Rumycoz caps 100mg #15

Rumycoz instruction

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Composition

1 capsule contains 100 mg of Itraconazole - the active substance.
Auxiliary ingredients: hypromellose, wheat starch, poloxamer (lutrol), sucrose.

Form of issue

Drug Rumycoz is available in the form of capsules of 6 or 15 pcs. packaged.

pharmachologic effect

Antifungal.

Pharmacodynamics and pharmacokinetics

Rumycoz - a derivative of triazole is a synthetic antifungal drug with a wide spectrum of action. The main mechanism of action of the active substance of the drug is the inhibition of the synthesis of ergosterol, which is one of the important constituents of the membrane of fungal cells.
Itraconazole is active against dermatophytes (Epidermophyton floccosum, Microsporum spp., Trichophyton spp.); yeast and yeast-like fungi (Pityrosporum spp., Cryptococcus neoformans, Trichosporon spp., Candida spp., Geotrichum); Aspergillus spp., Paracoccidioides brasiliensis, Histoplasma spp., Sporothrix schenckii, Cladosporium spp., Fonsecaea spp., Blastomyces dermatitidis, Penicillium marneffei, Pseudallescheria boydii, as well as other mold and yeast fungi.
Itraconazole with oral (internal) application is well absorbed in the gastrointestinal tract, reaching a peak content in the plasma for 3 to 4 hours after ingestion.
To achieve maximum bioavailability of Itraconazole, Rumycoz capsules are recommended immediately after a meal. After 7-14 days of treatment, equilibrium concentrations of the drug in plasma are observed.
The connection with plasma proteins is quite high. Itraconazole has good penetrating ability in the tissues of the body and its biological fluids, while in some organs (lungs, stomach, kidneys, liver, skeletal muscles) its concentrations exceed plasma concentrations by 2-3 times.
The active substance is deposited in keratin tissues (exceeding the analogous values ​​in plasma by 4 times), and the speed of its removal from the skin depends on the speed of regeneration of the epidermis. During the 14th-28th day after the discontinuation of the drug, therapeutic concentrations of Itraconazole are retained in the skin, and in the vaginal mucosa they are detected after 48 hours after the end of a three-day course of therapy at a daily dose of 200 mg, and for 72 hours at a daily dose of 400 mg.
In the keratin of the nail plates Itraconazole is determined 7 days after the initiation of therapy and for 6 months after the end of the three-month treatment. Itraconazole is also found in the secretion of sweat and sebaceous glands.
Metabolism Itraconazole occurs in the liver, with the release of active metabolites, and the effect of some of them is not inferior to the action of the unchanged drug.
Two-stage output from the plasma. T1 / 2 - 24-36 hours.
3-18% is excreted through the intestine and about 0.03% through the kidneys (unchanged), and 35% in the form of metabolites (for 7 days).
Bioavailability decreases with violations of immunity and renal failure. With cirrhosis of the liver along with a decrease in bioavailability, the half-life increases.

Indications for use

    fungal keratitis;
    dermatomycosis;
    onychomycosis caused by mold fungi, yeast and / or dermatophytes;
    systemic candidiasis and aspergillosis;
    blastomycosis;
    cryptococcosis, including cryptococcal meningitis (with immunodeficiency and cryptococcosis, the CNS is prescribed only if it is not possible to use first-line drugs);
    sporotrisosis;
    histoplasmosis;
    paracoccidioidomycosis;
    other tropical and systemic fungal infections;
    pityriasis lichen;
    deep visceral candidiasis;
    Candidomycosis with the defeat of the skin and mucous membranes, in particular vulvovaginal candidiasis (thrush).

Contraindications

Hypersensitivity to Itraconazole or to other components of the drug.
A combination of Rumycoz and the following groups of medicines:
    Astemizole, Terfenadine, Misolastine, Dofetilide, Cisapride, Quinidine, Levomethadone, Pimozide, Sertindol and other drugs that increase the QT interval and metabolized by the enzyme CYP3A4;
    Lovastatin, Simvastatin and other HMG-CoA reductase inhibitors, which are cleaved by the enzyme CYP3A4;
    Triazolam and midazolam for internal administration (tablets);
    Ergometrin, Dihydroergotamine, Methylergometrine, Ergotamine and other ergot alkaloids.

