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

It is active against Gram-positive (alpha and beta-hemolytic streptococci, Streptococcus pneumoniae, Staphylococcus spp., Bacillus anthracis, Clostridium spp.). Moderately active against most enterococci, incl. Enterococcus faecalis, Listeria spp., and gram-negative (Haemophilus influenzae, Neisseria meningitidis, Neisseria gonorrhoae, Proteus mirabilis, Yersinia multocida (formerly Pasteurella), many species Salmonella spp., Shigella spp., Escherichia coli) microorganisms, aerobic non-spore-forming bacteria.

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

Pharmacokinetics:

Absorption after oral administration is rapid, high, bioavailability - 40%; the time to reach the maximum concentration when taking 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, contents of blisters, urine (high concentrations), intestinal mucosa, bones, gall bladder, lungs, female genital tract, 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:

Infectious-inflammatory diseases caused by micro-organisms sensitive to ampicillin:

- respiratory tract and ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media, bronchitis, pneumonia, lung abscess);

- kidney and urinary tract (pyelonephritis, pyelitis, cystitis, urethritis);

- gonorrhea;

- bile ducts (cholangitis, cholecystitis);

- cervicitis;

- skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses);

- musculoskeletal system;

- Gastrointestinal tract (typhoid and paratyphoid, dysentery, salmonellosis).

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), the period of breastfeeding, children's age up to 3 years.

Carefully:

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

Pregnancy and lactation:

Use in pregnancy is possible when the intended benefit to the mother exceeds the potential risk to the fetus. Ampicillin is excreted in breast milk in low concentrations. If you need to use ampicillin during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Inside for 0.5-1 hour before meals with a little water.

Dosage regimen and duration of therapy are set individually depending on the severity of the course and localization of infection, the sensitivity of the pathogen to the drug (from 5-10 days to 2-3 weeks, and in chronic processes - for several months).

Adults and children from 3 years old with a body weight of more than 20 kg: on 0,25-0,5 g (1-2 tablets) every 6 hours. The maximum daily dose is 4 g.

Children from 3 years old with a body weight of up to 20 kg: appoint 12.5-25 mg / kg or 16.7-33.3 mg / kg every 8 hours.

With gonococcal urethritis - 3.5 g once.

Side effects:

From the digestive system: Dysbacteriosis, stomatitis, gastritis, dryness of the oral mucosa, taste changes, stomach ache, vomiting, nausea, diarrhea, glossitis, moderate increase in "liver" enzymes, pseudomembranous colitis.

From the central nervous system: headache, tremor, convulsions (with high-dose therapy).

Allergic reactions: itching and flaky skin, urticaria, rhinitis, conjunctivitis, angioedema, fever, arthralgia, eosinophilia, erythematous and maculopapular rash, exfoliative dermatitis, erythema multiforme exudative (including Stevens-Johnson syndrome), anaphylactic shock, reactions similar to serum sickness.

Other: interstitial nephritis, nephropathy, superinfection (especially in patients with chronic diseases or reduced resistance of the body), candidiasis of the vagina, rash (may disappear without discontinuing the drug).

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

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, salt laxatives, medicines to maintain the water-electrolyte balance and symptomatic. It is excreted by hemodialysis.

Interaction:

Antacids, glucosamine, laxatives, food and aminoglycosides 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 efficiency indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index).

Reduces efficiency estrogen-containing oral contraceptives (it is necessary to use additional methods of contraception), drugs, in the progress of metabolism of which is formed p-aminobenzoic acid, ethinyl estradiol (in the latter case, the risk of developing bleeding "breakthrough" is increased). Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion, increase the concentration of ampicillin in the plasma (due to a decrease in tubular secretion).

Allopurinol increases the risk of skin rash.

Reduces clearance and increases toxicity methotrexate.

Special instructions:

In the process of treatment, a systematic control of the kidneys, liver and peripheral blood picture is necessary. Patients with impaired renal function require a doctor recommended dosage adjustment in accordance with the values of creatinine clearance. It is possible to develop superinfection due to the growth of insensitive microflora, which requires a corresponding change in antibacterial therapy.

When using high doses in patients with renal insufficiency, a toxic effect on the central nervous system is possible.

With the use of ampicillin in patients with bacteremia (sepsis), a bacteriolysis reaction (the Yarisch-Gerxheimer reaction) is possible.

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.With severe diarrhea, you should see a doctor. Treatment should necessarily continue for another 48-72 hours after the disappearance of clinical signs of the disease.

At the first signs of an allergy the drug is canceled and desensitizing therapy is carried out.

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

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Tablets 250 mg.

Packaging:

For 10 tablets in a contoured cell pack of a polyvinyl chloride film and aluminum foil printed lacquered or paper with a polymer coating.

For 10 or 20 tablets in a jar of orange glass or in a plastic can.

1 jar or 1, 2 contour mesh packages together with instructions for use of the drug are placed in a pack of cardboard.

Storage conditions:

In dry, dark place at a temperature of no higher than 20 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N001546 / 01-2002

Date of registration:02.06.2008

Expiration Date:Unlimited

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Information update date: & nbsp22.08.2017

Illustrated instructions

Instructions

Ampicillin trihydrate (Ampicillin Trihydrate)