Zetsyl (Capsules, Powder) Instructions for Use

ATC Code

J01CA01 (Ampicillin)

Active Substance

Ampicillin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Broad-spectrum penicillin antibiotic, destroyed by penicillinase

Pharmacotherapeutic Group

Antibiotic, semi-synthetic penicillin

Pharmacological Action

A broad-spectrum antibiotic from the group of semi-synthetic penicillins. It exerts a bactericidal effect by inhibiting the synthesis of the bacterial cell wall.

It is active against aerobic gram-positive bacteria: Staphylococcus spp. (except for strains producing penicillinase), Streptococcus spp., Enterococcus spp., Listeria monocytogenes; aerobic gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Bordetella pertussis, some strains of Haemophilus influenzae.

It is destroyed by bacterial β-lactamases.

Pharmacokinetics

After oral administration, it is well absorbed from the gastrointestinal tract. Ampicillin is distributed in most organs and tissues. It crosses the placental barrier and poorly penetrates the blood-brain barrier. In inflammation of the meninges, the permeability of the blood-brain barrier increases sharply. 30% of ampicillin is metabolized in the liver. It is excreted in the urine and bile.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to ampicillin: including infections of the ear, throat, nose, odontogenic infections, bronchopulmonary infections, acute and chronic infections of the genitourinary tract, gastrointestinal infections (including salmonellosis, cholecystitis), gynecological infections, meningitis, endocarditis, septicemia, sepsis, rheumatism, erysipelas, scarlet fever, infections of the skin and soft tissues.

ICD codes

Dosage Regimen

Capsules, Powder

The dosage is set individually depending on the severity of the course, localization of the infection and the sensitivity of the pathogen.

For oral administration for adults, a single dose is 250-500 mg, the frequency of administration is 4 times/day. For children weighing up to 20 kg – 12.5-25 mg/kg every 6 hours.

For intramuscular, intravenous administration, a single dose for adults is 250-500 mg every 4-6 hours. For children, a single dose is 25-50 mg/kg.

The duration of treatment depends on the localization of the infection and the characteristics of the course of the disease.

The maximum daily dose for adults when taken orally is 4 g, with intravenous and intramuscular administration – 14 g.

Adverse Reactions

Allergic reactions urticaria, erythema, angioedema, rhinitis, conjunctivitis; rarely – fever, joint pain, eosinophilia; extremely rarely – anaphylactic shock.

From the digestive system nausea, vomiting.

Effects due to chemotherapeutic action oral candidiasis, vaginal candidiasis, intestinal dysbiosis, colitis caused by Clostridium difficile.

Contraindications

Infectious mononucleosis, lymphocytic leukemia, hypersensitivity to ampicillin and other penicillins, impaired liver function.

Use in Pregnancy and Lactation

Ampicillin can be used during pregnancy if indicated. Ampicillin is excreted in breast milk in low concentrations. If it is necessary to use ampicillin during lactation, the issue of stopping breastfeeding should be decided.

Use in Hepatic Impairment

Contraindicated in impaired liver function.

During treatment with ampicillin, systematic monitoring of liver function is necessary.

Use in Renal Impairment

Patients with impaired renal function require dose adjustment according to the creatinine clearance values.

During treatment with ampicillin, systematic monitoring of renal function is necessary. When used in high doses in patients with renal failure, a toxic effect on the central nervous system is possible.

Pediatric Use

Use is possible according to the dosage regimen.

Special Precautions

During treatment with ampicillin, systematic monitoring of kidney and liver function and the peripheral blood picture is necessary. Patients with impaired renal function require dose adjustment according to the creatinine clearance values.

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

When using ampicillin in patients with bacteremia (sepsis), a bacteriolysis reaction (Jarisch-Herxheimer reaction) is possible.

Drug Interactions

Sulbactam, an irreversible β-lactamase inhibitor, prevents the hydrolysis and destruction of ampicillin by microbial β-lactamases.

With the simultaneous use of ampicillin with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin), synergism is manifested; with bacteriostatic antibiotics (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) – antagonism.

Ampicillin enhances the effect of indirect anticoagulants by suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index.

Ampicillin reduces the effect of drugs in the metabolism of which PABA is formed.

Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs reduce the tubular secretion of ampicillin, which may be accompanied by an increase in its plasma concentration.

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce the absorption of ampicillin. Ascorbic acid increases the absorption of ampicillin.

Ampicillin reduces the effectiveness of oral contraceptives.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.