Important Safety Information
Indications and Usage:
ACIPHEX® Sprinkle™ (rabeprazole sodium delayed-release capsules) is a proton-pump inhibitor (PPI) indicated for the treatment of Gastroesophageal Reflux Disease (GERD) in pediatric patients 1 to 11 years of age.
- Patients with a history of hypersensitivity to rabeprazole.
- PPIs, including ACIPHEX ® Sprinkle™, are contraindicated in patients receiving rilpivirine-containing products.
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 Interstitial Nephritis: Observed in patients taking PPIs.
- Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk.
- 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 Sprinkle 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 Sprinkle.
- Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy.
Most common adverse reactions (>5%) are vomiting, abdominal pain, diarrhea, headache, and nausea
ADVERSE EVENT REPORTING
To report suspected adverse events or product complaints, please contact Aytu BioScience at 855-AYTU-BIO; FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.