillin Sandoz is available in the form of light or pale yellow oblong tablets covered with a thin film. There is a dividing strip on both convex sides. On the fault, the shade is light, without inclusions. Packaging - aluminum foil blisters or a container (plastic, metal for clinics) with a flat lid.

One plate contains 6-12 tablets of 500 mg or 100 mg, the jar contains 1000 or 9000 units of 500 mg. The cardboard box contains instructions, ½ blister or container. The pack is white, with a wide red stripe along the lower right corner and the designation S. The drug is odorless, slightly bitter when broken, so it is recommended to drink it whole.

Method of administration and dosage

Adults are prescribed from 500 mg to 3000 mg per day in several doses. For uncomplicated infections, it is sufficient to use 1500 mg twice a day with an interval of 12 hours.

For children, the amount is calculated based on body weight, typically 20-50 mg / kg at 24 hours in several approaches. The maximum is 60 mg / kg per day, which is determined by the severity of the disease and individual indicators.

In renal pathologies, the dosage is adjusted, focusing on the parameter characterizing the rate of passage of blood through the organ (CC). In patients with a level of 30 ml / min, it is recommended to increase the periods or reduce the amount to 500 mg after 12 hours. With a ground clearance of less than 10, the temporary pause is a day.

Children are prescribed 15 mg / kg of body weight at the same intervals.

With endocarditis, the patient is given 3000 mg of the drug to drink one hour before the operative measures and 6 hours after them another 3000 mg.

For patients with anuria, the daily dose is prescribed no more than 2000 mg.

The therapy lasts 3-4 days if the symptoms have disappeared. In cases where the disease is caused by streptococcus of the beta-hemolytic type, it will take 10 days of a therapeutic course to completely destroy the pathogen.

Application during pregnancy

Amoxicillin Sandoz does not cause severe adverse effects on the developing fetus. But in order to avoid potential danger to the child, the treatment of the mother is determined by vital signs. Breastfeeding should be discarded, since the drug can cause fungal infection of the intestinal mucosa or a high susceptibility to beta-lactam antibiotics, which leads to chronic allergies.

Contraindications

The drug is prohibited for use in patients with increased sensitivity to the components.

Precautionary measures

Before prescribing, it is necessary to make sure that the pathogens are not resistant to the composition, it is important to take into account the variable properties of the resistance of some strains.

In severe infections of the digestive system, oral administration is not recommended, which is associated with prolonged manifestation of diarrhea, nausea and low absorption. For such patients, the drug is replaced with amoxicillin powder for the preparation of a solution used parenterally. Also, drugs are not prescribed for the disorder of peristalsis.

The doctor monitors the condition of the kidneys, hematopoietic organs and liver. The product is not suitable for the treatment of respiratory diseases. To prevent crystalline formations of the active substance, it is necessary to monitor the hydrolysis balance in the body.

Combinations with other medicines

The main active substance, interacting with different drugs, can show a negative reaction, or enhance the effect of therapy with certain drugs:

• Allopurinol causes allergies, manifested in skin rashes
• Anticoagulants increase the risk of bleeding, therefore prothrombin gaps need to be monitored
• Probenicid changes the conditions of excretion: it reduces the percentage of excretion through urine and increases the content in the bile ducts and plasma
• Macrlides, sulfonamides, tetracycline group are incompatible with ampicillin
• Cytostatic drugs from the metabolite category increase toxicity
• The use of hormonal oral contraceptives loses its effectiveness
• Cephalosporins and other penicillin antibiotics may cause allergies
• Complete antagonism with ethanol.

With a long course, it is recommended to simultaneously take antifungal medications: Nystatin or Levorin. This will help preserve the intestinal microflora, protect against conditions favorable for the development of Helicobacter pylori, which cause pseudomembranous enterocolitis.

Adverse Reactions

When using tablets, some patients experienced negative effects in different body systems. But all manifestations are reversible upon discontinuation of therapy:

• Digestion: painful sensations in the intestines and stomach, vomiting, motility disorder, nausea, bitterness and dry mouth, the development of pseudomembranous colitis. Such reactions can be reduced or eliminated by taking the drug with meals, using a large amount of water when using tablets.
• Lymphatic system: anemia, increased platelet levels, decreased neutrophils
• Immunity and allergic reactions: anaphylactic shock, laryngeal edema, vasculitis, rashes, dermatitis
• Neurology: seizures, dizziness, fever
• With prolonged use, the development of a secondary infection, infection with resistant microorganisms, candidiasis was observed.

