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:

Aurobindo Pharma Limited

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: - 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 (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 administrat

Product summary:

Famotidine Tablets USP, 20 mg are yellow, rounded square shaped, biconvex, film-coated tablets debossed with ‘CC’ on one side and ‘60’ on the other side. Bottles of 30                                            NDC 65862-859-30 Bottles of 100                                          NDC 65862-859-01 Bottles of 500                                          NDC 65862-859-05 Bottles of 1,000                                       NDC 65862-859-99 10 x 10 Unit-dose Tablets                       NDC 65862-859-78 Famotidine Tablets USP, 40 mg are white, rounded square shaped, biconvex, film-coated tablets debossed with ‘CC’ on one side and ‘61’ on the other side. Bottles of 30                                            NDC 65862-860-30 Bottles of 100                                          NDC 65862-860-01 Bottles of 500                                          NDC 65862-860-05 Bottles of 1,000                                       NDC 65862-860-99 10 x 10 Unit-dose Tablets                       NDC 65862-860-78 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE - FAMOTIDINE TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
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.
In adults for the:
treatment of pathological hypersecretory conditions (e.g.,
Zollinger-Ellison syndrome, multiple
endocrine neoplasias).
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
See full prescribing information for complete dosing information,
including dosing in renal impairment,
and recommended treatment duration. (2.1, 2.2)
Administration (2.3):
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)
CONTRAINDICATIONS
History of serious hypersensitivity reactions (e.g., anaphylaxis) to
famotidine or other H receptor
antagonists. (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 symptoms does not preclude the presence
of gastric malignancy;
2
2