尼莫地平口服液获准用于蛛网膜下腔出血患者

圣路易斯(MD Consult)——2013年5月13日，雅培制药公司宣布，美国食品药品管理局(FDA)批准Nymalize(尼莫地平)口服液上市。该产品的适应证为改善成年蛛网膜下腔出血(SAH)患者的神经结局。尼莫地平通过降低颅内小动脉瘤破裂所致SAH相关性缺血性障碍的发生率和严重程度而发挥作用，而且独立于患者的发作后神经状况。

此前，尼莫地平仅有一种胶囊剂型。因为该产品通常是经鼻胃管给药，医务工作者需要用注射器从胶囊中抽取药品后方可使用。这导致偶尔会发生经静脉给予尼莫地平，而未经肠道途径给药。

在接受Nymalize治疗的患者中最常见的不良反应为低血压、头痛、恶心和心动过缓。

在Nymalize治疗期间应仔细监测血压。尼莫地平可能增强合并使用的降压药的药效，这些药物包括利尿剂、β受体阻滞剂、血管紧张素转换酶抑制剂、血管紧张素受体拮抗剂、其他钙通道阻滞剂、α肾上腺素能受体阻滞剂、5型磷酸二酯酶抑制剂和α甲基多巴等。

由于存在致严重低血压的风险，一般应避免将尼莫地平与细胞色素P-450 3A4强抑制剂合并使用。

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ST LOUIS (MD Consult) - On May 13, 2013, Arbor Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Nymalize (nimodipine) oral solution. The product is indicated for the improvement of neurologic outcome in adult patients with subarachnoid hemorrhage (SAH). Nimodipine works by reducing the incidence and severity of ischemic deficits associated with SAH from ruptured intracranial berry aneurysms regardless of a patient's post-ictus neurologic condition.

Before this approval, nimodipine was only available in gel-capsule form. Because the product is commonly administered to patients through a nasogastric tube, health care providers would need to extract the product from the gel capsule with a syringe to create a means to deliver the drug. This practice has resulted in accidental administrations of nimodipine intravenously instead of via the intended enteral route.

The most common adverse reactions that occurred in patients who received Nymalize were hypotension, headache, nausea, and bradycardia.

Blood pressure should be carefully monitored during treatment with Nymalize. Nimodipine may increase the blood pressure lowering effect of concomitantly administered antihypertensives such as diuretics, beta-blockers, angiotensin-converting-enzyme inhibitors, angiotensin-receptor blockers, other calcium-channel blockers, α-adrenergic blockers, phosphodiesterase type 5 inhibitors, and α-methyldopa.

Concomitant use of strong inhibitors of cytochrome P-450 3A4 with nimodipine should generally be avoided because of risk of significant hypotension.

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