PEPCID- famotidine powder, for suspension

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Salix Pharmaceuticals, Inc

ІПН (Міжнародна Ім'я):

FAMOTIDINE

Склад:

FAMOTIDINE 40 mg in 5 mL

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

PEPCID for oral suspension is indicated in adults for the treatment of: PEPCID for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of: PEPCID for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of: PEPCID 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-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 ri

Огляд продуктів:

PEPCID (famotidine) for oral suspension is supplied as follows: NDC Strength Quantity Description 0006-3538-92 40 mg Bottle white to off-white powder. When constituted as directed, PEPCID suspension is a smooth, mobile, off-white, homogeneous suspension with a cherry-banana-mint flavor, containing 40 mg of famotidine per 5 mL. Prior to dispensing, constitute PEPCID for oral suspension [see Dosage and Administration (2.3)] Storage Store PEPCID 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.

Статус Авторизація:

New Drug Application

Характеристики продукта

PEPCID- FAMOTIDINE POWDER, FOR SUSPENSION
SALIX PHARMACEUTICALS, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PEPCID FOR ORAL SUSPENSION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PEPCID FOR ORAL
SUSPENSION.
PEPCID® (FAMOTIDINE) FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
PEPCID is a histamine-2 (H2) receptor antagonist indicated (1): (1)
In adults for the treatment of: (1)
•
•
•
•
•
•
In pediatric patients 1 year of age and older for the treatment of:
(1)
•
•
In pediatric patients from birth to less than 1 year of age for the
treatment of: (1)
•
DOSAGE AND ADMINISTRATION
•
•
1 year to less than 17 years (2)
Starting dosage 0.5 mg/kg once daily; or (2)
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.
peptic ulcer
GERD with or without esophagitis and ulcerations
GERD.
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)
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; (