Amoxicillin Sandoz - Instructions For Use, Tablets 0.5 And 1 G, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Amoxicillin Sandoz

Amoxicillin Sandoz: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Amoxicillin Sandoz

ATX code: J01CA04

Active ingredient: amoxicillin (Amoxicillin)

Manufacturer: Sandoz, GmbH (Sandoz, GmbH) (Austria)

Description and photo update: 2019-10-07

Prices in pharmacies: from 97 rubles.

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Amoxicillin Sandoz is an antibiotic from the group of semi-synthetic penicillins.

Release form and composition

Dosage form - film-coated tablets: oblong (0.5 g each) or oval (1 g each), biconvex, with notches on both sides, from white to slightly yellowish (dosage 0.5 g: 10 and 12 each pcs. in blisters, in a cardboard box 1 blister and instructions for use of Amoxicillin Sandoz; packing for hospitals - in a cardboard box 100 blisters of 10 tablets; dosage 1 g: 6 and 10 pcs. in blisters, in a cardboard box 2 blisters and instructions to the drug; packaging for hospitals - in a cardboard box 100 blisters).

Composition of 1 tablet:

• active substance: amoxicillin (in the form of trihydrate) - 0.5 or 1 g;
• auxiliary components: microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A), magnesium stearate;
• film shell: hypromellose, talc, titanium dioxide.

Pharmacological properties

Pharmacodynamics

Amoxicillin - the active component of the drug - is a semi-synthetic penicillin with a bactericidal effect.

The mechanism of action is due to the ability of amoxicillin to damage the cell membrane of bacteria that are in the multiplying stage. The drug specifically inhibits the enzymes of the cell membranes of microorganisms (peptidoglycans), as a result of which their lysis and death occurs.

Amoxicillin Sandoz is active against the following bacteria:

• gram-positive aerobic microorganisms: Streptococcus spp. (including S. pneumoniae), Listeria monocytogenes, Enterococcus faecalis, Bacillus anthracis, Staphylococcus spp. (excluding strains producing penicillinase), Corynebacterium spp. (excluding C. jeikeium);
• gram-negative aerobic microorganisms: Neisseria spp., Borrelia spp., Shigella spp., Helicobacter pylori, Escherichia coli, Salmonella spp., Campylobacter, Haemophilus spp., Proteus mirabilis, Leptospira spp., Treponema spp.;
• anaerobic bacteria: Fusobacterium spp., Bacteroides melaninogenicus, Peptostreptococcus spp., Clostridium spp.;
• others: Chlamydia spp.

Amoxicillin Sandoz is inactive against the following microorganisms:

• gram-positive aerobic bacteria: Staphylococcus (lactamase-producing strains);
• gram-negative aerobic bacteria: Klebsiella spp., Citrobacter spp., Proteus spp., Acinetobacter spp., Pseudomonas spp., Serratia spp., Moraxella catarrhalis, Enterobacter spp., Providencia spp.;
• anaerobic bacteria: Bacteroides spp.;
• others: Rickettsia spp., Mycoplasma spp.

Pharmacokinetics

After oral administration of a dose of Amoxicillin Sandoz 0.5 g, the plasma concentration of the drug ranges from 6 to 11 mg / l. The time to reach the maximum plasma concentration is 1–2 hours. Food intake does not affect absorption (speed and degree). Absolute bioavailability is dose-dependent and can be 75-90%.

Plasma proteins bind 15–25% of the dose received. Amoxicillin quickly penetrates into bile, bronchial secretions, lung tissue, urine, middle ear fluid. In small quantities, it penetrates into the cerebrospinal fluid, provided there is no inflammation of the meninges, otherwise the content in the cerebrospinal fluid can reach 20% of the plasma concentration. Penetrates through the placenta, in small quantities into breast milk.

Up to 25% of the taken dose of the drug is metabolized with the formation of penicillic acid, which does not have pharmacological activity.

It is excreted: 60-80% of the dose - by the kidneys unchanged within 6 - 8 hours after taking Amoxicillin Sandoz, a small amount - with bile.

The half-life (T _½) is 1‒1.5 hours, with end-stage renal failure it can vary within 5–20 hours.

Amoxicillin is removed from the body by hemodialysis.

