Rumikoz

Description overdue on 07/10/2014

• Latin name: Rumycoz
• ATC code: J02AC02
• Active substance: Itraconazole (Itraconazole)
• Manufacturer: Valenta Pharmaceuticals OAO, Russia

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• Composition
• Product form
• Pharmacological action
• Pharmacodynamics and pharmacokinetics
• Indications
• Contraindications
• Side effects
• Instructions for use Rumikoza (method and dosage)
• Overdose
• Cooperation
• Terms of sale
• Storage conditions
• Shelf life
• Cautions
• Analogs
• Synonyms
• Babies
• With alcohol
• During pregnancy (and lactation)
• Reviews
• Price, where to buy

Composition

1 capsule containing 100 mg of Itraconazole   - Active substance.

Auxiliary ingredients: hypromellose, wheat starch, poloxamer (lutrol), sucrose.

Product form

Rumikoz medicament available in capsule form 6 or 15 pieces. packaged.

Pharmacological action

Antifungal.

Pharmacodynamics and pharmacokinetics

Rumikoz - derivative triazole It is a synthetic antifungal with a broad spectrum of action. The main mechanism of action of the active drug substance is inhibition of ergosterol synthesis.   which is one of the important components the cell membranes of fungi.

Itraconazole   shows activity 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 And other molds and yeast.

Itraconazole   the oral (domestic) application is well absorbed in the gastrointestinal tract, reaching peak plasma levels over the 3-for-4 hours after ingestion.

To achieve maximum bioavailability of itraconazole   Rumikoza recommend the capsules immediately after a meal. After 7-14 days of treatment, the equilibrium drug concentration observed in plasma.

Relationship to plasma proteins is quite high. Itraconazole   It has good penetration in the body tissue and body fluids, while in some organs (lungs, stomach, kidneys, liver, skeletal muscle) are superior to the plasma concentration of 2-3.

The active substance is deposited in keratin tissues   (exceeding that observed in plasma is 4 times), and the rate of its removal from the skin is dependent on the speed regeneration of the epidermis.   During the 14-day 28-after the drug is stored therapeutic concentrations of itraconazole   in the skin, and vaginal mucosa   they are detected even after 48 hours after a three day course of therapy in a daily dose of 200 mg, and for 72 hours at a daily dose of 400 mg.

AT keratin nail plates Itraconazole determined 7 days after initiation of therapy and for 6 months after the end of a three-month treatment. Itraconazole It is also found in secretion of sweat and sebaceous glands.

Metabolism Itraconazole   in the liver, with the release of the active metabolites, the effects of some of them have inferior effect unchanged drug.

Two-stage output of plasma. T1 / 2 - 24-36 hours.

3-18% is excreted through the intestines and about 0, 03% via the kidneys (in unmodified state), and 35% as metabolites (for 7 days).

Bioavailability decreases with impaired immunity and renal failure. With cirrhosis together with a reduction in bioavailability, half-life is increased.

Indications

• g ribkovy keratitis;
• ringworm;
• onychomycosis caused by molds, yeasts and / or dermatophyte;
• systemic candidiasis and aspergillosis;
• blastomycosis;
• Cryptococcosis, including cryptococcal meningitis   (for immunosuppression and CNS cryptococcosis   shall be appointed only if you can not use first-line therapy);
• sporotrizoz;
• histoplasmosis;
• paracoccidioidomycosis;
• Other tropical and systemic fungal infections;
• chromophytosis;
• deep visceral candidiasis;
• kandidomikoz with lesions of the skin and mucous membranes, such as vulvovaginal candidiasis (thrush).

Contraindications

Hypersensitivity to Itraconazole   or other ingredients.

Rumikoza combines reception and the following groups of drugs:

• Astemizole, terfenadine, mizolastine, dofetilide, cisapride, quinidine, Levo, pimozide, sertindole   and other drugs that increase QT interval and metabolized by the enzyme CYP3A4;
• Lovastatin, simvastatin   and others inhibitors of HMG-CoA reductase,   which are cleaved enzyme CYP3A4;
• Midazolam and triazolam for internal reception (tablets);
• Ergometrine, dihydroergotamine, metilergometrina, ergotamine   and others ergot alkaloids.

Carefully

• liver disease;
• children's age;
• heart failure severe.

