HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ACIPHEX safely and effectively. See full prescribing information for ACIPHEX.
ACIPHEX® (rabeprazole sodium) Delayed Release Tablets
Initial U.S. Approval: 1999
RECENT MAJOR CHANGES
Warnings and Precautions, Bone Fracture (5.6) 08/2010
INDICATIONS AND USAGE
ACIPHEX is a proton-pump inhibitor 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 the Risk of Duodenal Ulcer Recurrence (1.5)
Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (1.6)
ACIPHEX is a proton-pump inhibitor indicated for adolescent patients 12 years of age and above for:
Short-term treatment of Symptomatic GERD (1.3)
DOSAGE AND ADMINISTRATION
ACIPHEX tablets should be swallowed whole. The tablets should not be chewed, crushed or split.
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (2.1) 20 mg once daily
Maintenance of Healing of Erosive or Ulcerative GERD (2.2) 20 mg once daily
Treatment of Symptomatic GERD (2.3) 20 mg once daily
Healing of Duodenal Ulcers (2.4) 20 mg once daily after morning meal
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (2.5)
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
Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (2.6) Starting dose 60 mg once daily then adjust to patient needs
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg (3)
CONTRAINDICATIONS
History of hypersensitivity to rabeprazole (4.1)
WARNINGS AND PRECAUTIONS
Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy (5.4)
Patients treated with a proton pump inhibitor and warfarin may need to be monitored for increases in INR and prothrombin time due to risk of abnormal bleeding (5.5)
Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine (5.6)
ADVERSE REACTIONS
In the adult studies (4 to 8 weeks), there are no adverse reactions that occur at a rate greater than 5% and greater than placebo (6.1)
In the adolescent patient studies, adverse reactions were similar to those found in adults (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-888-274-2378 (fax 1-201-746-3207) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Increased INR and prothrombin times have been reported with concomitant use with warfarin. Patients need to be monitored (7.2)
Rabeprazole has been shown to inhibit cyclosporine metabolism in vitro (7.3)
ACIPHEX inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin) (7.4)
ACIPHEX may reduce the plasma levels of atazanavir (7.4)
USE IN SPECIFIC POPULATIONS
The safety and efficacy of ACIPHEX for GERD have not been established for pediatric patients less than 12 years of age.
The safety and efficacy of ACIPHEX for the other adult indications have not been established for pediatric patients.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 04/2011
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
1.1. Healing of Erosive or Ulcerative GERD
1.2. Maintenance of Healing of Erosive or Ulcerative GERD
1.3. Treatment of Symptomatic GERD
1.4. Healing of Duodenal Ulcers
1.5. Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
1.6. Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome
2 DOSAGE AND ADMINISTRATION
2.1. Healing of Erosive or Ulcerative GERD
2.2. Maintenance of Healing of Erosive or Ulcerative GERD
2.3. Treatment of Symptomatic GERD
2.4. Healing of Duodenal Ulcers
2.5. Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
2.6. Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome
2.7. Short-term Treatment of GERD in Adolescent Patients 12 Years of Age and Above
2.8. Elderly, Renal and Hepatic Impaired Patients
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1. Hypersensitivity to rabeprazole
4.2. Use of Clarithromycin and hypersensitivity to macrolide antibiotics
4.3. Concomitant use of Clarithromycin with pimozide and cisapride
4.4. Amoxicillin and hypersensitivity to penicillin
5 WARNINGS AND PRECAUTIONS
5.1. Clarithromycin use in pregnant women
5.2. Anaphylactic reactions associated with antibiotic use
5.3. Pseudomembranous colitis associated with antibiotic use
5.4. Presence of gastric malignancy
5.5. Concomitant use with warfarin
5.6. Bone Fracture
6 ADVERSE REACTIONS
6.1. Clinical Studies Experience
6.2. Postmarketing Experience
7 DRUG INTERACTIONS
7.1. Drugs metabolized by CYP450
7.2. Warfarin
7.3. Cyclosporine
7.4. Compounds dependent on gastric pH for absorption
7.5. Drugs metabolized by CYP2C19
7.6. Combined Administration with Clarithromycin
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6. Gender
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1. Healing of Erosive or Ulcerative GERD
14.2. Long-term Maintenance of Healing of Erosive or Ulcerative GERD
14.3. Treatment of Symptomatic GERD
14.4. Healing of Duodenal Ulcers
14.5. Helicobacter pylori Eradication in Patients with Peptic Ulcer Disease or Symptomatic Non-Ulcer Disease
14.6. Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
PATIENT INFORMATION
PRINCIPAL DISPLAY PANEL
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1. Healing of Erosive or Ulcerative 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.
1.2. Maintenance of Healing of Erosive or Ulcerative 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.