Overdose

Usually, the drug does not cause serious consequences, even with increased intake. Symptoms of exceeding the determined dose are side effects. Patients with kidney problems may develop signs of toxicity or dysmetabolic nephropatitis.

There is no specific treatment, the doctor prescribes traditional supportive and cleansing therapy (gastric lavage). Dialysis, restoration of electrolyte balance helps well.

Storage rules

The tablets can be used for 4 years. You need to keep in a darkened place, without access to moisture, closed from children, at a temperature of 20-25 0 C.

Analogs

There are means, the mechanism of operation of the active substances of which is identical to the principles of action on pathogens inherent in Amoxicillin Sandoz:

AVVA RUS, Russia
Price: Tab. 250 mg No. 20 - 60-80 rubles, 500 mg No. 20 - 100-130 rubles.

Antibacterial drug from the penicillin group, partially synthetic, with the main active ingredient amoxicillin trihydrate, which exhibits properties in an acidic environment. The tool stops the production of enzymes necessary to build the membrane walls of pathogens and destroys their cells. It is active against most pathogens, but viruses that produce beta-lactamases are either resistant or unstable. Before use, it is necessary to determine the type of microorganisms in order to prescribe adequate doses.

Ekobol exhibits therapeutic qualities in diseases of the respiratory and ENT organs, genitourinary infections, lesions of the digestive system, skin pathologies. Contraindicated in asthma, mononucleosis, allergic diathesis.

The box is cardboard, white with gray stains, on it there is an image of a human figure on a green ball. The package includes 20 oblong tablets of 250 or 500 mg in blisters. It is not recommended to crush or should be washed down with plenty of water to avoid a bitter taste.

Advantages:

• The composition contains lactulose, which stimulates the growth of bifidobacteria to preserve the intestinal microflora
• Affordable price.

Flaws:

• This form is not recommended for use in children under 3 years of age.
• Shows antagonism to bacteriostatics.

JSC synthesis, Russia
Price: Tab. 250 mg No. 10 - 25-30 rubles, 500 mg No. 10 - 60-70 rubles, Por for suspension. 125 mg pak. No. 10 - 40 rubles, 250 mg pack. No. 10 - 50-65 rubles.

Broad-spectrum antibiotic, bactericidal type. When taken, it inhibits the synthesis of peptiglycan enzymes, ensuring the lysis of cell membranes of pathogens. Shows activity in the division phase. The effect occurs within 15 minutes after use, lasts more than 8 hours. Bioavailability is 95%, the maximum plasma content is reached 90 minutes after consumption.

Suitable for the treatment of gynecological, kidney, gastric and intestinal infections. It is prescribed for inflammation of the respiratory system of a bacterial nature. Destroys most gram-positive and negative pathogens, except for those that are capable of producing enzymes that destroy penicillin.

It is produced in the form of oblong tablets with a dividing line on both sides of a creamy color. The blister contains 10 units of 250 or 500 mg each. The blue or greenish cardboard box contains instructions and 1 plate. The second option is a powder for preparing a suspension of a pale yellow or lemon shade with a specific smell and sweet taste. Cardboard box with orange stains, contains 1 bottle of the product, measuring spoon and instructions.

Advantages:

• Fast acting drug
• The suspension is prescribed for children from the first days of life.

Flaws:

• Concomitant use with aminoglycosides impairs absorption
• Incompatible with hormonal oral contraceptives.

Ospamox

Biochemi, Austria
Price: Tab 500 mg No. 12 - 180-200 rubles, 1000 mg No. 12 - 280-300 rubles, Por for suspension. 250 mg - 250-280 rubles.

A drug from the aminopenicillin group for oral use. Stops the process of cell division of pathogens by blocking the production of substances necessary for the construction of membrane walls. Thus, the antibiotic destroys all structures of the pathogen, down to the nucleus. Actively acts against streptococci, salmonella, shigella, proteus, bordothella. Strains that produce penicillinase show resistance.

Designed for the treatment of infections of the skin, urethral and reproductive system, respiratory organs. The dosage is determined depending on the location, age of the patient and the degree of the disease. Contraindications are cross-sensitivity to betalactam drugs and allergy to drug components.

It is produced in the form of white, oblong tablets, packed in blisters of 6 pieces. It is recommended to drink plenty of fluids while taking. An option for children under 3 years old is a powder from which a suspension with a sweet taste is prepared. To do this, add water to the bottle according to the measured risk, shake it up. The carton box contains 2 plates or 1 bottle. The tutu is white with a red mark and the company logo in the lower right corner.

