FAMOTIDINE powder, for suspension

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Lupin Pharmaceuticals, Inc.

INN (Nome Internazionale):

FAMOTIDINE

Composizione:

FAMOTIDINE 40 mg in 5 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Famotidine for oral suspension is indicated in adults 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. - treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). - reduction of the risk of duodenal ulcer recurrence. Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of: - peptic ulcer disease. - GERD with or without esophagitis and ulcerations. Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of: - GERD. Famotidine for oral suspension is 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

Dettagli prodotto:

Famotidine for Oral Suspension USP is a white to off-white granular powder forming an off-white suspension with characteristic odor on constitution, containing 40 mg of famotidine per 5 mL. The suspension is a cherry-banana-mint flavored. 50 mL                          NDC # 68180-150-01             Bottle containing 400 mg famotidine. Prior to dispensing, constitute famotidine for oral suspension [see DOSAGE AND ADMINISTRATION (2.3)] Storage Store famotidine for oral suspension dry powder and constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing. Discard unused constituted suspension after 30 days. Dispense in a USP tight, light-resistant container.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

FAMOTIDINE- FAMOTIDINE POWDER, FOR SUSPENSION
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FAMOTIDINE FOR ORAL SUSPENSION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FAMOTIDINE FOR ORAL SUSPENSION.
FAMOTIDINE FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
Famotidine for oral suspension is a histamine-2 (H2) receptor
antagonist indicated (1):
In adults 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.
treatment of pathological hypersecretory conditions (e.g.,
Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of DU recurrence.
In pediatric patients 1 year of age and older for the treatment of:
peptic ulcer
GERD with or without esophagitis and ulcerations
In pediatric patients from birth to less than 1 year of age for the
treatment of:
GERD.
DOSAGE AND ADMINISTRATION
Recommended adult dosage by indication (2.1):
Active DU
40 mg once daily; or
20 mg twice daily
Active GU
40 mg once daily
Symptomatic Nonerosive GERD
20 mg twice daily
Erosive Esophagitis due to GERD
20 mg twice daily; or
40 mg twice daily
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
Recommended pediatric dosage by indication (2.2):
Peptic Ulcer Disease
1 year to less than 17 years
Starting dosage 0.5 mg/kg once daily; or
0.25 mg/kg twice daily; may increase to 1 mg/kg once daily at bedtime
or 0.5
mg/kg twice daily;
Maximum of 40 mg per day
GERD
Birth to less than 3 months
Starting dosage 0.5 mg/kg once daily; may increase to 1 mg/kg once
daily
3 months to less than 1 year
Starting dosage 0.5 mg/kg twice daily; may increase to 1 mg/kg twice
daily;
Maximum of 40 mg per day
GERD with or without esophagitis and
ulce rations
1 year t