Voriconazole capsules

Not yet clear.

The main ingredient of this product is voriconazole, and its chemical name is: (2R, 3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidine)-1-(1H-1,2,4-triazol-1-yl)-2-butanol.

The contents of this product are white or off-white particles.

This product is a broad-spectrum triazole antifungal drug with the following indications: Treatment of invasive aspergillosis. Treatment of candidemia in non-neutropenic patients. Treatment of severe invasive infections caused by Candida species resistant to fluconazole (including Candida krusei). Treatment of severe infections caused by Actinomyces and Fusarium species. This product should be used primarily to treat patients with progressive, potentially life-threatening infections.

Oral administration: If the patient's treatment response is poor, the oral maintenance dose can be increased to 300 mg twice a day; for patients weighing less than 40 kg, the dose is adjusted to 150 mg twice a day. For other details, please refer to the instructions.

Overall, 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 adverse events related to treatment that led to discontinuation included increased liver function test values, rash, and visual impairment. Visual impairment and voriconazole-related visual impairment are common. In clinical trials, approximately 30% of patients experienced visual changes, enhanced vision, blurred vision, color vision changes, and/or photophobia. Visual impairment is usually mild and rarely leads to discontinuation. Visual impairment may be related to higher blood drug concentrations and/or doses. Although the site of action of voriconazole seems to be mainly limited to the retina, its mechanism of action remains unclear. In a study, the effects of 28 days of voriconazole treatment on retinal function were studied in healthy volunteers, and it was found that this product can reduce the amplitude of retinal electrogram waveforms, narrow the visual field, and change color vision. Electroretinograms are usually used to detect the current in the retina. Electroretinograms, visual fields, and color vision returned to normal 14 days after discontinuation of the drug. Voriconazole's visual effects can occur early in the course of medication and persist throughout the course of medication. There is evidence that visual impairment is related to multiple doses. Skin reactions In clinical trials, skin reactions were common in the voriconazole treatment group. The mechanism of these skin adverse events remains unclear. However, these patients usually also have other serious underlying diseases and need to receive multiple treatments at the same time. In clinical trials, the incidence of voriconazole-related rash was 6% (86/1493). Most rashes were mild to moderate, including Stevens-Johnson syndrome, toxic epidermal necrosis, and erythema multiforme. Once a patient develops a rash, he or she must be closely observed. If the skin lesions worsen, the drug must be discontinued. There have also been reports of photosensitivity, which is more common in patients receiving long-term treatment. Severe skin reactions are extremely rare. It is recommended to avoid strong direct sunlight during voriconazole treatment. Other rare adverse events The adverse events listed below have an incidence of 1% in all patients using voriconazole (including healthy volunteers, etc., N=2090). These adverse events include those that cannot be excluded as being related to voriconazole or that may help physicians manage the risks of their patients, but do not include those listed in the table above, nor do they include all adverse events reported in clinical trials. Systemic reactions: abdominal distension, allergic reaction, anaphylactoid reaction, ascites, weakness, back pain, cellulitis, edema, facial edema, flank pain, flu-like symptoms, graft-versus-host reaction, granuloma, infection, bacterial infection, fungal infection, injection site pain, injection site infection/inflammation, mucosal dysfunction, multi-organ failure, pain, pelvic pain, peritonitis, sepsis, substernal chest pain. Cardiovascular: Atrial arrhythmia, atrial fibrillation, complete atrioventricular block, bigeminy, bradycardia, bundle branch block, cardiomegaly, cardiomyopathy, cerebral hemorrhage, cerebral ischemia, cerebrovascular accident, congestive heart failure, deep thrombophlebitis, endocarditis, extrasystoles, cardiac arrest, myocardial infarction, nodal arrhythmia, palpitations, phlebitis, postural hypotension, pulmonary embolism, QT interval prolongation, supraventricular tachycardia, syncope, thrombophlebitis, vasodilation, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia (including torsade de pointes). Digestive system: anorexia, cheilitis, cholecystitis, cholelithiasis, constipation, duodenal ulcer perforation, duodenitis, indigestion, dysphagia, esophageal ulcer, esophagitis, flatulence, gastroenteritis, gastrointestinal bleeding, increased GGT/LDH, gingivitis, glossitis, gingival bleeding, gingival hyperplasia, hematemesis, hepatic coma, liver failure, hepatitis, intestinal perforation, intestinal ulcer, hepatomegaly, melena, oral