【药品通用名】依非韦伦
【商品名】施多宁
【英文名】Efavirenz Tablets
【拼音名】Yifeiweilun pian
【药品批准文号】注册证号H20040599
【生产企业】百时美-施贵宝集团制药有限公司
【药学一级分类】抗微生物药物
【药学二级分类】抗病毒药
【药学三级分类】非核苷类逆转录酶抑制剂
【功能主治/适应症】HIV-I感染的成人、青少年和儿童抗病毒联合治疗。
【用法用量】成人 推荐剂量为600 mg qd，睡前服用。青少年和儿童 体重13-15 kg者，200 mg qd ；体重15-20 kg者，250 mg qd ；体重20-25 kg者，300 mg qd ；体重25-32.5
kg者，350 mg qd ；体重32.5 -40 kg者，400 mg qd ； 体重≥ (greater than or equal to) 40 kg者，600 mg qd。
【不良反应】皮疹、头晕眼花、恶心、头痛、乏力、神经系统症状。肝酶升高。精神症状。
【注意事项】本药不得单独用于HIV治疗或者以单药加入无效的治疗方案。肝病患者慎用。服用本品的妇女应避孕。感染HIV的妇女不要母乳喂养。本品尚未在3岁以下或体重< 13 kg的儿童中进行评价。
【关联病症】 HIV-I感染的成人抗病毒 HIV-I感染的青少年抗病毒 HIV-I感染的儿童抗病毒
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注册证号 |
H20070268 |
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原注册证号 |
H20060215 |
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产品名称（中文） |
依非韦伦片 |
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产品名称（英文） |
Efavirenz Tablets |
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商品名（中文） |
施多宁 |
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商品名（英文） |
Stocrin |
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剂型（中文） |
片剂 |
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规格（中文） |
200mg |
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注册证号备注 |
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包装规格（中文） |
90片/瓶 |
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生产厂商（中文） |
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生产厂商（英文） |
Merck Sharp & Dohme (Australia) Pty. Ltd. |
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厂商地址（中文） |
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厂商地址（英文） |
54-68 Ferndell Street SOUTH GRANVILLE NSW 2142 Australia |
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厂商国家（中文） |
澳大利亚 |
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厂商国家（英文） |
Australia |
Generic Name for SUSTIVA TABLETS
Efavirenz 600mg.
Legal Classification:
Rx
Pharmacological Class for SUSTIVA TABLETS
Non-nucleoside reverse transcriptase inhibitor.
Manufacturer of SUSTIVA TABLETS
Bristol-Myers Squibb Virology
Indications for SUSTIVA TABLETS
HIV-1 infection.
Adults and Children:
Give once daily on an empty stomach, preferably at bedtime. Consider pretreating with antihistamine (for children) or steroid to minimize rash. <3years: not recommended. ≥3years (10kg to <15kg): 200mg; (15kg to <20kg): 250mg; (20kg to <25kg): 300mg; (25kg to <32.5kg): 350mg; (32.5kg to <40kg): 400mg; (≥40kg) and adults: 600mg. Concomitant voriconazole: increase voriconazole maintenance dose to 400mg every 12 hours and decrease efavirenz dose to 300mg once daily using capsule form.
Also:
SUSTIVA
Contraindications for SUSTIVA TABLETS
Concomitant bepridil, cisapride, ergots, midazolam, triazolam, pimozide, St. John's wort.
Warnings/Precautions for SUSTIVA TABLETS
CNS or psychiatric disturbances. Seizures. Hepatic impairment: moderate or severe: not recommended; mild: use caution. Monitor liver function before and during therapy; and in patients with underlying diseases (eg, hepatitis B or C coinfection, marked transaminase elevations, being treated with other hepatotoxic drugs). Monitor cholesterol and triglycerides before starting and periodically thereafter. Discontinue if severe rash (w. blistering, desquamation, mucosal involvement, or fever) occurs. Obtain (–) pregnancy test before starting; use adequate (barrier + hormonal) contraception. Elderly. Pregnancy (Cat.D; avoid esp. during 1st trimester). Nursing mothers: not recommended.
Interactions for SUSTIVA TABLETS
See Contraindications. Avoid concomitant other efavirenz-containing products (eg, Atripla), atazanavir (treatment-experienced), posaconazole, alcohol, psychoactive and/or other hepatotoxic drugs. Caution with drugs metabolized by, or that affect activity of, CYP2C9, CYP2C19, CYP3A4. Efavirenz levels decreased by phenobarbital, rifampin, rifabutin. May decrease levels of indinavir (increase indinavir to 1g every 8 hours), amprenavir, atazanavir, clarithromycin, calcium channel blockers (eg, diltiazem, felodipine, nicardipine, nifedipine, verapamil), itraconazole, ketoconazole, lopinavir (adjust dose: see literature), maraviroc, methadone, rifabutin (increase dose: see literature), sertraline, simvastatin, atorvastatin, pravastatin, progestins (eg, norelgestromin, levonorgestrel), immunosuppressants (eg, cyclosporine, sirolimus, tacrolimus). Efavirenz increases nelfinavir plasma levels. May affect or be affected by voriconazole (adjust dose). Levels of both drugs increased with ritonavir (monitor liver function and for adverse events). Levels of both drugs are decreased with saquinavir (do not use as sole protease inhibitor). Closely monitor warfarin, anticonvulsants (esp. phenytoin, phenobarbital, carbamazepine), rifabutin, others. May cause false (+) cannabis screening test (CEDIA DAU multi-level THC assay).
Adverse Reactions for SUSTIVA TABLETS
CNS effects (eg, dizziness, headache, insomnia, impaired concentration, abnormal dreams), psychiatric effects (eg, severe depression, suicidal ideation/attempt, aggression, paranoia, mania, delusions, psychosis), rash (may be severe; eg, Stevens-Johnson, erythema multiforme), GI upset, fatigue, fever, cough, dyspnea, immune reconstitution syndrome, redistribution of body fat.
Notes for SUSTIVA TABLETS
Register pregnant patients exposed to efavirenz by calling (800) 258-4263.
How is SUSTIVA TABLETS supplied?
Caps 50mg—30; 200mg—90; Tabs 600mg—30
