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当前位置:药品说明书与价格首页 >> 抗肿瘤药 >> 新药动态 >> FDA批准羟考酮(OxyContin)控释片新剂型

FDA批准羟考酮(OxyContin)控释片新剂型

2010-04-25 18:38:29  作者:新特药房  来源:互联网  浏览次数:360  文字大小:【】【】【
简介: 美国食品药品管理局(FDA)近日批准羟考酮(OxyContin)控释片,开发这一剂型的目的是防止羟考酮的误用和滥用。美国药物滥用与精神健康服务管理局(U.S.Substance Abuse and Mental Health Services Ad ...

美国食品药品管理局(FDA)近日批准羟考酮(OxyContin)控释片,开发这一剂型的目的是防止羟考酮的误用和滥用。美国药物滥用与精神健康服务管理局(U.S.Substance Abuse and Mental Health Services Administration)曾开展一项全国性药品使用与健康调查,结果数据显示,在2008年中,大约有500,000人首次出于非医疗目的使用OxyContin。

OxyContin缓慢释放活性成分羟考酮,从而为患者提供持续的、不间断的止痛效用,能够长时间缓解患者中至重度疼痛。由于其控释特性,OxyContin含羟考酮量高于普通片,从而能够减少患者的用药次数。而滥用普通片羟考酮立即大量释放,可能因过量致命,或导致高滥用率。

FDA要求制造商Purdue Pharma L.P.公司进行上市后新剂型降低药物滥用和误用的相关研究。

 

Oxycontin Generic Name: OXYCODONE (ox-i-KOE-done)

Oxycontin Drug Manufacturer: PURDUE-FREDERICK

Oxycontin Common Uses: This medicine is a narcotic analgesic used to treat or prevent moderate to severe pain. It may also be used to treat other conditions as determined by your doctor.

How to use this Oxycontin Medicine: Follow the directions for using this medicine provided by your doctor. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. STORE THIS MEDICINE at room temperature, away from heat and light. IF YOU MISS A DOSE OF THIS MEDICINE and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Oxycontin Cautions: IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to codeine, hydrocodone, dihydrocodeine, or oxycodone (such as Tylox, Tylenol with Codeine, Vicodin), contact your doctor or pharmacist BEFORE TAKING THIS MEDICINE. A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to this medicine or if a certain medicine contains codeine, hydrocodone, dihydrocodeine, or oxycodone, contact your doctor or pharmacist. Monitor your pain as directed by your doctor. If pain is left untreated and becomes intense, this medicine may not work as well to relieve it. DO NOT exceed the recommended dose, take this medicine more often, or for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. BEFORE YOU HAVE ANY MEDICAL OR DENTAL SURGERY OR EMERGENCY TREATMENT, tell the doctor or dentist that you are taking this medicine. AVOID ALCOHOL while you are using this medicine. This medicine will add to the effects of alcohol and other depressants. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. Caution should be used in the elderly since they may be more sensitive to the effects of this drug. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

Oxycontin Possible Side Effects: SIDE EFFECTS, that may go away during treatment, include drowsiness, dizziness, lightheadedness, nausea, vomiting, headache, or constipation. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience excessive drowsiness, rash, itching, sweating, seizures, shortness of breath, or difficulty breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

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