Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
RABEPRAZOLE SODIUM (UNII: 3L36P16U4R) (RABEPRAZOLE - UNII:32828355LL)
NuCare Pharmaceuticals, Inc.
RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM 20 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE NUCARE PHARMACEUTICALS, INC. ---------- 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 Przeczytaj cały dokument