药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201241519174027.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文Duexis处方资料(仅供参考)
FDA批准Duexis用于关节炎病治疗 Horizon是一家研发、生产、销售治疗关节炎、疼痛及炎症性疾病创新性药物的生物制药公司。该公司宣布其开发的一种含有固定剂量布洛芬(800mg)和法莫替丁(26.6mg)的新型复方片剂Duexis(布洛芬/法莫替丁)近日获美国FDA批准。FDA批准该药是基于对关键性临床试验REDUCE-1和REDUCE-2的数据支持,这两项试验结果显示;与单独接受布洛芬治疗相比,接受Duexis治疗的患者发生上消化道溃疡的发生率明显要低。
在1500多例中度至重度疼痛或关节炎患者中对Duexis进行了研究。REDUCE-1试验结果达到了主要临床终末点的要求,即在使用Duexis治疗的6个月期间,受试者胃溃疡的发生率明显降低。研究结果显示,与单独接受布洛芬治疗的患者相比,Duexis组患者的上消化道溃疡发生率的降低情况在统计学上具有显著意义(20.0%对10.5%)。
Duexis的最常见不良反应为恶心、腹泻、便秘、上腹部疼痛和头痛。总体而言,在REDUCE-1和REDUCE-2研究中,接受Duexis治疗的患者因不良反应而停止治疗的发生率与单独使用布洛芬相似。
DUEXIS Manufacturer: Horizon Pharma
Pharmacological Class: NSAID + H2 blocker.
Active Ingredient(s): Ibuprofen 800mg, famotidine 26.6mg; tabs.
Indication(s): Relief of signs/symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers (eg, gastric and/or duodenal ulcer), in patients who are taking ibuprofen for those indications.
Pharmacology: Duexis is a fixed-combination tablet of ibuprofen and famotidine.
Ibuprofen possesses analgesic and antipyretic activities. Its exact mechanism of action is not completely understood, but may be related to prostaglandin synthetase inhibition.
Famotidine is a competitive inhibitor of histamine H2-receptors. The primary pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output.
Clinical Trials: The efficacy of Duexis was evaluated in two multicenter, double-blind, active-controlled, randomized, 24-week studies in patients who were expected to require daily administration of an NSAID for at least the coming 6 months for conditions such as the following: osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain. Patients were assigned randomly, in approximately a 2:1 ratio, to treatment with either Duexis or ibuprofen 800mg three times daily. A total of 1533 patients were enrolled and ranged in age from 39–80 years (median age 55 years) with 68% females.
Studies 301 and 303 compared the incidence of upper gastrointestinal (gastric and/or duodenal) ulcer formation in a total of 930 patients taking Duexis (ibuprofen and famotidine) and 452 patients taking ibuprofen only, either as a primary or secondary endpoint. In both trials, Duexis was associated with a statistically significantly reduction in the risk of developing upper gastrointestinal ulcers compared to taking ibuprofen only during the 6 month study period.
Legal Classification: Rx
Adults: Swallow whole. 1 tab three times daily. Use lowest effective dose for the shortest duration.
Children: Not recommended.
Contraindication(s): Aspirin allergy. Coronary artery bypass graft surgery. Late stage pregnancy (≥30 weeks gestation).
Warnings/Precautions: Increased risk of serious cardiovascular or GI events. Renal impairment (CrCl <50mL/min): not recommended. Hypertension; monitor BP. Heart failure. Edema. History of ulcer disease or GI bleeding. Active peptic ulcer. Inflammatory bowel disease (eg, ulcerative colitis, Crohn’s disease). Seizures. Hepatic dysfunction. Bleeding disorders. Monitor blood, hepatic and renal function in chronic use. Discontinue if visual, rash, skin reactions, renal or liver dysfunction occurs. Asthma. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interaction(s): Increased risk of GI bleed with oral corticosteroids, aspirin, warfarin-type anticoagulants (monitor), alcohol, smoking. May antagonize ACE-inhibitors, diuretics. Increases lithium levels. May increase toxicity of methotrexate. Caution with concomitant SSRIs. Delayed absorption with cholestyramine.
Adverse Reaction(s): GI upset, constipation, upper abdominal pain, dyspepsia, headache, hemorrhage, dizziness; GI ulcer/bleed, elevated liver enzymes (discontinue if hepatotoxicity develops), blurred vision, rash/serious skin infections (discontinue if occurs), peripheral edema, anemia, hypertension, renal papillary necrosis, aseptic meningitis. See literature re: risk of cardiovascular events.
How Supplied: Tabs—90
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201241519174027.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |