Orungal

Орунгал Drug photo

The description is actual on 20.04.2016

  • Latin name: Orungal
  • ATH code: J02AC02
  • Active ingredient: Itrakonazol (Itraconazole)
  • Producer: Janssen-Cilag (Italy), Janssen Pharmaceutica (Belgium)

Structure

  • 1 capsule of drug Orungal contains 100 mg of an itrakonazol. Auxiliary components: gipromelloza, sucrose, macrogoal 20 000, gelatin, dyes.
  • 1 ml of solution Orungal includes 100 mg of an itrakonazol. Auxiliary components: sodium hydroxide, Acidum hydrochloricum, hydroxypropyl betadeks, propylene glycol, 70% sorbitol, sodium saccharinate, water, fragrance.

Release form

Pink gelatinous capsules with the transparent body and an opaque blue lid, contain cream pellets inside.

  • 4 capsules in the blister — 1 blister in a box from a cardboard.
  • 5 capsules in the blister — 3 blisters in a box from a cardboard.
  • 6 capsules in the blister — 1 blister in a box from a cardboard.
  • 14 capsules in the blister — 2, 3, 1 or 6 blisters in a box from a cardboard.

Yellow solution for oral administration with cherry aroma.

  • 150 ml of solution in a glass bottle — 1 bottle with a measured cup of 10 ml in a box from a cardboard.

Pharmacological action

Antifungal.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Antifungal means, has a big action spectrum, chemically represents derivative triazole. Slows down synthesis of ergosterol in a wall of cells of mushrooms that is antifungal effect of an itrakonazol.

Affects barmy and drozhzhepodobny mushrooms (the sorts Trichosporon, Pityrosporum, Geotrichum, Candida, and also on Cryptococcus neoformans; dermatophytes of the sort Trichophyton, Microsporum, and also on Ep. floccosum; representatives of the sort Aspergillus, Fonsecaea, Cladosporium, Histoplasma, and also on P. brasiliensis, Pseudoallescheria boydii, Blastomyces dermatitidis, Sporothrix schenckii, Penicillium marneffei and others.

Candida glabrata and tropicalis are least sensitive to effects of an itrakonazol from representatives of the sort Candida.

Zygomycetes (sorts Rhizopus, Mucor, Rhizomucor, Absidia), and also representatives of the sort Scedosporium, Fusarium, Scopulariopsis are not sensitive to effect of drug at all.

Pharmacokinetics of capsules

At oral administration the greatest bioavailability is noted at the use of capsules directly after food. The maximum content in blood comes 3-4 hours later.

Reacts with plasma proteins to 99.8%. Accumulation of medicine in skin, is approximately four times more than its accumulation in blood, and the speed of removal of an itrakonazol depends on regeneration of upper layers of skin. Therapeutic concentration of active component in skin remain for 3 weeks after the end of treatment. Itrakonazol is registered in a keratin of nails 1 week later and remains for half a year after a three-months course of treatment.

Well gets into the bodies subject to fungus diseases. Contents in lungs, a liver, kidneys, a stomach, bones, a spleen and muscles of active agent the about 3 times higher than the corresponding content in blood. Medical concentration in a vagina remain for 2 days after a three-day cycle of therapy.

It is transformed in a liver with an exit of a large number of derivatives, only one of which shows antifungal action. Time of semi-removal makes 24-36 hours. Within the first week of 36% of a dose it is allocated with kidneys in the form of derivatives; in an original form with urine about 0,03% are allocated. Through intestines from 3 to 18% of a dose are evacuated.

At persons with cirrhosis and a renal failure time of semi-removal of an itrakonazol and its content in plasma are raised.

Bioavailability of medicine at oral administration can be lowered at some groups of patients with the broken immunity.

Solution pharmacokinetics

After oral administration it is well soaked up. The greatest concentration in blood comes to light already 2,5 hours later.

Bioavailability at administration of drug together with food approaches 55%, and at the use on an empty stomach increases by 30%.

