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Voriconazole tablets (Lailikang)

Treatment of invasive aspergillosis. Treatment of severe invasive infections (including Candida Creutzfeldt) caused by fluconazole resistant Candida. Treatment of severe infections caused by actinomycetes and Fusarium. This product should be mainly used to treat progressive and life-threatening infections in patients with immune deficiency. More role
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Common name:
Voriconazole tablets
Product No.:
A14202207118
Approval No.:
Gyzz h20055840 (inquired by the State Drug Administration)
Jianke price:
¥300.00
Product specification:
50mg * 2 tablets 50mg*4s
Manufacturer:
Huashen pharmaceutical factory of Chengdu Taihe Health Technology Group Co., Ltd. (former pharmaceutical factory of Chengdu Huashen Group Co., Ltd.)
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      Product name Voriconazole tablets (Lailikang)
      Main raw materials Voriconazole.
      Main role Treatment of invasive aspergillosis. Treatment of severe invasive infections (including Candida Creutzfeldt) caused by fluconazole resistant Candida. Treatment of severe infections caused by actinomycetes and Fusarium. This product should be mainly used to treat progressive and life-threatening infections in patients with immune deficiency.
      Product specification 50mg*4s
      Usage and dosage First give the loading dose (the first 24 hours) - the patient's weight ≥ 40 kg: once every 12 hours, 400 mg each time (applicable to the first 24 hours); Patient weight < 40 kg: 200 mg once every 12 hours (for the first 24 hours). Then the maintenance dose (24 hours after the start of medication) - patient weight ≥ 40 kg: 200 mg twice a day; Patient weight < 40 kg: 100mg twice a day.
      manufacturing enterprise Huashen pharmaceutical factory of Chengdu Taihe Health Technology Group Co., Ltd. (former pharmaceutical factory of Chengdu Huashen Group Co., Ltd.)
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      [drug name] Voriconazole tablets (Lailikang)

      [common name] Voriconazole tablets

      [specification and model] 50mg*4s

      [manufacturer] Huashen pharmaceutical factory of Chengdu Taihe Health Technology Group Co., Ltd. (former pharmaceutical factory of Chengdu Huashen Group Co., Ltd.)

      [drug type] Western medicine

      [approval No.] Gyzz h20055840

      [validity period] 24 months

      [functional indications] Treatment of invasive aspergillosis. Treatment of severe invasive infections (including Candida Creutzfeldt) caused by fluconazole resistant Candida. Treatment of severe infections caused by actinomycetes and Fusarium. This product should be mainly used to treat progressive and life-threatening infections in patients with immune deficiency.

      [usage and dosage] First give the loading dose (the first 24 hours) - the patient's weight ≥ 40 kg: once every 12 hours, 400 mg each time (applicable to the first 24 hours); Patient weight < 40 kg: 200 mg once every 12 hours (for the first 24 hours). Then the maintenance dose (24 hours after the start of medication) - patient weight ≥ 40 kg: 200 mg twice a day; Patient weight < 40 kg: 100mg twice a day.

      [adverse reactions] The most common adverse events in treatment trials were visual impairment, fever, rash, nausea, vomiting, diarrhea, headache, sepsis, peripheral edema, abdominal pain and respiratory dysfunction. The most common treatment-related adverse events leading to drug withdrawal included increased liver function test values, rash and visual impairment.

