PHARMACODYNAMICS

Potent gastric acid suppression with ACIPHEX®1,2

Study design: A single-center, double-blind, placebo-controlled, randomized crossover study in healthy H. pylori-negative male subjects (N=24). Analysis was performed in 23 evaluable subjects.1

Gastric Acid Suppression chart

THE CORRELATION OF THESE PHARMACODYNAMIC DATA TO CLINICAL EFFECT HAS NOT BEEN ESTABLISHED.

ACIPHEX® maintained esophageal pH>4 for most of the 24-hour period on day 72,3

Study design: A single-center, double-blind, randomized, 2-way crossover study of 20- and 40-mg rabeprazole in GERD patients (N=20). In the 20-mg arm, percentage of time esophageal pH<4 decreased from a baseline of 24.7% to 5.1% on day 7.2,3

Esophageal pH chart

THE CORRELATION OF THESE PHARMACODYNAMIC DATA TO CLINICAL EFFECT HAS NOT BEEN ESTABLISHED.

 
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 adults, ACIPHEX® 20 mg bid, in combination with amoxicillin 1000 mg bid and clarithromycin 500 mg bid, for 7 days is indicated for H. pylori eradication to reduce the risk of duodenal ulcer recurrence
  • 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
Use of ACIPHEX® for H. pylori Eradication:
  • In H. pylori clinical trials using combination therapy with rabeprazole sodium plus amoxicillin and clarithromycin (RAC), no adverse events unique to this drug combination were observed. In the US multicenter study, the most frequently reported drug-related adverse events for patients who received RAC therapy for 7 days were diarrhea (8%) and taste perversion (6%)
  • No clinically significant laboratory abnormalities particular to the drug combinations were observed
  • Clarithromycin is contraindicated in patients taking cisapride or pimozide; or in patients with a known hypersensitivity to clarithromycin or any macrolide antibiotic. Clarithromycin may elevate digoxin serum concentrations. Serum digoxin levels should be carefully monitored while digoxin and clarithromycin are taken concomitantly. Clarithromycin should not be used in pregnant women except in circumstances where no alternative therapy is appropriate. (See WARNINGS and Drug Interactions in Prescribing Information for clarithromycin.) Amoxicillin is contraindicated in patients who are allergic to any penicillin
  • For more information on adverse events or laboratory changes with amoxicillin or clarithromycin, refer to their respective full Prescribing Information

For more information about ACIPHEX®, see full Prescribing Information.

Click here to view full Prescribing Information for ACIPHEX®.

References: 1. Williams MP, Sercombe J, Hamilton MI, Pounder RE. A placebo-controlled trial to assess the effects of 8 days of dosing with rabeprazole versus omeprazole on 24-h intragastric acidity and plasma gastrin concentrations in young healthy male subjects. Aliment Pharmacol Ther. 1998;12(11):1079-1089. 2. ACIPHEX® Prescribing Information. Raritan, NJ: Janssen Pharmaceuticals, Inc. 2011. 3. Robinson M, Maton PN, Rodriguez S, Greenwood B, Humphries TJ. Effects of oral rabeprazole on oesophageal and gastric pH in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 1997;11(5):973-980.

 
Thank you for visiting aciphex360.com.
By clicking "Continue" you will be taken to: