Nizatidine

FDA Drug Profile — Nizatidine

Drug Details

Generic Name
Nizatidine
Brand Names
Nizatidine
Application Number
ANDA077314
Sponsor
Dr Reddy's Laboratories Limited
NDC Codes
10
Dosage Forms
CAPSULE, POWDER
Routes
ORAL
Active Ingredients
NIZATIDINE

Indications and Usage

INDICATIONS AND USAGE 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.