二甲双胍Hcl er
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Questions & Answers
副作用和不良反应
Lactic Acidosis:
Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin hydrochloride extended - release tablets; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (> 5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels > 5 mcg/mL are generally found.
接受盐酸二甲双胍的患者中乳酸性酸中毒的发生率非常低（约0.03例/1000例患者年，约0.015例患者/1000例患者年）。在临床试验中，在超过20,000例患者年中接触二甲双胍，没有乳酸性酸中毒的报道。报告的病例主要发生在肾脏不足的糖尿病患者中，包括内在性肾脏疾病和肾脏灌注不足，通常是在多种伴随的医疗/手术问题和多种伴随药物的情况下。需要药理治疗的充血性心力衰竭的患者，特别是患有炎症和低氧血症风险的不稳定或急性充血性心力衰竭的患者，患有乳酸性酸中毒的风险增加。乳酸酸中毒的风险随肾功能障碍和患者年龄的程度而增加。因此，通过定期监测盐酸二甲双胍扩展 - 释放片剂以及使用最小有效剂量的盐酸盐酸盐酸盐扩展 - 释放片剂，可以通过定期监测肾脏功能的定期监测，可能会显着降低乳酸酸中毒的风险。特别是，应仔细监测肾功能的治疗。盐酸二甲双胍扩展 - 释放片剂治疗不应在≥80岁的患者中启动，除非肌酐清除率测量表明肾功能不会降低，因为这些患者更容易患乳酸酸中毒。此外，在存在与低氧血症，脱水或脓毒症有关的任何情况下，应立即扣留盐酸二甲双胍的扩展 - 释放片剂。由于肝功能受损可能会显着限制清除乳酸的能力，因此盐酸二甲双胍扩展 - 释放片剂通常应避免使用肝病的临床或实验室证据。 Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking metformin hydrochloride extended - release tablets, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, metformin hydrochloride extended - release tablets should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS).
乳酸性酸中毒的发作通常是微妙的，仅伴随着非特异性症状，例如不适，肌痛，呼吸窘迫，脾气暴躁和非特异性腹部遇险。可能存在相关的体温过低，低血压和耐药性心律失常，并具有更明显的酸中毒。患者和患者的医生必须意识到此类症状的重要性，应指示患者在发生的情况下立即通知医生（另请参见注意事项）。盐酸二甲双胍扩展 - 应撤回释放片，直到澄清情况为止。血清电解质，酮，血糖，如果指示，血液pH，乳酸水平甚至血二甲双胍水平可能是有用的。一旦患者在任何剂量水平的盐酸二甲双胍水平上稳定后，释放片剂，胃肠道症状就会在治疗开始期间常见，就不太可能与药物有关。后来发生胃肠道症状可能是由于乳酸酸中毒或其他严重疾病引起的。
服用二甲双胍盐酸盐延长的患者的空腹静脉血浆乳酸水平高于正常的上限但小于5 mmol/L的水平 - 释放片不一定表明即将发生的乳酸酸中毒，并且可以通过其他机制来解释，例如控制不良的糖尿病或肥胖症，剧烈的体育锻炼或样品处理中的技术问题。（另请参见预防措施。）
Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia).
乳酸酸中毒是必须在医院环境中进行治疗的医疗紧急情况。在服用盐酸二甲双胍延长的乳酸酸中毒患者中，释放片剂应立即停止使用该药物，并立即采取一般的支持措施。由于盐酸二甲双胍可透析（在良好的血液动力学条件下清除高达170 mL/min），因此建议迅速血液透析以纠正酸中毒并去除累积的二甲双胍。这种管理通常会导致症状和康复的迅速逆转。（另请参见禁忌症和预防措施。）
Please review the manufacturer's complete drug information available from the FDA at: www.fda.gov.
Permanent link: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=41a8bb80-7b0b-476c-8134-5d161c3239c8
法律问题
There is currently no legal information available for this drug.
FDA安全警报
目前，该药物没有FDA安全警报。
制造商警告
目前尚无该药物可用的制造商警告信息。
FDA标记更改
There are currently no FDA labeling changes available for this drug.
Uses
Metformin hydrochloride extended - release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
历史
There is currently no drug history available for this drug.
Other Information
Metformin hydrochloride extended - release tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:
二甲双胍-ER结构
Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5•HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.
Metformin hydrochloride extended - release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride USP as the active ingredient.
盐酸二甲双胍扩展 - 释放片500毫克含有非活性成分Xanthan口香糖，氢核糖，碳酸钠，Povidone，Povidone，滑石粉，二氧化硅胶体硅和硬脂酸镁。
盐酸二甲双胍扩展 - 释放片750毫克含有非活性成分Xanthan牙龈，氢核糖，碳酸钠，Povidone，Povidone，滑石粉，二氧化碳，硬脂酸镁和铁氧化物（红色）。
Metformin hydrochloride extended - release tablets meet USP dissolution test 10.
