Vifend

Вифенд Drug photo

The description is actual on 18.07.2016

  • Latin name: Vfend
  • ATH code: J02AC03
  • Active ingredient: Vorikonazol (Voriconazole)
  • Producer: Pharmacia & Upjohn Company (USA); Pfizer PGM (France); Heinrich Mack Nachf. (Germany)

Structure

In 1 tablet of a vorikonazol of 50 mg and 200 mg. Lactoses monohydrate, starch, magnesium stearate, sodium of a kroskarmelloz, povidone as excipients.

In 1 ml of suspension of a vorikonazol of 40 mg.

In 1 bottle of lyophilisate of a vorikonazol of 200 mg.

Release form

Tablets in a cover of 50 mg and 200 mg.

Powder for preparation of suspension with a measured spoon and the syringe.

Lyophilisate for preparation of infusion solution of 200 mg.

Pharmacological action

Antifungal.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

The antifungal drug of group of triazoles having a broad spectrum of activity. The mechanism of action is connected with inhibition of biosynthesis of the ergosterol necessary for creation of a cell of a mushroom. Antifungal activity of drug includes all strains of Candida spp.Aspergillus spp strains., and also  Scedosporium spp which are almost not sensitive to other antifungal means.

It is effective at the infections caused by Alternaria spp.Blastomyces dermatitidis, Cladosporium spp., Blastoschizomyces capitatus, Coccidioides immitis, Cryptococcus neoformans, Conidiobolus coronatus, Exserohilum rostratum, Fonsecaea pedrosoi, Exophiala spinifera, Madurella mycetomatis, Penicillium spp., Paecilomyces lilacinusAcremonium spp strains., Bipolaris spp., Alternaria spp., Histoplasma capsulatum, Cladophialophora spp. Growth of strains was suppressed at concentration of 0,05 — 2 mkg/ml.

Pharmacokinetics

It is completely soaked up at intake. Bioavailability makes 96%. Cmax in blood is defined by 1-2 h. At reception with Cmax greasy food decreases by 34%. Absorption does not depend on acidity of gastric contents. It is actively distributed in fabric and is defined in cerebrospinal fluid. Linkng with proteins — 58%.

It is metabolized by P450 cytochrome isoenzymes. CYP2C19 enzyme plays an important role at the same time, but possesses genetic polymorphism (the lowered metabolism at 20% of Asians). The main metabolite (72% among all metabolites) — N-oxide. It possesses insignificant antifungal activity. With urine in not changed look 2% of a dose, and the most part during 96 h after drug use are removed. The elimination half-life makes 6 hours.

Indications to use

  • gullet candidiasis;
  • invasive aspergillosis;
  • kandidemiya in the absence of a neutropenia;
  • invasive candidiases of a heavy current;
  • fungal infections which are caused by Fusarium spp. and Scedosporium spp.;
  • heavy invasive infections at intolerance of other antifungal drugs;
  • prevention of fungal infections at recurrence of a leukosis, depression of function of immune system, a neutropenia, after transplantation of stem cells.

Contraindications

With care it is appointed at heavy liver and a renal failure, at children till 2 flyings as safety of use is not established.

Side effects

The met side reactions are more often:

The met side reactions are more rare:

Vifend, application instruction (Way and dosage)

Treatment is begun with intravenous administration, and after clinical improvement passed to peroral forms of drug. Effect of drug at intravenous administration is twice higher, than at intake in the same dose. Treatment is carried out under strict medical control.

Pill Vifend should be taken inside in 1 hour prior to or in 1 h after food. The adult appoint in the first days in the saturating dose — to 400 mg there are each 12 hours to patients weighing more than 40 kg and 200 mg there are each 12 hours weighing patient less than 40 kg. Maintenance doses at all diseases make 200 mg each 12 hours at patients weighing more than 40 kg. In this case Vifend is more reasonable to appoint 200 mg.

Patients weighing less than 40 kg accept 100 mg of drug each 12 hours. The maintenance dose can be increased to 300 mg and respectively to 150 mg depending on the patient's weight. If bad portability of drug in this dose it is noted reduce to 200 mg again (or 100 mg) and accept each 12 hours.

Suspension Vifend prepares by addition to water powder in number of 46 ml in two steps. Water is measured by a measured cup. Then it is necessary to stir up well a bottle for receiving suspension. Ready suspension is good within 14 days therefore on a bottle it should be noted a validity deadline. Before the use a bottle well stir up a current of 10 seconds. Using the measured syringe, measure necessary quantity for reception: in 5 ml of suspension 200 mg of a vorikonazol, respectively in 2,5 ml — 100 mg contain. It is a maintenance dose at all diseases which is accepted each 12 hours depending on the patient's weight — 5 ml or 2,5 ml.

If according to the doctor the dose is inefficient, it increases to 7,5 ml of suspension (300 mg) for patients weighing more than 40 kg or to 3,75 ml (150 mg) for patients weighing less than 40 kg. Duration of peroral treatment depends on results of mycologic research, but in general should not exceed 6 months.