      [precautions] Warning visual impairment: the effect of voriconazole on visual function is unclear when the course of treatment exceeds 28 days. If continuous treatment exceeds 28 days, visual function, including visual acuity, visual range and color vision, shall be monitored. Hepatotoxicity: in clinical trials, severe adverse liver reactions (including hepatitis, cholestasis and fatal fulminant liver failure) are not common in the voriconazole treatment group. It has been reported that hepatotoxic reactions mainly occur in patients with serious basic diseases (mainly malignant hematological diseases). Liver reactions, including hepatitis and jaundice, can occur in patients without other identified risk factors. Usually, abnormal liver function can be improved after drug withdrawal. Monitoring liver function: liver function should be checked at the beginning and during voriconazole treatment. Patients with abnormal liver function at the beginning of treatment and during treatment must routinely monitor liver function to prevent more serious liver damage. Monitoring should include laboratory examination of liver function (especially liver function test and bilirubin). If the clinical symptoms and signs are consistent with the development of liver disease, drug withdrawal should be considered. Pregnant women: voriconazole can cause fetal damage when applied to pregnant women. Reproductive studies showed that voriconazole had teratogenic effects (cleft palate, hydronephrosis / hydroureter) in rats at the dose of 10mg / kg (calculated according to mg / m2, equivalent to 0.3 times the recommended maintenance dose). Voriconazole was embryotoxic to rabbits at a dose of 100 mg / kg (6 times the recommended maintenance dose). Other effects on rats include decreased ossification of sacrococcygeal, skull, pubis, hyoid and most ribs, sternal ganglion abnormalities and ureter / renal pelvis dilatation. Any dose of voriconazole can reduce the level of blood estradiol in pregnant rats. At the dose of 10mg / kg, voriconazole can also prolong the pregnancy time, dystocia and increase the perinatal mortality of young rats. In addition, voriconazole can increase the embryonic mortality of rabbits, reduce the weight of fetal rabbits, increase the rate of bone variation, and increase the ossification points of neck rib and sternum in vitro. If voriconazole is used during pregnancy or pregnant during medication, the patient should be informed of the potential danger of this product to the fetus. Galactose intolerance: voriconazole tablets contain lactose. It is not suitable for rare, congenital galactose intolerance, Lapp lactase deficiency or glucose galactose absorption disorder. General precautions: some pyrrole drugs, including voriconazole, can prolong the QT interval of ECG. In the clinical study and post marketing monitoring of voriconazole, there are few reports of tip torsional ventricular tachycardia. In severe patients with multiple mixed risk factors, such as cardiomyopathy, hypokalemia, cardiotoxic chemotherapy and other drugs that may cause torsade de pointe, torsade de pointe have been reported. Voriconazole should be used with caution in the above patients with potential arrhythmia risk. The abnormalities of potassium, magnesium and calcium must be strictly corrected before voriconazole treatment. Reactions related to intravenous drip the allergic reactions related to intravenous drip in healthy subjects during intravenous drip are mainly blushing, fever, sweating, tachycardia, chest tightness, dyspnea, syncope, nausea, pruritus and rash. The above reactions are not common and most of them are immediate reactions. Once the above reaction occurs, consider stopping the drug. Patients should be informed that voriconazole tablets should be taken at least 1 hour after or before meals. Voriconazole may cause visual changes, including blurred vision and photophobia. Therefore, you cannot drive at night during the use of voriconazole. If there are visual changes during the medication, you should avoid engaging in potentially dangerous work, such as driving or operating the machine. Strong and direct sunlight should be avoided during medication. Electrolyte disorders, including hypokalemia, hypomagnesemia and hypocalcemia, should be corrected before the use of voriconazole in laboratory examination. Renal function (mainly serum creatinine) and liver function (mainly liver function test and bilirubin) must be monitored during medication. Drug interactions are detailed in [drug interactions]. For patients with liver function impairment, it is recommended to continue monitoring liver function to observe whether there is further increase. It is suggested that the loading dose of voriconazole in patients with mild to moderate liver cirrhosis (child Pugh A and b) remains unchanged, but the maintenance dose is halved. At present, there is no study on the application of voriconazole in patients with severe liver cirrhosis (child pughc). It has been reported that voriconazole is related to abnormal liver function test and clinical signs of liver damage, such as jaundice. Therefore, patients with severe liver insufficiency must weigh the advantages and disadvantages when using this product, and closely monitor the toxic reaction of the drug. Moderate to severe renal dysfunction (creatinine clearance) in patients with renal impairment<50ml/min)的患者应用本品时,可能发生助溶剂SBECD蓄积。除非应用静脉制剂的利大于弊,否则应选用口服给药。肾功能障碍者静脉给药时必须密切监测血肌酐水平,如有升高应考虑改为口服给药。伏立康唑可经血液透析清除,清除率为121ml/min。4小时的血液透析仅能清除少许药物,无需调整剂量。助溶剂SBECD在血液透析中的清除率为55ml/min。肾脏不良事件,肾功能监测有报道重症患者应用本品时可发生急性肾衰竭。本品与具有肾毒性的药物合用以及当患者合并其他基础疾病时,可能会发生肾功能减退。应用本品时需要监测肾功能,其中包括实验室检查,特别是血肌酐值。皮肤反应在治疗中罕有发生表皮脱落者,如Stevens-Johnson综合征。如果患者出现皮疹需严密观察,如皮损进一步加重则需停药。另外本品可导致光过敏,特别是在长期治疗时。建议告知患者在应用本品治疗时避免阳光直射。致癌作用、致突变作用和生殖损害在大鼠和小鼠中进行了为期2年的伏立康唑致癌性研究。分别给大鼠口服6,18或50mg/kg的伏立康唑,或按mg/m2计算,分别给予0.2,0.6或1.6倍常用维持剂量的伏立康唑。在给予50mg/kg伏立康唑的雌鼠中检测到肝细胞腺瘤,在给予6mg/kg和50mg/kg剂量的雄鼠中检测到肝细胞癌。分别给小鼠口服10,30或100mg/kg的伏立康唑,或按mg/m2计算,分别给予0.1,0.4或1.4倍常用维持剂量的伏立康唑,在两种性别的小鼠中均检测到肝细胞腺瘤,在给予1.4倍常用维持量伏立康唑的雄小鼠中还检测到了肝细胞癌。在体外人淋巴细胞培养过程中加入伏立康唑,可观察到伏立康唑的致畸变作用(主要为染色体断裂)。在Ames试验、CHO试验,小鼠微核试验或DNA修复试验(非常规DNA合成试验)中均未发现伏立康唑有基因毒性。初步研究结果显示50mg/kg,或1.6倍推荐维持量的伏立康唑可使大鼠怀孕率显著下降,但大规模的生殖研究未发现上述显著差异。致畸性孕妇见[警告]。对驾驶和操作机器能力的影响本品可能引起一过性的、可逆性的视觉改变,包括视力模糊、视觉改变、视觉增强和/或畏光。患者出现上述症状时必须避免从事有危险的工作,例如驾驶或操作机器。请仔细阅读说明书并遵医嘱使用。