The main part of active contacts in plasma proteins (to 99.8%). Remained itrakonazol it is provided in plasma in an untied form.

Drug well gets into bodies: contents in kidneys, a stomach, a liver, bones, lungs, muscles and a spleen 3 times higher than the content in blood. Concentration in skin is 4 times higher than concentration in blood.

It is transformed in a liver with the participation of CYP3A4 isoenzyme with formation of a set of metabolites. Only one of them shows antifungal action.

Time of semi-removal reaches 39 hours. 4-19% of the entered dose are removed through intestines in an original form. About 35% of medicine are removed in the form of inactive derivatives by kidneys and about another 54% — through intestines.

At persons with a liver and renal failure time of semi-removal of an itrakonazol is increased.

Indications to use

Indications to use of capsules

Therapy of the fungal infections caused by activators, sensitive to medicine:

  • dermatomycoses;
  • fungal keratitis;
  • system mycoses: candidiasis, a paracoccidioidomycosis, aspergillomycosis, histoplasmosis, a cryptococcosis, a sporotrichosis, a zymonematosis and other mycoses, including tropical;
  • visceral deep candidiases;
  • candidiases of skin and mucous;
  • onychomycoses;
  • chromophytosis.

Indications to solution use

  • Therapy of candidiasis of a gullet and oral cavity at HIV-positive patients and persons with an immunodeficiency.
  • The prevention of systemic fungal infections at patients with malignant diseases of blood or at transferred transplantation of marrow with the increased probability of a neutropenia.

Contraindications

  • Joint reception of means, metaboliziruyemy by means of CYP3A4 enzyme and increasing a QT interval by an ECG, including Terfenadin, Quinidine, Astemizol, Dofetilid, Mizolastin, Tsizaprid, Sertindol, Pimozidum, Levometadon.
  • Simultaneous use with peroral Midazolam and Triazolam.
  • Joint reception with metaboliziruyemy CYP3A4 enzyme GMG-KOA-reduktazy blockers (Simvastatin and Lovastatin).
  • Joint use with ergot alkaloids (ergometrine, dihydroergotamine, ergotamine, methylergometrine).
  • Allergy to drug components.

It is necessary to appoint medicine with care at cirrhosis, hypersensitivity to other means from group of azoles, renal or heart failure in a chronic form, and also to persons is younger 18 or 65 years are more senior.

Side effects

  • Reactions from the alimentary system: abdominal pains, the dispepsichesky phenomena (vomiting, a lock, nausea, diarrhea, deterioration in appetite), hepatitis, temporary increase of concentration of liver enzymes in blood, acute insufficiency of work of a liver.
  • Reactions from nervous activity: dizziness, head pains, peripheral neuropathy.
  • Dermatological reactions: hair loss, photosensitization.
  • Allergic reactions: Quincke's edema, anaphylactic reactions, urticaria, itch, rash, Stephens-Johnson's syndrome.
  • Reactions from bodies of blood circulation: fluid lungs, heart failure of congestive type, peripheral hypostases.
    Other reactions: hypopotassemia, frustration of a menstrual cycle.

Application instruction of Orungal (Way and dosage)

Capsules Orungal, application instruction

Capsules use directly after food, swallowing entirely.

Vulvovaginal candidiasis treat appointment to 1 capsule of Orungal twice a day within one days or purpose of 1 capsule of times a day within three days.

For treatment of a chromophytosis and a dermatomycosis of skin appoint to accept on 1 capsule of times a day within one week.

At a fungal infection of hands and feet appoint 2 capsules twice a day of 200 mg within a week or one tablet of times a day within one month.

At treatment of a fungal keratitis accept 2 capsules of times a day within 3 weeks.

At therapy of oral candidiasis accept on 1 capsule of times a day for 2 weeks.

Bioavailability of medicine at oral administration decreases at patients with disorders of immunity, for example, at a neutropenia, after the postponed organ transplantation, and also at AIDS. In such cases there can be a requirement of increase in a dose twice.

