Ranitidine Hydrochloride (Page 5 of 5)

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 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 (each tablet contains ranitidine hydrochloride equivalent to either 150 mg or 300 mg ranitidine) are supplied as follows:

150 mg: Beige, round, biconvex tablet debossed WATSON in a semi-circle around the top edge and 760 across the bottom of one side and plain on the other side, in bottles of 60 and 500.

300 mg: Beige, capsule-shaped, biconvex, film-coated tablet debossed WATSON in a semi-circle around the top edge and 761 across the bottom of one side and plain on the other, in bottles of 30 and 100.

Store at 20°-25°C (68°-77°F) in a dry place. [See USP controlled room temperature.] Protect from light. Replace cap securely after each opening.

Dispense in a tight, light-resistant container as defined in USP/NF.

Manufactured for:
Watson Laboratories, Inc.
Corona, CA 92880 USA

Manufactured by:
Patheon Pharmaceuticals Inc.
Cincinnati, OH 45237 USA
Rev: June 2005

RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0760
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
Colloidal silicon dioxide
Hypromellose
Magnesium stearate
Maltodextrin
Microcrystalline cellulose
Polydextrose
Polyethylene glycol
Sodium bicarbonate
Synthetic red iron oxide
Synthetic yellow iron oxide
Talc
Titanium dioxide
Triethyl citrate
Product Characteristics
Color GRAY (Beige) Score no score
Shape ROUND (Round) Size 16mm
Flavor Imprint Code WATSON;760
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-0760-60 60 TABLET (60 TABLET) in 1 BOTTLE None
2 NDC:0591-0760-05 500 TABLET (500 TABLET) in 1 BOTTLE None
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0761
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
Colloidal silicon dioxide
Hypromellose
Magnesium stearate
Maltodextrin
Microcrystalline cellulose
Polydextrose
Polyethylene glycol
Sodium bicarbonate
Synthetic red iron oxide
Synthetic yellow iron oxide
Talc
Titanium dioxide
Triethyl citrate
Product Characteristics
Color GRAY (Beige) Score no score
Shape OVAL (Capsule-shaped) Size 16mm
Flavor Imprint Code WATSON;761
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-0761-30 30 TABLET (30 TABLET) in 1 BOTTLE None
2 NDC:0591-0761-01 100 TABLET (100 TABLET) in 1 BOTTLE None
Labeler — Watson Laboratories, Inc.

Revised: 12/2006 Watson Laboratories, Inc.

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