Preventive administration of drug after transplantation is begun in day of its carrying out and continued about 3 months. In rare instances prevention is prolonged till 6 months if immunosuppressive therapy is carried out or reaction "a transplant against the owner" develops. The dosing mode at prevention same, as well as at treatment.

Overdose

Cases of overdose were noted at children to whom the dose exceeding recommended five times was entered. The antidote is not known. At overdose of the drug accepted inside the gastric lavage is carried out, symptomatic therapy is shown. Active ingredient is removed at a hemodialysis.

Interaction

Level of active agent in blood considerably decreases at use with rifampicin and carbamazepine which it is contraindicated to appoint.

Insignificant interaction is noted, and correction of doses is not required at use with Cimetidinum and ranitidine. Erythromycin and azithromycin have no significant effect.

Vorikonazol can significantly increase concentration of substances, metabolized CYP450 isoenzymesterfenadin, tsizaprid, astemizol, Pimozidum, ergot alkaloids, sirolimus and quinidine therefore to use these drugs along with vorikonazoly it is contraindicated.

At use of the following drugs with vorikonazoly correction of doses in respect of reduction as it increases concentration of these drugs in plasma is necessary: cyclosporine, takrolimus, warfarin, fenprokumon, atsenokumarol, derivative sulfonilmochevina, lovastatin, benzodiazepines, Vincristinum and vinblastine.

Significant interaction with the following drugs is not revealed: Prednisolonum, digoxin, mikofenolovy acid.

Phenytoinum reduces  Vifend's Cmax, and the last raises Phenytoinum Cmax therefore at their simultaneous use determination of levels of Phenytoinum is recommended.

Rifabutin reduces Cmax of active ingredient. If there is a need of combined use, then a maintenance dose of Vifend it is necessary from 200 mg to 350 mg. The dose of an omeprazol is recommended to be reduced twice. Indinavir has no significant effect.

Terms of sale

According to the recipe.

Storage conditions

Temperature is up to 25 °C.

Period of validity

Tablets 3 years.

Vifend's analogs

Vorikonazol Kanon, Vorikonazol Teva, Vikand, Biflurin.

About Vifenda

The drug Vifend® is drug of the first line for treatment of an invasive aspergillosis which develops at the persons receiving immunosuppressive therapy at a granulematozny and multiple myeloma at patients with acute leukoses. Invasive mycoses are quite frequent complication after an allogenic organ transplantation therefore adequate prevention which is a condition of successful allotransplantation is necessary.

Researches showed that use of drug for primary prevention at these patients is effective and safe. Vorikonazol has big efficiency concerning sort Aspergillus mushrooms in comparison with itrakonazoly, possesses smaller toxicity, bigger bioavailability at oral administration. Also often drug is used by HIV-positive people at candidiasis of a gullet and patients with refractory fungal infections. It has reflection in responses — all note that treatment effective and is carried out is long.

  • "… The child has an acute lymphoblastoid leukosis. Conducted chemotherapy courses after which it is weakened, the fungal infection in lungs developed. Treatment very long and very expensive. Vifend accepted more than four months".
  • "… The daughter has an acute miyeloblastny leukosis. The illness proceeded hard and plus complication — a fungal infection of lungs. We accept I will fish half a year and still told as much. Treatment very expensive".
  • "… I have Hodzhkin's lymphoma. Transferred 12 courses of chemistry, later carried out autotransplantation. Concerning the developed aspergillosis of lungs accepted this drug. In 5 months of reception the analysis on an aspergillosis negative".
  • "… After the postponed courses of chemotherapy the aspergillosis developed. Accepted drug 3 months before obtaining negative analyses".
  • "… The child has a nekhodzhinsky lymphoma, completed 3 courses of treatment. All this time is accepted by Vifend".

Zdravzona

  • Vifend of 50 mg No. 14 tabletkiheinrich Mack Nachf.
  • Vifend of 200 mg No. 14 tabletkiheinrich Mack Nachf.
  • Vifend lyophilisate for solution 200 of mg No. 1 a flakonpfayzer Farmasyyutikelz
to show still

Apteka24

  • Vifend time. for p solution for inf. 200mgfl. No. 1gedeke AG (Germany)
Section: Antifungal
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Education: Graduated from Sverdlovsk medical school (1968 - 1971) as "Paramedic". Graduated from the Donetsk medical institute (1975 - 1981) as "An epidemiologist, a hygienist". Passed postgraduate study in the Central scientific research institute of epidemiology Moscow (1986 - 1989). An academic degree – the candidate of medical sciences (degree is awarded in 1989, protection – the Central scientific research institute of epidemiology Moscow). Numerous advanced training courses are studied in epidemiology and infectious diseases.

Experience: Work as the manager of department of disinfection and sterilization of 1981 - 1992. Work as the manager of department of especially dangerous infections of 1992 - 2010. Teaching activity at Medical institute 2010 - 2013.

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