FDA批准咳嗽和感冒处方药Vituz

圣路易斯(MD Consult)——2013年2月28日，Pernix Therapeutics宣布其子公司Hawthorn制药的口服溶液剂Vituz已获得美国食品药品管理局(FDA)批准，用于缓解上呼吸道过敏或普通感冒引起的咳嗽和其他症状。Vituz是止咳药酒石酸二氢可待因酮和组胺-1受体拮抗剂马来酸氯苯那敏的复方制剂。

Vituz治疗患者最常见不良反应包括镇静、嗜睡、精神朦胧、昏睡、精神和身体活动能力损害、焦虑、恐惧、烦躁、头晕、恶心、精神依赖、情绪改变、视力障碍、困惑、头痛、欣快、面肌运动障碍、眩晕、头晕、激越、易怒以及震颤。Vituz禁用于正在接受单胺氧化酶抑制剂治疗或停止该类药物治疗14天以内的患者，以及狭角青光眼、尿潴留、严重高血压或严重冠心病患者。

应注意服用Vituz出现耐受和(或)依赖的可能性，尤其是有药物依赖史患者。头部损伤、颅内病变或颅内压增高患者应避免服用Vituz。鉴于该药物可导致困倦，应建议服药者避免从事需要精神警觉和运动协调的危险性工作。

Pernix公司预计在2013年第二季度推出Vituz。

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ST LOUIS (MD Consult) - On February 28, 2012, Pernix Therapeutics announced that its subsidiary, Hawthorn Pharmaceuticals, has received US Food and Drug Administration (FDA) approval for Vituz, an oral solution indicated for the relief of cough and symptoms associated with upper respiratory allergies or the common cold in adults. Vituz is a combination of hydrocodone bitartrate, an antitussive, and chlorpheniramine maleate, a histamine-1 receptor antagonist.

The most common adverse reactions seen in patients receiving Vituz include sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, nausea, psychic dependence, mood changes, visual disturbances, confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, irritability, and tremor. Vituz is contraindicated in patients receiving monoamine oxidase inhibitor therapy or within 14 days of stopping such therapy, and in patients with narrow angle glaucoma, urinary retention, severe hypertension or severe coronary artery disease.

The possibility of tolerance and/or dependence occurring with the use of Vituz, particularly in patients with a history of drug dependence, should be considered. The use of Vituz should be avoided in patients with head injury, intracranial lesions, or increased intracranial pressure. Patients should be advised to avoid engaging in hazardous tasks that require mental alertness and motor coordination because use of the product may produce marked drowsiness.

Pernix expects to launch Vituz in the second quarter of 2013.