Amoxicillin DS - instructions for use, dose, side effects, contraindications

Capsule cap: gelatin, silicon dioxide, sodium lauryl sulfate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerin, acetic acid, titanium dioxide, brilliant blue, red charming, dye azorubin, quinoline yellow.

Capsule body: gelatin, silicon dioxide, sodium lauryl sulfate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerin, acetic acid, titanium dioxide, brilliant blue, red charming, dye azorubin, quinoline yellow.

Description:

For a dosage of 250 mg Hard capsules No. 2 with a yellow body and a lid of bright red color. For a dosage of 500 mg Hard capsules No. 0 with a yellow body and a lid of bright red color. The contents of the capsules are a granular powder from white to white with a yellowish hue of color.

Pharmacotherapeutic group:Antibiotic, penicillin semisynthetic

ATX: & nbsp

J.01.C.A.04 Amoxicillin

Pharmacodynamics:

Amoxicillin is a semisynthetic antibiotic of the third generation of penicillins. It has bactericidal action, has a wide spectrum of action. Violates the synthesis of peptidoglycan (supporting polymer of the cell wall) in the period of division and growth, causing bacterial lysis.

It is active against aerobic Gram-positive microorganisms: Staphylococcus spp. (with the exception of strains producing penicillinase), Streptococcus spp. and aerobic gram-negative microorganisms: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp. Strains producing penicillinase are resistant to the action of amoxicillin.

Pharmacokinetics:

Absorption - fast, high (93%), food intake does not affect absorption, does not break down in the acidic environment of the stomach. When taken orally, in a dose of 250 mg, the maximum concentration in the serum is 3.5-5 μg / ml. The time to reach the maximum concentration after oral administration is 1 -2 hours. It has a large volume of distribution: in high concentrations it is found in plasma, sputum, bronchial secretion (in the purulent bronchial secretion the distribution is weak), pleural and peritoneal fluid, urine, contents of skin blisters, lung tissue, intestinal mucosa, female genital organs,prostate gland, middle ear fluid (with its inflammation), bone, adipose tissue, gall bladder (with normal liver function), fetal tissues. When the dose is doubled, the concentration also doubles. Concentration in bile exceeds the concentration in plasma by 2-4 times. In amniotic fluid and vessels of the umbilical cord, the concentration of amoxicillin is 25-30% of the level in the plasma of a pregnant woman. Poor penetration of the blood-brain barrier, with inflammation of the meninges, the concentration in the cerebrospinal fluid is about 20% of the plasma level. The connection with plasma proteins is 17%.

Partially metabolized with the formation of inactive metabolites. Half-life is 1-1.5 hours. It is excreted by 50-70% kidneys in unchanged form (by tubular secretion - 80% and glomerular filtration - 20%), liver - 10-20%. In small amounts excreted in breast milk. If the kidney function is impaired (creatinine clearance less than or equal to 15 ml / min), the elimination half-life increases to 8.5 hours. Amoxicillin is removed during hemodialysis.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation: respiratory tract infections and ENT organs (sinusitis, pharyngitis, tonsillitis, acute otitis media, bronchitis, pneumonia), genitourinary system (pyelonephritis,pyelitis, cystitis, urethritis, gonorrhea, endometritis, cervicitis), gastrointestinal tract (enterocolitis, typhoid fever, cholangitis, cholecystitis), skin and soft tissue infections (erysipelas, impetigo, secondarily infected dermatoses), Leptospirosis, listeriosis, Lyme disease borreliosis), dysentery, salmonellosis, salmonella, endocarditis (prophylaxis).

Contraindications:

Hypersensitivity (including to other penicillins, cephalosporins, carbapenems), children under 10 years of age and / or body weight less than 40 kg (for this dosage form).

Carefully:

Allergic reactions (including in the anamnesis), infectious mononucleosis, gastrointestinal diseases in the anamnesis (especially colitis associated with the use of antibiotics), renal failure, severe violations of the liver, lymphocytic leukemia.

Pregnancy and lactation:

The use of amoxicillin during pregnancy is only permissible if the intended benefit to the mother exceeds the potential risk to the fetus. If necessary, the appointment in the lactation period should resolve the issue of stopping breastfeeding.

Dosing and Administration:

Inside, before or after eating.

Adults and children over 10 years of age (with a body weight of more than 40 kg) are prescribed 0.5 g 3 times a day; In severe infection, the maximum daily dose can be increased to 6 g.

The course of treatment is 5-12 days.

