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Nexium Generic Name & Formulations
Legal Class
Rx
General Description
Esomeprazole (as magnesium trihydrate) 20mg, 40mg; caps containing e-c del-rel pellets.
Pharmacological Class
Proton pump inhibitor.
See Also
How Supplied
Caps—30, 90, 1000; Susp—30 packets; IV soln (single-use vial)—10
Manufacturer
Generic Availability
YES
Nexium Indications
Indications
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).
Nexium Dosage and Administration
Adult
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.
Children
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 Contraindications
Contraindications
Concomitant rilpivirine-containing products.
Nexium Boxed Warnings
Not Applicable
Nexium 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. Pregnancy. Nursing mothers.
Nexium Pharmacokinetics
See Literature
Nexium Interactions
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.
Nexium Adverse Reactions
Adverse Reactions
Headache, diarrhea, abdominal pain, nausea, flatulence, constipation, dry mouth, inj site reactions, dizziness, vertigo; possible C. difficile-associated diarrhea; rare: rash, allergic reactions, hypomagnesemia and mineral metabolism. Children: Also, somnolence, regurgitation, tachypnea, increased ALT.
Nexium Clinical Trials
See Literature
Nexium Note
Notes
See Biaxin for more information on clarithromycin. See Amoxil for more information on amoxicillin.
Nexium Patient Counseling
See Literature
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