部分中文GLUMETZA ER处方信息(仅供参考) WARNING: Lactic Acidosis - Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure. The onset of lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate. If acidosis is suspected, GLUMETZA should be discontinued and the patient hospitalized immediately (see Full Prescribing Information, Warnings and Precautions, 5.1) CONTRAINDICATIONS GLUMETZA is contraindicated in patients with: •Renal impairment (e.g., serum creatinine levels ≥ 1.5 mg/dL for men, ≥ 1.4 mg/dL for women or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia. •Known hypersensitivity to metformin hydrochloride. •Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin. WARNINGS AND PRECAUTIONS •Lactic acidosis: Warn against excessive alcohol intake. GLUMETZA is not recommended in hepatic impairment and is contraindicated in renal impairment. Ensure normal renal function before initiating and at least annually thereafter. •Temporarily discontinue in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials or any surgical procedures necessitating restricted intake of food and fluids. •Vitamin B12 deficiency: Metformin may lower vitamin B12 levels. Monitor hematologic parameters annually. •Macrovascular outcomes: No conclusive evidence of macrovascular risk reduction with GLUMETZA or any other antidiabetic drug. ADVERSE REACTIONS The incidence and type of adverse reactions reported by >5% of patients for the combined GLUMETZA group versus placebo group are hypoglycemia, diarrhea, and nausea. DRUG INTERACTIONS •Cationic drugs: May reduce metformin elimination. Use with caution in patients who are taking cationic medications eliminated by renal tubular secretion. USE IN SPECIFIC POPULATIONS •Pediatric Use: Safety and effectiveness in children younger than 18 years of age have not been established. •Geriatric Use: Caution should be used when prescribing GLUMETZA to elderly patients because reduced renal function is associated with increasing age. The Important Safety Information does not include all the information needed to use GLUMETZA safely and effectively. See Full Prescribing Information for GLUMETZA for additional information.
------------------------------------------------------------ 通用名:盐酸二甲双胍缓释片 主要成分:本品主要成份为盐酸二甲双胍,其化学名为1,1-二甲基双胍盐酸盐。 【性状】本品为白色或类白色异形片。 【药理作用】 药理:能促进胰岛素与受体结合而提高糖尿病患者对胰岛素的敏感性,增加周围组织对糖的无氧酵解而促进糖的利用、抑制脂肪分解、减少血浆游离脂肪酸水平、削弱胰岛素抵抗而改善葡萄糖的利用而发挥降血糖、降血脂、抑制动脉硬化的作用。 【适应证】 (1)用于单纯饮食控制不满意的Ⅱ型(非胰岛素依赖型)糖尿病病人,尤其是肥胖者,可能有减轻体重的作用。 (2)对某些磺酰脲类疗效差的Ⅱ型糖尿病病人有效。 【用法】口服,晚餐时服用,用量依病情参照说明及遵医嘱服用。 【不良反应】 1、偶见恶心、呕吐、腹泻等胃肠道反应。 2、有乏力、疲倦、头晕、皮疹。 3、乳酸性酸中毒虽然发生率很低,但应予注意。 4、可减少肠道吸收维生素B12。 【禁忌】Ⅱ型糖尿病伴有酮症酸中毒、肝及肾功能不全(血清肌酐超过1.5mg/d l)、肺功能不全、心力衰竭、急性心肌梗死、严重感染和外伤、重大手术以及临床有低血压和缺氧情况;既往有乳酸性酸中毒史者,以及对本品过敏者禁用。 【注意事项】 1、在使用盐酸二甲双胍的病人中,由于盐酸二甲双胍的累积有可能发生乳酸性酸中毒。这是一种罕见而严重的代谢性并发症,一旦发生,会导致生命危险,对服用本品的患者应进行肾功能监测和给药以最低有效用量为标准,从而来显著降低乳酸性酸中毒的发生风险。 2、本品禁止嚼碎口服,应整片吞服,并在进食时或餐后服。 3、当患者需要进行放射性研究而使用静脉注射碘化造影剂时,患者应暂时停止服用本品,因为这可能导致急性肾功能改变。 4、本品与磺酰脲类药物合用时,可引起低血糖,应监测患者血糖情况。 5、本品与胰岛素合用会增强降血糖作用,故应调整剂量。 6、应定期监测血糖、糖化血红蛋白、尿糖、尿酮体情况。 7、部分病人发现在临床无症状的情况下,维生素B12的水平低于正常值,这可能是由于盐酸二甲双胍干扰了维生素B12的吸收,这可能导致贫血,虽然可能性很小,但仍建议监测患者的血象,至少每年检查一次血液参数。 8、本品与乙醇同服时会增强盐酸二甲双胍对乳酸代谢的影响,易导致乳酸性酸中毒发生,因此,服用本品时应尽量避免饮酒。 9、发生皮疹等过敏反应者应停止使用本品。 【剂型】缓释片剂 【贮藏】遮光,密闭保存 ------------------------------------------------------ 产地国家: 美国 原产地英文商品名: GLUMETZA ER 500 MG TABLET 原产地英文药品名: METFORMIN HCL 中文参考商品译名: GLUMETZA 24小时缓释片500毫克/片 100片/盒 中文参考药品译名: 盐酸二甲双胍 中文参考化合物名称: 1,1-二甲基双胍盐酸盐 生产厂家中文参考译名: SANTARUS 生产厂家英文名: SANTARUS 该药品相关信息网址1: http://baike.baidu.com/view/1692807.htm?fr=ala0_1 该药品相关信息网址2: http://www.medicinenet.com/metformin/article.htm
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