英文药名：Viracept Tab（Nelfinavir mesilate）

中文药名：奈非那韦甲磺酸片

生产厂家：中外制药

ビラセプト錠250mg

治疗类别名称
抗病毒化疗药物
商標名
Viracept Tab
一般名
ネルフィナビルメシル酸塩　Nelfinavir mesilate
化学名
(-)-(3S, 4aS, 8aS)-N-tert-butyl-2-［(2R, 3R)-2-hydroxy-3-(3-hydroxy-2-methylbenzoylamino)-4-(phenylthio)butyl］decahydroisoquinoline-3-carboxamide monomethanesulfonate
分子式
C32H45N3O4S・CH4O3S
分子量
663.89
化学構造式

性状
在白色的粉末微黄色，有一稍微刺激性气味。
该产品是甲醇，乙醇（99.5），溶于乙腈，微溶于氯仿，水在（去离子水）极微溶，并在乙醚中几乎不溶。
熔点
不显示熔点，它分解，在100〜200℃。
操作注意事项
由于这剂为吸湿性，开盘后，它被保存，以避免水分
适应病症
HIV感染症
用法用量
成人：每天口服三次，每次750毫克-1250毫克饭后服。此外，与给药时其它抗HIV药物结合使用。
药效药理
1. 作用机序
药物被选择性抑制自HIV-1衍生的蛋白酶的活性。这种药物，源于人的天冬氨酸蛋白酶（血管紧张肽原，胃蛋白酶，胃泌素，组织蛋白酶等）抑制活性是针对小，表示用于HIV蛋白酶高的酶的特异性。这种药物是在所述蛋白酶的活性中心，与HIV的前体多蛋白的竞争来抑制蛋白酶的活性，其结果是，病毒粒子的成熟过程中，防止了艾滋病毒前体多蛋白的裂解，传染性抑制HIV产生的。
2. 抗病毒活性（体外）
在HIV-1（RF和IIIB）股和人T-淋巴样细胞（CEM-SS和MT-2）由公司急性感染系统，在该药物的浓度为31和43nmol/L时，病毒生长抑制50％（对比未处理病毒感染的比较）为。在HIV-2（ROD）的股票和人类T淋巴细胞系的系统，该试剂是在9nmol / L病毒生长的50％抑制在使用单核细胞嗜测试病毒株（BAL），也是在培养的人类单核细胞/巨噬细胞，抑制HIV-1感染的由代理观察为好。此外，在齐多夫定的系统或一个非核苷逆转录酶抑制剂人类T淋巴被感染HIV临床分离，包括耐病毒的试剂细胞（MT-2）菌株，这种药物是在30〜60nmol/L的病毒生长被抑制50％。此外，在人T淋巴细胞系和HIV-1（射频）有限公司，通过联合使用的逆转录酶抑制剂（齐多夫定，拉米夫定，等），协同或HIV生长的添加剂的剂的感染的系统这表明有抑制作用。
3. 耐药性
患者这种药物已经施用，艾滋病毒易感性这种药物降低分离。抗艾滋病毒的对这种药物的表达已被证实，基于HIV蛋白酶的氨基酸取代，所述蛋白酶结构域的30个氨基酸的突变是最常见的，并且是用于对这种药物耐受最重要的已发现。还已经证实，有发生在其它进一步的突变在多个位置的情况。顺便提及，与在第30氨基酸突变耐药病毒频率，已经观察到在与齐多夫定和拉米夫定组合使用时是一种逆转录酶抑制剂，显著得到抑制。
4. 交差耐性
与敏感性降低这种药物有30个氨基酸的突变抗性病毒中，已经证实，通过保持灵敏度对其他蛋白酶抑制剂。另外，从谁开发耐其它蛋白酶抑制剂的患者中分离出的病毒中，61％（14/23株）尽管已经证实，通过保持敏感性这种药物和基因突变充分考虑尚未作出有关关系。这种药物和艾滋病毒之间的交叉抗性逆转录酶抑制剂，该药物的作用点是不同的，并为耐齐多夫定-HIV病毒株和吡啶酮系统的非核苷逆转录酶抗抑制剂的HIV病毒株由于这种药物的抗病毒作用的衰减不表达它是低估计的可能性观察。
5. 其他（参考）
豚鼠的全身过敏反应（过敏SC，诱导四）发现弱阳性反应，但在口服给药的临床路径下豚鼠的全身过敏反应，均为阴性。 （PO致敏，诱发IV）
此外，任何豚鼠PCA反应和鼠标PCA反应呈阴性。
包装规格
片：250毫克*300片/瓶

生产商
中外制药有限公司
完整处方资料附件：http://www.info.pmda.go.jp/go/pack/6250012F1037_1_04/

Viracept Tab. 250mg（ビラセプト錠250mg） 
Brand name : Viracept Tab. 250mg
　Active ingredient: Nelfinavir mesilate
　Dosage form: light blue tablet (major axis: approx. 19.1mm, minor axis: approx. 6.4mm, thickness: approx. 6.1mm)
　Print on wrapping: 
Effects of this medicine
This medicine discourages reproduction of infectious virus by inhibiting the function of HIV protease (enzyme which synthesizes protein). It is usually used to treat HIV infection in combination with other anti-HIV drugs.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you are a patient with hepatic function disorder, hemophilia, or bleeding tendency.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•General dosage regimen: For adults, take 5 tablets (1,250mg of nelfinavir) at a time, twice a day after each meal. Alternatively, take 3 tablets (750mg of nelfinavir) at a time, 3 times a day, after each meal. Be sure to take it after meal since the absorption of this medicine will be decreased if you take it on an empty stomach. Strictly follow the instructions of your doctor/pharmacist.
•This medicine may lose effectiveness if you miss a dose. So, it is important not to miss a dose. If you miss a dose by any chance and realize it, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take a double dose to make up for the missed dose.
•If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.
•Do not stop taking this medicine without the instructions of your doctor.
Precautions while taking this medicine
•This medicine does not cure HIV infection fundamentally. Even if you take this medicine, your disease may progress. Report all the changes of your physical status to your doctor.
•Avoid taking hypericum perforatum (Saint John's wort)-contained food, since it may accelerate metabolism of medicine and lower blood level.
Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: diarrhea, nausea, enlarged feeling of abdomen, acquired lipodystrophy (square-shoulder), headache, feeling of weariness, etc.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•thirst, excess intake of water, increased urinary volume, feeling weariness, lassitude [diabetes, elevation of blood sugar level]
•nose/gum bleeding, blue spot, continuous bleeding  [bleeding tendency (internal bleeding in brain, mediastinum, joint, etc.)]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children, away from direct sunlight, heat and moisture.
•Discard the remainder. Do not store them. Ask the pharmacist how to discard.
Chugai Pharmaceutical Co., Ltd.Internal
Published: 12/2009
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.