RABEPRAZOLE SODIUM- rabeprazole sodium tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Unit Dose Services

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Product: 50436-1070 NDC: 50436-1070-1 30 TABLET, DELAYED RELEASE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
Unit Dose Services
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17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide).
How to Take Rabeprazole Sodium Delayed-Release Tablets
Patients should be cautioned that rabeprazole sodium delayed-release
tablets should be swallowed whole.
The tablets should not be chewed, crushed, or split. Rabeprazole
sodium delayed-release tablets can be
taken with or without food.
Advise patient to immediately report and seek care for diarrhea that
does not improve. This may be a sign
of Clostridium difficile associated diarrhea [see Warnings and
Precautions (5.5)].
Manufactured by:
TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.
For:
TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ
07920.
8053134 Revised January 2015
MEDICATION GUIDE
Rabeprazole Sodium (ra-BEP-ra-zole SOE-dee-um) Delayed-Release Tablets
Read the Medication Guide that comes with rabeprazole sodium
delayed-release tablets before you start
taking them and each time you get a refill. There may be new
information. This Medication Guide does
not take the place of talking to your doctor about your medical
condition or treatment.
What is the most important information I should know about rabeprazole
sodium delayed-release tablets?
Rabeprazole sodium delayed-release tablets may help your acid-related
symptoms, but you could still
have serious stomach problems. Talk with your doctor.
Rabeprazole sodium delayed-release tablets can cause serious side
effects, including:
•
Diarrhea. Rabeprazole sodium delayed-release tablets may increase your
risk of getting severe
diarrhea. This diarrhea may be caused by an infection (Clostridium
difficile) in your intestines.
Call your doctor right away if you have watery stool, stomach pain,
and fever that does not go away.
•
Bone fractures. People who take multiple daily doses of Proton Pump
Inhibitor (PPI) medicines
for a long period of time (1 year or longer) may have an increased
risk of frac

Summary of Product characteristics

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
UNIT DOSE SERVICES
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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 with mo