Advantages:

• The medicine is active to the maximum a large number pathogens of different groups (gram-positive and negative, anaerobic)
• Good accumulation up to therapeutic concentrations.

Flaws:

• High price
• An increase in the period of excretion in kidney disease.

The information is valid for 2011 and is provided for informational purposes only. Please contact your doctor to choose a treatment regimen and be sure to first read the instructions for the drug.

Latin name: AMOXICILLIN SANDOZ

Marketing authorization holder: SANDOZ GmbH

Instructions for use of the drug AMOXICILLIN SANDOZ (AMOXICILLIN SANDOZ)

AMOXICILLIN SANDOZ - release form, composition and packaging

Film-coated tablets from white to slightly yellowish, oblong, biconvex, with notches on both sides.

The composition of the film shell:

10 pieces. - blisters (100) - cardboard boxes.
12 pcs. - contour cell packaging (1) - cardboard packs.

1000 pcs. - plastic containers.
9000 pcs. - containers.

Film-coated tablets from white to slightly yellowish, oval, biconvex, with notches on both sides.

Magnesium stearate, polyvidone, sodium starch glycolate, microcrystalline cellulose.

The composition of the film shell: titanium dioxide, talc, hypromellose.

6 pcs. - contour cell packaging (2) - cardboard packs.
10 pieces. - contour cell packaging (100) - cardboard boxes.
6500 pcs. - containers.

pharmachologic effect

Amoxicillin is an aminobenzyl penicillin that has a bactericidal effect by inhibiting bacterial cell wall synthesis.

The MIC thresholds for different susceptible organisms vary.

In accordance with NCCLS recommendations and when using NCCLS-specified methods M. catarrhalis(β-lactamase negative) and H. influenzae(β-lactamase negative) are considered sensitive at concentrations ≤ 1 μg / ml and resistant at ≥ 4 μg / ml; Str.pneumoniae considered susceptible at MIC ≤ 2 μg / ml and resistant at ≥ 8 μg / ml.

The prevalence of resistant strains varies geographically, so it is advisable to rely on local information on resistance, especially when treating severe infections. With such a level of prevalence of resistant strains, at which it becomes doubtful the advisability of using the drug, at least in the treatment of some infections, it is better to seek the help of a specialist.

Sensitive:

a)% of β-lactamase production.

b) penicillin resistance (including intermediate resistance).

# Until now, there are no reports of the appearance of β-lactamase-producing strains.

§ Variable sensitivity, sensitivity cannot be predicted without sensitivity tests.

* Clinical efficacy has been shown for susceptible strains when used as indicated.

Bacteria can be resistant to amoxicillin (and therefore ampicillin) as a result of the production of beta-lactamases that hydrolyze aminopenicillins, changes in penicillin-binding proteins, impaired drug permeability, or due to the functioning of special pump pumps that pump the drug out of the cell. Several resistance mechanisms can be simultaneously present in one microorganism, which explains the existence of variable and unpredictable cross-resistance to other beta-lactams and antibacterial drugs from other groups.

Pharmacokinetics

Suction:

The absolute bioavailability of amoxicillin depends on the dose and mode of administration and ranges from 75 to 90%. At doses from 250 mg to 750 mg, bioavailability (parameters: AUC and / or excretion in urine) is linearly proportional to the dose. At higher doses, the absorption is lower. Absorption is not affected by food intake. Amoxicillin is acid-fast. With a single oral dose of 500 mg, the concentration of amoxicillin in the blood is 6-11 mg / l. After a single dose of 3 g of amoxicillin, the concentration in the blood reaches 27 mg / l. C max in plasma are observed 1 to 2 hours after taking the drug.

Distribution:

About 17% of amoxicillin is associated with plasma proteins. The therapeutic concentration of the drug is rapidly achieved in plasma, lungs, bronchial secretions, middle ear fluid, bile and urine. Amoxicillin can penetrate the inflamed meninges into the cerebrospinal fluid. Amoxicillin crosses the placenta and is found in small amounts in breast milk.

Biotransformation and elimination:

The main place of excretion of amoxicillin is the kidneys. About 60-80% of an oral dose of amoxicillin is excreted within 6 hours after administration in an unchanged active form through the kidneys and a small fraction is excreted in the bile. Approximately 7-25% of the dose is metabolized to inactive penicillic acid. The half-life from plasma in patients with unchanged renal function is 1-1.5 hours. In patients with severe renal insufficiency, the half-life varies from 5 to 20 hours. The substance is amenable to hemodialysis.

