IMPORTANT SAFETY INFORMATION AND INDICATIONS
Select Safety Information for ACIPHEX® (rabeprazole sodium) delayed-release tablets
ACIPHEX® has a well-established safety profile. The most common side effect possibly related to ACIPHEX® is headache. Symptom relief does not rule out other serious stomach conditions. Patients on warfarin or other medications may need to be monitored more closely by their doctor. The risk of side effects goes up over time. Ask your doctor how long you should take this medication.
INDICATIONS AND USAGE
ACIPHEX® is a proton pump inhibitor (PPI), and is used for the treatment of persistent, frequent (2 or more days a week) heartburn and other symptoms associated with acid reflux disease
Indications For adults:
- Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)
- Maintenance of Healing of Erosive or Ulcerative GERD
- Treatment of Symptomatic GERD
- Healing of Duodenal Ulcers
- Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence
- Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome
Indications For Adolescents 12 and Older:
- Short-term Treatment of Symptomatic GERD
DOSAGE AND ADMINISTRATION
20 mg ACIPHEX® tablets should be taken with water. Dosage is determined by your doctor during prescription. Healthcare Professionals should consult the full ACIPHEX® Dosing Information
WARNINGS AND PRECAUTIONS
- Gastric Malignancy: In adults, symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing.
- Use with Warfarin: Monitor for increases in INR and prothrombin time.
- Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients.
- Clostridium difficile–Associated Diarrhea: PPI therapy may be associated with increased risk of.
- 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.
- Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous, new onset or exacerbation of existing disease; discontinue AcipHex® and refer to specialist for evaluation.
- Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
- Hypomagnesemia: Reported rarely with prolonged treatment with PPIs.
- Interaction with Methotrexate: Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of AcipHex® delayed-release tablets.
- Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy.
People should not take ACIPHEX® if:
- They are allergic to ACIPHEX®, rabeprazole, or any of its ingredients
- They are on certain (rilpivirine-containing) therapies for HIV/AIDs
- They are on certain antibiotic treatments, such as clarithromycin and amoxicillin
Most common adverse reactions in adults (>2%) are pain, pharyngitis, flatulence, infection, and constipation.
Most common adverse reactions in adolescents (≥2%) are headache, diarrhea, nausea, vomiting, and abdominal pain.
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.