Bays H E, Gadde K M
L-MARC Research Center, Louisville, Kentucky 40213, USA.
Drugs Today (Barc). 2011 Dec;47(12):903-14. doi: 10.1358/dot.2011.47.12.1718738.
Phentermine hydrochloride is a noradrenergic sympathetic amine approved for decades by the U.S. Food and Drug Administration (FDA) at doses as high as 37.5 mg/day for the short-term treatment of obesity. Topiramate is a sulfamate-substituted monosaccharide marketed since 1996, and approved by the FDA for seizure disorders at doses up to 400 mg/day and for the prevention of migraine headaches at doses up to 100 mg/day. Clinical trial data suggest topiramate promotes weight loss. The prescribing information of neither agent describes adverse drug interactions with the other. The controlled-release formulation of phentermine and topiramate at low, medium and full doses (with full dose containing 15 mg of phentermine hydrochloride and 92 mg of topiramate) promotes weight reduction, with clinical trial data supporting improvement in adiposopathic consequences leading to metabolic diseases. Reported adverse events with this combination agent are as expected, based upon knowledge of the individual components.
盐酸苯丁胺是一种去甲肾上腺素能交感胺，数十年来一直被美国食品药品监督管理局（FDA）批准用于短期治疗肥胖症，最高剂量为37.5毫克/天。托吡酯是一种自1996年上市的氨基磺酸酯取代的单糖，被FDA批准用于癫痫疾病，最高剂量为400毫克/天，用于预防偏头痛，最高剂量为100毫克/天。临床试验数据表明托吡酯可促进体重减轻。两种药物的处方信息均未描述与另一种药物的不良药物相互作用。低、中、全剂量的苯丁胺和托吡酯控释制剂（全剂量含有15毫克盐酸苯丁胺和92毫克托吡酯）可促进体重减轻，临床试验数据支持改善导致代谢疾病的脂肪病后果。基于对各成分的了解，这种复方制剂报告的不良事件在意料之中。