Dosages of the drug AMOXICILLIN SANDOZ

Infection therapy:

Parenteral therapy is indicated when it is impossible to carry out oral therapy and in the treatment of severe infections.

Adult dosages (including elderly patients):

Standard dose:

The usual dose ranges from 750 mg to 3 g of amoxicillin per day in divided doses. In some cases, it is recommended to limit the dose to 1500 mg per day in several doses.

Short course of therapy:

Uncomplicated urinary tract infections: double administration of the drug, 3 g for each administration, with an interval between doses of 10 - 12 hours.

Children's dosages (up to 12 years old)

The daily dose for children is 25-50 mg / kg / day in several doses (maximum 60 mg / kg / day), depending on the indication and the severity of the disease.

Children weighing over 40 kg should receive the adult dosage.

Dosing for renal failure:

In patients with severe renal impairment, the dose should be reduced. With renal clearance less than 30 ml / min, an increase in the interval between doses or a decrease in subsequent doses is recommended. In renal failure, short courses of therapy of 3 g are contraindicated.

Adults (including elderly patients):

For hemodialysis: 500 mg should be given after the end of the procedure.

Kidney dysfunction in children weighing less than 40 kg:

Prevention of endocarditis

For the prevention of endocarditis in patients not under general anesthesia, 3 g of amoxicillin should be administered 1 hour before the operation and, if necessary, another 3 g after 6 hours.

For more detailed information and descriptions of patient categories at risk for endocarditis, refer to your local official guidelines.

Drug interactions

Allopurinol

Concomitant use with allopurinol can lead to the development of allergic skin reactions.

Digoxin

An increase in the absorption of digoxin is possible during therapy with Ospamox.

Anticoagulants

The combined use of amoxicillin and anticoagulants such as coumarin may increase the likelihood of bleeding due to prolonged prothrombin time. When prescribing anticoagulants together with Ospamox, monitoring of homeostatic indicators is required.

Probenecid

Probenecid inhibits the excretion of amoxicillin through the kidneys, and leads to an increase in the concentration of amoxicillin in bile and blood.

Other antibiotics

There is a possibility of antagonism of the action of amoxicillin with the simultaneous administration of bacteriostatic drugs: macrolides, tetracyclines, sulfonamides and chloramphenicol.

Methotrexate

The combined use of methotrexate and amoxicillin may increase the degree of methotrexate toxicity, possibly as a result of competitive inhibition of renal tubular secretion of methotrexate by amoxicillin.

Amoxicillin should be used with caution with the following drugs:

Oral hormonal contraceptives

The use of amoxicillin can lead to a transient decrease in the concentration of estrogen and progesterone in the blood, and reduce the effectiveness of contraceptives. In this regard, it is recommended to additionally use other non-hormonal methods of contraception during treatment with amoxicillin.

Application of AMOXICILLIN SANDOZ during pregnancy

The use of the drug during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be resolved.

Childhood use

It should be used with caution in children, premature infants and newborns: it is necessary to monitor the functions of the kidneys, liver and hematological parameters.

AMOXICILLIN SANDOZ - side effects

Side effects are classified as follows:

Often: 10%, or less often, but more often 1%

Uncommon: 1%, or less often, but more often 0.1%

Rarely. 0.1% or less often, but more often 0.01%

Very rare, including isolated cases: 0.01% or less.

Infection and infection

Infrequently

Long-term and repeated use of the drug can lead to the development of superinfection and colonization of resistant microorganisms or fungi, for example, oral and vaginal candidiasis.

Disorders of the blood and lymphatic system

Rarely

Eosinophilia and hemolytic anemia.

Rarely

Isolated cases of leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia, myelosuppression, agranulocytosis, prolongation of bleeding time and prothrombin time have been reported. All changes were reversible upon discontinuation of therapy.

Immune system disorders

Rarely

Laryngeal edema, serum sickness, allergic vasculitis, anaphylaxis and anaphylactic shock are rare.

Neurological disorders

Rarely

CNS reactions are rare and include hyperkinesis, dizziness, and seizures. Convulsions can occur in patients with renal insufficiency or in patients receiving high doses of the drug.

Gastrointestinal Disorders

Often

Feeling of discomfort, nausea, loss of appetite, vomiting, flatulence, loose stools, diarrhea, enanthema (especially on the oral mucosa), dry mouth, impaired taste. As a rule, the listed effects are characterized by mild severity and often disappear with the continuation of therapy or very quickly after its termination. It is possible to reduce the incidence of these complications by taking amoxicillin with food.

