Hyperacidity, GERD, and ulcers:

Indications for ZEGERID for ORAL SUSPENSION:

Short-term treatment of active benign gastric ulcer, active duodenal ulcer, erosive esophagitis (EE). Symptomatic GERD. Maintenance of healing of EE. To reduce risk of upper GI bleed in critically ill patients (40mg oral susp only).

Adult:

Take on empty stomach. Caps: swallow whole with water only. Susp: mix in 15–30mL water only; drink immediately; refill cup with water and drink; or, may give via NG/OG tube (see full labeling). Due to sodium bicarbonate component, two 20mg packets or caps are not equivalent to one 40mg packet or cap. ≥18yrs: Active duodenal ulcer: 20mg once daily for 4 weeks; may continue 4 more weeks. Gastric ulcer: 40mg once daily for 4–8 weeks. GERD (no esophageal lesions): 20mg once daily for up to 4 weeks. EE with GERD symptoms: 20mg once daily for 4–8 weeks. Maintenance of healing of EE: 20mg once daily. GI bleed risk reduction: Day 1: initially 40mg susp once then 40mg susp 6–8hrs later, then 40mg susp once daily for up to 14 days.

Children:

<18yrs: not established.

Contraindications:

Concomitant rilpivirine-containing products.

Warnings/Precautions:

Symptomatic response does not preclude gastric malignancy. Discontinue if acute interstitial nephritis, cutaneous/systemic lupus erythematosus occurs. Sodium-restricted diets. CHF. Avoid in Bartter's syndrome, hypokalemia, hypocalcemia, or acid-base balance abnormalities. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12. Monitor magnesium levels during prolonged therapy. 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. Hepatic impairment or Asian patients: avoid use for maintenance of healing of EE. Pregnancy. Nursing mothers.

See Also:

Pharmacologic Class:

Proton pump inhibitor + antacid.

Interactions:

Avoid concomitant clopidogrel, St. John's Wort, rifampin, atazanavir, nelfinavir. May potentiate citalopram, cilostazol, diazepam, digoxin, phenytoin, warfarin (monitor INR/PT), tacrolimus, saquinavir, methotrexate (esp. high-dose); monitor. Potentiated by voriconazole. May alter absorption of pH-dependent drugs (eg, erlotinib, dasatinib, nilotinib, ketoconazole, itraconazole, mycophenolate mofetil, iron salts). Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram). Long-term use of bicarbonate with calcium or milk may cause milk-alkali syndrome. Concomitant digoxin, diuretics may predispose patients to hypomagnesemia. May interfere with neuroendocrine tumor diagnostic investigations, secretin stimulation tests; interrupt therapy for ≥14 days. May result in false (+) urine tests for tetrahydrocannabinol.

Adverse Reactions:

Headache, abdominal pain, nausea, diarrhea, vomiting, flatulence; bone fracture; possible C. difficile associated diarrhea; rare: hypomagnesemia.

Metabolism:

Hepatic. 95% protein bound.

Elimination:

Renal (major), fecal, biliary.

Generic Availability:

Caps (YES); susp (NO)

How Supplied:

Caps—30; Susp—30 packets/box