FAMOTIDINE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Mckesson Corporation DBA SKY Packaginng

INN (Միջազգային անվանումը):

Famotidine

Կազմը:

Famotidine 20 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater 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 is 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 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 obs

Ապրանքի ամփոփագիր:

Famotidine 20 mg tablets are round, white to off-white film-coated tablets coded with CTI 121 on one side and the other side plain, supplied as follows: Boxes of 10x10 UD 100 NDC 63739-645-10 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.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

FAMOTIDINE- FAMOTIDINE TABLET
MCKESSON CORPORATION DBA SKY PACKAGINNG
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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 is a histamine-2 (H
) receptor antagonist indicated (1):
In adult and pediatric patients 40 kg and greater for the treatment
of:
• active duodenal ulcer (DU).
• active gastric ulcer.
• symptomatic nonerosive gastroesophageal reflux disease (GERD).
• erosive esophagitis due to GERD, diagnosed by biopsy. (1)
In adults for the:
• treatment of pathological hypersecretory conditions (e.g.,
Zollinger-Ellison
syndrome, multiple endocrine neoplasias).
• reduction of the risk of DU recurrence. (1)
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
• See full prescribing information for complete dosing information,
including
dosing in renal impairment, and recommended treatment duration. (2.1,
2.2) (2)
(2)
Administration (2.3):
• Take once daily before bedtime or twice daily in the morning and
before
bedtime with or without food. (2)
(2)
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg (3) (3)
CONTRAINDICATIONS
History of serious hypersensitivity reactions (e.g., anaphylaxis) to
famotidine or
other H
receptor 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)
• GI Malignancy: Absence of GI s