With the development of severe persistent diarrhea, it is necessary to take into account the possibility of a very rare complication, pseudomembranous colitis. Prescription of drugs that suppress peristalsis is contraindicated.

Rarely

The appearance of a black color of the tongue.

Liver and biliary system disorders:

Infrequently

Transient moderate increase in the level of liver enzymes. Rare cases of hepatitis and cholestatic jaundice.

Disorders of the skin and subcutaneous fat:

Often

Skin reactions in the form of exanthema, itching, urticaria; a typical measles-like exanthema appears 5-11 days after the start of therapy. The immediate development of urticaria indicates an allergic reaction to amoxicillin and requires discontinuation of therapy.

Rare(see also section 4.4)

Angioedema (angioedema), exudative erythema multiforme, acute generalized pustular rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis.

Kidney disorders

Rarely

In rare cases, acute interstitial nephritis.

General disorders

Rarely

In rare cases, drug fever may develop.

Terms and conditions of storage of the drug AMOXICILLIN SANDOZ

The drug should be stored at a temperature not exceeding 25 ° C.

Best before date - 4 years.

The medicinal product should not be used after the expiry date printed on the package.

Indications for use of AMOXICILLIN SANDOZ

It is indicated for the oral therapy of the following bacterial infections caused by amoxicillin-sensitive gram-positive and gram-negative pathogens:

Upper respiratory tract infections, including ear, nose and throat infections: acute otitis media, acute sinusitis, and bacterial pharyngitis.

Lower respiratory tract infections: exacerbation of chronic bronchitis, community-acquired pneumonia.

Lower urinary tract infections: cystitis.

Gastrointestinal tract infections: bacterial enteritis. Combination therapy may be required for infections caused by anaerobic microorganisms.

Endocarditis: prevention of endocarditis in patients at risk of developing endocarditis - for example, during dental procedures.

Special instructions when taking AMOXICILLIN SANDOZ

Before starting therapy with amoxicillin, it is important to make sure that there is no history of hypersensitivity reactions to penicillins and cephalosporins that can cause a cross-allergic reaction (10-15%).

There are reports of the development of severe, sometimes fatal, hypersensitivity reactions (anaphylactoid) during therapy with penicillin. These reactions are more common in people with a history of hypersensitivity to beta-lactams.

In the presence of severe disorders of the gastrointestinal tract with diarrhea and vomiting, Ospamox should not be used, since these conditions can reduce its absorption. Such patients are recommended to prescribe the parenteral form of amoxicillin.

With the development of severe persistent diarrhea, it is necessary to take into account the likelihood of pseudomembranous colitis (in most cases caused by Clostridium difficile).

Long-term use of amoxicillin in some cases can lead to the growth of bacteria and fungi that are insensitive to it. In this regard, patients should be closely monitored for the development of superinfection.

Anaphylactic shock and other severe allergic reactions after oral administration of amoxicillin are rare. If such a reaction occurs, it is necessary to carry out a complex of urgent measures: intravenous administration of epinephrine, then antihistamines, volume replacement and the introduction of glucorticoids. Patients need close supervision and other therapeutic procedures if necessary (artificial respiration, oxygen).

The presence of amoxicillin in high concentration in urine can cause the drug to precipitate in the urinary catheter, so catheters should be checked periodically.

When using amoxicillin in high doses in order to minimize the risk of amoxicillin crystalluria, it is important to monitor the adequacy of fluid intake and excretion.

Forced diuresis leads to a decrease in the concentration of amoxicillin in the blood as a result of the acceleration of its excretion.

Diarrhea can impair absorption and reduce the effectiveness of drugs.

When determining the presence of glucose in urine during therapy with amoxicillin, it is recommended to use enzymatic glucose oxidant methods. When using chemical methods, a high concentration of amoxicillin in urine can cause frequent false positive test results.

Amoxicillin can reduce the concentration of estriol in the urine of pregnant women.

In high concentrations, amoxicillin can reduce blood glucose levels.

Amoxicillin can interfere with the results of protein studies when using colorimetric analysis.

Conditions of dispensing from pharmacies

AMOXICILLIN SANDOZ is a prescription drug.

Registration numbers:

* Description of the preparation is based on the officially approved instructions for use and approved by the manufacturer for the 2012 editions
AMOXICILLIN SANDOZ - description and instructions provided by the reference book of medicines "Vidal"

Instructions for the medical use of the drug

Description of the pharmacological action

Inhibits transpeptidase, disrupts the synthesis of peptidoglycan (a supporting protein of the cell wall) during division and growth, and causes lysis of microorganisms.

