Drug Catalog - Product Detail
NIZATIDINE CP 300MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00591-3138-30 | ACTAVIS PHARMA | 30 | 300MG | CAPSULE |
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Description
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: C 12 H 21 N 5 O 2 S 2 M.W. 331.46 It is an off-white to buff crystalline solid that is soluble in water. Nizatidine has a bitter taste and mild sulfur-like odor. Nizatidine Capsules USP, for oral administration, contain 150 mg or 300 mg nizatidine and the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate and pregelatinized starch. The capsule shells contain: ammonium hydroxide, black iron oxide, gelatin, potassium hydroxide, propylene glycol, shellac, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The 150 mg capsule shell also contains D&C Yellow No. 10 and FD&C Yellow No. 6. The 300 mg capsule shell also contains black iron oxide, red iron oxide and yellow iron oxide.
How Supplied
HOW SUPPLIED Nizatidine Capsules USP, 150 mg are #2, buff opaque capsules imprinted “WPI” and “3137”. Nizatidine Capsules USP, 300 mg are #0, light brown opaque capsules imprinted “WPI” and “3138”. They are supplied by Dispensing Solutions Inc. as follows: NDC Strength Quantity/Form Color Source NDC 68258-3006-1 300 mg 30 CAPSULE light brown 0591-3138-30 Storage Store at controlled room temperature 20°-25°C (68°-77°F). [See USP.] Dispense in a tight, light-resistant container as defined in the USP. This product was Manufactured By: Watson Laboratories, Inc. Corona, CA 92880 USA And Relabeled By: Dispensing Solutions Inc. 3000 West Warner Ave Santa Ana, CA 92704 United States Molecular Structure
Indications & 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.
Dosage and Administration
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. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration. Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency The dose for patients with renal dysfunction should be reduced as follows: Active Duodenal Ulcer, GERD and Benign Gastric Ulcer C cr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy C cr Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days Some elderly patients may have creatinine clearances of less than 50 mL/min, and based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.