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Axid Oral Solution

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Axid Oral Solution

Axid Oral Solution

INDICATIONS

Axid® Oral 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.

Axid® Oral 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.

Axid® 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.

Axid® 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, Axid® Oral Solution is indicated for ages 12 years and older. Axid® 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

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 Axid® Oral Solution contains 15 mg of nizatidine. In adults, Axid® 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. Axid® 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.

HOW SUPPLIED

Axid® (nizatidine) Oral Solution 15 mg/mL is formulated as a clear, yellow, oral solution with bubble gum flavor, available as:

Bottles of 120 mL (4 fl. oz.) – NDC#65726-147-58
Bottles of 480 mL (16 fl. oz.) – NDC# 65726-147-62

Store at 25°C (77°F); excursions permitted to 15 ° - 30 °C (59 ° - 86°F) [see USP Controlled Room Temperature] and dispense in tight, light-resistant container.

August 2004. Manufactured for: Reliant Pharmaceuticals, Inc. Liberty Corner, NJ 07938, USA. By: Lyne Laboratories, Inc., Brockton, MA 02301, USA. Address Medical Inquiries to: Reliant Pharmaceuticals Inc., Medical Affairs, 110 Allen Road Liberty Corner, NJ 07938, USA

Last reviewed on RxList: 8/24/2012
This monograph has been modified to include the generic and brand name in many instances.

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