Pregnancy: No evidence of risk in humans.
Lactation: Caution advised or effect undetermined.
Precautions: Exclude malignant disease before treatment. Impaired renal function, acute porphyria.
Treatment of duodenal, benign gastric and post-operative ulceration, including that due to NSAIDs. Prevention of NSAID induced duodenal ulcers. Duodenal ulcers associated with H. pylori. Oesophageal reflux, reduction of gastric acid, chronic episodic dyspepsia. Moderate to severe oesophagitis.
ORAL: Duodenal and gastric ulcer: Adults: 150 mg twice daily or 300 mg at bedtime for four weeks or 300 mg twice daily; maintenance, 150 mg at bedtime.
DU with H. pylori: Adults: 300 mg at bedtime for 4 weeks plus amoxicillin 750 mg three times daily and metronidazole 500 mg three times daily for 2 weeks.
IM: No dilution is needed. IV: Intermittent bolus: Dilute vials to 2.5 mg/ mL; infuse at 4 mL/min (5 min), intermittent infusion: Dilute vials to 0.5 mg/ mL; infuse at 5-7 mL/min (15-20 min). Continuous IV infusion: Administer at 6.25 mg/h and titrate dosage based on gastric pH by continuous infusion over 24 hours. Intermittent bolus injection: Dilute to max of 2.5 mg/ mL. Intermittent infusion: Dilute to max of 0.5 mg/ mL.
CYP1A2, 2D6, cyclosporin, gentamicin, glipizide, glyburide, midazolam, metoprolol, pentoxyfylline, phenytoin, quinidine, triazolam, warfarin, ketoconazole, itraconazole, procainamide, ferrous sulphate, non-depolarizing muscle relaxants, cefpodoxime, vitamin B12, diazepam, oxaprozin, atropine.
Headache, dizziness, changes in liver function. Rarely hepatitis, thrombocytopenia, leucopenia, agranulocytosis, pancytopenia, hypersensitivity, confusion, breast symptoms in men, reversible impotence, rash, bradycardia, pancreatitis.