      [taboo] This product is forbidden to those who have known allergic history to voriconazole or any excipient.

      [listing Permit Holder] Huashen pharmaceutical factory of Chengdu Taihe Health Technology Group Co., Ltd. (former pharmaceutical factory of Chengdu Huashen Group Co., Ltd.)

      [packaging unit] box

      [main ingredients] Voriconazole.

      [character] This product is a film coated tablet, which turns white to off white after removing the coating.

      [applicable population] adult

      [medication for pregnant and lactating women] At present, there is not enough data on the application of voriconazole in pregnant women. Animal experiments show that this product has reproductive toxicity (see preclinical safety data) However, the potential risk to human body has not been determined. Voriconazole should not be used in pregnant women unless the benefits to the mother are significantly greater than the potential toxicity to the fetus. Women of childbearing age need to take effective contraceptive measures during the application of voriconazole. Lactating women do not have data on the secretion of voriconazole in milk. Lactating women do not use voriconazole unless the obvious advantages outweigh the disadvantages Voriconazole should be used.

      [medication for children] The safety and efficacy of voriconazole in children under 12 years old have not been established. In the therapeutic study, 22 patients with invasive aspergillosis aged 12-18 years were selected, and 12 patients (55%) were given the maintenance dose of voriconazole once every 12 hours, 4mg / kg each time In the treatment research, there are few studies on the pharmacokinetics of voriconazole in adolescents.

      [medication for elderly patients] In the multi dose treatment study, patients ≥ 65 years old accounted for 9.2% and patients ≥ 75 years old accounted for 1.8%. A study in healthy volunteers showed that the total exposure (AUC) and peak plasma concentration (Cmax) of elderly men The pharmacokinetic data of 552 patients in 10 voriconazole treatment studies were analyzed. The results showed that the blood concentration of elderly patients was about 80% - 90% higher than that of young patients after intravenous or oral voriconazole. However, the overall safety of elderly people was similar to that of young people, so there was no need to adjust the dose.

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        Voriconazole tablets (Lailikang)

        ¥300.00

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