Indications for use

Amoxicillin Sandoz is indicated for the oral treatment of the following bacterial infections caused by amoxicillin-susceptible gram-positive and gram-negative pathogens:

Upper respiratory tract infections, including ear, nose and throat infections: acute otitis media, acute sinusitis, and bacterial pharyngitis;

Lower respiratory tract infections: exacerbation of chronic bronchitis, community-acquired pneumonia;

Lower urinary tract infections: cystitis;

Gastrointestinal tract infections: bacterial enteritis.

Combination therapy may be required for infections caused by anaerobic microorganisms;

Endocarditis: Prevention of endocarditis in patients at risk of developing endocarditis, for example, during dental procedures.

Release form

coated tablets 1 g; blister 12, pack of cardboard 1.
coated tablets 1 g; blister 6, pack of cardboard 2.
coated tablets 1 g; metal container 6500.
coated tablets 1 g; blister 10, cardboard box (box) 100.
film-coated tablets 500 mg; blister 10, cardboard box (box) 10.
film-coated tablets 500 mg; plastic container 1000.
film-coated tablets 500 mg; metal container 9000.
film-coated tablets 500 mg; blister 12, pack of cardboard 1.

Pharmacodynamics

Amoxicillin is an aminobenzyl penicillin that has a bactericidal effect by inhibiting bacterial cell wall synthesis.

Threshold values ​​of MIC for different susceptible organisms vary.

In accordance with the recommendations of the National Committee for Clinical Laboratory Standards (NCCLS) and when using NCCLS-indicated methods, M. catarrhalis (β-lactamase negative) and H. influenzae (β-lactamase negative) are regarded as sensitive at concentrations ≤1 μg / ml and resistant at ≥4 μg / ml; Str. pneumoniae are considered susceptible at MICs ≤2 μg / ml and resistant at ≥8 μg / ml.

The prevalence of resistant strains varies geographically, so it is advisable to rely on local information on resistance, especially when treating severe infections. With such a level of prevalence of resistant strains, at which it becomes doubtful the advisability of using the drug, at least in the treatment of some infections, it is better to seek the help of a specialist.

Bacteria can be resistant to amoxicillin (and therefore ampicillin) as a result of the production of β-lactamases that hydrolyze aminopenicillins, changes in penicillin-binding proteins, impaired drug permeability, or due to the functioning of special pump pumps that pump the drug out of the cell. Several resistance mechanisms can be simultaneously present in one microorganism, which explains the existence of variable and unpredictable cross-resistance to other β-lactams and antibacterial drugs from other groups.

Pharmacokinetics

Suction

The absolute bioavailability of amoxicillin depends on the dose and mode of administration and ranges from 75 to 90%. At doses from 250 to 750 mg, bioavailability (parameters: AUC and / or excretion in urine) is linearly proportional to the dose. At higher doses, the absorption is lower. Absorption is not affected by food intake. Amoxicillin is acid-fast. With a single oral dose of 500 mg, the concentration of amoxicillin in the blood is 6-11 mg / l. After a single dose of 3 g of amoxicillin, the concentration in the blood reaches 27 mg / l. Maximum plasma concentrations are observed 1-2 hours after taking the drug.

Distribution

About 17% of amoxicillin is associated with plasma proteins. The therapeutic concentration of the drug is rapidly achieved in plasma, lungs, bronchial secretions, middle ear fluid, bile and urine. Amoxicillin can penetrate the inflamed meninges into the cerebrospinal fluid. Amoxicillin crosses the placenta and is found in small amounts in breast milk.

Biotransformation and elimination

The main place of excretion of amoxicillin is the kidneys. About 60–80% of an oral dose of amoxicillin is excreted within 6 hours after administration in an unchanged active form through the kidneys and a small fraction is excreted in the bile. Approximately 7-25% of the dose is metabolized to inactive penicillic acid. T1 / 2 from plasma in patients with unchanged renal function is 1-1.5 hours. In patients with severe renal failure, T1 / 2 varies from 5 to 20 hours. The substance is amenable to hemodialysis.

Use during pregnancy

The use of amoxicillin during pregnancy and breastfeeding is possible only if the intended benefit to the mother outweighs the potential risk to the fetus and infant.

The drug is excreted in breast milk and, in rare cases, can lead to the development of diarrhea and / or fungal colonization of the mucous membrane in newborns. It is also important to consider the possibility of sensitizing the newborn to β-lactam antibiotics.

If necessary, the appointment of the drug during lactation should stop breastfeeding.

