FAMOTIDINE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Carlsbad Technology, Inc

INN (Tên quốc tế):

Famotidine

Thành phần:

Famotidine 20 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of: • active duodenal ulcer. • active gastric ulcer. • symptomatic non-erosive 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 is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H 2 ) receptor antagonists. 8.1 Pregnancy Risk Summary Available data with H 2 -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

Tóm tắt sản phẩm:

Famotidine 20 mg tablets are white, round, film-coated tablets engraved with CTI 121 on one side, supplied as follows: • NDC 61442-121-01 unit of use bottles of 100 • NDC 61442-121-10 unit of use bottles of 1000 Famotidine 40 mg tablets are white, round, film-coated tablets engraved with CTI 122 on one side, supplied as follows: • NDC 61442-122-01 unit of use bottles of 100 • NDC 61442-122-10 unit of use bottles of 1000 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 tight, light-resistant container.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

FAMOTIDINE- FAMOTIDINE TABLET
CARLSBAD TECHNOLOGY, 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.
INITIAL U.S. APPROVAL: 1986
FAMOTIDINE TABLETS
INDICATIONS AND USAGE
Famotidine is a histamine-2 (H2) receptor antagonist indicated (1):
(1)
In adult and pediatric patients 40 kg and greater 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). (1)
reduction of the risk of DU recurrence.
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 (2)
See full prescribing information for complete dosing information,
including
dosing in renal impairment, and recommended treatment duration. (2.1,
2.2) (2)
Administration (2.3): (2)
Take once daily before bedtime or twice daily in the morning and
before
bedtime with or without food.
(2)
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)
WARNINGS AND PRECAUTIONS
(5)
Central Nervous System (CNS) Adverse Reactions: Elderly patients and
2
patients with renal impairment at increased risk; reduce the dosage.
(2.2,
5.1, 8.5, 8.6) (5)
GI Malignancy: Absence of GI symptoms does not preclude the presence
of gastri