Prevacid SoluTab (lansoprazole) - America[美国药品]

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Prevacid SoluTab (lansoprazole)

2016-04-04 14:40:59 来源: 作者: 【大中小】浏览:455次评论:0条

Generic Name and Formulations:
Lansoprazole 15mg, 30mg; e-c del-rel microgranules in orally-disintegrating tabs; strawberry flavor; contains phenylalanine.

Company:
Takeda Pharmaceuticals North America, Inc.
Indications for PREVACID SOLUTAB:
Triple therapy (w. amoxicillin + clarithromycin) or dual therapy (w. amoxicillin; use only if allergic, intolerant, or resistant to clarithromycin) for H. pylori eradication in duodenal ulcer disease. Short-term treatment of active duodenal ulcer, active benign gastric ulcer, erosive esophagitis (EE), symptomatic GERD, and NSAID-associated gastric ulcers when NSAID use is continued. To reduce risk of NSAID-associated gastric ulcer in patients with history of gastric ulcer who need an NSAID. Maintenance of healing of duodenal ulcer, EE. Long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome).

Adult:
Take before eating. Do not crush or chew granules. Caps: swallow whole, or sprinkle granules and mix contents with food or juice (see full labeling) and take immediately. May open caps and mix granules in 40mL apple juice and give via NG tube; flush tube with more juice. SoluTabs: dissolve on tongue; swallow with or without water. May give via oral syringe or NG tube (see full labeling). ≥18yrs: Triple therapy: lansoprazole 30mg + amoxicillin 1g + clarithromycin 500mg, all every 12hrs for 10 or 14 days. Dual therapy: lansoprazole 30mg + amoxicillin 1g, both every 8hrs for 14 days. Duodenal ulcer: 15mg once daily for 4 weeks. Gastric ulcer treatment: 30mg once daily for up to 8 weeks. EE treatment: 30mg once daily for up to 8 weeks; may repeat for 8 more weeks. If relapse occurs, may repeat 8-week course. GERD: 15mg once daily for up to 8 weeks. Maintenance of healing of duodenal ulcer or EE: 15mg once daily. Healing of NSAID-associated gastric ulcer: 30mg once daily for 8 weeks; NSAID ulcer risk reduction: 15mg once daily for up to 12 weeks. Hypersecretory conditions: Initially 60mg once daily, adjust as needed; give daily doses >120mg in divided doses.

Children:
Take before eating. Do not crush or chew granules. Caps: swallow whole, or sprinkle granules and mix contents with food or juice (see full labeling) and take immediately. May open caps and mix granules in 40mL apple juice and give via NG tube; flush tube with more juice. SoluTabs: dissolve on tongue; swallow with or without water. May give via oral syringe or NG tube (see full labeling). GERD or EE: ≤1yr: not recommended. 1–11yrs: ≤30kg: 15mg once daily; >30kg: 30mg once daily. For both: give for up to 12 weeks; doses up to 30mg twice daily have been used.

Warnings/Precautions:
Symptomatic response does not preclude gastric malignancy. Discontinue if acute interstitial nephritis occurs. Long-term therapy (eg, >3yrs) may lead to malabsorption or deficiency of Vit.B12. Use lowest dose for shortest duration appropriate to condition. Increased risk of osteoporosis-related fractures of the hip, wrist or spine with long-term and multiple daily dose PPI therapy. Monitor magnesium levels with long-term therapy. Severe hepatic impairment (consider dose reduction). Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:
May antagonize atazanavir or nelfinavir: not recommended. May alter absorption of pH-dependent drugs (eg, ketoconazole, iron, erlotinib, mycophenolate mofetil, ampicillin, digoxin). Concomitant digoxin, diuretics may predispose patients to hypomagnesemia. Monitor theophylline, warfarin. May potentiate tacrolimus, methotrexate. Give at least 30 mins before sucralfate. May give antacids concomitantly.