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
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Labeler — Mckesson Corporation DBA SKY Packaginng (140529962) |
Revised: 03/2023 Mckesson Corporation DBA SKY Packaginng
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