HIGHLIGHTS OF PRESCRIBING INFORMATION

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

AvKARE

INN (Rahvusvaheline Nimetus):

RABEPRAZOLE SODIUM

Koostis:

RABEPRAZOLE SODIUM 20 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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. 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 sodium delayed-rel

Toote kokkuvõte:

Rabeprazole sodium delayed-release tablets, 20 mg are supplied as enteric-coated, delayed-release, yellow, round tablets, imprinted on one side of the tablet with black ink "93" "64". They available in bottles of 30 NDC 42291-721-30 bottles of 90 NDC 42291-721-90 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.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

AvKARE
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MEDICATION GUIDE
Rabeprazole Sodium Delayed-Release Tablets
Read the Medication Guide that comes with rabeprazole sodium
delayed-release tablets before you start
taking them 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:
•
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 Proton Pump
Inhibitor (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.
Talk to your doctor about your risk
of bone fracture if you take rabeprazole sodium delayed-release
tablets.
Rabeprazole sodium delayed-release tablets can have other serious side
effects. See “What are the possible
side effects of rabeprazole sodium delayed-release tablets?”
What are rabeprazole sodium delayed-release tablets?
Rabeprazole sodium delayed-release tablets are a prescription medicine
called a Proton Pump Inhibitor (PPI).
Rabeprazole sodium delayed-release tablets reduce the amount of acid
in your stomach.
Rabeprazole sodium delayed-release tablets are used in adults:
•
for up to 8 weeks to heal acid-related damage to the lining of the

Toote omadused

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
AVKARE
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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
RECENT MAJOR CHANGES
Warnings and Precautions, _Clostridium difficile_ Associated Diarrhea
( 5.3) 10/2012
Warnings and Precautions, Concomitant Use of Rabeprazole With
Methotrexate ( 5.6) 05/2012
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
Rabeprazole sodium delayed-release tablets should be swallowed whole.
The tablets should not be
chewed, crushed or split ( 2.10).
HEALING OF EROSIVE OR ULCERATIVE GASTROESOPHAGEAL
REFLUX DISEASE (GERD) ( 2.1)
20 mg once daily
MAINTENANCE OF HEALING OF EROSIVE OR ULCERATIVE GERD
( 2.2)
20 mg once daily
TREATMENT OF SYMPTOMATIC GERD IN ADULTS ( 2.3)
20 mg once daily
HEALING OF DUODENAL ULCERS ( 2.4)
20 mg once daily after morning meal
_HELICOBACTER PYLORI_ ERADICATION TO REDUCE THE RISK OF
DUODENAL ULCER RECURRENCE ( 2.5)
THREE DRUG REGIMEN:
_All three medications should be taken twice_
_daily with morning and evening meals for 7_
_days_
Rabeprazole sodium delayed-release 20 mg
Amoxicillin 1000 mg
Clarithromycin 500 mg
TREATMENT OF PAT