RABEPRAZOLE SODIUM- rabeprazole tablet, delayed release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Mylan Pharmaceuticals Inc.

Designación común internacional (DCI):

RABEPRAZOLE SODIUM

Composición:

RABEPRAZOLE SODIUM 20 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Rabeprazole Sodium Delayed-Release Tablets are available containing 20 mg of rabeprazole sodium, USP. The 20 mg tablets are beige, film-coated, round, unscored tablets with M over R7 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6709-93 bottles of 30 tablets NDC 0378-6709-77 bottles of 90 tablets NDC 0378-6709-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST:  Dispense a Medication Guide with each prescription.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Mylan Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Rabeprazole Sodium Delayed-Release Tablets
(ra bep′ ra zole soe′ dee um)
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 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 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 joint pain or a rash on your cheeks or arms that
gets worse in the sun.
T

Ficha técnica

RABEPRAZOLE SODIUM- RABEPRAZOLE TABLET, DELAYED RELEASE
MYLAN PHARMACEUTICALS 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, Fundic Gland Polyps (5.10) 06/2018
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 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
ne e ds
Symptomatic GERD in Adolescents 12 Years of Age and Older
20 mg once daily for up to 8 weeks
Administration Instructions (2):
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets: 20 mg (3)
CONTRAINDICATIONS
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