Indications for use

Amoxicillin Sandoz is used in the treatment of infectious and inflammatory diseases caused by bacteria sensitive to the drug:

• ENT organs, upper and lower respiratory tract: acute otitis media, tonsillitis, pharyngitis, pneumonia, bronchitis, lung abscess;
• genitourinary system: cystitis, endometritis, adnexitis, septic abortion, pyelitis, pyelonephritis, epididymitis, urethritis, chronic bacterial prostatitis, etc.;
• gastrointestinal tract: bacterial enteritis (for infections caused by anaerobic microorganisms, the drug is often used as part of combination therapy);
• biliary tract: cholecystitis, cholangitis;
• listeriosis, leptospirosis, Lyme disease (borreliosis);
• infections of the skin and soft tissues;
• endocarditis (including for its prevention during dental procedures).

Also, Amoxicillin Sandoz tablets are used as part of a combination therapy (together with clarithromycin, metronidazole or proton pump inhibitors) for the eradication of Helicobacter pylori.

Contraindications

Absolute:

• children under 3 years old;
• hypersensitivity to other beta-lactam antibiotics, for example, cephalosporins or carbapenems (cross-reaction is possible);
• breast-feeding;
• hypersensitivity to any component of the drug or penicillin.

Amoxicillin Sandoz tablets should be used with caution in the following cases:

• severe digestive disorders accompanied by prolonged diarrhea / vomiting;
• impaired renal function;
• viral infections;
• bronchial asthma;
• allergic diathesis;
• infectious mononucleosis (increased risk of erythematous skin rash);
• acute lymphoblastic leukemia;
• children's age from 3 years;
• pregnancy (the benefits to the mother must outweigh the risks to the fetus).

Amoxicillin Sandoz, instructions for use: method and dosage

Amoxicillin Sandoz should be taken orally. The duration of treatment is determined individually. It is usually recommended to continue taking the drug for another 2-3 days after the symptoms disappear. In infections caused by β-hemolytic streptococcus, for the complete eradication of the pathogen, therapy is required for at least 10 days.

Adults and children weighing more than 40 kg (over 12 years old), depending on the severity of the infectious process, are prescribed the drug in a daily dose of 0.750-3 g (in several doses).

In uncomplicated urinary tract infections, short courses of treatment are carried out using a dose of 3 g 2 times a day (at intervals of 10-12 hours).

For children under 12 years of age, Amoxicillin Sandoz is prescribed in a daily dose of 25-50 mg / kg (in divided doses), but not more than 60 mg / kg per day. The optimal dosage is determined by the indication and the severity of the disease.

For patients with severe renal insufficiency, the dosage regimen of Amoxicillin Sandoz is adjusted. When creatinine clearance is <30 ml / min, reduce subsequent doses and / or increase the intervals between doses. The appointment of short courses with a single dose of 3 g is contraindicated.

Recommended doses for adult patients (including the elderly) and children weighing more than 40 kg with impaired renal function:

• CC 10-30 ml / min - 0.5 g every 12 hours;
• CC <10 ml / min - 0.5 g every 24 hours.

On the day of hemodialysis, take a dose of Amoxicillin Sandoz after the end of the session.

Recommended doses for children weighing less than 40 kg:

• CC 10-30 ml / min - 15 mg / kg every 12 hours;
• CC <10 ml / min - 15 mg / kg every 24 hours.

For the prevention of endocarditis in adult patients not under general anesthesia, Amoxicillin Sandoz is prescribed at a dose of 3 g 1 hour before the operation. If necessary, it is possible to reapply a similar dose 6 hours after the intervention. For children, the recommended dose is 50 mg / kg. For more information and descriptions of patient categories at risk for endocarditis, refer to your local government guidelines.

