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:

Teva Pharmaceuticals USA, 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, 20 mg are supplied as enteric-coated, delayed-release, unscored, yellow, round tablets, imprinted on one side of the tablet with black ink “93” “64”. They are available in bottles of 30 (NDC 0093-0064-56). Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
Teva Pharmaceuticals USA, Inc.
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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.
•
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 join

Summary of Product characteristics

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
TEVA PHARMACEUTICALS USA, INC.
----------
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,
Acute Tubulointerstitial Nephritis (5.3) 11/2020
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 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 20 mg
_All three medications should be taken twice daily with_
_morning and evening meals for 7 days_
Amoxicillin 1000 mg
Clarithromycin 500 mg
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 fo