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

Excipients: potato starch - 0.086479 g or 0.1366 g, low molecular weight polyvinylpyrrolidone medical (povidone) - 0.0192 g, or 0.0363 g talc - 0.010621 g or 0.0201 g of magnesium stearate - 0.0037 g or 0.007 g, respectively.

Description:Tablets are white or almost white in color, flat-cylindrical, with a facet and a risk.

Pharmacotherapeutic group:Antibiotic, penicillin semisynthetic

ATX: & nbsp

J.01.C.A.04 Amoxicillin

Pharmacodynamics:

Antibacterial bactericidal acid-resistant broad spectrum agent from the group of semisynthetic penicillins. It inhibits transpeptidase, breaks the synthesis of peptidoglycan (the supporting protein of the cell wall) in the period of division and growth, causes bacterial lysis. It is active against aerobic gram-positive bacteria: Staphylococcus spp. (with the exception of strains producing penicillinase), Streptococcus spp; and aerobic Gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp. The microorganisms producing penicillinase are resistant to the action of amoxicillin.The action develops 15-30 minutes after administration and lasts 8 hours.

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 the form of a suspension (or tablets) at a dose of 125 and 250 mg, the maximum concentration is 1.5-3 μg / ml and 3.5-5 μg / ml, respectively. Time to reach maximum concentration after oral administration - 1-2 hours. Has a large volume of distribution - high concentrations are found in plasma, sputum, bronchial secretion (in the purulent bronchial secretion the distribution is weak), pleural and peritoneal fluid, urine, skin blisters, lung tissue, mucosa intestinal membrane, female genital organs, prostate gland, middle ear fluid, 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 (meningitis) concentration in the cerebrospinal fluid - about 20%.Connection with plasma proteins -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 excretion (80 %) and glomerular filtration (20%), the 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 less than or equal to 15 ml / min), the elimination half-life increases to 8.5 hours. Amoxicillin is removed during hemodialysis.

Indications:

Bacterial infections caused by sensitive microflora: infections of the respiratory tract and ENT organs (sinusitis, pharyngitis, tonsillitis, acute otitis media, bronchitis, pneumonia), urogenital system (pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, endometritis, cervicitis) (peritonitis, enterocolitis, typhoid fever, cholangitis, cholecystitis), skin and soft tissue infections (erysipelas, impetigo, secondarily infected dermatoses, leptospirosis, listeriosis, Lyme disease (borreliosis), dysentery, salmonellosis, salmonella, menin um, endocarditis (prophylaxis), septicemia.

Contraindications:

Hypersensitivity (including to other penicillins, cephalosporins, carbapenems), allergic diathesis, bronchial asthma, pollinosis, infectious mononucleosis, lymphocytic leukemia, liver failure, history of gastrointestinal disease (especially colitis associated with the use of antibiotics), period lactation.

Carefully:

Pregnancy, renal insufficiency, bleeding history, allergic reactions (including in the anamnesis).

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 - 0.75-1 g 3 times a day.

Children are prescribed as a suspension: at the age of 5-10 years - 0.25 g; 2-5 years - 0.125 g; younger than 2 years - 20 mg / kg 3 times a day; in severe infection - 60 mg / kg 3 times a day.

In preterm and newborns, the dose is reduced and / or the interval between doses is increased. 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 fever) and biliary tract, gynecological infections adults - 1.5-2 g three times a day, or 1-1.5 g 4 times a day.

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

When salmonellosis to adults - 1.5-2 g 3 times a day for 2-4 weeks.

For the prevention 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 creatinine clearance is less than 10 ml / min, the dose is reduced by 15-50%; with anuria - the maximum dose of 2 g / day.

Side effects:

Allergic reactions: hives, skin flushing, erythema, angioedema, rhinitis, conjunctivitis; rarely - fever, joint pain, eosinophilia, exfoliative dermatitis, erythema poliformnaya, Stevens - Johnson; reactions similar to serum sickness; in isolated cases - anaphylactic shock.

From the digestive system: dysbacteriosis, taste change, vomiting,nausea, diarrhea, stomatitis, glossitis, hepatic dysfunction, a moderate increase in activity of "liver" transaminases, 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, Candidiasis of the vagina, superinfection (especially in patients with chronic diseases or reduced resistance of the body).

Overdose:

Symptoms include nausea, vomiting, diarrhea, disruption of water and electrolyte balance (as a result of vomiting and diarrhea). Treatment: gastric lavage, Activated carbon, salt laxatives, preparations 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, cycloserine, vancomycin, rifampicin) - synergistic effect; bacteriostatic drugs (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".

Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, non-steroidal anti-inflammatory drugs; drugs that block tubular secretion - reducing tubular secretion, increase concentration.

Allopurinol increases the risk of skin rash.

Reduces clearance and increases the toxicity of methotrexate.

Increases the absorption of digoxin.

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.

In the treatment of patients with bacteremia, the development of a bacteriolysis reaction (the Yarisch-Gerxheimer reaction) is possible.

Have patients with increased sensitivity to penicillins may have cross-allergic reactions with cephalosporin antibiotics.

When treatment of mild diarrhea against the background of course treatment should be avoided antidiarrheal drugs that reduce intestinal motility; it is possible to 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.

With the simultaneous use of estrogen-containing oral contraceptives and amoxicillin, 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:

Tablets of 250 mg and 500 mg.

Packaging:

10 tablets per contour cell pack.

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.

He use after the expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-002643

Date of registration:28.09.2011 / 17.07.2014

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)