Side effects

While taking Amoxicillin Sandoz, the following side effects may develop (according to the frequency of development, these adverse reactions are classified as follows: more than 10% - very frequent; 1-10% - frequent; 0.1-1% - infrequent; 0.01-0, 1% - rare; less than 0.01% - very rare):

• blood and lymphatic system: often - eosinophilia, leukopenia; rarely - neutropenia, agranulocytosis, thrombocytopenia; very rarely - anemia (including hemolytic), pancytopenia, thrombocytopenic purpura;
• nervous system: often - drowsiness, dizziness, headache; rarely - change in behavior, anxiety, agitation, sleep disturbance, anxiety, tremor, ataxia, paresthesia, peripheral neuropathy, confusion, nervousness, convulsions, depression; very rarely - impaired sense of smell, vision and tactile sensitivity, hyperesthesia, hallucinations;
• cardiovascular system: often - phlebitis, tachycardia; rarely - a decrease in blood pressure; very rarely - lengthening of the QT interval;
• gastrointestinal tract and liver: very often - change in taste, glossitis, stomatitis, dysbiosis; often - diarrhea, nausea, an increase in the concentration of bilirubin in the blood serum and liver parameters (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase); rarely - pain in the epigastric region, dyspepsia, vomiting, cholestatic jaundice, hepatitis; very rarely - the appearance of a black color of the tongue, diarrhea with an admixture of blood, pseudomembranous colitis, acute liver failure;
• skin and subcutaneous tissues: often - rash, pruritis; rarely - urticaria; very rarely - edema of the skin and mucous membranes, photosensitivity reactions, toxic epidermal necrolysis (Lyell's syndrome), malignant exudative erythema (Stevens-Johnson syndrome);
• endocrine system: rarely - anorexia; very rarely - hypoglycemia (especially in patients with diabetes mellitus);
• respiratory system: rarely - bronchospasm, dyspnea; very rarely - allergic pneumonitis;
• musculoskeletal system: rarely - tendon diseases (including tendonitis), myalgia, arthralgia; very rarely - muscle weakness, tendon rupture (sometimes bilateral), rhabdomyolysis;
• genitourinary system: rarely - interstitial nephritis, increased serum creatinine concentration;
• others: vaginal candidiasis, shortness of breath; rarely - a feeling of weakness, reactions similar to serum sickness, the development of superinfection (especially in persons with reduced body resistance and patients with chronic diseases); very rarely - fever, anaphylactic shock.

Overdose

Taking an excessive dose of Amoxicillin Sandoz can cause nausea, vomiting, diarrhea, water-electrolyte imbalance, crystalluria, epileptic seizures, and nephrotoxicity.

Therapeutic measures: taking activated carbon, prescribing symptomatic therapy, if necessary - carrying out hemodialysis, correction of violations of the water-electrolyte balance.

special instructions

A prerequisite for successful therapy is the sensitivity of the causative agent of the disease to the drug, therefore, prior to the appointment of Amoxicillin Sandoz, appropriate studies must be carried out.

In severe infectious and inflammatory processes of the gastrointestinal tract, accompanied by constant diarrhea or vomiting, a significant decrease in the absorption of the drug and, as a result, a decrease in its effectiveness is possible, therefore, oral use of the antibiotic may be inappropriate.

In the case of mild diarrhea during the course of treatment, antidiarrheal drugs that reduce intestinal motility should not be taken. It is recommended to take preparations containing kaolin or attapulgite. If severe diarrhea develops, a doctor's consultation is required.

If severe persistent diarrhea occurs, it is necessary to discontinue Amoxicillin Sandoz and conduct appropriate studies to exclude the presence of pseudomembranous colitis caused by Clostridium difficile. It is contraindicated to take drugs that slow down intestinal motility.

With prolonged treatment, it is necessary to monitor blood counts, kidney and liver function.

Patients with bronchial asthma, allergic diathesis, and a history of colitis associated with the use of antibiotics should be especially careful during the period of therapy. With prolonged treatment, Amoxicillin Sandoz should be used in combination with levorin, nystatin, or other antifungal agents.

Patients with hypersensitivity to penicillins are at risk of developing cross-allergic reactions with other beta-lactam antibiotics.

For acute respiratory viral infections, Amoxicillin Sandoz is ineffective, therefore it is not recommended for use.

Women taking estrogen-containing oral contraceptives should use other or additional methods of contraception during antibiotic therapy.

While taking Amoxicillian Sandoz, there are no changes in the results of the enzymatic analysis of glucosuria, however, it is possible to obtain false-positive reactions of urine analysis for glucose.

During the period of therapy, it is necessary to ensure an abundant flow of fluid into the body in order to prevent the formation of amoxicillin crystals in the urine. It is not recommended to consume alcoholic beverages.

