RABEPRAZOLE SODIUM- rabeprazole sodium tablet, delayed release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

RABEPRAZOLE SODIUM (UNII: 3L36P16U4R) (RABEPRAZOLE - UNII:32828355LL)

Tilgjengelig fra:

Preferred Pharmaceuticals Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Rabeprazole Sodium Delayed-Release Tablets 20 mg are supplied as light yellow colored round, biconvex tablets with beveled edges and B683 printed on one side with black ink and plain on the other side. Bottles of 30 (NDC#68788-7143-3) Bottles of 60 (NDC#68788-7143-6) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [ see USP Controlled Room Temperature] . Protect from moisture.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE
Rabeprazole Sodium (ra-bep-ra-zole soe-dee-um) Delayed-Release Tablets
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 medicines,
incl

Preparatomtale

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
PREFERRED PHARMACEUTICALS INC.
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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
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:
•
•
•
•
•
•
In adolescent patients 12 years of age and older for:
•
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
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
Olde r
20 mg once daily for up to 8 weeks
Administration Instructions (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 the Risk of Duodenal Ulcer
Recurrence (1.5).
Treatment of Pathol