Carefully

    pathology of the liver;
    childhood;
    heart failure of severe course.

Side effects

Gastrointestinal tract:
    nausea;
    dyspepsia;
    vomiting;
    abdominal pain;
    decreased appetite;
    constipation or diarrhea.
Hepatobiliary system:
    hepatitis;
    increased activity of hepatic transaminases (reversible);
    severe toxic liver damage (cases of acute hepatic insufficiency with a fatal outcome are recorded).
Nervous system:
    peripheral neuropathy;
    dizziness;
    headache.
Skin:
    photosensitivity;
    alopecia.
Allergic manifestations:
    hives;
    itching and rash on the skin;
    angioedema;
    Stevens-Johnson syndrome.
Others:
    edematous syndrome;
    hypercreatininaemia;
    hypokalemia;
    disorders in the menstrual cycle;
    pulmonary edema;
    congestive heart failure;
    staining the urine in a dark color.

Instructions for use Rumycoz (Method and dosage)

Drug Rumycoz taken orally (by mouth). Instructions for Rumycoz recommend that you swallow capsules whole, without chewing or grinding, immediately after eating.
Duration of therapy Rumycoz and its dose is determined only by the attending physician, individually for each patient.
In the treatment of vulvovaginal candidiasis, there are two treatment regimens, one of them takes 1 day with the appointment of 200 mg of Rumycoz twice a day; according to another scheme, treatment is carried out for 3 days with a daily dose of 200 mg.
In the treatment of oral candidiasis, a daily dose of 100 mg is recommended for 15 days.
Patients with smooth skin dermatomycosis, fungal keratitis and pityriasis impose a daily dose of 200 mg. The duration of treatment for dermatomycosis and pityriasis is 7 days and 21 days for fungal keratitis. There is an alternative scheme of treatment of smooth skin dermatomycosis, with the appointment of 100 mg of the drug for 15 days.
Fungal lesions of highly keratinized areas require the administration of 200 mg of Rumycoz twice daily, for 7 days, or for a month, 100 mg every day.
It must be remembered that in case of diseases: neutropenia, AIDS, and also after organ transplantation, dose adjustment may be required.
In onychomycosis, a 1-week course of therapy with a daily dose of 200 mg is indicated. Then, after a 3-week break, the course is repeated. With onychomycosis nails spend 2 courses and 3 courses with onychomycosis of the toes. In case of severe lesion of nail plates on toes, taking Rumycoz, in the same dose, can be continuous for 3 months.
Systemic mycoses can be treated in daily doses from 100 mg to 400 mg, depending on the severity of the disease and the nature of the pathogen. Duration of treatment can take from 3 weeks to 8 months.
The following are the usual regimens for the treatment of systemic mycoses with Rumycoz.
Candidiasis is prescribed 100-200 mg per day, for 1 to 7 months (with 400 mg / day for disseminated or invasive flow).
In aspergillosis, the daily dose is 200 mg, for 2 to 5 months (for disseminated or invasive flow, 400 mg per day).
In cryptococcosis (the exception is meningitis) take 200 mg per day, for a period of 2 to 12 months.
In cryptococcal meningitis, a daily dose of 400 mg is given, over a period of 2 to 12 months.
With histoplasmosis appoint 200 mg 1-2 times a day for 8 months.
With sporotrichosis treatment lasts for 3 months in a daily dose of 100 mg.
With chromomycosis, it is recommended to take 100-200 mg of Itraconazole daily, for 6 months.
With blastomycosis, the daily dose of Rumycoz varies from 100 mg to 400 mg, depending on the severity of the condition. The course of therapy is 6 months.
With paracoccidioidomycosis, treatment is continued for 6 months, with a daily dose of 100 mg.

Overdose

There are no data on an overdose of Rumycoz.

