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Information on FORTAMET ER
INDICATIONS AND USAGE
FORTAMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
CONTRAINDICATIONS
FORTAMET is contraindicated in patients with:1.Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia .2.Known hypersensitivity to metformin.3.Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.FORTAMET should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.
DOSAGE AND ADMINISTRATION
There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with FORTAMET or any other pharmacologic agent. Dosage of FORTAMET must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose. The maximum recommended daily dose of FORTAMET Extended-Release Tablets in adults is 2500 mg.
FORTAMET should be taken with a full glass of water once daily with the evening meal. FORTAMET should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.During treatment initiation and dose titration, fasting plasma glucose should be used to determine the therapeutic response to FORTAMET and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of FORTAMET, either when used as monotherapy or in combination with sulfonylurea or insulin.Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.Short-term administration of FORTAMET may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.
SIDE EFFECTS
The most common side effects with metformin are nausea, vomiting, gas, bloating, diarrhea and loss of appetite. These symptoms occur in one out of every three patients. These side effects may be severe enough to cause therapy to be discontinued in one out of every 20 patients. These side effects are related to the dose of the medication and may decrease if the dose is reduced.
A serious but rare side effect of metformin is lactic acidosis. Lactic acidosis occurs in one out of every 30,000 patients and is fatal in 50% of cases. The symptoms of lactic acidosis are weakness, trouble breathing, abnormal heartbeats, unusual muscle pain, stomach discomfort, light-headedness and feeling cold. Patients at risk for lactic acidosis include those with reduced function of the kidneys or liver, congestive heart failure, severe acute illnesses, and dehydration.
Recommended Dosing Schedule
The usual starting dose of FORTAMET (metformin hydrochloride) Extended-Release Tablets is 1000 mg taken with a full glass of water once daily with the evening meal, although 500 mg may be utilized when clinically appropriate. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2500 mg once daily with the evening meal.
HOW SUPPLIED
FORTAMET(metformin hydrochloride) Extended-Release Tablets are supplied as biconvex-shaped, film-coated extended-release tablets containing 500 mg or 1000 mg of metformin hydrochloride.NDC 59630-574-60: 500 mg extended-release, white-colored tablets imprinted with Andrx logo and 574 on one side: bottles of 60.
NDC 59630-575-60: 1000 mg extended-release, white-colored tablets imprinted with Andrx logo and 575 on one side: bottles of 60.
STORAGE
Store at 20-25oC (68-77oF)- Excursions permitted to 15° - 30°C (59°-86°F) . Keep tightly closed (protect from moisture). Protect from light. Avoid excessive heat and humidity.
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部分中文 FORTAMET ER 处方信息（仅供参考）
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
注：以下产品不同规格和不同价格，购买时请以下面咨询电话为准！
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原产地英文商品名:
FORTAMET ER 500MG/TABLET 60TABLET/box
原产地英文药品名:
METFORMIN HYDROCHLORIDE Extended-Release Tablets
中文参考商品译名:
FORTAMET 缓释片 500毫克/片 60片/盒
中文参考药品译名:
盐酸二甲双胍缓释片
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:
ANDRX LABS LLC
生产厂家英文名:
ANDRX LABS LLC
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原产地英文商品名:
FORTAMET ER 1000MG/TABLET 60TABLETS/BOX
原产地英文药品名:
METFORMIN HYDROCHLORIDE Extended-Release Tablets
中文参考商品译名:
FORTAMET 缓释片 1000毫克/片 60片/盒
中文参考药品译名:
盐酸二甲双胍缓释片
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:
ANDRX LABS LLC
生产厂家英文名:
ANDRX LABS LLC
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