药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201231922104620.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文高特灵处方资料(仅供参考)
【商品名】高特灵 片剂 Hytrin
【通用名】盐酸特拉唑嗪片
【药理作用】本药是选择性α1肾上腺受体阻断剂,可减低外周血管总阻力,降低收缩和舒张血压,且舒张压降低更为显著。通常并不伴随反射性心动过速。本药通过阻断前列腺及膀胱出口平滑肌的肾上腺素受体,改善良性前列腺肥大病人的尿流动力和临床症状。临床对照研究中,以特拉唑嗪治疗,病人的血脂均有改进,单独服特拉唑嗪比服安慰剂患者的总胆固醇、结合的低密度及极低密度脂蛋白分数轻度降低,对比基线,这些患者的高密度脂蛋白和HDL/LDL的比率明显升高,甘油三酯明显降低。然而,安慰剂组这些改变并不明显。
【药代动力学】口服吸收完全,不受进食的影响。首次经肝脏的代谢很少,几乎全部以原型进入循环。服药后1小时血药浓度达到峰值,半衰期约为12小时。药物与血浆蛋白高度结合,原型药物自尿中排出约占口服剂量的10%,大便排出约占20%,其余的以代谢产物形式排出。总的自尿排出量约为40%,自粪便排出约为60%。药代动力学与肾功能无关,故肾功能损害患者不需要作剂量调整。口服后15分钟内,血压逐渐降低,数小时后血药浓度达峰值,血压降低最明显,药效持续24小时。 【毒理研究】体外体内检查评价(包括Ames试验,体外细胞遗传试验,小鼠显性致死试验,中国仓鼠染色体畸变试验和V79致突变前瞻分析),均未发现潜在致突变作用。小白鼠的致癌分析中,一系列试验未发现致突变性 ;未发现各形细胞致癌性 ;大鼠和小鼠两种均未发现总肿瘤数目增加。
【适应症】高血压。良性前列腺肥大,其指征为 :无前列腺切除手术指征者 ;不能接受外科治疗者 ;择期手术者 ;不愿手术者。 【用法用量】高血压 初始剂量1 mg/日(睡前给药),可逐渐增加剂量,最高可达20 mg/日。良性前列腺肥大 初始剂量为1 mg/日,睡前服用。缓慢增加至5-10 mg/日。 【不良反应】乏力、头痛,心悸、体位性低血压、视力模糊、头晕、瞌睡,鼻塞、恶心、肢端浮肿。
【警告】本药能引起明显的低血压,尤其是体位性低血压,服用首剂及首几剂之后可能发生晕厥,如在服用数剂之后突然停药,亦可发生晕厥。为了减少发生晕厥及严重的体位性低血压,治疗必须从每日1 mg之低剂量开始,并在睡前服用,增加剂量时应缓慢。一旦发生晕厥,应让病人平卧,并采取对症支持治疗。
【注意事项】服首剂及增加剂量后12小时内,或停药时,应避免驾驶及操作机器。与其它抗高血压药或利尿剂合用时,应减低本药的用量。
【孕妇及哺乳期妇女用药】对妊娠的安全性尚未确定,故不推荐使用。本药是否经母乳分泌尚不清楚,故哺乳者慎用。
【儿童用药】儿童用药的药效和安全性尚未确定。 【药物过量】服用过量可引起低血压,应采取对心血管的支持治疗。
【贮藏】40度以下保存。
GENERIC NAME: terazosin
BRAND NAME: Hytrin
DRUG CLASS AND MECHANISM: Terazosin belongs to a class of medications called alpha 1 blockers which relax the smooth muscles of the arteries, the prostate, and the bladder neck. Other alpha blockers include doxazosin (Cardura), alfuzosin (Uroxatral), tamsulosin (Flomax), and prazosin (Minipress). Relaxing the smooth muscles of the arteries lowers blood pressure. Relaxing the smooth muscles around the bladder neck relieves urinary obstruction caused by an enlarged prostate (prostate hypertrophy). Terazosin relaxes the smooth muscles of the bladder neck and the prostate, increasing urine flow. The FDA approved terazosin in 1987.
PRESCRIPTION: Yes
GENERIC AVAILABLE: Yes
PREPARATIONS: Tablets or Capsules: 1, 2, 5, and 10 mg.
STORAGE: Terazosin should be stored at room temperature below 86 F (30 C) in a tight container.
PRESCRIBED FOR: Terazosin is used to treat the symptoms of urinary obstruction due to an enlarged prostate caused by benign prostatic hypertrophy (BPH). Terazosin also is used alone or in combination with another blood pressure medication to treat high blood pressure.
DOSING: Terazosin may be taken with or without food. The recommended starting dose for treating BPH is 1 mg daily. The dose should be increased in a stepwise fashion up to 10 mg daily which is the effective dose for most patients. Some patients may show additional improvement with a 20 mg dose. For high blood pressure the recommended dose is 1 to 5 mg once daily. Some patients may benefit from doses as high as 20 mg per day. Terazosin also may be administered twice daily.
DRUG INTERACTIONS: PDE-5 inhibitors used primarily for erectile dysfunction (for example, vardenafil [Levitra, Staxyn], Adcirca, tadalafil [Cialis], sildenafil [Viagra, Revatio) add to the blood pressure lowering effects of terazosin and may result in orthostatic or postural hypotension. (See Side Effects.) Individuals who take terazosin should be on a stable dose before a PDE-5 inhibitor is started, and the PDE-5 inhibitor should be started at the lowest dose. If the patient is already taking a PDE-5 inhibitor terazosin should be started at the lowest dose.
PREGNANCY: There are no adequate studies of terazosin in pregnancy. It is not recommended during pregnancy unless the benefits justify the potential but unknown risks to the fetus
NURSING MOTHERS: It is not known whether terazosin is excreted in breast milk.
SIDE EFFECTS: Besides postural hypotension and dizziness, side effects include weakness, fatigue, headaches, swelling of the legs (edema), palpitations, nasal congestion, sleepiness, decreased libido, impotence, and blurred vision. By relaxing the smooth muscles and dilating the arteries, terazosin can cause a marked lowering of the blood pressure especially when the patient stands up (orthostatic or postural hypotension). Postural hypotension can cause the patient to faint upon standing. Postural hypotension and fainting usually are associated with the first dose or the first few days of treatment. Hypotension and fainting also can occur when doses of medication are increased abruptly or another blood pressure medication is added. In order to decrease the likelihood of excessive hypotension and fainting, terazosin is initiated low doses. Prostate cancer and prostatic hypertrophy both cause similar symptoms of obstruction to the flow of urine. Prostate cancer and prostatic hypertrophy can co-exist. Therefore, patients being treated for prostate hypertrophy should be evaluated to exclude the presence of prostate cancer.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201231922104620.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |