Aciphex360 - Full Prescribing Information

INDICATIONS

In adults (≥18 years of age), ACIPHEX^® 20 mg is indicated for: treatment of daytime and nighttime heartburn and other symptoms associated with GERD; short-term, up to 4 weeks, treatment in the healing and symptomatic relief of duodenal ulcers; short-term, 4 to 8 weeks, treatment in the healing and symptomatic relief of erosive GERD; and maintenance of healing and reduction in relapse rates of heartburn symptoms in erosive GERD (controlled maintenance studies do not extend beyond 12 months)
In adolescent patients 12 years of age and above, ACIPHEX^® 20 mg is indicated for: short-term, up to 8 weeks, treatment of daytime and nighttime heartburn and other symptoms associated with GERD

IMPORTANT SAFETY INFORMATION

Contraindications:

ACIPHEX^® is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation

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
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 (eg, diuretics)

Adverse Events:

In adolescents, the related reported adverse reactions that occurred in ≥2% of patients were headache and nausea. The adverse reactions reported without regard to relationship to ACIPHEX^® that occurred in ≥2% of patients were headache, diarrhea, nausea, vomiting, and abdominal pain
In adults, clinical trials revealed the following adverse reactions appearing in ≥2% of ACIPHEX^® patients and with a frequency greater than placebo: pain, pharyngitis, flatulence, infection, and constipation

Drug Interactions:

ACIPHEX^® inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts and digoxin)
ACIPHEX^® may reduce the plasma levels of atazanavir
Rabeprazole has been shown to inhibit cyclosporine metabolism in vitro

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FULL PRESCRIBING INFORMATION