Due to the growth of insensitive microflora, the development of superinfection is possible. In this case, a change in the antibiotic therapy regimen is required.

Influence on the ability to drive vehicles and complex mechanisms

Amoxicillin Sandoz in some cases causes side effects that affect the speed of reactions and the ability to concentrate (headache, drowsiness, confusion). In this regard, it is recommended to observe safety precautions when driving a car and engaging in potentially hazardous activities.

Application during pregnancy and lactation

In animal studies, it was found that amoxicillin does not have mutagenic, teratogenic and embryotoxic effects. However, in pregnant women, adequate and strictly controlled studies have not been conducted, therefore the use of Amoxicillin Sandoz is possible only in cases where the expected benefits outweigh the potential risks.

Amoxicillin passes into the mother's milk and can cause diarrhea in the infant, fungal colonization of the mucous membrane, the development of sensitization to beta-lactam antibiotics. If a woman is indicated for antibiotic therapy, she should stop breastfeeding.

Pediatric use

Due to the solid dosage form, Amoxicillin Sandoz tablets 1 g and 0.5 g are not prescribed for children under 3 years old, in children from 3 years old they are used with caution.

With impaired renal function

In case of renal failure, the drug must be used with caution, correction of the dosage regimen is required.

For violations of liver function

The dose of Amoxicillin Sandoz in liver failure does not need to be adjusted, however, with prolonged treatment, liver function should be monitored.

Use in the elderly

For the elderly, Amoxicillin Sandoz is prescribed in the usual doses recommended for adult patients.

Drug interactions

• other bacteriostatic agents (chloramphenicol, tetracyclines, macrolides, sulfonamides): antagonism may develop, when combined with aminoglycosides - a synergistic effect (it is recommended to avoid these combinations);
• digoxin: the time of its absorption may increase;
• probenecid: the excretion of amoxicillin by the kidneys decreases, and its concentration in the blood and bile increases;
• disulfiram: the risk of developing allergic reactions increases (their combined use should be avoided);
• ascorbic acid: absorption of amoxicillin is enhanced;
• glucosamine, laxatives, aminoglycosides, antacids: absorption of amoxicillin slows down;
• allopurinol: increased risk of skin rash;
• nonsteroidal anti-inflammatory drugs, diuretics, oxyfenbutazone, allopurinol, phenylbutazone and other drugs that block tubular secretion: the plasma concentration of amoxicillin increases;
• methotrexate: its toxicity may increase;
• estrogen-containing oral contraceptives: their effectiveness decreases;
• ethinyl estradiol: the likelihood of breakthrough bleeding increases;
• indirect anticoagulants: their effect is enhanced (due to the suppression of intestinal microflora, a decrease in the synthesis of vitamin K and the prothrombin index).

Analogs

Analogs of Amoxicillin Sandoz are: Lancid Kit, Amoxivan, Augmentin, Betaklav, Rapiklav, Medoklav, Foraklav, Panklav, Amoxisar, Amosin, Danemox, Gonoform, Ospamox, Ecobol, Ampicillin, Penodil, Maripen, Pensilina, etc.

Terms and conditions of storage

Store at temperatures up to 25 ° C out of reach of children.

Shelf life is 4 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of Amoxicillin Sandoz

According to reviews, Amoxicillin Sandoz is an effective antibiotic that is highly active in diseases caused by microorganisms sensitive to the drug, including Helicobacter pylori. The tablets are conveniently shaped, therefore easy to swallow. Amoxicillin Sandoz is generally well tolerated and affordable.

The price of Amoxicillin Sandoz in pharmacies

Depending on the pharmacy network, the price of Amoxicillin Sandoz 0.5 g per pack of 12 tablets is 119-138 rubles. You can buy a package (12 tablets) of Amoxicillin Sandoz 1 g for 159-176 rubles.

Amoxicillin Sandoz: prices in online pharmacies

Drug name Price Pharmacy

Amoxicillin Sandoz 500 mg film-coated tablets 12 pcs. RUB 97 Buy

Amoxicillin Sandoz tablets p.o. 500mg 12 pcs. 110 RUB Buy

Amoxicillin Sandoz 1 g film-coated tablets 12 pcs. 143 r Buy

Amoxicillin Sandoz tablets p.o. 1g 12 pcs. 146 r Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!