Rumicosis
Rumicosis: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. In case of impaired renal function
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Rumycoz
ATX code: J02AC02
Active ingredient: Itraconazole (Itraconazole)
Manufacturer: Valenta Pharmaceuticals JSC, Russia
Description and photo update: 2019-12-08
Prices in pharmacies: from 320 rubles.
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Rumicosis is an oral antifungal drug.
Release form and composition
Dosage form Rumikoz - capsules: size No. 0, with a white body and a pink-brown lid; content - spherical microgranules from light yellow to yellowish-beige color (6 or 5 pcs. in blister strip packs, in a cardboard box, 1 or 3 packs, respectively).
Active ingredient: itraconazole - 100 mg in 1 capsule.
Auxiliary components: poloxamer (lutrol), sucrose, hypromellose, wheat starch, black iron oxide.
Capsule composition: titanium dioxide, gelatin, iron oxide red, sunset yellow, quinoline yellow, azorubin.
Pharmacological properties
Pharmacodynamics
Rumicosis is a broad-spectrum antifungal drug of artificial origin and related to triazole derivatives. It inhibits the production of ergosterol, an important component of the fungal cell membrane.
Itraconazole exhibits pharmacological activity against yeast-like fungi and yeasts (Candida spp., Including Candida krusei, Candida glabrata and Candida albicans, Cryptococcus neoformans, Geotrichum spp., Trichosporon spp., Pityrosporum spp., Flosporum spp., Trichophyton spp.), Penicillium marneffei, Aspergillus spp., Pseudallescheria boydii, Histoplasma spp., Blastomyces dermatitidis, Paracoccidioides brasiliensis, Cladosporium spp., Fonsecaea spp., Sporothrix scabies and other yeasts
Pharmacokinetics
When taken orally, the maximum bioavailability of itraconazole is observed when the drug is used immediately after a meal. Its maximum plasma level is recorded 3-4 hours after ingestion.
The equilibrium concentration of the active component of Rumicose in plasma 3-4 hours after taking the drug is 2 μg / ml (when a dosage of 200 mg is prescribed 2 times a day), 1.1 μg / ml (when a dosage of 200 mg is prescribed once a day) and 0.4 μg / ml (when prescribing a dosage of 100 mg once a day). With long-term therapy, the equilibrium concentration is reached within 1-2 weeks. The active substance of the drug binds to plasma proteins by 99.8%. It penetrates well and is distributed throughout all organ systems and tissues. The content of itraconazole in bones, muscles of the skeleton, lungs, stomach, liver, spleen, kidneys is 2-3 times higher than its content in plasma.
Itraconazole is accumulated in keratin tissues, especially skin, at concentrations 4 times higher than those in plasma, and the rate of excretion is determined by the speed of epidermal regeneration.
Plasma concentrations of itraconazole are not determined as early as 1 week after discontinuation of Rumicosis, however, the therapeutic concentration of the substance in the skin remains for 2-4 weeks after the completion of a four-week course of treatment. In the vaginal mucosa, the therapeutic concentration of itraconazole remains stable for 2 days after the completion of the three-day course of treatment (the daily dose was 200 mg) and 3 days after the completion of the one-day course of treatment (the dosage was 200 mg 2 times a day). The therapeutic concentration of Rumicosis in the keratin of the nail plates is detected 1 week after the start of therapy and persists for 6 months after undergoing a three-month course of treatment.
Itraconazole is also excreted in the secretions of the sweat and sebaceous glands and is metabolized in the liver to form active metabolites. One of them, hydroxy-itraconazole, has an in vitro antifungal effect similar to itraconazole.
Itraconazole is eliminated from blood plasma in two stages. The terminal half-life is approximately 24-36 hours. From 3 to 18% of the dose taken is excreted through the intestines, less than 0.03% of the dose is excreted through the kidneys. Approximately 35% of the dose taken is excreted in the form of metabolites in the urine for 1 week.
In patients with renal failure or impaired immunity (neutropenia, AIDS, organ transplantation), the bioavailability of itraconazole is usually slightly reduced. In patients with liver cirrhosis, there is a decrease in the bioavailability of this substance and an increase in its half-life.
Indications for use
- onychomycosis caused by dermatophytes and / or molds and yeasts;
- candidiasis with skin or mucous membrane lesions (including vulvovaginal candidiasis);
- fungal keratitis;
- pityriasis versicolor;
- dermatomycosis;
- deep visceral candidiasis;
- systemic mycoses: histoplasmosis, blastomycosis, sporotrichosis, aspergillosis, paracoccidioidomycosis, candidiasis, cryptococcosis (including cryptococcal meningitis), as well as other systemic and tropical mycoses.