At treatment of onychomycoses use pulse therapy according to the following schemes:

  • at damage of nails of feet with involvement or without involvement in process of nails of brushes accept 2 capsules a day in the first, fifth and ninth weeks of treatment (in other weeks the patient stops Orungal's reception);
  • at damage of nails of brushes accept two capsules a day in the first and fifth weeks of treatment (in other weeks the patient stops Orungal's reception).

Results come to light after end of a cycle of treatment, in process of growth of a nail.

Pulse therapy can be replaced with a course of continuous reception when drug is accepted on 2 capsules a day for three months.

Optimum mycologic effects are registered 3-4 weeks later after the termination of a cycle of treatment at diseases of skin and 7-9 months later after the termination of a cycle of treatment at diseases of nails.

Treatment by Orungal at system mycoses:

  • at an aspergillosis accept 2 capsules a day for 3-5 months;
  • at candidiasis accept 1-2 capsules of times a day within 3-7 months;
  • at a cryptococcosis appoint to use 2 capsules of times a day for a period of up to 1 year;
  • at a zymonematosis accept on 1 capsule to two times a day for 6 months;
  • at histoplasmosis use on 2 capsules to two times a day for 8 months;
  • at cryptococcal meningitis appoint 2 capsules twice in a duck for a period of up to 1 year;
  • at a sporotrichosis appoint 1 capsules of times a day within 3 months;
  • at a parakoktsidiomikoza and chromomycosis appoint on 1 capsule of times a day for half a year.

Solution Orungal, application instruction

Solution is accepted orally, on an empty stomach. At first solution it is necessary to rinse an oral cavity, and then to swallow it. It is not necessary to rinse an oral cavity water after that. The daily dose is allowed to be divided into 2 receptions.

At therapy of candidiasis of a gullet or mouth Orungal accept 2 measured cups (200 mg of means) a day within 7 days. In the absence of effect of treatment in a week, the course of therapy should be prolonged for 7 days.

At therapy of candidiasis of a gullet or mouth against resistance to Flukonazol accept 2-4 measured cups a day for 14 days. In the absence of effect of treatment in 14 days, the course of therapy should be prolonged for 14 days.

For the prevention of systemic fungal infections drug accept from calculation in a dose 5 mg/kg of weight a day. The day dose is divided into 2 receptions. The use of drug is begun in 7 days prior to therapy with cytostatics or in 7 days after transplantation of marrow and completed only after recovery of neutrophils to the number of 1000 C / mkl.

Overdose

At accidental overdose at 1st o'clock after reception the gastric lavage is effective. Enterosorbents are appointed. The hemodialysis is inefficient. The antidote is not known.

Interaction

Stimulators of a microsomal oxidation (Rifabutin, Rifampicin, Phenytoinum) reduce bioavailability of drug and its efficiency. With Carbamazepine, the Isoniazid and Phenobarbital it is possible to expect similar effects from joint reception.

Potential blockers of an isoenzyme of CYP3A4 (Indinavir, Klaritromitsin, Ritonavir, Erythromycin) increase values of bioavailability of an itrakonazol.

Itrakonazol brakes a metabolism of means, metaboliziruyemy CYP3A4. Prolongation or strengthening of their action, and also increase of emergence of side effects can be result of similar process.

Joint reception of Orungal and means, metaboliziruyemy by means of CYP3A4 enzyme and increasing a QT interval by an ECG, including Quinidine, Terfenadin, Dofetilid, Astemizol, Mizolastin, Tsizaprid, Sertindol, Pimozidum, Levometadon is not recommended.

Simultaneous use of Orungal with peroral forms of Midazolam and Triazolam is not recommended.

Joint reception of Orungal with metaboliziruyemy CYP3A4 enzyme GMG-KOA-reduktazy blockers (Simvastatin and Lovastatin) or with ergot alkaloids (ergometrine, dihydroergotamine, ergotamine and methylergometrine) is not recommended.

