Hyperacidity, GERD, and ulcers:
Indications for: NEXIUM for ORAL SUSPENSION
Triple therapy (w. amoxicillin + clarithromycin) for H. pylori eradication in duodenal ulcer disease. Short-term treatment and maintenance of healing of erosive esophagitis (EE), symptomatic GERD. Short-term treatment of EE due to acid-mediated GERD in infants 1 month–<1yr. To reduce risk of NSAID-associated gastric ulcer. Long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome).
Take 1hr before food. Caps: swallow whole or may open caps and sprinkle pellets on 1 tablespoon applesauce and take immediately. May open caps and mix granules in 50mL of water and give via NG tube; flush tube with more water. Susp: mix 2.5mg packet with 5mL of water; mix 10mg, 20mg, or 40mg packet with 15mL of water. Leave 2–3 mins to thicken, then stir and drink within 30 mins. NG or gastric tube: see full labeling. Triple therapy: esomeprazole 40mg once daily + amoxicillin 1g twice daily + clarithromycin 500mg twice daily; all for 10 days. EE: 20 or 40mg once daily for 4–8 weeks, may continue 4–8 more weeks. Maintenance of healing of EE: 20mg once daily. Symptomatic GERD: 20mg once daily for 4 weeks, may continue 4 more weeks. NSAID-associated ulcer risk reduction: 20mg or 40mg once daily for up to 6 months. Hypersecretory conditions: initially 40mg twice daily, adjust if needed; doses up to 240mg daily have been used. Severe hepatic impairment: see full labeling.
EE due to acid-mediated GERD: <1 month: not established. 1 month–<1yr: 3kg–5kg: 2.5mg; >5kg–7.5kg: 5mg; >7.5kg–12kg: 10mg; for all: give once daily for up to 6 weeks. Healing of EE: <1yr: not established. 1–11yrs: <20kg: 10mg; ≥20kg: 10 or 20mg; 12–17yrs: 20 or 40mg; for all: give once daily for up to 8 weeks. Symptomatic GERD: <1yr: not established. 1–11yrs: 10mg once daily for up to 8 weeks; 12–17yrs: 20mg once daily for 4 weeks.
NEXIUM for ORAL SUSPENSION Contraindications:
Concomitant rilpivirine-containing drugs.
NEXIUM for ORAL SUSPENSION Warnings/Precautions:
Symptomatic response does not preclude gastric malignancy. Discontinue and evaluate if acute tubulointerstitial nephritis, cutaneous/systemic lupus erythematosus occurs. 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. Pregnancy. Nursing mothers.
NEXIUM for ORAL SUSPENSION Classification:
Proton pump inhibitor.
NEXIUM for ORAL SUSPENSION Interactions:
Avoid concomitant St. John's wort, rifampin, nelfinavir. May potentiate saquinavir; monitor for toxicity. May reduce absorption of gastric pH-dependent drugs (eg, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole). Antagonizes clopidogrel; consider alternative anti-platelets. May affect drugs metabolized by CYP2C19. May potentiate digoxin, tacrolimus, cilostazol (consider reduced dose), citalopram (limit dose to max 20mg/day), high-dose methotrexate (consider temporary withdrawal of PPI). Caution with drugs that may cause hypomagnesemia (eg, digoxin, diuretics); monitor. Monitor INR, PT with warfarin. Potentiated by voriconazole; may need to adjust esomeprazole dose in Zollinger-Ellison syndrome. May give antacids concomitantly. May cause false (+) results in diagnostic investigations for neuroendocrine tumors; discontinue esomeprazole 14 days prior to CgA level assessment; may need repeat test. May cause false (+) results with secretin stimulation test or urine tests for tetrahydrocannabinol.
Headache, diarrhea, abdominal pain, nausea, flatulence, constipation, dry mouth, inj site reactions, dizziness, vertigo; possible C. difficile-associated diarrhea; rare: rash, allergic reactions, hypomagnesemia. Children: Also, somnolence, regurgitation, tachypnea, increased ALT.
See Biaxin for more information on clarithromycin. See Amoxil for more information on amoxicillin.
Generic Drug Availability:
Caps—30, 90, 1000; Susp—30 packets; IV soln (single-use vial)—10