METRONIDAZOLE Film-coated tablet Ref.[6986] Active ingredients: Methronidazole

Absorption

Metronidazole is readily absorbed following administration by mouth and bioavailability is 90-100%. Peak plasma concentrations occur after 20 minutes to 3 hours. Absorption may be delayed, but is not reduced overall, by administration with food.

Distribution

Metronidazole is widely distributed. It appears in most body tissues and fluids. It also crosses the placenta and rapidly enters foetal circulation. No more than 20% is bound to plasma proteins.

Biotransformation

Metronidazole is metabolised in the liver by side-chain oxidation and glucuronide formation. The half-life of metronidazole is 6.5 ± 2.9 hours. The half-life of metronidazole is reported to be longer in neonates and in patients with severe liver disease.

Elimination

The majority of a dose of metronidazole is excreted in the urine, mainly as metabolites; a small amount appears in the faeces. Metronidazole can be used in chronic renal failure; it is rapidly removed from the plasma by dialysis. Metronidazole is excreted in milk but the intake of a suckling infant of a mother receiving normal dosage would be considerably less than the therapeutic dosage for infants.

None.Metronidazole has been shown to be carcinogenic in the mouse and in the rat following chronic oral administration however similar studies in the hamster have given negative results. Epidemiological studies have provided no clear evidence of an increased carcinogenic risk in humans.

Metronidazole has been shown to be mutagenic in bacteria in vitro. In studies conducted in mammalian cells in vitro as well as in rodent or humans in vivo, there was inadequate evidence of a mutagenic effect of metronidazole, with some studies reporting mutagenic effects, while other studies were negative.