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

Excipients: cellulose microcrystalline, silicon dioxide, magnesium stearate, corn starch, sodium lauryl sulfate, sodium carboxymethyl starch, talc purified.

Composition of the film shell: hypromellose, propylene glycol, titanium dioxide.

Description:

Tablets are white or almost white in color, oval in shape, covered with a film membrane. On one side engraving NP on the background of a tree, on the other side a dividing strip.

Pharmacotherapeutic group:Antibiotic, penicillin semisynthetic

ATX: & nbsp

J.01.C.A.04 Amoxicillin

Pharmacodynamics:

Antibacterial preparation of a wide spectrum of action.

Inhibits transpeptidase, breaks the synthesis of peptidoglycan (supporting polymer 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.; aerobic gram-negative bacteria: Neisseria gonorrhea, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp. The microorganisms 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, at a dose of 250 mg, the maximum concentration in the serum is 3.5-5 μg / ml. Time to reach the maximum concentration after oral intake - 1-2 hours. Has a large volume of distribution - high concentrations are found in plasma, sputum, bronchial secretion (in the purulent bronchial secretion is weak), pleural and peritoneal fluid, urine, skin blisters, lung tissue , intestinal mucosa, 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% of the level in the plasma. 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% by kidneys in the unaltered form by tubular excretion (80%) and by glomerular filtration (20%), by the liver - by 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:

Infectious-inflammatory diseases caused by sensitive microflora: 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 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, 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; with a severe course of infection 0.75-1 g 3 times a day.

Children aged 5-10 years - 0.25 g; with a heavy 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 administration 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 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, hyperemia of the skin, erythema, angioedema, rhinitis, conjunctivitis; rarely - fever, joint pain, eosinophilia, exfoliative dermatitis,multiforme exudative erythema (Stevens-Johnson syndrome); reactions similar to serum sickness; in isolated cases - anaphylactic shock.

From the gastrointestinal tract: dysbacteriosis, taste change, nausea, vomiting, diarrhea, stomatitis, glossitis, impaired liver function, moderate increase in the 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, vaginal candidiasis, 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 the concentration of amoxicillin in the blood serum.

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.

Perhaps the development of 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.

In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

In the treatment of mild diarrhea against the background of course treatment should be avoided anti-diarrheal drugs that reduce peristalsis of the intestine; it is possible to use kaolin- or attapulgite-containing antidiarrhoeic agents. With severe diarrhea, you need to 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.

Form release / dosage:

Tablets, film-coated, 500 mg.

Packaging:For 10, 20 tablets in a PVC / A1 blister. By 1,2, 3, 4, 5 blisters in a cardboard box with instructions for use.

Storage conditions:

At a temperature not above 25 ° C, in a dry, protected from light place.

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:П N014454 / 02

Date of registration:13.10.2008

Expiration Date:Unlimited

Date of cancellation:2017-03-02

The owner of the registration certificate:Natur Product Europe BVNatur Product Europe BV Netherlands

Manufacturer: & nbsp

NATUR PRODUKT EUROPE, B.V. Netherlands

Information update date: & nbsp19.08.2017

Illustrated instructions

Instructions

Amoxicillin (Amoxicillin)