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Each
Tablet contains:
Rabeprazole sodium
tablets............................
10/20 mg
COMPOSITION :
Aciprex
– 10
Each enteric-coated tablet contains
Rabeprazole ……….. 10 mg
Colours: Yellow oxide of Iron & Titanium
Dioxide
Aciprex
– 20
Each enteric-coated tablet contains
Rabeprazole ……….. 20 mg
Colour: Titanium Dioxide
INDICATIONS :
1.Healing
of Erosive or Ulcerative GERD
ACIPREX 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 ACIPREX may be considered.
2. Maintenance of
Healing of Erosive or Ulcerative GERD
ACIPREX 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.
3. Treatment of
Symptomatic GERD
ACIPREX is
indicated for the treatment of daytime
and nighttime heartburn and other
symptoms associated with GERD in adults
and adolescents 12 years of age and
above.
4. Healing of
Duodenal Ulcers
ACIPREX 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.
5. Helicobacter
pylori Eradication to Reduce the Risk of
Duodenal Ulcer Recurrence
ACIPREX 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.
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.
6. Treatment of
Pathological Hypersecretory Conditions,
Including Zollinger-Ellison Syndrome
ACIPREX is
indicated for the long-term treatment of
pathological hypersecretory conditions,
including Zollinger-Ellison syndrome.
DOSAGE AND
ADMINISTRATION:-
ACIPREX tablets should be
swallowed whole. The tablets should not
be chewed, crushed, or split.
RABEPRAZOLE can be taken with or without
food.
1. Healing of Erosive or Ulcerative
GERD
The recommended adult oral dose is one
ACIPREX 20 mg delayed-release tablet to
be taken once daily for four to eight
weeks. For those patients who have not
healed after 8 weeks of treatment, an
additional 8-week course of ACIPREX may
be considered.
2. Maintenance of Healing of Erosive
or Ulcerative GERD
The recommended adult oral dose is
one ACIPREX 20 mg delayed-release
tablet to be taken once daily.
3. Treatment of Symptomatic GERD
The recommended adult oral dose is
one ACIPREX 20 mg delayed-release
tablet to be taken once daily for 4
weeks. If symptoms do not resolve
completely after 4 weeks, an additional
course of treatment may be considered.
4. Healing of Duodenal Ulcers
The recommended adult oral dose is
one ACIPREX 20 mg delayed-release
tablet to be taken once daily after the
morning meal for a period up to four
weeks. Most patients with duodenal ulcer
heal within four weeks. A few patients
may require additional therapy to
achieve healing.
5. Treatment of Pathological
Hypersecretory Conditions Including
Zollinger-Ellison Syndrome
The dosage of ACIPREX 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 ACIPREX for
up to one year.
6. Short-term Treatment of GERD in
Adolescent Patients 12 Years of Age and
Above
The recommended oral dose for
adolescents 12 years of age and above is
20 mg once daily for up to 8 weeks.
7. Renal Impairment
No dosage adjustment is necessary in
patients with renal disease 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.
8. Hepatic Impairment
No dosage adjustment is necessary 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 lack of clinical
data on rabeprazole in patients with
severe hepatic impairment, caution
should be exercised in those patients.
9. Geriatric Use
No dosage adjustment is necessary in
elderly patients.
CONTRAINDICATIONS
Rabeprazole is
contraindicated in patients with known
hypersensitivity to rabeprazole,
substituted benzimidazoles or to any
component of the formulation.
PACKAGING
INFORMATION
Aciprex
-10...................... Strip pack of
tablets
Aciprex -20.......................Strip
pack of tablets
Presentations: 10/20mg
MRP
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