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

active substance: Ampicillin trihydrate (in terms of ampicillin) - 250 mg; Excipients: calcium stearate - 3.8 mg, talc - 2.85 mg, potato starch - sufficient amount to obtain a tablet weighing 380 mg.

Description:Tablets are white, flat-cylindrical, with a risk and facet.

Pharmacotherapeutic group:Antibiotic, penicillin semisynthetic

ATX: & nbsp

J.01.C.A Penicillins of a wide spectrum of action

J.01.C.A.01 Ampicillin

Pharmacodynamics:

Semisynthetic penicillin of a broad spectrum of action, bactericidal. Acid-resistant. Suppresses the synthesis of the bacterial cell wall. It is active against Gram-positive (alpha and beta-hemolytic streptococci, Streptococcus pneumoniae, Staphylococcus spp., Bacillus anthracis, Clostridium spp., moderately active against the majority Enterococcus spp., in t.ch. Enterococcus faecalis, Listeria spp.) and gram-negative (Haemophilus influenzae, Neisseria meningitidis, Neisseria gonorrhoeae (strains not producing penicillinase), Proteus mirabilis, Yersinia multocida (formerly Pasteurella), many species Salmonella spp., Shigella spp., Escherichia coli) microorganisms.

Ineffective against penicillinase-producing strains Staphylococcus spp., all strains Pseudomonas aeruginosa, most strains Klebsiella spp. and Enterobacter spp.

Pharmacokinetics:Absorption after oral administration - fast, high, bioavailability - 40%; time to reach the maximum concentration in the blood serum by oral intake of 500 mg - 2 hours, the maximum concentration - 3-4 μg / ml. Connection with plasma proteins - 20%. Half-life is 1-2 hours. It is evenly distributed in the organs and tissues of the body, it is found in therapeutic concentrations in pleural, peritoneal, amniotic and synovial fluids, cerebrospinal fluid, blistering matter, urine (high concentrations), intestinal mucosa, bones, gall bladder, lungs, tissues of female genital organs, bile, in bronchial secretion (in the purulent bronchial secretion the accumulation is weak), paranasal sinuses, middle ear fluid (with its inflammation), saliva, fetal tissues. Poorly penetrates the blood-brain barrier (permeability increases with inflammation of the meninges). It is excreted mainly by the kidneys (70-80%), in the urine very high concentrations of the unchanged antibiotic are created; partially - with bile, in nursing mothers - with milk. Do not cumulate. Removed during hemodialysis.

Indications:

Bacterial infections caused by susceptible to ampicillin pathogens: respiratory tract and ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media, bronchitis, pneumonia, lung abscess), infections of the kidneys and urinary tract (pyelonephritis, pyelitis, cystitis, urethritis), gonorrhea, infection of the biliary system (cholangitis, cholecystitis), cervicitis, skin and soft tissue infections: erysipelas, impetigo, secondarily infected dermatoses; infections of the musculoskeletal system; infections of the gastrointestinal tract (typhoid fever and paratyphoid, dysentery, salmonellosis, salmonella carcinoma).

Contraindications:

Hypersensitivity to ampicillin (including other penicillins, cephalosporins, carbapenems) and other components of the drug, infectious mononucleosis, lymphocytic leukemia, hepatic insufficiency, history of the gastrointestinal tract (especially colitis associated with the use of antibiotics), lactation , children under 3 years of age with a body weight of less than 20 kg (for this dosage form).

Carefully:Bronchial asthma, pollinosis and other allergic diseases, renal failure, history of bleeding, pregnancy.

Pregnancy and lactation:

Contraindicated in the period of lactation.

During pregnancy, use the drug only in those cases where the intended benefit to the mother exceeds the possible risk to the fetus.

Dosing and Administration:

Inside for 0,5-1 h before meals with a little water, adults and children weighing over 20 kg - 250-500 each mg every 6 hours. The maximum daily dose is 4000 mg / day.

With gonococcal urethritis - 3500 mg once.

The duration of treatment depends on the severity of the disease (from 5-10 days to 2-3 weeks, and in chronic processes - for several months).

Side effects:

Allergic reactions: itching and flaky skin, urticaria, rhinitis, conjunctivitis, angioedema, fever, arthralgia, eosinophilia, erythematous and maculopapular rash, exfoliative dermatitis, multiform exudative erythema (including Stevens-Johnson syndrome), reactions similar to serum sickness, anaphylactic shock, non-allergic ampicillin rash, can disappear without drug withdrawal.

From the digestive system: dysbacteriosis, stomatitis, gastritis, dry mouth, taste change, abdominal pain,vomiting, nausea, diarrhea, stomatitis, glossitis, impaired liver function, moderate increase in the activity of "liver" transaminases, pseudomembranous colitis.

From the central nervous system: agitation or aggressiveness, anxiety, confusion, behavior change, depression, convulsions (with high-dose therapy).

Laboratory indicators: leukopenia, neutropenia, thrombocytopenia, agranulocytosis, anemia.

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

Overdose:

Symptoms: manifestations of toxic effects on the central nervous system (especially in patients with renal insufficiency); nausea, vomiting, diarrhea, violation of water-electrolyte balance (as a consequence of vomiting and diarrhea).

Treatment: gastric lavage, Activated carbon, saline laxatives, medicines to maintain the water-electrolyte balance and symptomatic. It is excreted by hemodialysis.

Interaction:

Antacids, glucosamine, laxative drugs, food and aminoglycosides (with enteral administration) 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 (it is necessary to use additional methods of contraception), drugs that metabolize para- aminobenzoic acid (PABA), ethinyl estradiol (in the latter case, the risk of bleeding "breakthrough" increases).

Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion, increase the concentration of ampicillin in the plasma (by reducing tubular secretion).

Allopurinol increases the risk of skin rash.

Reduces clearance and increases the toxicity of methotrexate.

Special instructions:

At 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. With the appointment of patients with sepsis, the development of a bacteriolysis reaction (the Yarisch-Gerxheimer reaction) is possible.

With a mild infection in children, it is preferable to prescribe the drug in the form of a suspension.

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 caused by Clostridium difficile, arising against the background of course treatment should be avoided anti-diarrheal drugs that reduce intestinal peristalsis; You can use kaolin- or attapulgite-containing antidiarrhoeal drugs, the withdrawal of the drug is indicated. When severe diarrhea should be referred to a doctor.

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

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

Does not affect.

Form release / dosage:

Tablets 250 mg.

Packaging:

10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil. Two contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Packaging for hospitals: 150, 240 contour packs with an equal number of instructions for use are placed in cardboard boxes.

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:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001047

Date of registration:10.08.2010 / 28.04.2016

Expiration Date:Unlimited

The owner of the registration certificate:BELMEDPREPARATY, RUP BELMEDPREPARATY, RUP Republic of Belarus

Manufacturer: & nbsp

BELMEDPREPARATY, RUP Republic of Belarus

Information update date: & nbsp21.08.2017

Illustrated instructions

Instructions

Ampicillin (Ampicillin)