A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Aciphex Indications, Dosage, Storage, Stability - Rabeprazole Sodium
Aciphex Indications, Dosage, Storage, Stability - Rabeprazole Sodium
INDICATIONS AND USAGE
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease
(GERD)
ACIPHEX® is 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.
Maintenance of Healing of Erosive or Ulcerative Gastroesophageal
Reflux Disease (GERD)
ACIPHEX® is 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.
Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
ACIPHEX® is indicated for the treatment of daytime and
nighttime heartburn and other symptoms associated with GERD.
Healing of Duodenal Ulcers
ACIPHEX® is indicated for short-term (up to four weeks)
treatment in the healing and symptomatic relief of duodenal ulcers. Most patients
heal within four weeks.
Helicobacter pylori Eradication to Reduce the Risk of
Duodenal Ulcer Recurrence
ACIPHEX® in combination with amoxicillin and clarithromycin
as a three drug regimen, is indicated for the treatment of patients with H.
pylori infection and duodenal ulcer disease (active or history within the
past 5 years) to eradicate H. pylori. Eradication of H. pylori
has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL
STUDIES and DOSAGE AND ADMINISTRATION.)
In patients who fail therapy, susceptibility testing should
be done. If resistance to clarithromycin is demonstrated or susceptibility testing
is not possible, alternative antimicrobial therapy should be instituted. (See
CLINICAL PHARMACOLOGY, Microbiology and the
clarithromycin package insert, CLINICAL PHARMACOLOGY,
Microbiology.)
Treatment of Pathological Hypersecretory Conditions, Including
Zollinger-Ellison Syndrome
ACIPHEX® is indicated for the long-term treatment of pathological
hypersecretory conditions, including Zollinger-Ellison syndrome.
DOSAGE AND ADMINISTRATION
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease
(GERD)
The recommended adult oral dose is one ACIPHEX® 20 mg delayed-release
tablet to be taken once daily for four to eight weeks. (See INDICATIONS
AND USAGE). For those patients who have not healed after 8 weeks of
treatment, an additional 8-week course of ACIPHEX® may be considered.
Maintenance of Healing of Erosive or Ulcerative Gastroesophageal
Reflux Disease (GERD Maintenance)
The recommended adult oral dose is one ACIPHEX® 20 mg delayed-release
tablet to be taken once daily. (See INDICATIONS AND
USAGE).
Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
The recommended adult oral dose is one ACIPHEX® 20 mg delayed-release
tablet to be taken once daily for 4 weeks. (See INDICATIONS
AND USAGE). If symptoms do not resolve completely after 4 weeks, an
additional course of treatment may be considered.
Healing of Duodenal Ulcers
The recommended adult oral dose is one ACIPHEX® 20 mg delayed-release
tablet to be taken once daily after the morning meal for a period up to four
weeks. (See INDICATIONS AND USAGE). Most
patients with duodenal ulcer heal within four weeks. A few patients may require
additional therapy to achieve healing.
Helicobacter pylori Eradication to Reduce the Risk of
Duodenal Ulcer Recurrence
Three Drug Regimena:
|
Aciphex
|
20 mg
|
Twice Daily for 7 Days
|
|
Amoxicillin
|
1000 mg
|
Twice Daily for 7 Days
|
|
Clarithromycin
|
500 mg
|
Twice Daily for 7 Days
|
|
All three medications should be taken twice daily with
the morning and evening meals.
|
|
a It is important that patients comply with
the full 7-day regimen. (See CLINICAL STUDIES
section.)
|
Treatment of Pathological Hypersecretory Conditions Including
Zollinger-Ellison Syndrome
The dosage of ACIPHEX® in patients with pathologic hypersecretory
conditions varies with the individual patient. The recommended adult oral starting
dose is 60 mg once a day. Doses should be adjusted to individual patient needs
and should continue for as long as clinically indicated. Some patients may require
divided doses. Doses up to 100 mg QD and 60 mg BID have been administered. Some
patients with Zollinger-Ellison syndrome have been treated continuously with
ACIPHEX® for up to one year.
No dosage adjustment is necessary in elderly patients, in patients
with renal disease or in patients with mild to moderate hepatic impairment.
Administration of rabeprazole to patients with mild to moderate liver impairment
resulted in increased exposure and decreased elimination. Due to the lack of
clinical data on rabeprazole in patients with severe hepatic impairment, caution
should be exercised in those patients.
ACIPHEX® tablets should be swallowed whole. The tablets
should not be chewed, crushed, or split. ACIPHEX® can be taken with or without
food.
HOW SUPPLIED
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)
Bottles of 90 (NDC#62856-243-90)
Unit Dose Blisters Package of 100 (10 x 10) (NDC#62856-243-41)
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Protect from moisture.
ACIPHEX® is a registered trademark of Eisai
Co., Ltd., Tokyo, Japan.
Manufactured and Marketed by Eisai Inc., Teaneck,
NJ 07666 Marketed by Janssen Pharmaceutica Inc., Titusville, NJ 08560, Revised
August 2003 200298 © 2003 Eisai Inc.
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