Contraindications for use

Hypersensitivity to penicillin; it is also necessary to take into account the possibility of cross-allergy with other β-lactam antibiotics, such as cephalosporins, carbapenems.

Carefully:

Allergic diathesis and asthma;

Renal failure (it is possible to slow down the elimination of amoxicillin, which, depending on the degree of failure, may require a decrease in the daily dose of the drug);

Children, premature infants and newborns: it is necessary to monitor the functions of the kidneys, liver and hematological parameters;

Viral infections, acute lymphoblastic leukemia and infectious mononucleosis (due to an increased risk of erythematous skin rash).

Side effects

Side effects are classified as follows: often - 10% or less, but more often 1%; infrequently - 1% or less, but more often 0.1%; rarely - 0.1% or less, but more often 0.01%; very rarely, including isolated cases - 0.01% or less.

Infection and infection: infrequently - prolonged and repeated use of the drug can lead to the development of superinfection and colonization of resistant microorganisms or fungi, for example, oral and vaginal candidiasis.

Disturbances from the blood and lymphatic system: rarely - eosinophilia and hemolytic anemia; very rarely - isolated cases of leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia, myelosuppression, agranulocytosis, prolongation of bleeding time and PT have been reported. All changes were reversible upon discontinuation of therapy.

Immune system disorders: rarely - laryngeal edema, serum sickness, allergic vasculitis, anaphylaxis and anaphylactic shock.

Neurological disorders: rarely - reactions from the central nervous system, including hyperkinesis, dizziness and seizures. Convulsions can occur in patients with renal insufficiency or in patients receiving high doses of the drug.

Gastrointestinal disorders: often - a feeling of discomfort, nausea, loss of appetite, vomiting, flatulence, loose stools, diarrhea, enanthema (especially on the oral mucosa), dry mouth, impaired taste. As a rule, the listed effects are characterized by mild severity and often disappear with the continuation of therapy or very quickly after its termination. It is possible to reduce the frequency of these complications when taking amoxicillin with food; with the development of severe persistent diarrhea, it is necessary to take into account the possibility of a very rare complication, pseudomembranous colitis (prescription of drugs that suppress peristalsis is contraindicated); very rarely - the appearance of a black color of the tongue.

Disturbances from the liver and biliary system: infrequently - a transient, moderate increase in the level of liver enzymes; rarely - cases of hepatitis and cholestatic jaundice.

Violations of the skin and subcutaneous fat: often - skin reactions in the form of exanthema, itching, urticaria; typical measles-like exanthema appears on the 5-11th day from the start of therapy. The immediate development of urticaria indicates an allergic reaction to amoxicillin and requires discontinuation of therapy; rarely - angioedema (angioedema), exudative erythema multiforme, acute generalized pustular rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis.

Renal disorders: rarely - acute interstitial nephritis.

General disorders: rarely - the development of drug fever.

Method of administration and dosage

Inside.
Infection therapy

As a rule, it is recommended to continue therapy for 2-3 days after the symptoms disappear. In the case of infections caused by β-hemolytic streptococcus, complete eradication of the pathogen requires therapy for at least 10 days.

Parenteral therapy is indicated when it is impossible to carry out oral therapy and in the treatment of severe infections.

Adult dosages (including elderly patients)

Standard dose: The usual dose ranges from 750 mg to 3 g of amoxicillin per day in divided doses. In some cases, it is recommended to limit the dose to 1500 mg per day in several doses.

A short course of therapy: uncomplicated urinary tract infections - two doses of the drug, 3 g for each injection, with an interval between doses of 10-12 hours.

Children's dosages (up to 12 years old)

The daily dose for children is 25-50 mg / kg / day in several doses (maximum 60 mg / kg / day), depending on the indication and the severity of the disease.

Children weighing over 40 kg should receive the adult dosage.

Dosing for renal failure

In patients with severe renal impairment, the dose should be reduced. With renal clearance less than 30 ml / min, an increase in the interval between doses or a decrease in subsequent doses is recommended.

In renal failure, short courses of therapy of 3 g are contraindicated.

Prevention of endocarditis

For the prevention of endocarditis in patients not under general anesthesia, 3 g of amoxicillin should be administered 1 hour before the operation and, if necessary, another 3 g after 6 hours.

For more detailed information and descriptions of patient categories at risk for endocarditis, refer to your local official guidelines.