Side effects

Gastrointestinal tract:

• nausea;
• dyspepsia;
• vomiting;
• abdominal pain;
• decreased appetite;
• constipation or diarrhea.

Hepatobiliary System:

• hepatitis;
• increase in liver transaminases (reversible);
• severe toxic liver damage   (documented cases of acute liver failure with a fatal outcome).

Nervous system:

• peripheral neuropathy;
• dizziness;
• headache.

Skin:

• sensitivity to light;
• alopecia.

Allergic symptoms:

• hives;
• itching and rashes on the skin;
• angioedema;
• Stevens-Johnson syndrome.

Others:

• edematous syndrome;
• hypercreatininemia;
• hypokalemia;
• irregularities in the menstrual cycle;
• pulmonary edema;
• congestive heart failure;
• staining of urine a dark color.

Instructions for use Rumikoza (method and dosage)

The drug is taken orally Rumikoz (orally). Instructions on Rumikoz recommends swallow capsules whole without chewing or crushing, immediately after a meal.

The duration of therapy and dose Rumikozom only defines the physician individually for each patient.

When treating vulvovaginal candidiasis   There are two regimens, one of which is a 1-day treatment with the appointment of 200 mg twice daily Rumikoza; according to another scheme, the treatment is carried out 3 days with a daily dose of 200 mg.

In therapy oral candidiasis   recommended daily dose of 100 mg during 15 days.

Patients with tinea skin . fungal keratitis and pityriasis versicolor prescribe a daily dose of 200 mg. The duration of treatment with ringworm and pityriasis versicolor   - 7 days and 21 days - when fungal keratitis.   There is an alternative regimen ringworm smooth skin, with the appointment of 100 mg for 15 days.

Fungal vysokokeratinizirovannyh areas   require Rumikoza receiving 200 mg twice daily for 7 days, or within a month of 100 mg daily.

It must be remembered that in diseases: neutropenia, AIDS, as well as after organ transplantation, you may need a dose adjustment.

With onihomikozah It is shown holding a 1-week course of treatment with a daily dose of 200 mg. Then, after a 3-week break, repeat the course. With onihomikozah polish   spend 2 courses and 3 courses at onihomikozah toes . In the case of a heavy defeat nail plates on their toes Rumikoza reception, the same dose can be continuously for 3 months.

Systemic fungal infections   treatable at daily doses ranging from 100 mg to 400 mg depending on the severity of disease and the nature of the pathogen. The duration of treatment can take anywhere from 3 weeks to 8 months.

Here are the usual regimen systemic mycosis   Rumikoz drug.

With candidiasis administered 100-200 mg per day, for from 1 to 7 months ( with disseminated or invasive flow   - 400 mg per day).

With aspergillosis daily dose is 200 mg, for a duration of 2 to 5 months ( with disseminated or invasive flow   - 400 mg per day).

With cryptococcosis   (with the exception of   meningitis ) Receiving 200 mg per day, for from 2 to 12 months.

With cryptococcal meningitis   It shows a daily dose of 400 mg, for a duration of 2 to 12 months.

With histoplasmosis prescribed 200 mg 1-2 times a day for 8 months.

With sporotrichosis   Treatment lasts for 3 months at a daily dose of 100 mg.

With chromomycosis recommended intake of 100-200 mg Itraconazole a day for 6 months.

With blastomycosis   Rumikoza daily dose ranges from 100 mg to 400 mg depending on the severity of the condition. The course of treatment - 6 months.

With paracoccidioidomycosis course of treatment lasts for 6 months, with taking a daily dose - 100 mg.

Overdose

Data on drug overdose Rumikoz not.

Cooperation

Drugs that reduce gastric pH, reduced absorption Itraconazole.

Splitting Itraconazole It occurs mainly on the means of action enzyme CYP3A4 . Inductors enzyme CYP3A4: Rifabutin, Rifampin, Phenytoin, Isoniazid, carbamazepine   When combined with the admission Rumikozom significantly reduce the bioavailability of the latter, which had a negative impact on its effectiveness.

Indinavir, ritonavir, erythromycin, clarithromycin,   It is powerful inhibitors of the enzyme CYP3A4 On the contrary increase the bioavailability Rumikoza.