Contraindications
- the simultaneous use of drugs that are metabolized with the participation of the CYP3A4 isoenzyme and are able to increase the QT interval (cisapride, mizolastine, dofetilide, astemizole, quinidine, sertindole, pimozide, terfenadine, levomethadone), oral forms of midazolam and triazolam-c-HMG reductase inhibitors the participation of the CYP3A4 isoenzyme (for example, lovastatin, simvastatin), ergot alkaloids (ergotamine, ergometrine, dihydroergotamine, methylergometrine);
- lactation period;
- hypersensitivity to the components of Rumicosis.
Carefully:
- chronic renal failure;
- liver disease and liver failure;
- severe heart failure;
- hypersensitivity to other azole antifungal agents.
For pregnant women and children, Rumicosis is prescribed only in exceptional cases, after a careful assessment of the balance of benefits and risks.
Instructions for the use of Rumikoz: method and dosage
Rumicosis should be taken orally after meals.
Recommended dosage regimens for fungal diseases:
- pityriasis versicolor: 2 capsules 1 time / day for 7 days;
- fungal keratitis: 2 caps. 1 time / day for 21 days;
- dermatomycosis of smooth skin: 2 caps. 1 time / day in a 7-day course or 1 caps. 1 time / day for 15 days;
- oral candidiasis: 1 caps. 1 time / day for 15 days;
- vulvovaginal candidiasis: 2 caps. 2 times / day for 1 day or 2 caps. 1 time / day with a course of 3 days;
- lesions of highly keratinized areas of the skin (hands and / or feet): 2 caps. 2 times / day for 7 days or 1 caps. 1 time / day for 30 days.
Depending on the dynamics of the clinical picture of the disease, the doctor can adjust the duration of treatment.
Due to the fact that in case of impaired immunity (for example, in patients who have undergone organ transplantation, with neutropenia or acquired immunodeficiency syndrome), the bioavailability of itraconazole received orally may decrease, these categories of patients may need to increase the daily dose by 2 times.
Recommended dosage regimens for Rumicosis for systemic mycoses:
- candidiasis: 1-2 caps. 1 time / day with a course, depending on the course of the disease, from 3 weeks to 7 months. If the disease has an invasive or disseminated form, the dose is increased to 2 caps. 2 times / day;
- aspergillosis: 2 caps. 1 time / day for 2-5 months. If the disease has an invasive or disseminated form, the dose is increased to 2 caps. 2 times / day;
- sporotrichosis: 1 caps. 1 time / day in a 3-month course;
- histoplasmosis: 2 caps. 1-2 times / day for, as a rule, 8 months;
- chromomycosis: 1-2 caps. 1 time / day for 6 months;
- blastomycosis: depending on the severity of the disease, the dose may vary from 1 caps. 1 time / day up to 2 caps. 2 times / day, duration of treatment - 6 months;
- paracoccidioidomycosis: 1 caps. 1 time / day in a 6-month course;
- cryptococcosis (excluding meningitis): 2 caps. 1 time / day, the duration of therapy, depending on the severity of the disease, can vary from 2 months to 1 year;
- cryptococcal meningitis: 2 caps. 2 times / day for 2-12 months (as maintenance therapy).
Depending on the type of infection and the characteristics of the course of the disease, the doctor may adjust the dose.
With onychomycosis, one of two treatment regimens is used:
- pulse therapy: 2 caps. 2 times / day for 7 days, a total of 2 (with damage to the nail plates of the hands) or 3 (with damage to the nail plates of the feet) of such courses at intervals of 3 weeks between courses;
- continuous therapy (in case of damage to the nail plates of the feet without damage or with damage to the nail plates of the hands): 2 caps. 1 time per day in a 3-month course.
Since itraconazole is excreted from the skin and nail plates more slowly than from blood plasma, the optimal mycological and clinical effects are achieved 2-4 weeks after the end of the treatment of skin lesions and 6-9 months after the end of therapy for nail diseases.
Side effects
- allergic reactions: skin rashes, urticaria, pruritus, angioedema; rarely - Stevens-Johnson syndrome (erythema multiforme exudative);
- dermatological reactions: photosensitivity, alopecia;
- from the central and peripheral nervous system: dizziness, headache, peripheral neuropathy;
- from the digestive system: a reversible increase in the activity of liver enzymes, diarrhea / constipation, decreased appetite, nausea, abdominal pain, dyspepsia, vomiting, hepatitis; in very rare cases - severe toxic liver damage, including acute liver failure with a fatal outcome;
- others: dark urine staining, edema syndrome, hypercreatininemia, hypokalemia, pulmonary edema, congestive heart failure, menstrual irregularities.
Overdose
There is no exact information on cases of overdose of Rumicosis. In case of accidental intake of too high doses of the drug, supportive measures are recommended: during the first hour, resort to gastric lavage and, if necessary, take activated charcoal. It is impractical to use hemodialysis to remove itraconazole from the body. The specific antidote is unknown.
special instructions
In patients with cryptococcosis of the central nervous system and immunodeficiency, Rumicosis can be prescribed only when first-line drugs cannot be used in these cases or are ineffective.
