RABEPRAZOLE SODIUM tablet, delayed release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Proficient Rx LP

DCI (Dénomination commune internationale):

RABEPRAZOLE SODIUM

Composition:

RABEPRAZOLE SODIUM 20 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Rabeprazole sodium delayed-release tablets, 20 mg are supplied as yellow, round, biconvex, coated tablets, imprinted with "L020" (black ink) on one side. Bottles of 30 (NDC# 63187-788-30) Bottles of 60 (NDC# 63187-788-60) Bottles of 90 (NDC# 63187-788-90) 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.

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
Proficient Rx LP
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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?
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 tablet 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 tablet 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

Résumé des caractéristiques du produit

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
PROFICIENT RX LP
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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 tablet is a proton-pump inhibitor
(PPI) indicated in adults for:
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In adolescent patients 12 years of age and older for:
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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 daily for up to 8 weeks
Administration Instructions (2):
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DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets: 20 mg (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LUPIN PHARMACEUTICALS,
INC. AT 1-800-399-2561 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GO