INDICATION FOR USE: In pediatric patients, 1 – 11 years of age, ACIPHEX ® Sprinkle ™ is indicated for treatment of GERD for up to 12 weeks.
IMPORTANT SAFETY INFORMATION REGARDING ACIPHEX ® Sprinkle ™ (rabeprazole sodium) Delayed-Release Capsules:
ACIPHEX ® Sprinkle ™is contraindicated in patients with known hypersensitivity to rabeprazole, substituted
benzimidazoles, or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis,
anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria. PPIs, including ACIPHEX Sprinkle, are contraindicated with rilpivirine-containing products.
WARNINGS AND PRECAUTIONS:
- Symptomatic response to therapy does not preclude the presence of gastric malignancy
- As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death
- Acute interstitial nephritis has been observed in patients taking PPIs. Discontinue ACIPHEX Sprinkle if acute interstitial nephritis develops
- Daily long-term use may lead to malabsorption or deficiency of vitamin B-12
- PPI therapy may be associated with an increased risk of C. difficile associated diarrhea, especially in hospitalized patients.
- 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
- Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. Serious adverse events include tetany, arrhythmias, and seizures. Consider monitoring magnesium levels in patients on prolonged PPI therapy or concomitant medications such as digoxin or medications that may cause hypomagnesemia (e.g., diuretics)
- Concomitant use of PPIs with high dose methotrexate may elevate and prolong methotrexate serum levels or its metabolite. Withdrawal of PPI may be considered in some patients.
- In children (1-11 years of age) adverse reactions that occurred in ≥5% of patients included vomiting, abdominal pain, diarrhea, headache, and nausea.
- ACIPHEX ® Sprinkle ™ may reduce plasma levels of some antiretroviral drugs (e.g. rilpivirine, atazanavir, and nelfinavir) while increasing plasma levels of other antiretroviral drugs (e.g. saquinavir).
- PPIs, including AcipHex Sprinkle, may increase the INR and prothrombin time in patients taking warfarin.
- ACIPHEX ® Sprinkle ™ inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, and itraconazole).
- ACIPHEX ® Sprinkle ™ may increase serum levels of methotrexate
For more information, please refer to the ACIPHEX ® Sprinkle ™ Full Prescribing Information provided.