PAMECIL Powder for solution for injection or infusion Ref.[28317] Active ingredients: Ampicillin

Source: Υπουργείο Υγείας (CY)  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Penicillins with extended spectrum, Beta-lactam antibacterials, Penicillins
ATC code: J01CA01

Ampicillin is a semisynthetic penicillin with a broad spectrum ob bactericidal activity against many gram-positive and gram-negative microorganisms. It acts by inhibiting the biosynthesis of cell wall mucopeptide.

5.2. Pharmacokinetic properties

Ampicillin is bactericidal at low concentrations. Following intramuscular administration of a 500 mg ampicillin dose, peak plasma concentrations occur within an hour. Detectable amounts persist for about 6 hours. It diffuses readily into most body tissues and fluids; however, penetration into the cerebrospinal fluid and brain occurs only when the meninges are inflamed. Elimination half life is 1-2 hours, rising to 15-20 in oliguric patients. Ampicillin is excreted largely unchanged in the urine; excretion can be delayed by concurrent administration of probenecid that inhibits the renal tubular secretion of ampicillin. In blood serum, ampicillin is the least bound of all the penicillins; an average of about 20% of the drug is bound to the plasma proteins as compared to 60 to 90 % for the other penicillins.

5.3. Preclinical safety data

There are no long term studies in animals to evaluate carcinogenesis mutagenesis, or impairment of fertility in males or females. Reproductive studies in animals have revealed no evidence of impaired fertility or harm to the foetus due to penicillin.

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