FAMOTIDINE tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

A-S Medication Solutions

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 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 other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Reproductive studies have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine. While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Risk Summary There are limited data available on the presence of famotidine in human breast milk. There were no effects on the breastfed infant. There are no data on famotidine effects on milk production. Famotidine is present in the milk of lactating rats (see Data) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for famotidine and any potential adverse effects on the breastfed child from PEPCID or from the underlying maternal condition. Data Animal Data Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of famotidine at least 600 times the usual human dose. The safety and effectiveness of famotidine have been established in pediatric patients for the treatment of peptic ulcer disease (i.e., duodenal ulcer, gastric ulcer) and GERD (i.e., symptomatic nonerosive GERD, erosive esophagitis as diagnosed by endoscopy). The use of famotidine and the recommended dosage of famotidine in these pediatric patients is supported by evidence from adequate and well-controlled studies of famotidine in adults and published pharmacokinetic and pharmacodynamic data in pediatric patients [see Dosage and Administration (2.1), Clinical Pharmacology (12.2,  12.3)] . In pediatric patients, the safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established. Famotidine 20 and 40 mg tablets are not recommended for use in pediatric patients weighing less than 40 kg because these tablet strengths exceed the recommended dose for these patients [see Dosage and Administration (2.1)] . For pediatric patients weighing less than 40 kg, consider another famotidine formulation (e.g., oral suspension, lower dose tablet). Of the 1442 famotidine-treated patients in clinical studies, approximately 10% were 65 and older. In these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients. In postmarketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine [see Warnings and Precautions (5.1)] . Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine may be greater in elderly patients, particularly those with impaired renal function [see Use in Specific Populations (8.6)] . In general, use the lowest effective dose of famotidine for an elderly patient and monitor renal function [see Dosage and Administration (2.2)]. CNS adverse reactions and prolonged QT intervals have been reported in patients with moderate and severe renal impairment [see Warnings and Precautions (5.1)]. The clearance of famotidine is reduced in adults with moderate and severe renal impairment compared to adults with normal renal function [see Clinical Pharmacology (12.3)]. No dosage adjustment is needed in patients with mild renal impairment (creatinine clearance greater than or equal to 60 mL/minute). Dosage reduction is recommended in adult and pediatric patients greater than or equal to 40 kg with moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) [see Dosage and Administration (2.2)].

Περίληψη προϊόντος:

Product: 50090-3888 NDC: 50090-3888-0 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-3888-1 90 TABLET, FILM COATED in a BOTTLE

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FAMOTIDINE - FAMOTIDINE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
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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.
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