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Therapeutic Index

 aciprex

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            Retailer          Stockiest


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