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Aciphex Generic Name & Formulations
Legal Class
Rx
General Description
Rabeprazole sodium 20mg; del-rel, e-c tabs.
Pharmacological Class
Proton pump inhibitor.
See Also
How Supplied
Tabs—30
Manufacturer
Generic Availability
YES
Mechanism of Action
Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H2-receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H+, K+ATPase at the secretory surface of the gastric parietal cell.
Aciphex Indications
Indications
In adults: triple therapy (w. amoxicillin + clarithromycin) for H. pylori eradication in duodenal ulcer disease. Short-term treatment in healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD) or duodenal ulcers. Heartburn and other symptoms associated with GERD. Maintenance of healing and reduction in relapse rates of heartburn symptoms in erosive or ulcerative GERD. Long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome). In adolescents (≥12yrs of age): treatment of symptomatic GERD.
Aciphex Dosage and Administration
Adult
Swallow tabs whole. ≥18yrs: Triple therapy: rabeprazole 20mg + amoxicillin 1g + clarithromycin 500mg, all twice daily (w. AM and PM meals) for 7 days. GERD healing: 20mg once daily for 4–8 weeks; may repeat for 8 more weeks. GERD symptoms: 20mg once daily for 4 weeks; may repeat for 4 more weeks. GERD maintenance: 20mg once daily. Duodenal ulcer healing: 20mg once daily after breakfast for up to 4 weeks. Hypersecretory conditions: initially 60mg once daily; titrate; doses up to 100mg once daily or 60mg twice daily have been used. Symptomatic GERD (≥12yrs): 20mg tab once daily for up to 8 weeks.
Children
<12yrs: not recommended.
Aciphex Contraindications
Contraindications
Concomitant rilpivirine-containing products.
Aciphex Boxed Warnings
Not Applicable
Aciphex Warnings/Precautions
Warnings/Precautions
Symptomatic response does not preclude gastric malignancy. Discontinue and evaluate if acute tubulointerstitial nephritis, severe cutaneous adverse reactions, or cutaneous/systemic lupus erythematosus occurs. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12. Monitor magnesium levels during prolonged therapy. Consider monitoring magnesium, calcium levels in those with preexisting risk of hypocalcemia (eg, hypoparathyroidism). Increased risk of fundic gland polyps with long-term use (esp. >1yr) or osteoporosis-related fractures (hip, wrist or spine) with long-term (>1yr) and multiple daily dose PPI therapy. Use lowest dose for shortest duration appropriate to condition. Severe hepatic impairment: not recommended. Pregnancy. Nursing mothers.
Aciphex Pharmacokinetics
Absorption
Absolute bioavailability: ~52%.
Distribution
Plasma protein bound: 96.3%.
Elimination
Renal (90%), fecal. Half-life: 1 to 2 hours.
Aciphex Interactions
Interactions
See Contraindications. May antagonize atazanavir, nelfinavir (avoid). May potentiate saquinavir, digoxin, methotrexate (consider temporary withdrawal of the PPI), tacrolimus; monitor. May alter absorption of pH-dependent drugs (eg, iron, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole). Caution with digoxin or drugs that may cause hypomagnesemia (eg, diuretics); monitor. Monitor warfarin. May interfere with neuroendocrine tumor diagnostic tests; discontinue rabeprazole at least 14 days prior to CgA level assessment. Interrupt therapy at least 14 days before secretin stimulation test. May cause false (+) urine screening tests for THC.
Aciphex Adverse Reactions
Adverse Reactions
Pain, pharyngitis, flatulence, infection, constipation, headache, diarrhea, nausea, vomiting, abdominal pain; possible C. difficile-associated diarrhea; rare: hypomagnesemia and mineral metabolism.
Aciphex Clinical Trials
See Literature
Aciphex Note
Notes
Note: See Amoxil entry for more information on amoxicillin. See Biaxin entry for more information on clarithromycin.
Aciphex Patient Counseling
See Literature
