PRINICPAL DISPLAY PANEL - 60g Bottle Carton
NDC 61958-0403-1
Viread®
(tenofovir disoproxil fumarate)
Oral Powder, 40 mg/scoop
Each level dosing scoop provides approximately
1g of the oral powder which contains 40 mg of
tenofovir disoproxil fumarate, which is
equivalent to 33 mg of tenofovir disoproxil.
60g per bottle
Rx only
GILEAD
Generic Name for VIREAD ORAL POWDER
Tenofovir disoproxil fumarate 40mg per 1g pwd.
Legal Classification:
Rx
Pharmacological Class for VIREAD ORAL POWDER
Nucleotide analogue (reverse transcriptase and polymerase inhibitor).
Manufacturer of VIREAD ORAL POWDER
Gilead Sciences, Inc.
Indications for VIREAD ORAL POWDER
HIV-1 infection. Chronic hepatitis B virus (HBV) in adults.
Adult dose for VIREAD ORAL POWDER
Use tabs or oral pwd. Mix oral pwd with 2–4oz of soft food not requiring chewing (eg, applesauce, baby food, yogurt). HIV or HBV: 300mg once daily. Renal impairment: CrCl 30–49mL/min: 300mg every 48 hours; CrCl 10–29mL/min: 300mg every 72–96 hours; hemodialysis: 300mg once per week or after a total of 12 hours of dialysis; CrCl <10mL/min: not recommended.
Children's dosing for VIREAD ORAL POWDER
<2yrs: not recommended. HIV: Mix oral pwd with 2–4oz of soft food not requiring chewing (eg, applesauce, baby food, yogurt). ≥2yrs: 8mg/kg once daily; max 300mg/day. ≥17kg: may use tablets if able to swallow. 17–<22kg: 150mg once daily. 22–<28kg: 200mg once daily. 28–<35kg: 250mg once daily. ≥35kg: 300mg once daily.
Also:
VIREAD
Warnings/Precautions for VIREAD ORAL POWDER
Suspend if lactic acidosis or hepatotoxicity occurs. Calculate CrCl prior to initiating therapy. Monitor CrCl and serum phosphorus in patients at risk for renal impairment. Decompensated liver disease. Women, obesity, prolonged nucleoside exposure, other risk factors for hepatic dysfunction: increased risk of toxicity. Monitor hepatic function during and for several months after stopping anti-HBV treatment (discontinuing therapy may exacerbate HBV infection). HIV-1 and HBV coinfection: do HIV-1 antibody testing for HBV-infected patients, and test for presence of HBV in HIV-1 infected patients before starting therapy. History or risk of fractures or osteopenia: monitor bone mineral density (BMD); consider Vit. D and calcium supplementation. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.
Interactions for VIREAD ORAL POWDER
Avoid concomitant drugs that contain tenofovir or adefovir dipivoxil. Potentiates didanosine toxicity (>60kg; reduce dose of didanosine); discontinue if toxicity develops. Monitor drugs that reduce renal function or compete for renal tubular secretion (eg, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir). Potentiated by lopinavir/ritonavir, atazanavir; monitor for toxicity. Concomitant atazanavir: must give with ritonavir. Caution with triple nucleoside-only regimens (high rate of early viral non-response); monitor and consider alternative therapy. See literature for dosing of concomitant didanosine or ritonavir.
Adverse Reactions for VIREAD ORAL POWDER
Rash, GI upset, headache, pain, depression, asthenia; lactic acidosis, severe hepatomegaly with steatosis, fat redistribution, immune reconstitution syndrome, worsening renal impairment, decreased BMD, severe acute exacerbation of hepatitis.
Notes for VIREAD ORAL POWDER
Note: Register pregnant patients exposed to tenofovir DF by calling (800) 258-4263.
How is VIREAD ORAL POWDER supplied?
Tabs—30
Oral pwd—60g (w. dosing scoop)
Related Disease:
Hepatitis~antivirals
HIV~antivirals
项目名称：富马酸替诺福韦二吡呋酯
英文名称：Tenofovirdisoproxil fumarate
化学名称：（R）-[[2-（6-氨基-9H-嘌呤-9-基）- 1-甲基乙氧基]甲基]膦酸二异丙氧羰氧基甲酯富马酸盐
分子式：C23H34N5O14P
分子量：635.5149
CAS.No: 202138-50-9
适 应 症：
用于治疗HIV、HBV感染。本品和其他逆转录酶抑制剂合用于HIV-1感染、乙肝的治疗。
药理作用及作用机制
富马酸替诺福韦二吡呋酯是替诺福韦酯类前药的延胡索酸盐形式。替诺福韦的酯类被吸收后转化为活性成分替诺福韦，替诺福韦是一种单磷酸核苷类似物。替诺福韦随后由结构表达的细胞酶作用转化为活性代谢产物替诺福韦二磷酸——一种专一性链终止剂。替诺福韦二磷酸细胞内半衰期为10小时活性状态和50小时静息外周血单核细胞（PBMCs）。替诺福韦二磷酸通过竞争性结合自然脱氧核糖核酸底物，随后在DNA链终止剂的作用下结合DNA，从而抑制HIV-1逆转录酶和HBV聚合酶。替诺福韦二磷酸是一种微弱的细胞聚合酶α、β和γ抑制剂。在体外分析试验中，浓度直到30μnol/L时，替诺福韦对线粒体DNA的合成和乳酸产物都没有影响。
适应症
HIV-1感染
替诺福韦酯与其它抗逆转录病毒药品联合用药以治疗感染HIV-1的成年人。
对使用过抗逆转录病毒药品的HIV-1感染患者使用替诺福韦酯应在个人病毒抵抗力测试和或有用药史的基础上进行。
乙型肝炎病毒感染
替诺福韦酯用以治疗以下几类感染慢性乙型肝炎病毒的成年人：
1）代偿性肝疾病，显著的活性病毒复制，持续的血清ALT水平增高和组织上活性炎症和/或纤维化。
2）代偿失调性肝疾病。
用法用量
1）成年人：替诺福韦酯用于治疗HIV感染或慢性乙型肝炎病毒时每日口服(一片）一次，用餐时服用。
2）慢性乙型肝炎：用药最佳时间尚未清楚。根据以下情况可停止用药：
（1）对于没有出现肝硬变的HBeAg阳性患者，应在确认了HBe血清转换现象（经抗HBe检测发现HBeAg缺失和HBV DNA缺失）或直到HBs血清转化或者效应缺失后至少6-12个月再开始给药。用药停止后应有规律地检测血清ALT和HBV DNA，以检测任何迟发性滤过性病原体复发。
（2）对于没有出现肝硬变的HBeAg阴性患者，至少要等HBs血清转化或者效应缺失再开始给药。用药期延长超过2年，建议进行规律的重新评估来确认持续进行所选择的治疗对该患者仍然合适。
如果患者在通常用药的时间段内12小时没有服用替诺福韦酯，这名患者应该尽快在进餐时服用替诺福韦酯并且重新按正常用药时间用药。如果患者超过正常用药时间12个小时仍没有服药，患者不可补充用药，应该直接重新按正常用药时间用药。
如果患者在服用替诺福韦酯1个小时内出现呕吐，应该服用另一片。如果患者在服用替诺福韦酯1个小时以上出现呕吐，则不需要再服药。