Voriconazole Canon

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from RUB 16889

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Voriconazole Canon is an antifungal drug.

Release form and composition

Dosage form - tablets, film-coated: biconvex round, almost white or white, the core is almost white (in a blister strip: 50 mg or 200 mg - 2 pcs., In a cardboard box 1 package; 7 pcs.., in a cardboard box 1, 2, 4 or 8 packages; 10 pcs., in a cardboard box 1, 3, 5 or 10 packages; 50 mg - 20 pcs., in a cardboard box 5 packages; 28 pcs., in a cardboard box 1 or 2 packages; 30 pcs., in a cardboard box 1 package; 200 mg - 14 pcs., in a cardboard box 1, 2 or 4 packages; 15 pcs., in a cardboard box 2 packages).

1 tablet contains:

active substance: voriconazole - 50 mg or 200 mg;
auxiliary components: mannitol, croscarmellose sodium, pregelatinized corn starch, microcrystalline cellulose, magnesium stearate;
shell composition: opadry II white (macrogol, polyvinyl alcohol, titanium dioxide, talc).

Indications for use

severe invasive candidiasis (including Candida krusei);
invasive aspergillosis;
esophageal candidiasis;
severe forms of fungal infections caused by Fusarium speciales and Scedosporium speciales;
candidemia in the absence of neutropenia;
other types of severe invasive fungal infections in patients with intolerance or refractoriness to other drugs;
prevention of "breakthrough" fungal infections with reduced function of the immune system, fever and neutropenia in allogeneic bone marrow recipients, patients with recurrent leukemia.

Contraindications

age up to 3 years;
concomitant use of astemizole, terfenadine, cisapride, quinidine, pimozide, sirolimus, carbamazepine, rifampicin, long-acting barbiturates (phenobarbital), efavirenz (in a daily dose of 400 mg and above), ergot alkaloids (dihydroergotamine 800 dose), ritonavirgotamine 800 mg and above), St. John's wort, rifabutin;
period of breastfeeding;
hypersensitivity to the components of the drug.

Caution should be exercised when prescribing Voriconazole Canon to patients with hypersensitivity to azole derivatives, severe renal failure, severe liver failure, proarrhythmic conditions: an increase in the QT interval (congenital or acquired), sinus bradycardia, cardiomyopathy (especially against the background of heart failure), symptomatic arrhythmia; with hypokalemia, hypocalcemia, hypomagnesemia, concomitant therapy with drugs that cause prolongation of the QT interval.

During pregnancy, the use of the drug is indicated only when the expected benefit from therapy for the mother is undoubtedly higher than the potential threat to the fetus.

Method of administration and dosage

The tablets are taken orally, swallowed whole and washed down with water 1 hour before or 1 hour after a meal.

Recommended dosage for patients over 12 years old:

saturating dose (within the first 24 hours): with a body weight of up to 40 kg - 200 mg every 12 hours; with a weight of 40 kg and above - 400 mg every 12 hours;
maintenance dose: with a body weight of up to 40 kg - 100 mg, with a weight of 40 kg and more - 200 mg. Frequency rate of admission - every 12 hours.

To achieve the desired therapeutic effect, during treatment, the maintenance dose can be increased: with a body weight of up to 40 kg - up to 150 mg, with a weight of 40 kg and more - up to 300 mg, with a frequency of administration every 12 hours.

If, after increasing the maintenance dose, the patient has a poor tolerance to the drug, then the dose should be reduced to the usual maintenance dose gradually by 50 mg every 12 hours.

The simultaneous appointment of phenytoin is possible with an increase in the maintenance dose of Voriconazole Canon in patients with a body weight of 40 kg and above - up to 400 mg every 12 hours, and with a body weight of up to 40 kg - up to 200 mg every 12 hours.

The simultaneous use of efavirenz in a daily dose of 300 mg is possible with an increase in a single maintenance dose of voriconazole to 400 mg.

No dose adjustment is required for any degree of renal impairment or in elderly patients.

In acute damage to liver function [increased activity of alanine aminotransferase (ALT), aspartate aminotransferase (ACT)], the dose is not adjusted, but treatment should be accompanied by monitoring the functional parameters of the liver.

In case of mild or moderate severity of liver dysfunction (classes A and B according to the Child-Pugh classification), a standard saturating dose of the drug is prescribed, and the maintenance dose is reduced by 2 times. Prescribing the drug for severe liver dysfunction is indicated only if the expected effect of therapy outweighs the risk of a possible toxic effect. For the timely detection of signs of toxicity, taking pills must be accompanied by constant monitoring of the patient's condition.