Women of childbearing age should use reliable contraceptive methods throughout the course of treatment, up to the first menstrual period after it ends.
Itraconazole has a negative inotropic effect, and therefore increases the risk of developing heart failure. For this reason, patients with chronic heart failure (including a history of) Rumicosis can be prescribed only in cases where the expected benefits outweigh the potential risks.
In renal failure, the bioavailability of itraconazole may decrease, so dose adjustment may be required.
With the simultaneous use of antacids, Rumicosis must be taken at least 2 hours after them.
Patients with achlorhydria and patients receiving proton pump inhibitors or blockers of histamine H 2 receptors, the drug is recommended to be taken with acidic drinks.
There are very rare cases of the development of severe toxic liver damage, including acute liver failure and death. This side effect of Rumicosis has been observed in people with concomitant liver disease and in people undergoing treatment with drugs with hepatotoxic effects. In this regard, during treatment, it is necessary to regularly monitor liver function.
If neuropathy develops, Rumicosis therapy should be discontinued.
No negative effect of the drug on the reaction rate and the ability to concentrate was noted.
Application during pregnancy and lactation
According to the instructions, Rumicosis during pregnancy is prescribed only in cases where there is an acute threat to the mother's health. If it is necessary to take the drug during lactation, it is recommended to refuse breastfeeding.
Patients with preserved reproductive function taking Rumicosis should use reliable methods of contraception throughout the course of therapy until the start of the next menstrual cycle after its end.
With impaired renal function
Since the bioavailability of itraconazole is somewhat reduced in patients with renal insufficiency, dose adjustment may be required.
Drug interactions
If possible, calcium channel blockers should not be used concomitantly with itraconazole, since they can also have a negative inotropic effect, which can be enhanced with this combination.
Powerful inducers of the CYP3A4 isoenzyme (rifabutin, rifampicin, isoniazid, carbamazepine) significantly reduce the bioavailability of itraconazole, significantly reducing its effectiveness, so this combination is undesirable.
Potent inhibitors of the CYP3A4 enzyme (eg, erythromycin, clarithromycin, indinavir, and ritonavir) can increase the bioavailability of itraconazole.
Drugs that reduce the acidity of gastric juice reduce the absorption of itraconazole.
Itraconazole is able to suppress the CYP3A4-mediated metabolism of drugs, as a result of which it is possible to increase or prolong their effects, including side effects. After the abolition of Rumicosis, the concentration of itraconazole in the blood plasma decreases gradually, depending on the dose used and the duration of therapy. These data should be taken into account when a combination therapy is required.
With the simultaneous administration of the following drugs with Rumicosis, one should monitor their concentration in blood plasma, action and side effects:
- antineoplastic drugs (trimetrexate, busulfan, pink vinca alkaloids, docetaxel);
- calcium channel blockers (eg verapamil or dihydropyridine), metabolized by the CYP3A4 isoenzyme;
- oral anticoagulants;
- immunosuppressive agents (tacrolimus, cyclosporine, sirolimus);
- some glucocorticosteroids (dexamethasone, budesonide, methylprednisolone);
- inhibitors of HIV protease (indinavir, ritonavir, saquinavir);
- inhibitors of HMG-CoA reductase, metabolized with the participation of the isoenzyme CYP3A4;
- other drugs: intravenous midazolam, repaglinide, alfentanil, carbamazepine, rifabutin, cilostazol, alprazolam, digoxin, eletriptan, ebastin, disopyramide, buspirone, halofantrine, reboxetine, brotizolam.
Analogs
Analogues of Rumicoz are: Fluconazole, Diflazon, Mikomax, Procanazole, Vikand, Irunin, Itraconazole, Itrazol, Canditral, Orungal, Orungamin, Teknazol.
Terms and conditions of storage
Store in a dark, dry place out of reach of children at temperatures up to 25 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Rumikoz
According to reviews, Rumicosis is most effective in the treatment of fungal diseases when used as an element of long-term combination therapy. Cases of complete recovery after one course of treatment are extremely rare.
Many patients who took the drug report good results in the treatment of nail fungus, pityriasis versicolor, candidiasis and other diseases caused by fungi. However, there are references to unpleasant side effects. They are very diverse, and the most severe of them are associated with disorders of the liver. Therefore, when undergoing antifungal therapy with Rumicosis, it is necessary to constantly monitor the patient's condition. The disadvantage is the rather high cost of the drug.
Price for Rumicosis in pharmacies
The approximate price for Rumicosis in a package containing 6 capsules is 384–465 rubles, a package containing 15 capsules will cost 922–1113 rubles.
Rumicosis: prices in online pharmacies
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Drug name Price Pharmacy |
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Rumicosis 100 mg capsules 6 pcs. 320 RUB Buy |
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Rumicosis 100 mg capsules 15 pcs. 769 RUB Buy |
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Rumicosis capsules 100mg 15 pcs. 1019 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
