PEPCID- famotidine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)

Available from:

Bausch Health US LLC

INN (International Name):

FAMOTIDINE

Composition:

FAMOTIDINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PEPCID tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: PEPCID tablets are indicated in adults for the: reduction of the risk of duodenal ulcer recurrence. PEPCID is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H2) receptor antagonists. Risk Summary Available data with H2-receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see Data) . The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background ris

Product summary:

PEPCID (famotidine) tablets are supplied as follows: NDC Strength Quantity Description 0187-4420-30 20 mg unit of use bottles of 30 round, white to off-white film-coated tablets coded with MP 973 on one side and the other side plain 0187-4420-10 20 mg unit of use bottles of 100 round, white to off-white film-coated tablets coded with MP 973 on one side and the other side plain 0187-4440-30 40 mg unit of use bottles of 30 round, white to off-white film-coated tablets coded with MP 974 on one side and the other side plain 0187-4440-10 40 mg unit of use bottles of 100 round, white to off-white film-coated tablets coded with MP 974 on one side and the other side plain 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PEPCID- FAMOTIDINE TABLET, FILM COATED
BAUSCH HEALTH AMERICAS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PEPCID TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR PEPCID TABLETS.
PEPCID (FAMOTIDINE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
PEPCID is a histamine-2 (H2) receptor antagonist indicated (1): (1)
In adult and pediatric patients 40 kg and greater for the treatment
of: (1)
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In adults for the: (1)
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DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg, 40 mg (3) (3)
CONTRAINDICATIONS
History of serious hypersensitivity reactions (e.g., anaphylaxis) to
famotidine or other H2 receptor antagonists. (4) (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions are: headache, dizziness,
constipation, and diarrhea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT VALEANT PHARMACEUTICALS
NORTH AMERICA LLC AT 1-800-
321-4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Dosage in Renal Impairment
®
active duodenal ulcer (DU).
active gastric ulcer.
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
treatment of pathological hypersecretory conditions (e.g.,
Zollinger-Ellison
syndrome, multiple endocrine neoplasias).
reduction of the risk of DU recurrence.
Central Nervous System (CNS) Adverse Reactions: Elderly patients and
patients with renal impairment at increased
risk; reduce the dosage. (2.2, 5.1, 8.5, 8.6)
GI Malignancy: Absence of GI symptoms does not preclude the presence
of gastric malignancy; evaluate prior to
initiating therapy. (5.2)
Drugs Dependent on Gastric pH for Absorption: Systemic exposure of the
concomitant drug may be significantly
reduced leading to los