Famotidine (Page 5 of 5)

Concomitant Use of Antacids

Antacids may be given concomitantly if needed.

Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response.

Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

HOW SUPPLIED

Famotidine Tablets USP (white round tablets) containing 20mg of famotidine and engraved with .

Bottle of 30 (NDC 61442-121-30)
Bottle of 100 (NDC 61442-121-01)
Bottle of 500 (NDC 61442-121-05)
Bottle of 1,000 (NDC 61442-121-10)

Famotidine Tablets USP (white round tablets) containing 40mg of famotidine and engraved with .

Bottle of 30 (NDC 61442-122-30)
Bottle of 100 (NDC 61442-122-01)
Bottle of 500 (NDC 61442-122-05)
Bottle of 1,000 (NDC 61442-122-10)

STORAGE

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Manufactured and Distributed by:
Carlsbad Technology, Inc.
Carlsbad, CA 92008

Revised: 06/12CTI-12 Rev. C

Principal Display Panel – Bottle Label

NDC 66336-0187-XX

NDC 66336-0187-30

FAMOTIDINE famotidine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66336-187(NDC:61442-122) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Famotidine (Famotidine) Famotidine 40 mg

Inactive Ingredients Ingredient Name Strength magnesium stearate cellulose, microcrystalline polydextrose sodium starch glycolate type A potato starch, corn talc triacetin titanium dioxide

Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code CTI;122 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66336-187-30 30 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075805 04/16/2001

Labeler — Dispensing Solutions, Inc. (066070785)

Registrant — PSS World Medical, Inc. (101822682)

Establishment
Name	Address	ID/FEI	Operations
Dispensing Solutions, Inc.		066070785	relabel (66336-187), repack (66336-187)

Revised: 10/2013 Dispensing Solutions, Inc.