ACIPHEX- rabeprazole sodium tablet, delayed release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Eisai Inc.

INN (Международно Name):

RABEPRAZOLE SODIUM

Композиция:

RABEPRAZOLE SODIUM 20 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

ACIPHEX 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 ACIPHEX may be considered. ACIPHEX 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. ACIPHEX 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.  ACIPHEX 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. ACIPHEX delayed-release tablets, in combination with amoxicillin and clarithromycin as

Каталог на резюме:

ACIPHEX 20 mg is supplied as delayed-release light yellow enteric-coated tablets.  The name and strength, in mg, (ACIPHEX 20) is imprinted on one side.       Bottles of 30 (NDC 62856-243-30)       Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [ see USP Controlled Room Temperature ] .  Protect from moisture.

Статус Оторизация:

New Drug Application

Листовка

ACIPHEX- rabeprazole sodium tablet, delayed release
Eisai Inc.
----------
MEDICATION GUIDE
ACIPHEX® (a-se-feks)
(rabeprazole sodium)
delayed-release tablets
What is the most important information I should know about ACIPHEX?
You should take ACIPHEX exactly as prescribed, at the lowest dose
possible and for the shortest time
needed.
ACIPHEX may help your acid-related symptoms, but you could still have
serious stomach problems. Talk
with your doctor.
ACIPHEX can cause serious side effects, including:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including ACIPHEX, may develop a kidney
problem called acute
tubulointerstitial nephritis that can happen at any time during
treatment with ACIPHEX. 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 ACIPHEX, 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.
Talk to your doctor about your risk of these serious side effects.
ACIPHEX can have other serious side effects. See “What are the
possible side effects of ACIPHEX?”
What is ACIPHEX?
ACIPHEX is a prescription

Данни за продукта

ACIPHEX- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
EISAI INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACIPHEX DELAYED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ACIPHEX
DELAYED-RELEASE TABLETS.
ACIPHEX (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
ACIPHEX delayed-release tablets 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:
ACIPHEX 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):
Swallow ACIPHEX delayed-release