88．曲马朵
出处：按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第493页（5834字）
【中文释文】：
胶囊活性物质：盐酸曲马朵
〔成分〕
每粒曲马朵胶囊含盐酸曲马朵50mg。
化学名为(1RS；2RS)-2-(二甲氨甲基)-1-(间一甲氧苯基)-环己醇盐酸盐。
〔适应证〕
中度至剧烈的急性或慢性疼痛以及诊断措施或治疗而引起的痛楚。
〔禁忌证〕
酒精、镇静剂、镇痛剂或其他中枢神经系统作用药物所致急性中毒病人禁用。
〔注意事项〕
根据目前普遍的推荐，怀孕期间，应当在仔细权衡利弊之后才使用。
哺乳期使用，约有0．1%的剂量进入乳汁中。
本品对阿片类反应强烈的病人慎用，惊厥的病人使用本品时应小心监护。
〔副作用〕
用药后可能出现出汗、眩晕、恶心、呕吐、口干、疲劳等现象。在极少数病例中也可能发现对心血管系统有影响(如心悸、体位性低血压或心血管性虚脱)，特别在病人疲劳情况下副作用会出现。
〔特别注意〕
本品在治疗期间尚未发现呼吸阻抑的情况，但如用量比规定量超过很多或与中枢抑制剂合用时则不能排除这种可能性。
〔驾驶员应注意〕
本品即使按照指导的服法使用，也会有可能影响病人的驾驶或机械操作的反应能力尤其与酒同服时为甚。
〔与其它药物的相互作用〕
本品与中枢神经系统药物(如安定药、镇静药)合用时有强化镇静的作用；但本品若与安定药共同使用时也会出现满意的镇痛效果。本品不宜用于接受单胺氧化酶抑制剂治疗的病人。
〔用法与用量〕
本品用量视疼痛程序而定。除另有医嘱外，本品的用法与用量(与用餐无关)如下：成人或14岁以上者一次为1粒胶囊，用水送服。此剂量通常已能解除痛楚。但如效果不理想时，可在0．5h或1h后再服一粒。一般情况下不宜超过400mg／d(即8粒胶囊)。肝肾功能不全的病人酌量使用。
〔疗程〕
使用本品作长期治疗时不能完全排除产生依赖性的可能。因此，应由医师决定疗程长短或是否需暂停用药。本品的疗程不应超过治疗所需。
〔有效期〕
本品不宜在包装上失效期后使用。
请保存好药品，避免儿童误服!
〔使用者须知〕
本品是一种解除疼痛如外伤、骨折、剧烈的神经痛、肿瘤痛、心脏病突发等的强效镇痛剂，但不宜用于轻度疼痛。本品的作用迅速，药效能持续数小时。
〔包装规格〕
每盒10粒胶囊或每盒20粒胶囊。医院用包装。
〔其他规格及剂型〕
曲马朵50mg注射液，曲马朵100mg注射液，曲马朵滴剂，曲马朵栓剂。
〔生产厂家〕
德国格兰泰公司
【外文释文】：
Active substance：tramadol hydrochloride
Composition
One Tnamal capsule contains 50mg of tramadol hydrochloride．The chemical designation is(1 RS；2 RS)-2-(dimethylaminomethyl)-1-(m-methoxypheny)-cyclohexanol-hydrochloride．
Indications
Moderate to severe acute or chronic pain and in painful diagnostic or therapeutic measures．
Contraindications
Acute intoxication with alcohol，hypnotics，analgesics or other CNS-acting drugs．
Note
In accordance with currently prevailing recommendations medication with Tramal capsules during pregnancy should only be resorted to after careful consideration of the risks．On use during lactation it is to be taken into account that about 0．1%of the dose passes into the milk．
The preparation should be used with care in patients with increased reactivity to opioids．
Patients known to suffer from convulsions should be carefully monitored during treatment with Tramal．
Side-effects
Sweating，dizziness，nausea，vomiting，dry mouth，and fatigue may occur after Tramal administration．Influence on cardiovascular regulation(e．g．palpitations，postural hypotension or cardiovascular collapse)has been observed in rare caese．In isolated cases convulsions have been observed in connection with the administration of Tramal．Undesirable effects occur particularly when the patient is under physical strain．
Special Note
Respiratory depression has so far not been observed during treatment with Tramal capsules．However，it cannot definitely be ruled out if the recommended dosage is considerably exceeded or on the concomitant administration of other centrally depressant drugs．
Note to Road Users
Even when taken according to instructions the preparation may affect the reaction ability of the patient to such an extent that his capacity to drive or operate machines may be impaired．This applies particularly in conjunction with alcohol．
Interaction with Other Drugs
On the concomitant administration of Tramal with substances which also ac t on the central nervous system(e．g．tranquillizers，hypnotics)the sedative effect(fatigue)may be intensified．At the same time，however，combining Tramal with a tranquillizer，for example，will probably have a favourable effect on pain sensation．
Tramal should not be used in patients receiving MAO inhibitors．
Application and Dosage
The dosage should be adjusted to the intensity of the pain．Unless otherwise prescribed，Tramal should be taken as follows-independent of meal：
Single dose for adults and adolescents over 14 years of age：
1 Capsule to be taken with a little liquid．
In general the daily dose should not exceed 400 mg tramadol HCl(equivalent to 8 Tramal capsules)．
In impaired renal or hepatic function it may be necessary to adjust the dose．
Duration of Treatment
During long-term treatment with Tramal the possibility of dependence cannot be entirely excluded．Therefore the physician is to decide on the duration of treatment and whether the preparation is to be withdrawn temporarily．
Tramal should not be given for longer than therapeutically necessary．
Special Note
Tramal should not be used after the expiry date printed on the packing．
Keep drugs out of children’s reach!
Information for the Patient
Tramal is a potent drug for the relief of pain，e．g．in wound pain，fractures，severer nerve pain，tumour pain，heart attack．It should not be used for minor pain．The effect sets in quickly and lasts for some hours．
Pack Sizes
Packs of 10 and 20 capsules
Hospital packs
Other Presentations
Tramal，suppositories
Tramal 50，solution for injection
Tramal 100，solution for injection
Tramal drops，solution
Manufacturer
Grunenthal GmbH，Germany