RABEPRAZOLE SODIUM- rabeprazole 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:

Proficient Rx LP

INN (International Name):

RABEPRAZOLE SODIUM

Composition:

RABEPRAZOLE SODIUM 20 mg

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. Rabeprazole sodium delayed-release tablets are indicated for short-term (up to 4 weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within 4 weeks. Rabeprazole sodium delayed-releas

Product summary:

Rabeprazole Sodium Delayed-release Tablets are available containing 20 mg of rabeprazole sodium. The 20 mg tablets are beige, film-coated, round, unscored tablets with M over R7 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 63187-158-30 bottles of 30 tablets NDC 63187-158-60 Bottles of 60 tablets NDC 63187-158-90 Bottles of 90 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RABEPRAZOLE SODIUM- RABEPRAZOLE TABLET, DELAYED RELEASE
Proficient Rx LP
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MEDICATION GUIDE
RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS
(ra bep′ ra zole soe′ dee um)
20 mg
Read the Medication Guide that comes with rabeprazole sodium
delayed-release tablets before you start
taking it 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 medicines for a long
period of time (one year or longer) may have an increased risk of
fractures of the hip, wrist, or
spine. You should take rabeprazole sodium delayed-release tablets
exactly as prescribed, at the
lowest dose possible for your treatment and for the shortest time
needed. Talk to your doctor about
your risk of bone fracture if you take rabeprazole sodium
delayed-release tablets.
•
Rabeprazole sodium delayed-release tablets can have other serious side
effects. See “ What are the
possible side effects of rabeprazole sodium delayed-release
tablets?”.
What are rabeprazole sodium delayed-release tablets?
Rabeprazole sodium delayed-release tablets are a prescription medicine
called a proton pump inhibitor
(PPI). Rabeprazole sodium delayed-release tablets reduce the amount of
acid in your stomach.
Rabeprazole sodium delay

Summary of Product characteristics

RABEPRAZOLE SODIUM- RABEPRAZOLE TABLET, DELAYED RELEASE
PROFICIENT RX LP
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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
Warnings and Precautions, _Clostridium difficile_ associated diarrhea
(5.3) 10/2012
Warnings and Precautions, Concomitant use of rabeprazole sodium
delayed-release tablets with Methotrexate
(5.6) 05/2012
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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Rabeprazole sodium delayed-release tablets are a proton-pump inhibitor
(PPI) indicated in adults for:
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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:
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Short-term treatment of Symptomatic GERD (1.7)
Rabeprazole sodium delayed-release tablets should be swallowed whole.
The tablets should not be chewed, crushed
or split (2.10).
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 IN ADULTS (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:
Rabeprazole sodium delayed-release tablets 20 mg
Amoxicillin 1000 mg
Clarithromycin 500 mg
_All three medications should be t