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Zantac (Ranitidine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ZANTAC is indicated in:

  1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
  2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.
  3. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
  4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
  5. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.
  6. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ZANTAC 150 mg b.i.d.
  7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ZANTAC 150 mg q.i.d.
  8. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.

Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

DOSAGE AND ADMINISTRATION

Active Duodenal Ulcer

The current recommended adult oral dosage of ZANTAC for duodenal ulcer is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) twice daily. An alternative dosage of 300 mg or 20 mL of syrup (4 teaspoonfuls of syrup equivalent to 300 mg of ranitidine) once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared to the other in a particular patient population have yet to be demonstrated (see Clinical Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.

Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

Maintenance of Healing of Duodenal Ulcers

The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) at bedtime.

Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome)

The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) twice a day. In some patients it may be necessary to administer ZANTAC 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.

Benign Gastric Ulcer

The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) twice a day.

Maintenance of Healing of Gastric Ulcers

The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) at bedtime.

GERD

The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) twice a day.

Erosive Esophagitis

The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) 4 times a day.

Maintenance of Healing of Erosive Esophagitis

The current recommended adult oral dosage is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) twice a day.

Pediatric Use

The safety and effectiveness of ZANTAC have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of ZANTAC in neonatal patients (less than 1 month of age) to make dosing recommendations.

The following 3 subsections provide dosing information for each of the pediatric indications. Also, see the subsection on Preparation of ZANTAC 25 EFFERdose Tablets, below.

Treatment of Duodenal and Gastric Ulcers

The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.

Maintenance of Healing of Duodenal and Gastric Ulcers

The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.

Treatment of GERD and Erosive Esophagitis

Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg per day, usually given as 2 divided doses.

Dosage Adjustment for Patients With Impaired Renal Function

On the basis of experience with a group of subjects with severely impaired renal function treated with ZANTAC, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) every 24 hours. Should the patient's condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.

Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics and PRECAUTIONS: Geriatric Use).

Preparation of ZANTAC 25 EFFERdose Tablets

Tablets should not be chewed, swallowed whole, or dissolved on the tongue. Dissolve 1 tablet in no less than 5 mL (1 teaspoonful) of water in an appropriate measuring cup. Wait until the tablet is completely dissolved before administering the solution to the infant/child. The solution may be administered by medicine dropper or oral syringe for infants.

HOW SUPPLIED

ZANTAC 150 Tablets (ranitidine HCl equivalent to 150 mg of ranitidine) are peach, film-coated, 5-sided tablets embossed with "ZANTAC 150" on one side and "Glaxo" on the other. They are available in bottles of 60 (NDC 0173-0344-42), 180 (NDC 0173-0344-17), and 500 (NDC 0173-0344-14) tablets.

ZANTAC 300 Tablets (ranitidine HCl equivalent to 300 mg of ranitidine) are yellow, film-coated, capsule-shaped tablets embossed with "ZANTAC 300" on one side and "Glaxo" on the other. They are available in bottles of 30 (NDC 0173-0393-40) tablets.

Store between 15°and 30°C (59°and 86°F) in a dry place. Protect from light. Replace cap securely after each opening.

ZANTAC 25 EFFERdose Tablets (ranitidine HCl equivalent to 25 mg of ranitidine) are white to pale yellow, round, flat-faced, bevel-edged tablets embossed with “GS” on one side and “25C” on the other side. They are packaged in foil strips and are available in a carton of 60 (NDC 0173-0734-00) tablets.

Store between 2°and 30°C (36° and 86°F).

ZANTAC Syrup, a clear, pale yellow, peppermint-flavored liquid, contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine per 1 mL (75 mg/5 mL) in bottles of 16 fluid ounces (one pint) (NDC 0173-0383-54).

Store between 4° and 25°C (39° and 77°F). Dispense in tight, light-resistant containers as defined in the USP/NF.

GlaxoSmithKline

Research Triangle Park, NC 27709

ZANTAC and EFFERdose are registered trademarks of Warner-Lambert Company, used under license.

©2008, GlaxoSmithKline. All rights reserved.

March 2008 ZNT:2PI

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