ACIPHEX SPRINKLE rabeprazole sodium capsule delayed release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

RABEPRAZOLE SODIUM (UNII: 3L36P16U4R) (RABEPRAZOLE - UNII:32828355LL)

זמין מ:

Avadel Pharmaceuticals (USA), Inc.

INN (שם בינלאומי):

RABEPRAZOLE SODIUM

הרכב:

RABEPRAZOLE SODIUM 5 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

New Drug Application

מאפייני מוצר

ACIPHEX SPRINKLE- RABEPRAZOLE SODIUM CAPSULE, DELAYED RELEASE
AVADEL PHARMACEUTICALS (USA), INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACIPHEX SPRINKLE SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ACIPHEX SPRINKLE.
ACIPHEX SPRINKLE™ (RABEPRAZOLE SODIUM DELAYED-RELEASE CAPSULES), FOR
ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions, Cutaneous and
Systemic Lupus Erythematosus (5.6)
10/2016
INDICATIONS AND USAGE
ACIPHEX Sprinkle is a proton-pump inhibitor (PPI) indicated for the
treatment of Gastroesophageal Reflux Disease
(GERD) in pediatric patients 1 to 11 years of age (1).
DOSAGE AND ADMINISTRATION
Dosage Regimen (2.1):
The recommended dosage in pediatric patients 1 to 11 years of age for
up to 12 weeks is:
_Less than 15 kg_: 5 mg once daily with the option to increase to 10
mg once daily, if inadequate response
_15 kg or more_: 10 mg once daily
Administration Recommendations (2.2):
Take dose 30 minutes before a meal
Do not swallow the capsule whole
Open an ACIPHEX Sprinkle capsule and sprinkle granule contents on a
spoonful of soft food or liquid (e.g., applesauce).
Food or liquid should be at or below room temperature.
Do not chew or crush the granules
Take entire dose within 15 minutes of preparation
DOSAGE FORMS AND STRENGTHS
Delayed-Release Capsules: 5 mg and 10 mg (3).
CONTRAINDICATIONS
Patients with a history of hypersensitivity to rabeprazole (4).
PPIs, including ACIPHEX Sprinkle, are contraindicated in patients
receiving rilpivirine-containing products (4, 7).
WARNINGS AND PRECAUTIONS
Gastric Malignancy: In adults, symptomatic response to therapy with
rabeprazole does not preclude the presence of
gastric malignancy. Consider additional follow-up and diagnostic
testing (5.1).
Use with Warfarin: Monitor for increases in INR and prothrombin time
(5.2, 7).
Acute Interstitial Nephritis: Observed in patients taking PPIs (5.3).
_Clostridium difficile_-Associated Diarrhea: PPI therapy