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:

Golden State Medical Supply, Inc.

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 20 mg are supplied as delayed-release blue enteric-coated round tablets debossed with "KU" on one side and "7" on the other. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] . Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Golden State Medical Supply, Inc.
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Dispense with Medication Guide available at:
www.lannett.com/med-guide/rabeprazole
MEDICATION GUIDE
Rabeprazole Sodium
(ra bep’ ra zole soe’ dee um)
Delayed-Release Tablets
What is the most important information I should know about Rabeprazole
Sodium Delayed-Release
Tablets?
You should take Rabeprazole Sodium Delayed-Release Tablets exactly as
prescribed, at the lowest dose
possible and for the shortest time needed.
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 tubulointerstitial nephritis).Some
people who take proton pump
inhibitor (PPI) medicines, including Rabeprazole Sodium
Delayed-Release Tablets, may develop
a kidney problem called acute tubulointerstitial nephritis that can
happen at any time during
treatment with Rabeprazole Sodium Delayed-Release Tablets. Call your
doctor right away if you
have a decrease in the amount that you urinate or if you have blood in
your urine.
•
Diarrheacaused by an infection ( Clostridium difficile) in your
intestines. Call your doctor right
away if you have watery stools or stomach pain that does not go away.
You may or may not have
a fever.
•
Bone fractures (hip, wrist, or spine).Bone fractures in the hip,
wrist, or spine may happen in
people who take multiple daily doses of PPI medicines for a long
period of time (a year or
longer). Tell your doctor if you have a bone fracture, especially in
the hip, wrist, or spine.
•
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 medicines,
including Rabeprazole Sodium Delayed-Release Tablets, may develop
certain types of lupus
erythematosus or have worsening of the lupus they already have. Call
your doctor right away if
you have

Summary of Product characteristics

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM 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
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
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:
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 to patient
needs
Symptomatic GERD in Adolescents 12 Years of
Age and Older
20 mg once daily for up to 8 weeks
Administration