In acute uncomplicated gonorrhea appoint 3 g once.

In acute infectious diseases of the gastrointestinal tract and biliary tract, with gynecological infectious diseases - 1.5-2 g 3 times a day or 1-1.5 g 4 times a day.

With leptospirosis - 0.5-0.75 g 4 times a day for 6-12 days.

With salmonella bearers, 1.5-2 g 3 times a day for 2-4 weeks.

With Borreliosis - 0.5-1 g 3 times a day.

For prophylaxis of endocarditis with small surgical interventions for adults - 3-4 g for 1 h before the procedure. If necessary, appoint a second dose after 8-9 hours. In children, the dose is reduced by half.

In patients with impaired renal function with creatinine clearance of 15-40 ml / min, the interval between doses is increased to 12 h; when the creatinine clearance is less than 10 ml / min, the dose is reduced by 15-20%; with anuria - the maximum dose of 2 g / day.

Side effects:

Allergic reactions: hives, skin flushing, erythematous rashes, angioedema, rhinitis, conjunctivitis; rarely - fever, arthralgia, eosinophilia, exfoliative dermatitis, multiform exudative erythema (incl.Stevens-Johnson syndrome); reactions similar to serum sickness; in isolated cases - anaphylactic shock.

From the digestive system: dysbacteriosis, taste change, vomiting, nausea, diarrhea, stomatitis, glossitis, moderate increase in the activity of "liver" transaminases; rarely - pseudomembranous enterocolitis.

From the nervous system: agitation, anxiety, insomnia, ataxia, confusion, behavior change, depression, peripheral neuropathy, headache, dizziness, convulsive reactions.

Laboratory indicators: leukopenia, neutropenia, thrombocytopenic purpura, anemia.

Other: shortness of breath, tachycardia, interstitial nephritis, vaginal candidiasis, superinfection (especially in patients with chronic diseases or reduced resistance of the body).

Overdose:

Symptoms: nausea, vomiting, diarrhea, violation of water-electrolyte balance (as a consequence of vomiting and diarrhea).

Treatment: gastric lavage, Activated carbon, salt laxatives, medicines to maintain the water-electrolyte balance; hemodialysis.

Interaction:

Antacids, glucosamine, laxative drugs, aminoglycosides slow down and reduce absorption; ascorbic acid increases absorption. Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic medicinal products (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic.

Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index); reduces the effectiveness of estrogen-containing oral contraceptives; medicines, in the process of metabolism of which parahaminobenzoic acid is formed, ethinyl estradiol - the risk of bleeding "breakthrough".

Amoxicillin reduces clearance and increases the toxicity of methotrexate; increases absorption of digoxin.

Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion, increase the concentration of amoxicillin in the blood serum. Allopurinol increases the risk of skin rash.

Special instructions:

In course treatment it is necessary to monitor the status of the functions of the organs of hematopoiesis, liver and kidneys.

It is possible to develop superinfection due to the growth of insensitive microflora, which requires a corresponding change in antibacterial therapy.

When appointing patients with sepsis, the development of a bacteriolysis reaction (the Yarisch-Gerxheimer reaction) is possible (rarely).

In patients who have increased sensitivity to penicillins, there may be cross-allergic reactions with other beta-lactam antibiotics. In the treatment of mild diarrhea against the background of course treatment, anti-diarrheal drugs should be avoided, which reduce intestinal peristalsis; it is possible to use kaolin- or attapulgite-containing antidiarrhoeal drugs. With severe diarrhea, you should see a doctor.

Treatment necessarily continues for another 48-72 hours after the disappearance of clinical signs of the disease.

When using estrogen-containing oral contraceptives and amoxicillin concomitantly, other or additional methods of contraception should be used whenever possible.

Form release / dosage:

Capsules 250 and 500 mg.

Packaging:10 capsules per blister of aluminum foil / PVC.1 or 2 blisters together with instructions for use in a cardboard box.

Storage conditions:

List B. Store in dry the dark place at a temperature of no higher than 30 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-007828/08

Date of registration:06.10.2008

Expiration Date:Unlimited

The owner of the registration certificate:Mekofar Chemical-Pharmaceutical Joint Stock CompanyMekofar Chemical-Pharmaceutical Joint Stock Company Vietnam

Manufacturer: & nbsp

MEKOPHAR CHEMICAL-PHARMACEUTICAL, Joint Stock Company Vietnam

Information update date: & nbsp19.08.2017

Illustrated instructions

Instructions

Amoxicillin DS (Amoxicillin DS)