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:

REMEDYREPACK 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 yellow, round, biconvex, coated tablets, imprinted with "L020" (black ink) on one side. NDC: 70518-0656-00 NDC: 70518-0656-01 PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 60 in 1 BOTTLE PLASTIC Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [see USP Controlled Room Temperature]. Protect from moisture. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
REMEDYREPACK INC.
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MEDICATION GUIDE
Rabeprazole Sodium (ra bep′ ra zole soe′ dee um)
Delayed-Release Tablets
Rx Only
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?
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 a

Summary of Product characteristics

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
REMEDYREPACK 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 tablet is 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
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 d