Nizatidine

FDA Drug Profile — Nizatidine

Drug Details

Generic Name
Nizatidine
Brand Names
Nizatidine
Application Number
ANDA075616
Sponsor
Dr. Reddy's Laboratories Limited
NDC Codes
10
Dosage Forms
POWDER, CAPSULE
Routes
ORAL
Active Ingredients
NIZATIDINE

Indications and Usage

INDICATIONS AND USAGE Nizatidine capsules are indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Nizatidine capsules are 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 capsules are 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 capsules are 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.