Interaction

Medicines that reduce the pH of gastric juice, reduce the absorption of Itraconazole.
The splitting of Itraconazole mainly occurs by means of the action of the enzyme CYP3A4. Inductors of the enzyme CYP3A4: Rifabutin, Rifampicin, Phenytoin, Isoniazid, Carbamazepine with a combined admission with Rumycoz significantly reduce the bioavailability of the latter, which negatively affects its effectiveness.
Indinavir, Ritonavir, Erythromycin, Clarithromycin, which are potent inhibitors of the enzyme CYP3A4, in contrast increase the bioavailability of Rumycoz.
Itraconazole can inhibit the metabolism of drugs that are cleaved by the SURZA4 enzyme, which can result in prolongation or intensification of their action, as well as side effects.
After the abolition of therapy with Rumycoz, the concentration of its active component in the plasma, depending on the duration of treatment and on the dose, decreases gradually. This must be taken into account in the appointment of other drugs, the effectiveness of which can be reduced by the inhibition of their action by Itraconazole.
Do not recommend the joint use of Rumycoz and calcium channel blockers, because of the general method of metabolism, as well as the possible joint inotropic effect.
When combined with Rumycoz, follow the action, concentration in the plasma, side effects, and if necessary adjust the dose of the following drugs:
    HIV protease inhibitors (indinavir, ritonavir, saquinavir);
    oral anticoagulants;
    some antitumor drugs (Busulfan, Trimetrexate, Docetaxel, vinca alkaloids pink);
    Verapamil, as well as dihydropyridine derivatives;
    Cyclosporine, Rapamycin, Tacrolimus;
    Atorvastatin;
    Budesonide, Methylprednisolone, Dexamethasone;
    Digoxin, Buspirone, Carbamazepine, Alfentanil, Brotisolam, Alprazolam, Midazolam (w / w), Rifabutin, Reboxetine, Ebastin, Cilostazolum, Eletriptan, Disopyramide, Repaglinide, Halofantrine.
Interactions of Rumycosis with fluvastatin and Zidovudine were not detected.
Itraconazole does not affect the metabolism of Norethisterone and Ethinyl estradiol.
In vitro studies have shown that there is no interaction of Rumycosis with Propranolol, Imipramine, Diazepam, Indometacin, Cimetidine, Sulfamerazine, and Tolbutamide when bound to plasma proteins.

Terms of sale

You don't need a prescription to buy Rumycoz.

Storage conditions

At a temperature of no higher than 25 ° C.
Shelf life - 24 months.

special instructions

Throughout the course of taking Rumycoz, women of childbearing age need to apply reliable contraceptive measures.
It must be noted that itraconazole may have a negative inotropic effect.
There have been cases of developing heart failure, with therapy with the use of Rumycoz, in this regard, it is better not to prescribe this drug in this disease, including in the anamnesis.
In renal failure, the bioavailability of Rumycoz is reduced, which may be an indicator for dose adjustment.
When taking antacid preparations, they are recommended not earlier than 2 hours after Rumycoz.
Patients with achlorhydria and those who take proton pump inhibitors or H2-histamine blockers are recommended to take Rumycoz with acidic drinks.
During therapy, it is necessary to regularly monitor liver function.
You should stop taking Rumycoz with the development of neuropathy.

Children

In childhood, Rumycoz can be used in exceptional cases, under the strict supervision of a doctor and with extreme caution.

With alcohol

Alcohol has a disastrous effect on the whole organism, and in particular on the central nervous system (dizziness, headaches), on the digestive tract (nausea, vomiting) and on the liver. Because these symptoms are identical to the side effects of Rumycoz, and the drug itself is quite hepatotoxic, we can conclude that alcohol and Rumycoz are incompatible.

During pregnancy (and lactation)

In pregnancy, Rumycoz is prescribed only in the case of the potential benefit of therapy, compared with the potential risk to the fetus.
If there is a need for taking Rumycoz during lactation, breastfeeding is discontinued.

Reviews about Rumycoz

With the treatment of any fungal diseases, doctors' reviews are reduced to the necessity of long-term and more often combined treatment of these ailments. Of course, in some cases it was possible to achieve complete recovery of the patient, having completed only one course of therapy, although this is more likely an exception to the rule.
If we talk about this drug, then reviews of Rumycoz with thrush, with pityriasis, with nail fungus and other fungal lesions are mostly positive, although with reference to various side effects.
It should be remembered that antifungal drugs have many side effects and the heaviest of them can be on the liver side. In this regard, when passing antifungal therapy, you must constantly monitor its condition.