NEXIUM for ORAL SUSPENSION Rx
Generic Name and Formulations:
Esomeprazole (as magnesium trihydrate) 2.5mg, 5mg, 10mg, 20mg, 40mg; per packet; e-c delayed release granules.
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: max 20mg/day.
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: 1–11yrs: 10mg once daily for up to 8 weeks; 12–17yrs: 20mg once daily for 4 weeks.
Gastric malignancy. Atrophic gastritis (w. long-term therapy). Increased risk of osteoporosis-related fractures (hip, wrist, or spine) with long-term and multiple daily dose PPI therapy. Monitor magnesium levels with long-term therapy. Use lowest dose for shortest duration. Pregnancy (Cat.C). Nursing mothers.
Concomitant St. John's wort, rifampin, atazanavir, nelfinavir: not recommended. May potentiate saquinavir; monitor and consider reducing saquinavir dose. May alter absorption of gastric pH-dependent drugs (eg, ketoconazole, iron salts, erlotinib, digoxin). Antagonizes clopidogrel; consider alternative anti-platelets. May affect drugs metabolized by CYP2C19. May potentiate tacrolimus, cilostazol (consider reduced dose), methotrexate (consider temporary withdrawal of PPI). Caution with drugs that may cause hypomagnesemia (eg, digoxin, diuretics); monitor. Monitor warfarin. May give antacids concomitantly. May cause false (+) results in diagnostic investigations for neuroendocrine tumors.
Headache, diarrhea, abdominal pain, nausea, flatulence, constipation, dry mouth, inj site reactions, dizziness, vertigo; rare: rash, allergic reactions, hypomagnesemia, possible C. difficile associated diarrhea. Children: Also, somnolence, regurgitation, tachypnea, increased ALT.
Hepatic (CYP2C19, CYP3A4). 97% protein bound.
Renal (primarily), fecal.
See Biaxin for more information on clarithromycin. See Amoxil for more information on amoxicillin.
Caps—30, 90, 1000; Susp—30 packets/box; IV soln (single-use vial)—10