Overview
DESCRIPTION Nizatidine, USP is a histamine H 2 -receptor antagonist. Chemically, it is N -[2-[[[2-[(Dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]- N' -methyl-2-nitro-1,1-ethenediamine. The structural formula is represented below: It is an off-white to buff crystalline solid that is soluble in water. Nizatidine, USP has a bitter taste and mild sulfur-like odor.
Mechanism of Action
CLINICAL PHARMACOLOGY Nizatidine is a competitive, reversible inhibitor of histamine at the histamine H2-receptors, particularly those in the gastric parietal cells. Antisecretory Activity – 1. Effects on Acid Secretion : Nizatidine significantly inhibited nocturnal gastric acid secretion for up to 12 hours. Nizatidine also significantly inhibited gastric acid secretion stimulated by food, caffeine, betazole, and pentagastrin (Table 1). Table 1. – Effect of Oral Nizatidine on Gastric Acid Secretion Time After Dose (h) % Inhibition of Gastric Acid Output by Dose (mg) 20 to 50 75 100 150 300 Nocturnal Up to 10 57 73 90 Betazole Up to 3 93 100 99 Pentagastrin Up to 6 25 64 67 Meal Up to 4 41 64 98 97 Caffeine Up to 3 73 85 96 2.
Indications
- 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.
Common Doses
- 300 mg
- 150 mg
- 50 mL
- 20 mL
Dosage
DOSAGE AND ADMINISTRATION Active Duodenal Ulcer – The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily. Maintenance of Healed Duodenal Ulcer – The recommended oral dosage for adults is 150 mg once daily at bedtime. Gastroesophageal Reflux Disease – The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily. Active Benign Gastric Ulcer – The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime.
Side Effects
- ADVERSE REACTIONS Worldwide, controlled clinical trials of nizatidine included over 6,000 patients given nizatidine in studies of varying durations. Placebo-controlled trials in the United States and Canada included over 2,600 patients given nizatidine and over 1,700 given placebo. Among the adverse events in these placebo-controlled trials, anemia (0.2% vs 0%) and urticaria (0.5% vs 0.1%) were significantly more common in the nizatidine group.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.