ulcer, pancreatitis, parotid enlargement, periodontitis, proctitis, pseudomembranous colitis, rectal dysfunction, rectal bleeding, gastric ulcer, gastritis, tongue enlargement. Endocrine: adrenal insufficiency, diabetes insipidus, hyperthyroidism, hypothyroidism. Blood and Lymph: Agranulocytosis, anemia (macrocytic anemia, megaloblastic anemia, microcytic anemia, normocytic anemia), aplastic anemia, hemolytic anemia, prolonged bleeding time, cyanosis, disseminated intravascular coagulation, ecchymoses, eosinophilia, hypervolemia, lymphadenopathy, lymphangitis, bone marrow suppression, petechiae, purpura, splenomegaly, thrombotic thrombocytopenic purpura. Nutrition and Metabolism: proteinuria, increased urea nitrogen, increased creatinine phosphokinase, edema, impaired glucose tolerance, hypercalcemia, hypercholesterolemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hyperuricemia, hypocalcemia, hypoglycemia, hyponatremia, hypophosphatemia, uremia. Musculoskeletal: arthralgia, arthritis, bone gangrene, bone pain, calf cramps, myalgia, myasthenia, myopathy, osteomalacia, osteoporosis. Nervous system: abnormal dreams, acute brain syndrome, agitation, akathisia, amnesia, anxiety, ataxia, cerebral edema, coma, mental confusion, convulsions, delirium, dementia, depersonalization, depression, diplopia, encephalitis, encephalopathy, euphoria, extrapyramidal syndrome, grand mal seizures, Guillain-Barré syndrome, hypertonia, hypoesthesia, insomnia, increased intracranial pressure, decreased libido, neuralgia, neuropathy, nystagmus, eye cyclotorsion crisis, paresthesia, psychosis, drowsiness, suicidal tendencies, tremor, vertigo. Respiratory system: increased cough, dyspnea, epistaxis, hemoptysis, hypoxia, pulmonary edema, pharyngitis, pleural effusion, pneumonia, respiratory dysfunction, respiratory distress syndrome, respiratory tract infection, rhinitis, sinusitis, voice changes. Skin and Appendages: Alopecia, angioedema, contact dermatitis, discoid lupus erythematosus, eczema, erythema multiforme, exfoliative dermatitis, mixed drug eruption, furunculosis, herpes simplex, melanosis, photosensitivity skin reaction, psoriasis, skin discoloration, skin disease, dry skin, Stevens-Johnson syndrome, sweating, toxic epidermal necrosis, urticaria. Special Senses: Accommodation abnormalities, blepharitis, color blindness, conjunctivitis, corneal opacities, deafness, earache, eye pain, dry eyes, keratitis, keratoconjunctivitis, mydriasis, night blindness, optic atrophy, optic neuritis, otitis externa, papilledema, retinal hemorrhage, retinitis, scleritis, loss of taste, taste abnormalities, uveitis, tinnitus, visual field loss. Urogenital system: anuria, atrophic eggs, decreased creatinine clearance, dysmenorrhea, dysuria, epididymitis, diabetes, hemorrhagic cystitis, hematuria, hydronephrosis, impotence, renal pain, renal tubular necrosis, irregular uterine bleeding, nephritis, nephropathy, oliguria, scrotal edema, urinary incontinence, urinary retention, urinary tract infection, uterine bleeding, vaginal bleeding. Edit this section Other contraindications This product is contraindicated in patients with a known history of allergy to voriconazole or any of the excipients. This product is contraindicated for use with CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine, because this product can increase the blood concentration of the above drugs, resulting in prolonged Q-T interval and occasional torsade de pointes ventricular tachycardia (see [Drug Interactions]). This product is contraindicated for use with rifampicin, carbamazepine and phenobarbital, the latter of which can significantly reduce the blood concentration of this product. This product should not be used in combination with ergot alkaloids (ergotamine, dihydroergotamine). Ergot alkaloids are substrates of CYP3A4. When the two are used together, the blood concentration of ergot drugs increases, which can lead to ergot poisoning. When sirolimus is used in combination with voriconazole, the blood concentration of the former may increase significantly, so these two drugs cannot be used at the same time. This product is prohibited from being used in combination with ritonavir (400 mg each time, once every 12 hours). When healthy subjects used ritonavir (400 mg each time, once every 12 hours) and voriconazole at the same time, the blood concentration of voriconazole was significantly reduced. Ritonavir 100 mg each time, once every 12 hours is used to inhibit CYP3A, thereby increasing the concentration of other antiretroviral drugs, but the effect of this dosing regimen on the concentration of voriconazole has not been studied. This product is prohibited from being used simultaneously with efavirenz. When the two are used simultaneously, the blood concentration of voriconazole is significantly reduced, while the blood concentration of efavirenz is significantly increased. This product is forbidden to be used simultaneously with rifabutin. When the two are used together, the blood concentration of voriconazole is significantly reduced, while the blood concentration of rifabutin is significantly increased.

