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Aciphex (rabeprazole sodium)

OTHER BRAND NAMES

Aciphex Sprinkle

THERAPEUTIC CLASS

Proton pump inhibitor (PPI)

DEA CLASS

RX

INDICATIONS

Short-term treatment (4-8 weeks) in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). Maintenance of healing and reduction in relapse rates of heartburn symptoms with erosive or ulcerative GERD. Treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks. Short-term treatment (up to 4 weeks) in the healing and symptomatic relief of duodenal ulcers (DUs). In combination with amoxicillin and clarithromycin as a 3-drug regimen for the treatment of Helicobacter pylori infection and DU disease (active or history within the past 5 yrs) for H. pylori eradication to reduce the risk of DU recurrence. Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Treatment of symptomatic GERD in adolescents ≥12 yrs of age for up to 8 weeks. Treatment of GERD in children 1-11 yrs of age for up to 12 weeks.

ADULT DOSAGE

Helicobacter pylori Eradication

Treatment of H. pylori infection and duodenal ulcer disease (active or history w/in past 5 yrs) for H. pylori eradication to reduce the risk of duodenal ulcer recurrence

20mg tab + clarithromycin 500mg + amoxicillin 1000mg, all bid w/ am and pm meals for 7 days

Pathological Hypersecretory Conditions

Treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome

Initial: 60mg qd or in divided doses
Titrate: Adjust to individual needs and continue for as long as clinically indicated

Doses up to 100mg qd and 60mg bid have been administered. Some have been treated for up to 1 yr

Gastroesophageal Reflux Disease

Healing of Erosive or Ulcerative GERD:
20mg tab qd for 4-8 weeks; consider an additional 8 weeks if not healed after 8 weeks of treatment

Maint of Healing of Erosive or Ulcerative GERD:
20mg tab qd; controlled studies do not extend beyond 12 months

Symptomatic GERD:
Treatment of daytime and nighttime heartburn and other symptoms associated w/ GERD

20mg tab qd for 4 weeks; consider an additional course of treatment if symptoms do not resolve completely after 4 weeks

Duodenal Ulcers

Healing and Symptomatic Relief of Duodenal Ulcers:
20mg tab qd after am meal for up to 4 weeks; some patients may need additional therapy to achieve healing

PEDIATRIC DOSAGE

Gastroesophageal Reflux Disease

Treatment of GERD:
Cap:
1-11 Years:
<15kg: 5mg qd for up to 12 weeks w/ the option to increase to 10mg if inadequate response
≥15kg: 10mg qd for up to 12 weeks

Treatment of Symptomatic GERD:
Tab:
≥12 Years:
20mg qd for up to 8 weeks

ADMINISTRATION

Oral route

Tab
Swallow whole; do not chew, crush, or split
May be taken w/ or w/o food

Cap
Take 30 min ac
Open cap and sprinkle entire contents on a small amount of soft food (eg, applesauce, fruit or vegetable based baby food, yogurt) or empty contents into a small amount of liquid (eg, infant formula, apple juice, pediatric electrolyte sol); do not chew or crush granules
Take whole dose w/in 15 min of preparation
Food or liquid should be at or below room temperature; do not store mixture for future use

HOW SUPPLIED

Cap, Delayed-Release (Sprinkle): 5mg, 10mg; Tab, Delayed-Release: 20mg

WARNINGS/PRECAUTIONS

Symptomatic response does not preclude the presence of gastric malignancy. Acute interstitial nephritis reported; d/c if this develops. Cyanocobalamin (vitamin B12) deficiency may occur with daily long-term treatment (eg, >3 yrs) with any acid-suppressing medications. May increase risk of Clostridium difficile-associated diarrhea (CDAD), especially in hospitalized patients. May increase risk of osteoporosis-related fractures of the hip, wrist, or spine, especially with high-dose and long-term therapy. Use lowest dose and shortest duration appropriate to the condition being treated. Hypomagnesemia reported and may require Mg2+ replacement and discontinuation of therapy; consider monitoring Mg2+ levels prior to and periodically during therapy with prolonged treatment. Caution with severe hepatic impairment.

ADVERSE REACTIONS

Headache, flatulence, pain, pharyngitis, diarrhea, N/V, abdominal pain.

DRUG INTERACTIONS

May reduce absorption of drugs where gastric pH is an important determinant of their bioavailability; ketoconazole, atazanavir, iron salts, erlotinib, and mycophenolate mofetil (MMF) absorption can decrease, while digoxin absorption can increase. May substantially decrease atazanavir levels and reduce its therapeutic effect; concomitant use is not recommended. Caution in transplant patients receiving MMF. May inhibit cyclosporine metabolism. Increased INR and PT reported with warfarin. Combination with amoxicillin and clarithromycin may increase levels of rabeprazole and 14-hydroxyclarithromycin. May elevate and prolong levels of methotrexate (MTX) and/or its metabolite, possibly leading to MTX toxicities; consider temporary withdrawal of therapy with high-dose MTX. Caution with digoxin or with drugs that may cause hypomagnesemia (eg, diuretics).

PREGNANCY AND LACTATION

Category C, caution in nursing.

MECHANISM OF ACTION

Proton pump inhibitor; substituted benzimidazole that suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell. Blocks the final step of gastric acid secretion.

PHARMACOKINETICS

Absorption: (Tab) Tmax=2-5 hrs; absolute bioavailability (52%). (Cap) Tmax=2.5 hrs (median). Distribution: Plasma protein binding (96.3%). Metabolism: Liver (extensive) via CYP3A, CYP2C19; thioether and sulphone (primary metabolites). Elimination: Urine (90% metabolites), feces; T1/2=1-2 hrs.

ASSESSMENT

Assess for hypersensitivity to the drug, hepatic impairment, risk for osteoporosis-related fractures, pregnancy/nursing status, and possible drug interactions. Obtain baseline Mg2+ levels.

MONITORING

Monitor for signs/symptoms of acute interstitial nephritis, cyanocobalamin deficiency, CDAD, bone fractures, hypersensitivity reactions, and other adverse reactions. Monitor Mg2+ levels periodically. Monitor INR and PT when given with warfarin.

PATIENT COUNSELING

Instruct to take ud. Advise to immediately report and seek care for diarrhea that does not improve.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.

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