系统组件和性能 - 金表甲盐酸盐扩展 - 释放片剂包括亲水性聚合物基质系统。盐酸二甲双胍与控制聚合物形成单相基质系统的药物释放结合。给药后，胃肠道（GI）的流体进入片剂，导致聚合物水合和膨胀。通过通过凝胶基质扩散的过程基本独立于pH，从剂型释放出来。水合聚合物系统不是刚性的，预计将被胃肠道中的正常蠕动分解。片剂的生物惰性成分有时可能在胃肠道运输过程中保持完整，并在粪便中以软性水合质量消除。
Please review the manufacturer's complete drug information available from the FDA at: www.fda.gov.
Permanent link: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=41a8bb80-7b0b-476c-8134-5d161c3239c8
来源
二甲双胍制造商
-
Northwind Pharmaceuticals
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二甲双胍Hcl er| Northwind Pharmaceuticals
There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride extended - release tablets or any other pharmacologic agent. Dosage of metformin hydrochloride extended - release tablets must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin hydrochloride extended - release tablets in adults is 2000 mg.
Metformin hydrochloride extended - release tablets should generally be given once daily with the evening meal. Metformin hydrochloride extended - release tablets 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.
治疗期间起始和剂量滴定法(see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin hydrochloride extended - release tablets 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 metformin hydrochloride extended - release tablets, 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 metformin hydrochloride extended - release tablets may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.
盐酸二甲双胍扩展 - 释放片必须吞咽整体，并且永远不会碎或咀嚼。有时，盐酸二甲双胍的非活性成分扩展 - 释放片剂将在粪便中以软性水合质量消除。（请参阅下面打印的患者信息。）
建议给药时间表
Adults - In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms.
The usual starting dose of metformin hydrochloride extended - release tablets is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on metformin hydrochloride extended - release tablets 2000 mg once daily, a trial of metformin hydrochloride extended - release tablets 1000 mg twice daily should be considered. (See CLINICAL PHARMACOLOGY: Clinical Studies.)
在一项随机试验中，目前用盐酸二甲双胍治疗的患者切换到盐酸二甲双胍扩展 - 释放片剂。该试验的结果表明，接受二甲双胍盐酸盐片治疗的患者可以安全地切换到盐酸二甲双胍延长 - 每天以相同的每日总剂量释放一次片剂，每天每天每天一次释放2000毫克。从二甲双胍盐酸片转换为盐酸二甲双胍扩展 - 释放片剂后，应密切监测血糖控制并进行相应的剂量调整（请参阅临床药理：临床研究）。
Pediatrics - Safety and effectiveness of metformin hydrochloride extended - release tablets in pediatric patients have not been established.
Transfer From Other Antidiabetic Therapy
当将患者从氯丙酰胺以外的标准口服降血糖药物转移到盐酸二甲双胍延长释放片剂时，通常不需要过渡期。当从氯丙酰胺中转移患者时，应在头两周内进行谨慎，因为氯丙酰胺长期保留在体内，导致药物作用重叠和可能的低血糖。
成年患者伴随二甲双胍盐酸盐延长 - 释放片和口服磺酰脲治疗
如果患者未对最大剂量的二甲双胍盐酸盐的最大剂量进行反应 - 释放片剂单一疗法应考虑逐渐添加口腔磺酰脲，同时继续以最大的剂量（即使先前的原理或先前的原理或先前的原理或先前的原理）或最大剂量，发生了磺酰脲的继发失败。临床和药代动力学药物 - 药物相互作用数据目前仅适用于二甲双胍和格列本比（Glibenclamide）。
With concomitant metformin hydrochloride extended - release tablets and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant metformin hydrochloride extended - release tablets and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. (See Package Insert of the respective sulfonylurea.)
If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of metformin hydrochloride extended - release tablets and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without metformin hydrochloride extended - release tablets.
成年患者伴有二甲双胍盐酸盐延长 - 释放片和胰岛素治疗
当前的胰岛素剂量应该继续initiation of metformin hydrochloride extended - release tablets therapy. Metformin hydrochloride extended - release tablets therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of metformin hydrochloride extended - release tablets should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose is 2000 mg for metformin hydrochloride extended - release tablets. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and metformin hydrochloride extended - release tablets. Further adjustment should be individualized based on glucose-lowering response.
Specific Patient Populations
Metformin hydrochloride extended - release tablets are not recommended for use in pregnancy. Metformin hydrochloride extended - release tablets are not recommended in pediatric patients (below the age of 17 years).
The initial and maintenance dosing of metformin hydrochloride extended - release tablets should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of metformin hydrochloride extended - release tablets.
Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly. (See WARNINGS.)
Please review the manufacturer's complete drug information available from the FDA at: www.fda.gov.
Permanent link: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=41a8bb80-7b0b-476c-8134-5d161c3239c8
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