FAMOTIDINE powder, for suspension

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Zydus Pharmaceuticals USA Inc.

Designación común internacional (DCI):

FAMOTIDINE

Composición:

FAMOTIDINE 40 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 H2 -rece

Resumen del producto:

Famotidine for oral suspension is supplied as follows: 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.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

FAMOTIDINE - FAMOTIDINE POWDER, FOR SUSPENSION
ZYDUS PHARMACEUTICALS USA 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 is a histamine-2 (H ) receptor antagonist indicated (1):
(1)
In adults for the treatment of: (1)
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:
(1)
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: (1)
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 (2)
1 year to less than 17 years (2)
Starting dosage 0.5 mg/kg once daily; or (2)
0.25 mg/kg twice daily; may increase to (2)
1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily; (2)
Maximum of 40 mg per day (2)
GERD(2)
Birth to less than 3 months (2)
Starting dosage 0.5 mg/kg once daily; (2)
may increase to 1 mg/kg once daily (2)
3 months to less than 1 year (2)
Starting dosage 0.5 mg/kg twice daily; (2)
may increase to 1 mg/kg twice daily; (2)
Maximum of 40 mg per day (2)
GERD