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

Excipients: Talc - 3.70 mg (for 250 mg) or 7.00 mg (for 500 mg); Magnesium stearate - 3.70 mg (for 250 mg) or 7.00 mg (for 500 mg); Potato starch - to obtain a tablet weighing 370 mg (for 250 mg) or 700 mg (for 500 mg).

Description:

Tablets are white or almost white in color, capsular shaped, with a risk on one side.

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. The time to reach the maximum concentration after oral administration is 1-2 hours. It 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 , intestinal mucosa, female genitalia, prostate gland, middle ear fluid, bone, adipose tissue, gall bladder (with normal function liver), the tissues of the fetus. With an increase in the dose of 2 times the concentration is also! increases by 2 times. 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 penetrates the blood-brain barrier, with inflammation of the meninges (meningitis), the concentration in the cerebrospinal fluid is about 20 %. 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 unchanged form by tubular excretion (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 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) (bile duct, impetigo, secondarily infected dermatosis), leptospirosis, listeriosis, Lyme disease (borreliosis), dysentery, salmonellosis, salmonellosis, meningiosis ngitis, endocarditis (prophylaxis), sepsis.

Contraindications:

Hypersensitivity (incl.to other penicillins, cephalosporins, carbapenems). Children up to 10 years.

Carefully:

Pregnancy, lactation, allergic diseases (including history), renal, hepatic insufficiency, infectious mononucleosis, lymphatic leukemia, history of the gastrointestinal tract (especially colitis associated with the use of antibiotics), bleeding in the anamnesis.

Pregnancy and lactation:

The use of the drug during pregnancy and lactation is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

Amoxicillin is excreted in breast milk, so if it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Inside, before or after eating, the tablet can be swallowed whole, divided into parts or chewed, washed down with a glass of water.

Adults and children over 10 years of age (with a body weight of more than 40 kg) are prescribed 500 mg 3 times a day; when the infection is severe - 750-1000 mg 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 - 1500-2000 mg 3 vase per day or 1000-1500 mg 4 times a day.

When leptospirosis adults - 500-750 mg 4 times a day for 6-12 days.

With salmonella carrying adults - 1500-2000 mg 3 times a day for 2-4 weeks.

For the prevention of endocarditis in small surgical interventions for adults - 3000-4000 mg for 1 hour 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 hepatic 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 2000 mg / day.

Side effects:

Allergic reactions: hives, skin flushing, erythema, angioedema, rhinitis, conjunctivitis; rarely - fever, bs5li in joints, eosinophilia, exfoliative dermatitis, polymeric exudative erythema, 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, 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 (incl.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.

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

In the treatment of mild diarrhea against the background of course treatment, antidiarrheal drugs should be avoided, which reduce intestinal peristalsis; 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:During the use of the drug, patients should be very careful to drive and engage in other potentially hazardous activities, due to possible adverse reactions from the nervous system, such as dizziness, agitation, behavioral disorders.

Form release / dosage:

Tablets of 250 mg and 500 mg.

Packaging:When manufacturing at JSC "AVVA RUS":

10 tablets per contour cell pack.

1 or 2 contour squares, together with instructions for use, are placed in a pack of cardboard.

In production at PJSC "Biokhimik":

10 tablets per contour cell pack.

For 20 tablets in a jar glass. Each jar, 1 or 2 contour mesh packages together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

In a dry, protected from light 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-001745/09

Date of registration:10.03.2009 / 28.06.2017

Expiration Date:Unlimited

The owner of the registration certificate:EN.S. PHARM, LTD. EN.S. PHARM, LTD. Russia

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

BIOCHEMIST, OJSC Russia

Information update date: & nbsp19.08.2017

Illustrated instructions

Instructions

Amoxicillin (Amoxicillin)