PAMECIL Hard capsule Ref.[28315] Active ingredients: Ampicillin

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral administration, it has occurred in patients on oral penicillins. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.

Prolonged use of antibiotics may promote the overgrowth of nonsusceptible organisms, including fungi. Should superinfection occur, appropriate measures should be taken.

In prolonged therapy, and particularly with high dosage regimens, periodic evaluation of the renal, hepatic, and hematopoietic systems is recommended.

In streptococcal infections, therapy must be sufficient to eliminate the organism (10 days minimum); otherwise, the sequelae of streptococcal disease may occur. Cultures should be taken following completion of treatment to determine whether streptococci have been eradicated.

Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin.

In patients with impaired renal function, such as renal failure, neonates and premature infants, dosage reduction is required.

When administered concurrently, the following drugs may interact with ampicillin:

• Allopurinol-Increased possibility of skin rash, particularly in hyperuricemic patients, may occur.
• Bacteriostatic Antibiotics-Chloramphenicol, erythromycins, sulfonamides, or tetracyclines may interfere with the bactericidal effect of penicillins. This has been demonstrated In Vitro; however, the clinical significance of this interaction is not well-documented.
• Oral Contraceptives-May be less effective and increased breakthrough bleeding may occur.
• Probenecid-May decrease renal tubular secretion of ampicillin resulting in increased blood levels and/or ampicillin toxicity.

It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of ampicillin, false positive readings are common with chemical methods.

Pregnancy

Pregnancy category: B

Animal studies with ampicillin trihydrate have shown no teratogenic effect. Ampicillin trihydrate has been in extensive clinical use since 1961 and its use in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, ampicillin trihydrate may be considered appropriate.

Breast-feeding

Ampicillin-class antibiotics are excreted in milk. Ampicillin use by nursing mothers may lead to sensitization of infants; therefore, a decision should be made whether to discontinue nursing or to discontinue ampicillin, taking into account the importance of the drug to the mother.

None.

As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria.

The following adverse reactions have been reported as associated with the use of ampicillin:

• Blood and lymphatic system disorders: Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
• Gastrointestinal disorders: glossitis, stomatitis, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea.
• Hepatobiliary disorders: A moderate elevation in the serum glutamic-oxaloacetic transaminase (SGOT) has been noted, but the significance of this finding is unknown. There have been isolated reports of chelestasis and jaundice in association with severe Stevens-Johnson syndrome.
• Skin and subcutaneous tissue disorders: Hypersensitivity Reactions: an erythematous, mildly pruritic, maculopapular skin rash has been reported fairly frequently. The rash, which usually does not develop within the first week of therapy, may cover the entire body including the soles, palms, and oral mucosa. The eruption usually disappears in three to seven days. Other hypersensitivity reactions that have been reported are: skin rash, pruritus, urticaria, erythema multiforme, and an occasional case of exfoliative dermatitis. Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form of the drug.
• Renal and urinary disorders: Creatinine clearance rate may be reduced. Interstitial nephritis has been reported, it is believed to be caused by hypersensitivity.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

None known.