Prevacid I.V. (Lansoprazole) - Drug Interactions, Contraindications, Overdosage

DRUG INTERACTIONS

Pregnancy

Teratogenic Effects

Pregnancy Category B

Teratology studies have been conducted in rats and rabbits using intravenous doses of up to 30 mg/kg/day (approximately 8 times in rats and 16 times in rabbits of the recommended human dose based on body surface area). Treatment with lansoprazole did not result in any impairment of fertility or harm to the fetus.

However, there are no adequate and well-controlled studies in pregnant women using the intravenous route. Because animal reproduction studies are not always predicative of human response, this drug should be used during pregnancy only if clearly needed.

OVERDOSAGE

Single intravenous doses of lansoprazole at 218 mg/kg in mice (approximately 30 times the recommended human dose based on body surface area) and 167 mg/kg in rats (approximately 46 times the recommended human dose based on body surface area) were lethal. The symptoms of acute toxicity were decreased locomotor response, ataxia, ptosis and tonic convulsions.

Lansoprazole is not removed from the circulation by hemodialysis.

CONTRAINDICATIONS

PREVACID I.V. for Injection is contraindicated in patients with known hypersensitivity to any component of the formulation.