PREGNANCY CATEGORY BOral reproduction studies in pregnant rats at doses up to 1500 mg/kg/day (9000 mg/m2/day, 40.5 times the recommended human dose based on body surface area) and in pregnant rabbits at doses up to 275 mg/kg/day (3245 mg/m2/day, 14.6 times the recommended human dose based on body surface area) have revealed no evidence of impaired fertility or harm to the fetus due to nizatidine.
There are, however, no adequate and well-controlled studies in pregnant women.Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nizatidine is indicated for up to 8 weeks for the treatment of active duodenal ulcer.
In most patients, the ulcer will heal within 4 weeks.Nizatidine is indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg h.s.
after healing of an active duodenal ulcer.
The consequences of continuous therapy with nizatidine for longer than 1 year are not known.Nizatidine is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.Nizatidine is indicated for up to 8 weeks for the treatment of active benign gastric ulcer.Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.
Nizatidine is contraindicated in patients with known hypersensitivity to the drug.Because crosssensitivity in this class of compounds has been observed, H2-receptor antagonists, including nizatidine, should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.