Drug Catalog - Product Detail
NIZATIDINE ORAL SOLUTION SOL 15MG/ML 473ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65162-0659-90 | AMNEAL PHARMACEUTICALS | 473ML | 15MG/ML | SOLUTION |
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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 as follows: Nizatidine, USP Nizatidine, USP has the empirical formula C 12 H 21 N 5 O 2 S 2 representing a molecular weight of 331.47. 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. Nizatidineoral solution is a clear, pale-yellow, peppermint flavored solution and each 1 mL contains 15 mg of nizatidine, USP. Nizatidineoral solution also contains the inactive ingredients anhydrous citric acid, glycerin, magnasweet, methylparaben, natural peppermint extract, povidone, propylparaben, purified water, saccharin sodium, sodium chloride, sodium citrate, sucrose and xanthan gum. 8cb170bc-figure-01
How Supplied
How Supplied: Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available as Bottles of 480 mL – NDC# 65162-659-90 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN Rx only Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2021-02
Indications & Usage
Indications and Usage: Nizatidineoral solution is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Nizatidineoral solution 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 oral solution 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 oral solution 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. In pediatric patients, nizatidine oral solution is indicated for ages 12 years and older. Nizatidine oral solution is indicated for up to 8 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.
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. Each mL of nizatidine oral solution contains 15 mg of nizatidine. In adults, nizatidine oral solution may be substituted for any of the above indications using equivalent doses of the oral solution. Pediatric Dosing— Each mL of oral solution contains 15 mg of nizatidine. Nizatidine oral solution is indicated for pediatric patients 12 years of age or older. For pediatric patients 12 years of age and older, the dosage of nizatidine is 150 mg b.i.d. (2 tsp, b.i.d.) The following dosage recommendations are provided: Erosive Esophagitis —For pediatric patients 12 years or older, the dosage is 150 mg b.i.d. (300 mg/d). The maximum daily dose for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks. Gastroesophageal Reflux Disease — For pediatric patients 12 years or older, the dosage is 150 mg b.i.d. (300 mg/d). The maximum daily dose for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks. 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 Creatinine Clearance Dose 20 – 50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Creatinine Clearance 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. Based on the pharmacokinetic data in elderly patients with renal impairment, pediatric patients with creatinine clearances less than 50 mL/min, should have their dose of nizatidine reduced accordingly. The clinical effects of this dose reduction in pediatric patients with renal failure have not been evaluated.