Since the tablets cannot be chewed, they should only be given to children who can swallow the tablet whole.

It is not recommended to prescribe a saturating dose to children.

The maintenance dose for children aged 3–12 years and adolescents 12–14 years old with a body weight of less than 50 kg is determined at the rate of 9 mg per 1 kg of body weight 2 times a day. The maximum dose is 350 mg 2 times a day.

Tolerability and pharmacokinetics of higher doses of the drug, as well as the safety of using voriconazole in impaired renal or liver function in children aged 3–12 years, have not been established.

Side effects

infections and invasions: often - flu-like syndrome, gastroenteritis; rarely - pseudomembranous colitis;
on the part of the cardiovascular system: very often - peripheral edema; often - lowering blood pressure (BP), phlebitis, thrombophlebitis; infrequently - syncope, ventricular arrhythmia, ventricular fibrillation, atrial arrhythmia, bradycardia, supraventricular arrhythmia, tachycardia, supraventricular tachycardia; rarely - hypertension, ventricular tachycardia (including ventricular flutter), complete atrioventricular block, ventricular tachysystolic arrhythmia of the "pirouette" type, bundle branch block, lymphangitis, nodal arrhythmias;
laboratory indicators: often - liver dysfunction (including an increase in the level of bilirubin concentration, alkaline phosphatase activity, ACT, ALT, gamma-glutamyltransferase, lactate dehydrogenase), an increase in plasma creatinine; infrequently - hypercholesterolemia, lengthening of the QT interval, increased residual urea nitrogen;
from the hematopoietic and lymphatic system: often - inhibition of bone marrow hematopoiesis, pancytopenia, leukopenia, thrombocytopenia, purpura, anemia (including normocytic, macrocytic, microcytic, aplastic, megaloblastic); infrequently - lymphadenopathy, disseminated intravascular coagulation syndrome, eosinophilia, agranulocytosis;
from the nervous system: very often - headache; often - confusion, dizziness, agitation, paresthesia, tremor; infrequently - ataxia, cerebral edema, vertigo, hypesthesia, diplopia; rarely - drowsiness, seizures, encephalopathy, extrapyramidal disorders, Guillain-Barré syndrome, peripheral neuropathy;
mental disorders: often - anxiety, hallucinations, depression; rarely - insomnia;
from the vestibular apparatus and the organ of hearing: infrequently - tinnitus, hypoacusia;
on the part of the organ of vision: very often - visual disturbances (photophobia, change in color perception, increased visual perception, the appearance of a "veil" in front of the eyes); infrequently - scleritis, edema of the papilla of the optic nerve, blepharitis, nystagmus, optic neuritis; rarely - optic nerve atrophy, retinal hemorrhage, oculogyric crisis, corneal opacity;
on the part of the respiratory system, chest and mediastinum: often - respiratory failure, acute respiratory distress syndrome, chest pain, pulmonary edema;
from the hepatobiliary system: often - cholestatic jaundice, jaundice; infrequently - cholelithiasis, cholecystitis, liver enlargement, liver failure, hepatitis; rarely - hepatic coma;
from the gastrointestinal tract: very often - abdominal pain, diarrhea, nausea, vomiting; infrequently - dyspepsia, constipation, duodenitis, pancreatitis, glossitis, tongue edema, gingivitis, peritonitis; rarely - a violation of taste;
dermatological reactions: often - itching, facial edema, rash (maculopapular, macular and / or papular), alopecia, photosensitivity, exfoliative dermatitis, erythema, cheilitis; infrequently - urticaria, fixed drug rash, Stevens-Johnson syndrome, angioedema, psoriasis, eczema; rarely - erythema multiforme, discoid lupus erythematosus, pseudoporphyria, toxic epidermal necrolysis; frequency unknown - squamous cell carcinoma;
from the genitourinary system: often - hematuria, acute renal failure; infrequently - nephritis, albuminuria; rarely - renal tubular necrosis;
from the musculoskeletal system: often - back pain; infrequently - arthritis; frequency unknown - periostitis;
from the endocrine system: infrequently - insufficiency of the adrenal cortex; rarely - hypothyroidism, hyperthyroidism;
nutritional and metabolic disorders: often - hypoglycemia, hypokalemia;
from the immune system: often - sinusitis; infrequently - the development of allergic reactions, anaphylactoid reactions;
others: very often - fever; often - asthenia, chills.

special instructions

Samples for laboratory studies on the isolation and identification of pathogens must be taken before starting therapy. Taking the tablets can be started after taking samples, the dosage regimen is adjusted based on the results of laboratory tests.

