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ACIPHEX SPRINKLE
Hyperacidity, GERD, and ulcers
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Drug Name:

ACIPHEX SPRINKLE Rx

Generic Name and Formulations:
Rabeprazole sodium 5mg, 10mg; del-rel caps

Company:
Avadel Pharmaceuticals

Therapeutic Use:

Indications for ACIPHEX SPRINKLE:

Triple therapy (w. amoxicillin + clarithromycin) for H. pylori eradication in duodenal ulcer disease. Short-term treatment of erosive or ulcerative gastroesophageal reflux disease (GERD) or duodenal ulcers. Short-term treatment of symptomatic GERD in patients ≥12yrs of age. 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). Treatment of GERD in pediatric patients 1–11yrs of age.

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.

Children:

Sprinkle caps: take 30 mins before meal. Open capsule and sprinkle contents on a small amount of soft food (eg, applesauce, fruit or vegetable based baby food, yogurt) or into a small amount of liquid (eg, infant formula, apple juice, pediatric electrolyte solution). <1yr: not recommended. Treatment of GERD: 1–11yrs (<15kg): 5mg once daily for up to 12 weeks; may increase to 10mg if inadequate response; (≥15kg):10mg once daily for up to 12 weeks. Tabs: swallow whole. Treatment of symptomatic GERD: ≥12yrs: 20mg tab once daily for up to 8 weeks.

Contraindications:

Concomitant rilpivirine-containing products.

Warnings/Precautions:

Symptomatic response does not preclude gastric malignancy. Discontinue if acute interstitial nephritis, cutaneous/systemic lupus erythematosus occurs. Long-term therapy (eg, >3yrs) may lead to malabsorption or deficiency of Vit.B12. Increased risk of osteoporosis-related fractures (hip, wrist or spine) with long-term and multiple daily dose PPI therapy. Severe hepatic impairment: not recommended. Monitor magnesium levels with long-term therapy. Pregnancy. Nursing mothers.

Interactions:

See Contraindications. May antagonize atazanavir, nelfinavir (avoid). May potentiate saquinavir, digoxin, methotrexate (consider temporary withdrawal of the PPI); 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.

See Also:

ACIPHEX

Pharmacological Class:

Proton pump inhibitor.

Adverse Reactions:

Pain, pharyngitis, flatulence, infection, constipation; possible C. difficile-associated diarrhea; rare: hypomagnesemia (w. prolonged PPI therapy). Also children: vomiting, abdominal pain, diarrhea, headache, nausea.

Note:

Note: See Amoxil entry for more information on amoxicillin. See Biaxin entry for more information on clarithromycin.

How Supplied:

Tabs—30, 90; Caps—30

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