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

For a dosage of 250 mg: Capsule number 0: titanium dioxide - 2%, gelatin to 100%. For a dosage of 500 mg: Capsule number 0: azorubin E 122-0.2%, quinoline yellow E 104-0.4%, titanium dioxide-1.3333%, gelatin up to 100%. Capsule №00: azorubin E 122-0.2%, quinoline yellow E 104-0.4%, titanium dioxide-1.3333%, gelatin up to 100%.

Description:

Hard gelatin capsules.

For dosage of 250 mg of capsule No. 0 with a white body and a lid of white color. For the dosage of 500 mg of capsule No. 0 or No. 00 with a white body and a lid of a red color. The contents of the capsules are a granular powder of white or white with a yellowish hue.

Pharmacotherapeutic group:Antibiotic, penicillin semisynthetic

ATX: & nbsp

J.01.C.A.04 Amoxicillin

Pharmacodynamics:

Bactericidal broad-spectrum antibiotic from the group of semisynthetic penicillins. 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 administered orally in a dose 125 and 250 mg the maximum concentration is 1.5-3 and 3.5-5 μg / ml, respectively. 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, skin blisters, lung tissue, intestinal mucosa, female genital organs, prostate gland, fluid of the middle ear (with its inflammation), bones, 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 the pregnant woman: Poorly penetrates 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. The elimination half-life is 1-1.5 hours. It is output on 50-70 % kidneys in unchanged form (by tubular secretion - 80 % and glomerular filtration - 20%), liver - 10-20%. In small amounts excreted in breast milk. Half-life in preterm, newborns and children up to 6 months is 3-4 hours. If renal function is impaired (creatinine clearance is 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 sensitive pathogens: infections of the lower respiratory tract (bronchitis, pneumonia) and ENT organs (sinusitis, pharyngitis, tonsillitis, acute otitis media), urogenital system (pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, endometritis, cervicitis ), the gastrointestinal tract (cholangitis, cholecystitis, dysentery, salmonellosis, salmonella carcinoma), infections of the skin and soft tissues (face, impetigo,secondarily infected dermatoses), leptospirosis, listeriosis, Lyme disease (borreliosis), meningitis, endocarditis (prophylaxis).

Contraindications:

Hypersensitivity (including to other penicillins, cephalosporins, carbapenems), children under 5 years (for this dosage form).

Carefully:Allergic diseases (including history), diseases of the gastrointestinal tract in history (especially colitis, associated with the use of antibiotics), kidney failure, severe liver problems, pregnancy, lactation, infectious mononucleosis, lymphatic leukemia.

Pregnancy and lactation:

The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Inside. 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 - 0.75-1 g 3 times a day.

Children aged 5-10 years are prescribed 0.25 g three times a day; in severe infection - 60 mg / kg 3 times a day.

The course of treatment is 5-12 days.

In acute uncomplicated gonorrhea appoint 3 g once; in the treatment of women, repeated intake of this dose is recommended.

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

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

With salmonella carrying adults -1.5-2 g 3 times a day for 2-4 weeks.

For prophylaxis of endocarditis with small surgical interventions, 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 2 times.

In patients with impaired renal function with QC 15-40 ml / min, the interval between doses is increased to 12 h; at CC below 10 ml / min the dose is reduced by 15-50%; with anuria - the maximum dose of 2 g / day.

Side effects:

Allergic reactions: possible urticaria, skin hyperemia, erythematous rashes, angioedema, rhinitis, conjunctivitis; rarely - fever, arthralgia, eosinophilia, exfoliative dermatitis, multiform exudative erythema (including 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: excitement, 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 low resistance body).

Overdose:

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

Treatment: gastric lavage, Activated carbon, saline laxatives,

medicines for maintaining the water-electrolyte balance; hemodialysis.

Interaction:

Antacids, glucosamine, laxatives, food, aminoglycosides slow down and reduce absorption; ascorbic acid increases absorption. Bactericidal antibiotics (including aminoglycosides, cephalosporins, 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; drugs, in the process of metabolism of which forms para-aminobenzoic acid, 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.

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, antidiarrheal drugs should be avoided, which reduce intestinal peristalsis; can use kaolin- or attapulgite-containing antidiarrhoeic agents. 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.

Effect on the ability to drive transp. cf. and fur:

Data on the adverse effects of Amoxicillin at recommended doses on the rate of psychomotor reactions and concentration of attention are not available.However, given the possible side effects from the central nervous system, care should be taken when managing vehicles and other mechanisms.

Form release / dosage:

Capsules 250 mg, 500 mg.

Packaging:For 8 or 10 capsules in a wide or narrow contour mesh box made of polyvinylchloride film and aluminum foil. For 1 or 2 contour mesh packages along with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006129/08

Date of registration:01.08.2008 / 20.05.2014

Expiration Date:Unlimited

The owner of the registration certificate:Barnaul Plant of Medical Preparations, LLC Barnaul Plant of Medical Preparations, LLC Russia

Manufacturer: & nbsp

Barnaul Plant of Medical Preparations, LLC Russia

Information update date: & nbsp19.08.2017

Illustrated instructions

Instructions

Amoxicillin (Amoxicillin)