Women of reproductive age should use reliable contraception during treatment.

Drug-associated lengthening of the QT interval on electrocardiography may be accompanied by fibrillation or flutter of the ventricles in patients with multiple severe risk factors, including cardiotoxic chemotherapy, cardiomyopathy, hypokalemia, or concomitant therapy contributing to the development of this complication.

Treatment with Voriconazole Canon must be accompanied by constant monitoring of liver function for timely discontinuation of the drug in the event of clinically significant signs of its impairment. Severe liver side effects occur mainly in patients with malignant blood tumors. In the absence of risk factors, transient reactions such as hepatitis and jaundice may develop.

Visual disturbances are usually mild, transient, and often completely disappear within an hour. They rarely require discontinuation of the drug and do not cause any long-term consequences.

The development of undesirable effects on the part of the kidneys may be associated with the simultaneous administration of nephrotoxic drugs. Patients with concomitant pathologies need careful monitoring of renal function.

Patients with risk factors for the development of acute pancreatitis should be prescribed the drug based on the results of an examination of pancreatic function.

With the development of exfoliative skin reactions, lesions caused by melanoma or squamous cell carcinoma of the skin, the drug should be canceled. Since long-term treatment with voriconazole is accompanied by the appearance of photosensitivity, prolonged or intense exposure to direct sunlight should be avoided during the period of taking the drug.

If pain in the bones and changes on the radiograph, characteristic of periostitis, appear, against the background of prolonged use of voriconazole after transplantation, the drug should be discontinued.

Since Voriconazole Canon can cause visual impairment, control of vehicles and mechanisms should be avoided during the period of treatment.

Drug interactions

With the simultaneous use of Voriconazole Canon:

St. John's wort inhibits the metabolism of voriconazole;
rifampicin, ritonavir, carbamazepine, phenobarbital and other long-acting barbiturates contribute to a significant decrease in the concentration of the drug in the blood plasma;
cimetidine, ranitidine, erythromycin, azithromycin have a slight effect on the pharmacokinetics of the drug, which does not require dose adjustment;
terfenadine, astemizole, pimozide, cisapride, quinidine significantly increase their plasma concentration, causing a prolongation of the QT interval and increasing the risk of ventricular fibrillation or flutter;
sirolimus, ergot alkaloids (dihydroergotamine, ergotamine) increase their plasma concentration and cause the development of ergotism;
cyclosporine, tacrolimus, methadone, alfentanil (short-acting narcotic analgesics), fentanyl, oxycodone, warfarin (oral anticoagulants) significantly increase their plasma concentration (dose adjustment is required);
sulfonylurea derivatives (tolbutamide, glipizide, glyburide) increase the level of their content in blood plasma, promote the development of hypoglycemia;
statins - an increase in their plasma concentrations may be accompanied by the development of rhabdomyolysis;
midazolam, triazolam, alprazolam (benzodiazepines) - against the background of an increase in their plasma concentrations, a prolonged sedative effect of benzodiazepines may develop;
vincristine and vinblastine (vinca alkaloids), increasing their levels in blood plasma, cause neurotoxicity;
non-steroidal anti-inflammatory drugs increase their toxic effect;
prednisolone, digoxin, mycophenolic acid do not cause significant pharmacokinetic interactions and do not require correction of their dosage regimen;
phenytoin reduces the concentration of voriconazole and significantly increases its content in blood plasma;
omeprazole in a daily dose of 40 mg increases its content in blood plasma by 2 times;
oral contraceptives do not interfere with their contraceptive activity;
saquinavir, amprenavir, nelfinavir reduce their metabolic rate and can suppress the metabolism of voriconazole (the risk of toxic effects increases);
efavirenz causes a decrease in the concentration of voriconazole in blood plasma and increases its level;
delavirdine may slow down the metabolism of voriconazole;
nevirapine can induce drug metabolism;
non-nucleoside reverse transcriptase inhibitors slow down their metabolism (the risk of toxic effects increases);
fluconazole in a daily dose of 200 mg increases the content of voriconazole in the blood;
everolimus significantly increases its plasma concentration;
rifabutin in a daily dose of 300 mg slows down its metabolism and causes a significant decrease in the concentration of voriconazole.

Analogs

Analogues of Voriconazole Canon are: tablets - Biflurin, Vfend, Vikand, Voriconazole-Teva.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C, protected from moisture and light.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Voriconazole Canon: prices in online pharmacies

Drug name

Price

Pharmacy

Voriconazole Canon 200 mg film-coated tablets 14 pcs.

RUB 16889

Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!