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 CTI 121
.

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 CTI 122
.

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

NDC 66336-0187-XX
(click image for full-size original)
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.

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