FAMOTIDINE tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Preferred Pharmaceuticals, Inc.

INN (Међународно име):

FAMOTIDINE

Састав:

FAMOTIDINE 20 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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. 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 risk of birth defect, loss, or o

Резиме производа:

Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of; Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid storage of famotidine tablets at temperatures above 40°C (104°F). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
----------
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
Re ocurre nce
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
•
•
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 without food.
2
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 sy