FAMOTIDINE- 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:

Mylan Pharmaceuticals Inc.

INN (International Name):

FAMOTIDINE

Composition:

FAMOTIDINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: Famotidine tablets are indicated in adults for the: Famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H2 ) receptor antagonists. 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 risk of birth defect, loss, or other adverse

Product summary:

Famotidine Tablets, USP are available containing 20 mg or 40 mg of famotidine, USP. They are available as follows: The 20 mg tablets are yellow, film-coated, round, unscored tablets debossed with M over F1 on one side of the tablet and blank on the other side. NDC 0378-3020-01 bottles of 100 tablets NDC 0378-3020-05 bottles of 500 tablets The 40 mg tablets are green, film-coated, round, unscored tablets debossed with M over F2 on one side of the tablet and blank on the other side. NDC 0378-3040-01 bottles of 100 tablets Storage:  Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FAMOTIDINE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FAMOTIDINE TABLETS.
FAMOTIDINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
Famotidine tablets are a histamine-2 (H ) receptor antagonist
indicated (1):
In adult and pediatric patients 40 kg and greater for the treatment
of:
•
•
•
•
In adults for the:
•
•
DOSAGE AND ADMINISTRATION
Indication
Recommended Dosage (2.1)
_Adult and Pediatric Patients_
_40 kg and greater_
Active DU
40 mg once daily; or
20 mg twice daily
Active Gastric Ulcer
40 mg once daily
GERD
20 mg twice daily
Erosive Esophagitis
20 mg twice daily; or
40 mg twice daily
_Adults_
Pathological Hypersecretory Conditions
20 mg every 6 hours; adjust to patient needs; maximum 160
mg every 6 hours
Risk Reduction of DU Recurrence
20 mg once daily
•
Administration (2.3):
•
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg, 40 mg (3)
CONTRAINDICATIONS
History of serious hypersensitivity reactions (e.g., anaphylaxis) to
famotidine or other H receptor antagonists. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common adverse reactions are: headache, dizziness,
constipation, and diarrhea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
2
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.
See full prescribing information for complete dosing information,
including dosing in renal impairment, and
recommended treatment duration. (2.1, 2.2)
Take once daily before bedtime or twice daily in the morning and
before bedtime with or with