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

Pharmacodynamics:Semisynthetic penicillin, a broad spectrum of action, bactericidin. 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.) 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. Moderately active against the majority Enterococcus spp., in t.ch. Enterococcus faecalis, Listeria spp. 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%; TSmah (time to reach the maximum concentration of ampicillin in the blood) with oral intake of 500 mg - 2 hours, Cmah (the maximum concentration of the drug in the blood) is 3-4 mcg / ml. Connection with plasma proteins - 20%. T1 / 2 (half-life) - 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. Poor penetration through the BBB (blood-brain barrier) (permeability increases with inflammation of the meninges). Excreted mainly by the kidneys (70-80%) in urine are very high concentrations of the unchanged antibiotic; 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;

- biliary tract (cholangitis, cholecystitis);

- cervicitis;

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

- the musculoskeletal system;

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

Contraindications:

Hypersensitivity to ampicillin and other components of the drug, as well as to other penicillins, cephalosporins, carbapenems, infectious mononucleosis, lymphocytic leukemia, liver failure, a history of gastrointestinal disease (especially colitis associated with the use of antibiotics), the period of breastfeeding, (for a given dosage form).

Carefully:

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

Pregnancy and lactation:

It is possible to use ampicillin during pregnancy if the 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, you should decide whether to stop breastfeeding.

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: prescribe 12.5-25 mg / kg every 6 hours or 16.7-33.3 mg / kg every 8 hours.

With gonococcal urethritis - 3.5 g once.

Side effects:

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

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

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

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

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

Overdose:

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

Treatment: gastric lavage, Activated carbon, saline laxatives, medicines (LS) to maintain vodnoelektrolitnogo 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 (incl. aminoglycosides, cephalosporins, cycloserine, Vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (.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), LS, in the process of metabolism of which forms para-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 with ampicillin, a systematic control of kidney function, liver and peripheral blood picture. Patients with impaired renal function require correction of the regimen dosing in accordance with the values of creatinine clearance.

- When high doses are used in patients with renal insufficiency possibly toxic effects on the central nervous system.

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

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

- 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 mild diarrhea caused by Clostridium difficile, arising against the background of course treatment should be avoided antidiarrhoeal drugs, reducing peristalsis of the intestine; You can use kaolin- or attapulgite containing anti-diarrheal 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.

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:

By 10, 24 tablets in a contour cell package of polyvinyl chloride film and aluminum foil printed lacquered.

For 10 tablets in a contour non-cellular package of paper with a polymer coating.

1, 2 contourcell packs of 10 tablets, or 1 circuit cell pack of 24 tablets, along with instructions for medical use, are placed in a pack of cardboard.

100, 200, 400, 500, 600, 800 or 1000 contour non-jawed packages with an equal number of instructions for medical use are placed in a cardboard box (for hospitals).

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.Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-004479

Date of registration:28.09.2017

Expiration Date:28.09.2022

The owner of the registration certificate:UZOLE-SIBERIAN CHEMICAL PLANT, OJSC UZOLE-SIBERIAN CHEMICAL PLANT, OJSC Russia

Manufacturer: & nbsp

UZOLE-SIBERIAN CHEMICAL PLANT, OJSC Russia

Information update date: & nbsp18.10.2017

Illustrated instructions

Instructions

Ampicillin trihydrate (Ampicillin trihydrate)