ACIPHEX- rabeprazole sodium tablet, delayed release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Physicians Total Care, Inc.

INN (Alþjóðlegt nafn):

RABEPRAZOLE SODIUM

Samsetning:

RABEPRAZOLE SODIUM 20 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Enter section text here ACIPHEX is indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of ACIPHEX may be considered. ACIPHEX is indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months. ACIPHEX is indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults and adolescents 12 years of age and above. ACIPHEX is indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks. ACIPHEX in combination with amoxicillin and clarithromycin as a three drug regimen, is indicated for the treatment of patients with

Vörulýsing:

ACIPHEX 20 mg is supplied as delayed-release light yellow enteric-coated tablets. The name and strength, in mg, (ACIPHEX 20) is imprinted on one side. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature] Protect from moisture.

Leyfisstaða:

New Drug Application

Vara einkenni

ACIPHEX - RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACIPHEX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ACIPHEX. ACIPHEX (RABEPRAZOLE SODIUM)
TABLET, DELAYED RELEASE FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Indication and Usage (1.3) June/2008
Dosage and Administration, Pediatric Patients (2.7) June/2008
Use in Specific Populations, Pediatric Use (8.4) June/2008
INDICATIONS AND USAGE
ACIPHEX is a proton-pump inhibitor indicated for:
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease
(GERD) (1.1)
Maintenance of Healing of Erosive or Ulcerative GERD (1.2)
Treatment of Symptomatic GERD (1.3)
Healing of Duodenal Ulcers (1.4)
_Helicobacter pylori_ Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence (1.5)
Treatment of Pathological Hypersecretory Conditions, Including
Zollinger-Ellison Syndrome (1.6)
ACIPHEX is a proton-pump inhibitor indicated for adolescent patients
12 years of age and above for:
Short-term treatment of Symptomatic GERD (1.3)
DOSAGE AND ADMINISTRATION
ACIPHEX tablets should be swallowed whole. The tablets should not be
chewed, crushed or split.
HEALING OF EROSIVE OR ULCERATIVE GASTROESOPHAGEAL REFLUX DISEASE
(GERD) (2.1)
20 mg once daily
MAINTENANCE OF HEALING OF EROSIVE OR ULCERATIVE GERD (2.2)
20 mg once daily
TREATMENT OF SYMPTOMATIC GERD (2.3)
20 mg once daily
HEALING OF DUODENAL ULCERS (2.4)
20 mg once daily after morning meal
Helicobacter pylori ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER
RECURRENCE (2.5)
THREE DRUG REGIMEN _ALL THREE MEDICATIONS SHOULD BE TAKEN TWICE DAILY
WITH MORNING AND EVENING MEALS FOR 7 DAYS_:
ACIPHEX 20 mg
Amoxicillin 1000 mg
Clarithromycin 500 mg
TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS, INCLUDING
ZOLLINGER-ELLISON SYNDROME (2.6)
Starting dose 60 mg once daily then adjust to patient needs
SHORT-TERM TREATMENT OF GERD IN ADOLESCENT PATIENTS 12 YEARS OF AG