Ranitidine Hydrochloride (Page 6 of 6)

Active Duodenal Ulcer

The current recommended adult oral dosage of ranitidine for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg 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 PHARMACOLOGY: 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 at bedtime.

Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome)

The current recommended adult oral dosage is 150 mg twice a day. In some patients it may be necessary to administer ranitidine 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 twice a day.

Maintenance of Healing of Gastric Ulcers

The current recommended adult oral dosage is 150 mg at bedtime.

GERD

The current recommended adult oral dosage is 150 mg twice a day.

Erosive Esophagitis

The current recommended adult oral dosage is 150 mg four times a day.

Maintenance of Healing of Erosive Esophagitis

The current recommended adult oral dosage is 150 mg twice a day.

Pediatric Use

The safety and effectiveness of ranitidine has been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of ranitidine 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.

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 two 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 ranitidine, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg 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).

HOW SUPPLIED

Ranitidine Tablets, USP for oral administration, are available as:

150 mg: round, off-white, unscored tablets, film-coated pink, debossed GG 705 on one side and plain on the reverse side.

300 mg: round, off-white, unscored tablets, film-coated orange, debossed GG 706 on one side and plain on the reverse side.

Ranitidine Capsules, for oral administration, are available as:

150 mg: Opaque caramel capsules, imprinted GG 614 in white ink, filled with off-white powder.

300 mg: Opaque caramel capsules, imprinted GG 615 in white ink, filled with off-white powder.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0776-1 150 mg 30 Tablets in a Blister Pack PINK 0781-1883

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature) in a dry place. Protect from light. Replace cap securely after each opening.

Dispense in a tight, light-resistant container.

Sandoz Inc.

Princeton, NJ 08540

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

PRINCIPAL DISPLAY PANEL

ranitidine hydrochloride 150 mg tablet blister pack
(click image for full-size original)

150 mg Tablet Blister Pack

Ranitidine

Tablet, USP

150 mg

53808-0776-1

RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0776(NDC:0781-1883)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 30
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE 2910 (3 CPS)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
PEPPERMINT
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 8mm
Flavor Imprint Code GG;705
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-0776-1 30 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074467 07/01/2009
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack

Revised: 04/2010 State of Florida DOH Central Pharmacy

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