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:

Major Pharmaceuticals

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 20 mg is supplied as yellow colored, round, biconvex delayed-release tablets imprinted with '107' on one side in black ink and plain on other side. Bottles of 30                           NDC 13668-107-30 Bottles of 90                           NDC 13668-107-90 Bottles of 500                         NDC 13668-107-05 Bottles of 4000                       NDC 13668-107-40 100 Unit dose Tablets            NDC 13668-107-74 Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] . Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Major Pharmaceuticals
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MEDICATION GUIDE
MEDICATION GUIDE
Rabeprazole sodium (ra-BEP-ra-zole SOE-dee-um) delayed-release tablets
What is the most important information I should know about r
abeprazole 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 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 right away if you have a
decrease in the amount that you urinate
or if you have blood in your urine.
• Diarrhea caused 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 and 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 new or worsening joint
pain or a rash on your cheeks or arms that gets worse in the sun.

Summary of Product characteristics

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
MAJOR PHARMACEUTICALS
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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
INDICATIONS AND USAGE
Rabeprazole sodium delayed-release tablets are a proton pump inhibitor
(PPI) indicated in adults for: (1)
•
•
•
•
•
•
In adolescent patients 12 years of age and older for: (1)
•
DOSAGE AND ADMINISTRATION
INDICATION
(2)
RECOMMENDED DOSAGE (2)
(2)
Healing of Erosive or Ulcerative Gastroesophageal Reflux
Disease (GERD)
(2)
20 mg once daily for 4 to 8 weeks
(2)
Maintenance of Healing of Erosive or Ulcerative GERD
*studied for 12 months
(2)
20 mg once daily*
(2)
Symptomatic GERD in Adults
(2)
20 mg once daily for 4 weeks
(2)
Healing of Duodenal Ulcers
(2)
20 mg once daily after morning meal for up to 4 weeks
(2)
_Helicobacter pylori _Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence
(2)
Three Drug Regimen:
Rabeprazole sodium delayed-release tablets 20 mg
Amoxicillin 1000 mg
Clarithromycin 500 mg
(2)
_All three medications should be taken twice daily with_
_morning and evening meals for 7 day._
(2)
Pathological Hypersecretory Conditions, Including Zollinger-
Ellison Syndrome
(2)
Starting dose 60 mg once daily then adjust to patient needs
(2)
Symptomatic GERD in Adolescents 12 Years of Age and
Olde r
(2)
20 mg once daily for up to 8 weeks
(2)
Administration Instructions (2): (2)
•
•
•
•
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
Zol