Ranitidine (Page 5 of 5)

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 daily. 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 daily.

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 daily.

Erosive Esophagitis:

The current recommended adult oral dosage is 150 mg 4 times daily.

Maintenance of Healing of Erosive Esophagitis:

The current recommended adult oral dosage is 150 mg twice daily.

Pediatric Use:

The safety and effectiveness of ranitidine have 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/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 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 PHARMACOLGOY: Pharmacokinetics: Geriatrics and PRECAUTIONS: Geriatric Use ).

HOW SUPPLIED

Product: 50436-6942

NDC: 50436-6942-1 30 TABLET, FILM COATED in a BOTTLE

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15 o to 30 o C (59 o to 86 o F) [see USP Controlled Room Temperature]. Protect from light. Replace cap securely after each opening.

Manufactured by:

Shasun Pharmaceuticals Limited,

Unit-II,
R.S. No. 32, 33 & 34, Shasun Road, Periyakalapet,
Puducherry — 605 014. India.

Manufactured for:

glenmark-logo

Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115
www.glenmarkpharma.com

December 2018

MULTISTIX is a registered trademark of Bayer Healthcare LLC.

RANITIDINE TABLET, FILM COATED

Label Image
(click image for full-size original)
RANITIDINE
ranitidine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50436-6942(NDC:68462-249)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 300 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
FD&C RED NO. 40
TITANIUM DIOXIDE
TRIACETIN
HYPROMELLOSE, UNSPECIFIED
Product Characteristics
Color PINK Score no score
Shape ROUND (Circular, biconvex, beveled edge) Size 13mm
Flavor Imprint Code G51;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50436-6942-1 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50436-6942-4 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:50436-6942-3 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078542 11/19/2008
Labeler — Unit Dose Services (831995316)
Establishment
Name Address ID/FEI Operations
Unit Dose Services 831995316 REPACK (50436-6942), RELABEL (50436-6942)

Revised: 05/2019 Unit Dose Services

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