Voriconazole is prohibited from being dripped in the same intravenous line with other drugs, including parenteral nutrition agents (such as Aminofusin 10% Plus). Voriconazole is physically incompatible with Aminofusin 10% Plus, and the two can produce insoluble particles after storage at 4°C for 24 hours. Voriconazole should not be dripped simultaneously with blood products or any electrolyte supplements. Voriconazole injection can be dripped intravenously at the same time as total parenteral nutrition solution in a different intravenous line. There is a contraindication for the use of 4.2% sodium bicarbonate intravenous injection with voriconazole, and the weak alkalinity of this diluent can cause voriconazole to slightly degrade after storage at room temperature for 24 hours. Although refrigeration is recommended for the diluted voriconazole solution, it is still not recommended to use 4.2% sodium bicarbonate injection as a diluent. This product

Precautions for children: The safety and efficacy of voriconazole in children under 12 years old have not been established. In the therapeutic study, a total of 22 patients with invasive aspergillosis aged 12-18 years were enrolled and given a maintenance dose of voriconazole, i.e. 4 mg/kg once every 12 hours. Twelve patients (55%) were effectively treated. In the therapeutic study, the pharmacokinetic properties of voriconazole in adolescents were rarely studied. Precautions for pregnancy and lactation: There is currently insufficient data on the use of voriconazole in pregnant women. Animal experiments have shown that this product has reproductive toxicity (see preclinical safety data), but the potential risk to humans has not been determined. Voriconazole should not be used in pregnant women unless the benefits to the mother significantly outweigh the potential toxicity to the fetus. Women of childbearing age Women of childbearing age should take effective contraceptive measures during the use of voriconazole. There is no data on the secretion of voriconazole in breast milk for lactating women. Voriconazole should not be used by lactating women unless the benefits clearly outweigh the risks. Elderly precautions: In multiple-dose treatment studies, 9.2% of patients were aged ≥65 years and 1.8% were aged ≥75 years. A study conducted in healthy volunteers showed that the total exposure (AUC) and peak blood concentration (Cmax) of elderly men were higher than those of younger men. Analysis of pharmacokinetic data of 552 patients in 10 voriconazole treatment studies showed that after intravenous or oral administration of voriconazole, the blood concentration of elderly patients was approximately 80%-90% higher than that of younger patients. However, the overall safety of the elderly is similar to that of young people, so there is no need to adjust the dose.

Not yet clear.

Sealed, store in a dry place.

50 mg

24 months

Sichuan Meidakang Huakang Pharmaceutical Co., Ltd.

• Founded in:

  2001-02-27

• Address:

  No. 1 Zhenjiang Road, Jiangsu Industrial Park, Mianzhu Economic Development Zone, Sichuan

• Tax NO.:

  915106836208704965

• Registered Funds:

  160 million yuan

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