RANITIDINE (Page 3 of 3)

OVERDOSAGE

There has been limited experience with overdosage. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience (see ADVERSE REACTIONS). In addition, abnormalities of gait and hypotension have been reported.

When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.

Studies in dogs receiving dosages of ranitidine in excess of 225 mg/kg per day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively.

DOSAGE AND ADMINISTRATION

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 Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in U.S. 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 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 four times daily.

Maintenance of Healing of Erosive Esophagitis: The current recommended adult oral dosage is 150 mg twice daily.

Pediatric Use: The safety and effetiveness of ranitidine have been established in the agegroup 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 three 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 recommendations 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 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 150 mg (Ranitidine HCl equivalent to 150 mg of ranitidine) are white, film-coated, unscored, six-sided tablets debossed with on one side and plain on the other. They are available in bottles of 60 (NDC 64679-906-01), 100 (NDC 64679-906-06), 180 (NDC 64679-906-02), 500 (NDC 64679-906-03), 1000 (NDC 64679-906-04) and Unit Dose Pack of 10 x 10 blister (NDC 64679-906-05) tablets.

Ranitidine Tablets, USP 300 mg (Ranitidine HCl equivalent to 300 mg of ranitidine) are white, film-coated, unscored, capsule-shaped tablets debossed with W 907 on one side and plain on the other. They are available in bottles of 30 (NDC 64679-907-01), 100 (NDC 64679-907-04), 250 (NDC 64679-907-02) and Unit Dose Pack of 10 x 10 blister (NDC 64679-907-03) tablets.

Bottle contains desiccant.

Store between 20° and 25°C (68° and 77°F) in a dry place. Protect from light. Replace cap securely after each opening.

SPL UNCLASSIFIED

Manufactured by:

Wockhardt Limited

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Rev.170810

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ranitidine Tablets USP 150 mg

64679-906-02

5000T – Bulk pack

150 mg -- Bulk Label
(click image for full-size original)

Ranitidine Tablets USP 300 mg

64679-907-09

3750T – Bulk pack

300 mg -- Bulk Label
(click image for full-size original)
RANITIDINE ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-906
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
CASTOR OIL
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (15 MPA.S)
MAGNESIUM STEARATE
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white) Score no score
Shape HEXAGON (6 SIDED) (Hexagonal shaped) Size 11mm
Flavor Imprint Code W906
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-906-01 60 TABLET in 1 BOTTLE None
2 NDC:64679-906-06 100 TABLET in 1 BOTTLE None
3 NDC:64679-906-02 180 TABLET in 1 BOTTLE None
4 NDC:64679-906-03 500 TABLET in 1 BOTTLE None
5 NDC:64679-906-04 1000 TABLET in 1 BOTTLE None
6 NDC:64679-906-05 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (64679-906-05)
7 NDC:64679-906-11 15000 TABLET in 1 DRUM None
8 NDC:64679-906-12 5000 TABLET in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075208 12/17/1998
RANITIDINE ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-907
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
CASTOR OIL
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (15 MPA.S)
MAGNESIUM STEARATE
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white) Score no score
Shape CAPSULE (capsule shaped) Size 16mm
Flavor Imprint Code W907
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-907-01 30 TABLET in 1 BOTTLE None
2 NDC:64679-907-04 100 TABLET in 1 BOTTLE None
3 NDC:64679-907-02 250 TABLET in 1 BOTTLE None
4 NDC:64679-907-03 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (64679-907-03)
5 NDC:64679-907-08 7500 TABLET in 1 DRUM None
6 NDC:64679-907-09 3750 TABLET in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075208 12/17/1998
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Wockhardt Limited (650069115)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 916489953 ANALYSIS (64679-906), ANALYSIS (64679-907), LABEL (64679-906), LABEL (64679-907), MANUFACTURE (64679-906), MANUFACTURE (64679-907), PACK (64679-906), PACK (64679-907)

Revised: 11/2019 Wockhardt USA LLC.

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