ST LOUIS (MD Consult) - On September 8, 2009, Salix Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted marketing approval for Metozolv ODT (metoclopramide hydrochloride) 5- and 10-mg orally disintegrating tablets. Metozolv ODT is indicated for treatment of symptoms associated with acute and recurrent diabetic gastroparesis in adults. The drug is also approved as short-term therapy (4-12 weeks) for symptomatic, documented gastroesophageal reflux disease (GERD) in adults whose condition has not responded to conventional therapy.
Metoclopramide is a potent dopamine-receptor antagonist that promotes gastric emptying and functions as an antiemetic. Before the approval of Metozolv ODT, metoclopramide was available in intravenous, intramuscular, and oral tablet formulations. Metoclopramide has been available in the United States since 1980.
Metozolv ODT is contraindicated in patients with intestinal obstruction, hemorrhage, or perforation; pheochromocytoma; or epilepsy; or who are receiving concomitant medications associated with extrapyramidal reactions. The medication should be used with caution in patients with neuroleptic malignant syndrome; hypertension; congestive heart failure; ventricular arrhythmia; or with a medical history of depression and in patients demonstrating acute dystonic reactions, drug-induced parkinsonism, or other extrapyramidal symptoms. Patients may experience withdrawal symptoms after discontinuing Metozolv ODT.
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases in which therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
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圣路易斯（MD Consult）——Salix 制药公司在2009年9月8日宣布：5mg 和 10mg Metozolv ODT（盐酸甲氧氯普胺口服崩解片）已获美国食品药品管理局（FDA）的上市批准。Metozolv ODT获批用于成年患者急性和复发性糖尿病胃轻瘫相关症状的治疗。该药物还可用于常规治疗无效的有症状的胃食管反流病（GERD）成年患者的短期治疗（4～12周）。
甲氧氯普胺是一种强效多巴胺受体拮抗剂，具有促进胃排空和止吐的功效，自1980年起就开始在美国使用。在Metozolv ODT获批之前，甲氧氯普胺有静注、肌注和口服片剂配方。
Metozolv ODT禁用于肠梗阻、出血、穿孔、嗜铬细胞瘤、癫痫或正在接受锥体外系反应相关合并用药的患者。抗精神病药恶性综合征（NMS）、高血压、充血性心力衰竭、室性心律失常和有抑郁症病史的患者以及表现有急性弛缓性反应、药源性帕金森综合征或其他锥体外系症状的患者应慎用此药。患者停用Metozolv ODT后可能会出现戒断症状。
临床上应用甲氧氯普胺可引起迟发性运动障碍，这是一种严重的运动失调，往往不可逆。迟发性运动障碍的发生风险随治疗持续时间和总累积剂量的增加而增加。应尽量避免使用甲氧氯普胺超过12周，除了极少数治疗获益超过迟发性运动障碍发生风险的患者。
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