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:

Golden State Medical Supply, Inc.

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 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:

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 60429-232-30 bottles of 30 tablets NDC 60429-232-90 bottles of 90 tablets NDC 60429-232-05 bottles of 500 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

Golden State Medical Supply, Inc.
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MEDICATION GUIDE
Rabeprazole Sodium Delayed-Release Tablets
(ra bep′ ra zole soe′ dee um)
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:
•
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump inhibitor
(PPI) medicines, including rabeprazole sodium delayed-release tablets,
may develop a kidney
problem called acute interstitial nephritis that can happen at any
time during treatment with
rabeprazole sodium delayed-release tablets. Call your doctor if you
have a decrease in the amount
that you urinate or if you have blood in your urine.
•
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 PPI medicines
for a long period of time (1
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.
•
Certain types of lupus erythematosus. Lupus erythematosus is an
autoimmune disorder (the body’s
immune cells attack other cells or organs in the body). Some people
who take PPI medi

Summary of Product characteristics

RABEPRAZOLE SODIUM- RABEPRAZOLE TABLET, DELAYED RELEASE
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS
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) 04/2016
Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus (
5.6) 10/2016
INDICATIONS AND USAGE
Rabeprazole sodium delayed-release tablets are 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 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:
Short-term Treatment of Symptomatic GERD ( 1.7)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
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
studie d
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:
Rabeprazole sodium delayed-release tablets 20 mg
Amoxicillin 1000 mg
Clarithromycin 500 mg
_All three medications should be taken twice daily with_
_morning and evening meals for 7 days_
Pathological Hypersecretory Conditions, Including Zollinger-
Ellison Syndrome
Starting dose 60 mg once daily then adjust