Sibling bonding during snacktime

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.

CONTRAINDICATIONS:

  • 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.

ADVERSE REACTIONS

Most common adverse reactions (>5%) are vomiting, abdominal pain, diarrhea, headache, and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact Avadel Pharmaceuticals (USA), Inc. at 1-877-622-2320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Important Safety Information

  • 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.

SEE ADDITIONAL IMPORTANT SAFETY INFORMATION BELOW