Famotidine (Page 5 of 5)

14.5 Pathological Hypersecretory Conditions

In trials of patients with pathological hypersecretory conditions such as Zollinger-Ellison Syndrome with or without multiple endocrine neoplasias, Famotidine significantly inhibited gastric acid secretion and controlled associated symptoms. Orally administered Famotidine dosages from 20 mg to 160 mg every 6 hours maintained basal acid secretion below 10 mEq/hour; initial dosages were titrated to the individual patient need and subsequent adjustments were necessary with time in some patients.

14.6 Risk Reduction of Duodenal Ulcer Recurrence

Two randomized, double-blind, multicenter trials in patients with endoscopically confirmed healed DUs demonstrated that patients receiving treatment with orally administered Famotidine 20 mg tablets at bedtime had lower rates of DU recurrence, as compared with placebo.


• In the U.S. trial, DU recurrence within 12 months was 2.4 times greater in patients treated with placebo than in the patients treated with Famotidine. The 89 Famotidine-treated patients had a cumulative observed DU recurrence rate of 23%, compared to a 57% in the 89 patients receiving placebo (p<0.01).


• In the international trial, the cumulative observed DU recurrence within 12 months in the 307 Famotidine-treated patients was 36%, compared to 76% in the 325 patients who received placebo (p<0.01).

Controlled trials have not extended beyond one year.

16 HOW SUPPLIED/STORAGE AND HANDLING

Famotidine 20 mg tablets are round, white to off-white film-coated tablets coded with CTI 121 on one side and the other side plain, supplied as follows:


Boxes of 10×10 UD 100 NDC 63739-645-10


Storage
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container.

17 PATIENT COUNSELING INFORMATION

Central Nervous System (CNS) Adverse Reactions


Advise elderly patients and those with moderate and severe renal impairment of the risk of CNS adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy [see Warnings and Precautions (5.1)]. Report symptoms immediately to a healthcare provider.


QT Prolongation


Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation [see Use in Specific Populations (8.6)]. Report new cardiac symptoms, such as palpitations, fainting and dizziness or lightheadedness immediately to a healthcare provider.


Administration


Advise patients:
• Take Famotidine once daily before bedtime or twice daily in the morning and before bedtime, as recommended.
• Famotidine tablets may be taken with or without food.
• Famotidine tablets may be given with antacids.

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


Distributed by:
McKesson Corporation dba SKY Packaging
Memphis, TN 38141

21315-5

March 2023

Famotidine

Famotidine
(click image for full-size original)

FAMOTIDINE famotidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-645(NDC:61442-121)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
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 6mm
Flavor Imprint Code CTI;121
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-645-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-645-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075805 04/16/2001
Labeler — Mckesson Corporation DBA SKY Packaginng (140529962)

Revised: 03/2023 Mckesson Corporation DBA SKY Packaginng

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