RABEPRAZOLE SODIUM- rabeprazole sodium tablet, delayed release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NuCare Pharmaceuticals, Inc.

INN (International Name):

RABEPRAZOLE SODIUM

Sammensetning:

RABEPRAZOLE SODIUM 20 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Rabeprazole sodium delayed-release tablets are 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 rabeprazole sodium delayed-release tablets may be considered. Rabeprazole sodium delayed-release tablets are 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. Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks. Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks. Rabeprazole

Produkt oppsummering:

Rabeprazole sodium 20 mg is supplied as yellow colored, round, biconvex delayed-release tablets imprinted with '107' on one side in black ink and plain on other side. Bottles of 60 NDC 68071-2173-6 Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [ see USP Controlled Room Temperature]. Protect from moisture.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
NUCARE PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS.
RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Contraindications (4) 12/2014
Warnings and Precautions; Acute Interstitial Nephritis (5.3) 12/2014
Warnings and Precautions; Cyanocobalamin (vitamin B-12)
Deficiency (5.4) 12/2014
INDICATIONS AND USAGE
Rabeprazole sodium delayed-release tablets are a proton-pump inhibitor
(PPI) indicated in adults for: (1)
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)
In adolescent patients 12 years of age and older for: (1)
Short-term treatment of Symptomatic GERD (1.7)
DOSAGE AND ADMINISTRATION
Rabeprazole sodium delayed-release tablets should be swallowed whole.
The tablets should not be chewed, crushed, or
split (2.10). (2)
HEALING OF EROSIVE OR ULCERATIVE GASTROESOPHAGEAL REFLUX DISEASE
(GERD) (2.1)
20 mg once daily for 4 to 8 weeks
MAINTENANCE OF HEALING OF EROSIVE OR ULCERATIVE GERD (2.2) *studied
for 12 months
20 mg once daily*
TREATMENT OF SYMPTOMATIC GERD IN ADULTS (2.3)
20 mg once daily for 4 weeks
HEALING OF DUODENAL ULCERS (2.4)
20 mg once daily after morning meal for up to 4 weeks
_HELICOBACTER PYLORI _ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER
RECURRENCE (2.5)
THREE DRUG REGIMEN:
Rabeprazole sodium delayed-release tablets 20 mg
Amoxicillin 1000 mg
Clarithromycin 500 mg
_All three medications should be taken twice daily