RABEPRAZOLE SODIUM tablet, delayed release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Medsource Pharmaceuticals

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

Rabeprazole Sodium Delayed-Release Tablets 20 mg is supplied as yellow, round , biconvex, beveled, coated tablets imprinted ‘20’ in black on one side. Bottles of 30                                                               (NDC 67877-443-30) Bottles of 90                                                               (NDC 67877-443-90) Carton of 100 (10 X 10 Unit-dose Tablets)               (NDC 67877-443-38) Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature] . Protect from moisture.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
MEDSOURCE PHARMACEUTICALS
----------
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
Warnings and Precautions, Fundic Gland Polyps (5.10) 06/2018
INDICATIONS AND USAGE
Rabeprazole sodium delayed-release tablets is a proton pump inhibitor
(PPI) indicated in adults 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 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:
· Short-term Treatment of Symptomatic GERD ( 1.7)
DOSAGE AND ADMINISTRATION
Indication
Recommended Dosage (2)
Healing of Erosive or Ulcerative Gastroesophageal Reflux
Disease (GERD)
20 mg once daily for 4 to 8 weeks
Maintenance of Healing of Erosive or Ulcerative GERD*
studied for 12 months
20 mg once daily*
Symptomatic GERD in Adults
20 mg once daily for 4 weeks
Healing of Duodenal Ulcers
20 mg once daily after morning meal for up to 4 weeks
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence
Three Drug Regimen:
All three medications should be taken twice daily with
morning and evening meals for 7 days
Rabeprazole sodium delayed-release tablets 20 mg
Amoxicillin 1000 mg
Clarithromycin 500 mg
Pathological Hypersecretory Conditions, Including Zollinger-
Ellison Syndrome
Starting dose 60 mg once daily then adjust to patient needs
Symptomatic GERD in Adolescents 12 Years of Age and
Older
20 mg once dai