At joint reception it is recommended to be careful with blockers of channels of calcium because blockers of channels of calcium render the negative inotropic effect strengthened by similar effect of an itrakonazol. Itrakonazol brakes a metabolism of the above-stated group of drugs.

At simultaneous use with Orungal it is necessary to lower dosages of the listed below means: number of antineoplastic drugs (alkaloids of a pink periwinkle, Dotsetaksel, Busulfan, Trimetreksat); peroral anticoagulants; HIV protease blockers; the blockers of channels of calcium (Dihydropyridine and Verapamil) which are metabolized by means of CYP3A4; number of GMG-KOA-reduktazy blockers, metaboliziruyemy by means of CYP3A4; some immunosuppressive drugs (Takrolimus, Cyclosporine, Sirolimus); some glucocorticosteroids (Dexamethasone, Budesonid, Methylprednisolonum); Carbamazepine, Brotiozolam, Buspiron, Digoxin, Alprazolam, parenteral forms of Midazolam, Alfentanil, Ebastin, Repaglinida, Reboksetin, Disopyramidum, Eletriptana, Tsilostazola, Galofantrin.

Terms of sale

Drug can be bought only in the presence of the recipe.

Storage conditions

To protect from children. To store at the room temperature.

Period of validity

Two years. After opening of a bottle solution needs to be used within 2 months.

Special instructions

Very seldom at drug use Orungal (Orungal) the toxic severe damage of a liver developed. As a rule it occurred against already available liver diseases, or at the patients receiving other drugs having hepatotoxic effect. In this regard it is regularly necessary to control indicators of work of a liver at the persons receiving treatment by Orungal.

Itrakonazol has property to provoke a negative inotropic effect. Because of it it is not necessary to appoint drug suffering from congestive forms of heart failure or with presence of this symptom complex at the past.

At purpose of drug persons with disturbances of work of a liver and kidneys because of a possibility of lowering of bioavailability of active agent are recommended to exercise regular control of the maintenance of an itrakonazol in blood and if necessary to lower its dosage.

In case of identification of a neuropathy against reception of solution of Orungal, therapy should be stopped.

To persons does not consult on a heavy neutropenia to apply Orungal to initial therapy because of the increased risk of fast emergence of system candidiases.

Drug has no effect on ability to manage motor transport.

Orungal's analogs

The most widespread analogs of Orungal are listed below: Irunin, Itrazol, Kanditral, Orungamin, Rumikoz, Izol, Orunzol, Trioksal, Vifend, Diaflu, Diflazon, Diflucan, Mikosist, Flukonazol.

Zdravzona

  • Orungal ml solution 10mgml 150 flakonyansen-Silag
  • Orungal of 100 mg No. 14 kapsulyyansen-Silag

Drugstore of IFC

  • Orungal kaps 100 mg No. 14, Janssen Pharmaceuticaitaliya
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Apteka24

  • Orungaljanssen-Cilag (Italy)

Paniapteka

  • Orungal kaps. 100 mg No. 15

BIOSPHERE

  • Orungal of 100 mg No. 14 kaps.
  • Orungal of 10 mg/ml 150 ml solution for intake
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Section: Antifungal
in more detail

Education: Graduated from the Vitebsk state medical university majoring in "Surgery". At university headed Council of students' scientific society. Professional development in 2010 - in "Oncology" and in 2011 - in "A mammology, visual forms of oncology".

Experience: Work in an all-medical network 3 years the surgeon (The Vitebsk hospital of an emergency medical service, Lioznensky TsRB) and in combination the regional oncologist and the traumatologist. Work farm the representative within a year in the Rubicon company.

Provided 3 improvement suggestions on the subject "Optimization of an Antibioticotherapia depending on Species Composition of Microflora", 2 works took prizes in a republican competition review of student's scientific works (1 and 3 categories).
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