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
150 mg Tablet Blister Pack
Ranitidine
Tablet, USP
150 mg
53808-0776-1
| RANITIDINE HYDROCHLORIDE ranitidine hydrochloride tablet, film coated | ||||||||||||||||||||||
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| Labeler — State of Florida DOH Central Pharmacy (829348114) |
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| 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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