Overdose

Symptoms Amoxicillin usually does not cause acute toxic effects, even with occasional high doses. Overdose can manifest itself as symptoms of gastrointestinal disorders, imbalance in water and electrolyte balance. In patients with severe renal impairment, an overdose of large doses of amoxicillin may be accompanied by signs of nephrotoxicity and crystalluria.

Treatment. There is no specific antidote for amoxicillin. Therapy includes the introduction of activated charcoal (there are usually no indications for gastric lavage) or symptomatic measures. Particular attention should be paid to the water-electrolyte balance. The use of hemodialysis is possible.

Interaction with other drugs

Digoxin. An increase in the absorption of digoxin is possible during therapy with Amoxicillin Sandoz.

Anticoagulants. The combined use of amoxicillin and anticoagulants such as coumarin may increase the likelihood of bleeding due to prolonged PT. When prescribing anticoagulants together with Amoxicillin Sandoz, monitoring of hemostatic parameters is required.

Probenecid. Probenecid inhibits the excretion of amoxicillin through the kidneys and leads to an increase in the concentration of amoxicillin in bile and blood.

Other antibiotics. There is a possibility of antagonism of the action of amoxicillin with the simultaneous administration of bacteriostatic drugs: macrolides, tetracyclines, sulfonamides and chloramphenicol.

Methotrexate. The combined use of methotrexate and amoxicillin may increase the toxicity of methotrexate, possibly as a result of competitive inhibition of renal tubular secretion of methotrexate by amoxicillin.

Amoxicillin should be used with caution with the following drugs
Oral hormonal contraceptives. The use of amoxicillin can lead to a transient decrease in the concentration of estrogen and progesterone in the blood and reduce the effectiveness of contraceptives. In this regard, it is recommended to additionally use other non-hormonal methods of contraception during treatment with amoxicillin.

Special instructions for admission

Before starting therapy with amoxicillin, it is important to make sure that there is no history of hypersensitivity reactions to penicillins and cephalosporins that can cause a cross-allergic reaction (10-15%).

There are reports of the development of severe, sometimes fatal, hypersensitivity reactions (anaphylactoid) during therapy with penicillin. These reactions are more common in people with a history of hypersensitivity to β-lactams.

In the presence of severe gastrointestinal disorders with diarrhea and vomiting, Amoxicillin Sandoz should not be used, since these conditions can reduce its absorption. Such patients are recommended to prescribe the parenteral form of amoxicillin.

With the development of severe persistent diarrhea, it is necessary to take into account the likelihood of pseudomembranous colitis (in most cases caused by Clostridium difficile).

Long-term use of amoxicillin in some cases can lead to the growth of bacteria and fungi that are insensitive to it. In this regard, patients should be closely monitored for the development of superinfection.

Anaphylactic shock and other severe allergic reactions after oral administration of amoxicillin are rare. If such a reaction occurs, it is necessary to carry out a complex of urgent measures: intravenous administration of epinephrine, then antihistamines, volume replacement and the introduction of glucorticoids. Patients need close supervision and, possibly, additional therapeutic procedures if necessary (artificial respiration, oxygen).

The presence of amoxicillin in high concentration in urine can cause the drug to precipitate in the urinary catheter, so catheters should be checked periodically.

When using amoxicillin in high doses in order to minimize the risk of amoxicillin crystalluria, it is important to monitor the adequacy of fluid intake and excretion.

Forced diuresis leads to a decrease in the concentration of amoxicillin in the blood as a result of the acceleration of its excretion.

Diarrhea can impair absorption and reduce the effectiveness of drugs.

When determining the presence of glucose in urine during therapy with amoxicillin, it is recommended to use enzymatic glucose oxidant methods. When using chemical methods, a high concentration of amoxicillin in urine can cause frequent false-positive test results.

Amoxicillin can reduce the concentration of estriol in the urine of pregnant women.

In high concentrations, amoxicillin can reduce blood glucose levels.

Amoxicillin can interfere with the results of protein studies when conducting colorimetric analysis.

Storage conditions

List B.: At a temperature not higher than 25 ° C.

Best before date

Belonging to ATX classification:

** The Medication Guide is intended solely for informational purposes. For more information, please refer to the manufacturer's annotation. Do not self-medicate; Before using Amoxicillin Sandoz, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of the information posted on the portal. Any information on the site does not replace the consultation of a doctor and cannot serve as a guarantee of the positive effect of the drug.

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** Attention! The information provided in this medication guide is intended for healthcare professionals and should not be used as a basis for self-medication. The description of the drug Amoxicillin Sandoz is given for information purposes only and is not intended for prescribing treatment without the participation of a doctor. Patients need a specialist consultation!

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