部份中文Dutoprol片处方资料(仅供参考)
美国上市治疗高血压药物Dutoprol片 Dutoprol含有能够利尿的活性成分Toprol-XL(美托洛尔),能够在24小时内降低患者血压。 Toprol-XL用于治疗高血压,可以单独使用或者和其他药物配合使用。 阿斯利康公司负责商标的首席执行官史蒂夫戴维斯说:“DUTOPROL为高血压患者提供了新选择,而且这种品牌组合药物一天服用一片,非常方便。”
Manufacturer: AstraZeneca Pharmaceuticals
Pharmacological Class: Cardioselective β1-blocker + diuretic.
Active Ingredient(s): Metoprolol succinate extended-release, hydrochlorothiazide; 25/12.5mg, 50/12.5mg, 100/12.5mg; tablets.
Indication(s): Hypertension.
Pharmacology: Metoprolol is a cardioselective β1-adrenergic receptor-blocking agent. At higher plasma concentrations, metoprolol also inhibits β2-adrenoreceptors in the bronchial and vascular musculature. Metoprolol has no intrinsic sympathomimetic activity, and membrane-stabilizing activity is detectable only at plasma concentrations much greater than required for beta-blockade. Clinical studies have confirmed the beta-blocking activity of metoprolol as shown by (1) reduction in heart rate and cardiac output at rest and upon exercise, (2) reduction of systolic blood pressure upon exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia.
Hydrochlorothiazide (HCTZ) is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride. Indirectly, the diuretic action of HCTZ reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium.
Clinical Trials: A randomized, double-blind, placebo-controlled, 8-week, unbalanced factorial study (N=1571) evaluated the antihypertensive effects of various doses of metoprolol succinate extended release (25mg, 50mg, 100mg and 200mg) and HCTZ (6.25mg, 12.5mg and 25mg), and 9 of their combinations. The trial established that metoprolol succinate extended release and HCTZ both contribute to the antihypertensive effect, change from baseline to week 8 in sitting diastolic (p=0.0015) and systolic (p=0.0006) blood pressure. Blood pressure declines were apparent within 2 weeks and were maintained throughout the 8-week study. The blood pressure lowering 24hrs post dosing retained approximately 96% of the peak (6hrs post dosing) effect.
There are no trials of Dutoprol demonstrating reductions in cardiovascular risk in patients with hypertension, but both the metoprolol and HCTZ components have demonstrated such benefits.
Legal Classification: Rx
Adults: Individualize. Take once daily. Replacement therapy: may be substituted for individual components. Titrate, if necessary, every 2 weeks up to max 200/25mg. Severe renal impairment: not recommended. Moderate hepatic impairment: consider initiating with lower HCTZ component.
Children: Not established.
Contraindication(s): Cardiogenic shock. Overt heart failure. 2nd- or 3rd-degree AV block. Sinus bradycardia. Anuria. Sulfonamide allergy.
Warnings/Precautions: Ischemic heart disease. Bronchospastic disease. Pheochromocytoma. Major surgery. Renal or hepatic disease. Diabetes and hypoglycemia. Thyrotoxicosis (hyperthyroidism). Peripheral vascular disease. CHF. SLE. Acute myopia. Secondary angle-closure glaucoma. Gout. Post-sympathectomy. Avoid abrupt cessation. Monitor electrolytes. Pregnancy (Cat.C). Nursing mothers.
Interaction(s): Additive effects with catecholamine-depleting drugs (eg, reserpine, MAOIs). Potentiated by CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine, propafenone). Risk of bradycardia with digitalis, clonidine, diltiazem, verapamil. Potentiated by alcohol, barbituates, narcotics, other antihypertensives. Hypokalemia with corticosteroids, ACTH. May increase lithium toxicity. Antagonized by NSAIDs (monitor). Adjust antidiabetic drugs. Decreased absorption with cholestyramine and colestipol resins. Antagonizes norepinephrine. Possible increased response to muscle relaxants (eg, tubocurarine). May interfere with parathyroid tests.
Adverse Reaction(s): Nasopharyngitis, fatigue, dizziness, back pain, nausea; bronchospasm, bradycardia, CHF, heart block.
How Supplied: Tabs—30
Last Updated: 5/21/2012
--------------------------------------------------------------- 原产地英文商品名: DUTOPROL SR 24H (100/12.5)MG/TAB 30TABS/BOTTLE 原产地英文药品名: METOPROLOL SUCCINATE/HYDROCHLOROTHIAZIDE 中文参考商品译名: DUTOPROL 24小时缓释片 (100/12.5)毫克/片 30片/瓶 中文参考药品译名: 琥珀酸美托洛尔/氢氯噻嗪 生产厂家中文参考译名: 阿斯利康 生产厂家英文名: ASTRAZENECA --------------------------------------------------------------- 原产地英文商品名: DUTOPROL SR 24H (25/12.5)MG/TAB 30TABS/BOTTLE 原产地英文药品名: METOPROLOL SUCCINATE/HYDROCHLOROTHIAZIDE 中文参考商品译名: DUTOPROL 24小时缓释片 (25/12.5)毫克/片 30片/瓶 中文参考药品译名: 琥珀酸美托洛尔/氢氯噻嗪 生产厂家中文参考译名: 阿斯利康 生产厂家英文名: ASTRAZENECA --------------------------------------------------------------- 原产地英文商品名: DUTOPROL SR 24H (50/12.5)MG/TAB 30TABS/BOTTLE 原产地英文药品名: METOPROLOL SUCCINATE/HYDROCHLOROTHIAZIDE 中文参考商品译名: DUTOPROL 24小时缓释片 (50/12.5)毫克/片 30片/瓶 中文参考药品译名: 琥珀酸美托洛尔/氢氯噻嗪 生产厂家中文参考译名: 阿斯利康 生产厂家英文名: ASTRAZENECA
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