Description

The tablet should be taken with at least 50-100 ml fluid. As the bioavailability is practically unaffected by simultaneous food intake, This tablets are best taken with or immediately after a meal.

There have been no reports on allergy to Pivmecillinam among patients with a known history of hypersensitivity to penicillins and cephalosporins. Nevertheless, it seems reasonable to exclude such patients from treatment with Pivmecillinam until further experience has been gained.

Pivmecillinam is generally well tolerated, even by patients with reduced kidney function. Upper gastrointestinal disturbances such as nausea, vomiting and diarrhoea or indigestion may occur when a dose has been given on an empty stomach. Skin rashes have been reported in some cases, but the characteristic ampicillin-rash has never been observed, nor has there been any evidence of hepato-, nephro-, or ototoxicity. The occurrence of anaphylaxis, though not yet reported, cannot be entirely excluded.

Mecillinam concentrations approximately 1/3 of the serum levels have been found in the umbilical cord, and low but detectable amounts in the amniotic fluid. So, use of pivmecillinam in pregnancy should be avoided. Mecillinam is not excreted into the milk of lactating mother

As with other antibiotics, which are excreted mainly by the kidneys, raised blood levels of mecillinam may occur if repeated doses are given with impaired renal function.

Based on information available to date for patients with impaired renal function, the initial dose can remain unchanged as can the interval between doses. However, the amount administered as the maintenance dose should be changed according to the following criteria: CrCl 30 ml/min or greater: full dosage CrCl 10-30 ml/min: 50% dosage CrCl <10 ml/min: 25% dosage Use of Pivmecillinam in infants under 3 months of age should be avoided.