FAMOTIDINE tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

BluePoint Laboratories

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of: - active duodenal ulcer (DU). - active gastric ulcer (GU). - symptomatic nonerosive gastroesophageal reflux disease (GERD). - erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: - treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). - reduction of the risk of duodenal ulcer recurrence. Famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H 2 ) receptor antagonists. Risk Summary Available data with H 2 -receptor antagonists, including famotine, 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 observ

Обзор продуктов:

Famotidine Tablets, USP, 20 mg, are yellow colored, circular, biconvex film-coated tablets embossed with ‘L113’on one side and ‘20’ on the other side. NDC 68001-240-00         bottles of 100 NDC 68001-240-08         bottles of 1000 Famotidine Tablets USP, 40 mg, are brown colored, circular, biconvex film-coated tablets embossed with ‘L114’on one side and ‘40’ on the other side. NDC 68001-241-00         bottles of 100 NDC 68001-241-03         bottles of 500 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed, light-resistant containers.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

FAMOTIDINE- FAMOTIDINE TABLET
BLUEPOINT LABORATORIES
----------
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 tablet is a histamine-2 (H
) receptor antagonist indicated (1): (1)
In adult and pediatric patients 40 kg and above for the treatment of:
(1)
active duodenal ulcer (DU).
active gastric ulcer.
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
In adults for the: (1)
treatment of pathological hypersecretory conditions (e.g.,
Zollinger-Ellison syndrome, multiple
endocrine neoplasias).
reduction of the risk of DU recurrence.
DOSAGE AND ADMINISTRATION
Indication
(2)
Recommended Dosage (2.1)
(2)
_Adults and Pediatric Patients 40 kg and greater_
(2)
Active DU
(2)
40 mg once daily; or
20 mg twice daily
Active Gastric Ulcer
(2)
40 mg once daily
GERD
(2)
20 mg twice daily
(2)
Erosive Esophagitis
(2)
20 mg twice daily; or
40 mg twice daily
(2)
_Adults_
(2)
Pathological Hypersecretory Conditions
(2)
20 mg every 6 hours; adjust to patient needs;
maximum 160 mg every 6 hours
(2)
Risk Reduction of DU Recurrence
(2)
20 mg once daily
(2)
See full prescribing information for complete dosing information,
including dosing in renal impairment,
and recommended treatment duration. (2.1, 2.2)
Administration (2.3): (2)
Take once daily before bedtime or twice daily in the morning and
before bedtime with or without food.
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg, 40 mg (3) (3)
CONTRAINDICATIONS
History of serious hypersensitivity reactions (e.g., anaphylaxis) to
famotidine or other H
receptor
antagonists. (4) (4)
2
2
antagonists. (4) (4)
WARNINGS AND PRECAUTIONS
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)
G