Prescription Drug Information: Ranitidine Immediate Release (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Active Duodenal Ulcer: The current recommended adult oral dosage of ranitidine tablets 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 Trials: Active Duodenal Ulcer ). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US trials, 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 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 upto 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 (aged younger than 1 month) 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 trials 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 trials 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 PHARMACOLOGY: Pharmacokinetics: Geriatrics and PRECAUTIONS: Geriatric Use).

HOW SUPPLIED

Ranitidine tablets, USP 150 mg (ranitidine HCI USP equivalent to 150 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with “S/429″ on one side and plain on the other side. They are available in bottles of 60 (NDC 51407-244-60), 180 (NDC 51407-244-18), and 1000 (NDC 51407-244-10) tablets.

Ranitidine tablets, USP 300 mg (ranitidine HCI USP equivalent to 300 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with “S/430″ on one side and plain on the other side. They are available in bottles of 30 (NDC 51407-245-30) and 250 (NDC 51407-245-25) tablets.

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

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA 93012 USA

Revised: 06/ 2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx only

NDC 51407-244-18

Ranitidine Tablets, USP

150 mg

180 Tablets

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA 93012 USA

//rxdruglabels.com/lib/images-rx/ranitidine-immediate-release-8/51407-244-18lb-ranitidine-150-mg-tabs-300x223.jpg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Only

NDC 51407-245-30

Ranitidine Tablets, USP

300 mg

30 Tablets

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA 93012 USA

51407-245-30LB RANITIDINE 300 MG TABS.jpg
(click image for full-size original)
RANITIDINE IMMEDIATE RELEASE ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-244(NDC:64380-936)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 150 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
HYPROMELLOSES
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE RED
Product Characteristics
Color brown Score no score
Shape ROUND (circular, biconvex, beveled edge) Size 10mm
Flavor Imprint Code S;429
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-244-60 60 TABLET in 1 BOTTLE None
2 NDC:51407-244-18 180 TABLET in 1 BOTTLE None
3 NDC:51407-244-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205512 08/22/2016
RANITIDINE IMMEDIATE RELEASE ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-245(NDC:64380-937)
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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
HYPROMELLOSES
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE RED
Product Characteristics
Color brown Score no score
Shape ROUND (circular, biconvex, beveled edge) Size 13mm
Flavor Imprint Code S;430
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-245-25 250 TABLET in 1 BOTTLE None
2 NDC:51407-245-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205512 08/22/2016
Labeler — Golden State Medical Supply Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply Inc. 603184490 relabel (51407-244), repack (51407-245), relabel (51407-245), repack (51407-244)

Revised: 09/2019 Golden State Medical Supply Inc.

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