Itraconazole   It can inhibit the metabolism of drugs that are broken down enzyme SURZA4 , Whereby can occur prolongation or enhancement of their action as well as side effects.

After discontinuation using Rumikoza, its concentration of active ingredient in the plasma, depending on the duration of treatment and the dose is gradually reduced. This should be considered in the appointment of other drugs, whose effectiveness can be reduced by inhibiting their action Itraconazole.

I do not recommend the use of joint and Rumikoza calcium channel blockers Due to the general method of metabolism and possible co- inotropic effect.

When combined with the admission Rumikozom should follow the action, the plasma concentration, side effects, and if necessary, adjust the dose of the following drugs:

• HIV protease inhibitors (indinavir, ritonavir, saquinavir)
• oral anticoagulants;
• Some anticancer drugs ( Busulfan, trimetrexate, docetaxel, vinca alkaloids );
• Verapamil And derivatives dihydropyridine;
• Cyclosporin, rapamycin, tacrolimus;
• Atorvastatin;
• Budesonide, methylprednisolone, dexamethasone;
• Digoxin, buspirone, carbamazepine, alfentanil, brotizolam, alprazolam, midazolam (w / w), rifabutin, Reboxetine, ebastine, cilostazol, Eletriptan, disopyramide, Repaglinide, halofantrine.

Interactions with Rumikoza Fluvastatin and zidovudine   not detected.

Itraconazole   It does not affect the metabolism Norethisterone and ethinylestradiol.

Studies in vitro have shown no interaction with Rumikoza Propranolol, imipramine, diazepam, indomethacin, cimetidine, tolbutamide and sulfamerazine   when bound to plasma proteins.

Terms of sale

Prescription.

Storage conditions

The temperature is not above 25 ° C.

Shelf life

24 months.

Cautions

Throughout the course of treatment Rumikoza, women of childbearing age should use reliable measures contraception.

Please note that Itraconazole   may cause negative inotropic effect.

There have been cases of Heart Failure In the therapy using Rumikoza, therefore better to not assign the drug in this disease, including a history.

With renal failure Rumikoza decreased bioavailability, which may be an indicator for dose adjustment.

At reception antacids   recommend their use no earlier than 2 hours after Rumikoza.

Patients achlorhydria   and those who accept proton pump inhibitors or H2 histamine blockers It recommends taking Rumikoz with acidic beverages.

During treatment should regularly monitor liver function.

It should stop taking the development of Rumikoza neuropathy.

Analogs

Match code ATC 4th level:

• Flucostat
• Diflyuzol
• Futsis
• Vero Fluconazole
• Kandizol
• Kanditral
• Itraconazole
• Mikosist
• Diflazon
• Itrazol
• Diflucan
• Orungal
• Mikomaks
• Fluconazole
• Irunine

Of course, for administration of any drug, including Rumikoza people try to pick up its analogs cheaper cost, often neglecting efficiency. It should be said that very often the drugs, which are twice cheaper than recommended may require a double, or even triple dose application.

It depends on the raw materials from which the drug purity of the active substance, the number of inclusions, and more. Therefore, before buying a cheap analog, make sure that its effectiveness will not yield to prescribe the drug.

Analogs Rumikoza:

• Fluconazole;
• Diflazon;
• Diflucan;
• Mikomaks;
• Prokanazol;
• Vikand   and many others.

Synonyms

• Irunine;
• Itraconazole;
• Kanditral;
• Orungal;
• Teknazol etc.

Babies

In childhood Rumikoza may use in exceptional cases, under the strict supervision of a physician and with extreme caution.

With alcohol

Alcohol detrimental effect on the whole body, and in particular CNS (dizziness, headaches) On Gastrointestinal (nausea, vomiting)   and liver.   Since these symptoms are identical Rumikoza side effects, and the drug is quite hepatotoxic , We can conclude that alcohol and Rumikoz incompatible.

During pregnancy (and lactation)

During pregnancy appoint Rumikoz only if the potential benefits of therapy, compared to the potential risk to the fetus.

If there is a need to receive Rumikoza during lactation, breast-feeding is stopped.

Reviews Rumikoze

In the treatment of any fungal diseases   reviews of doctors are reduced to the necessity of a long and often combined treatment of these diseases. Of course, in some cases, been able to achieve full recovery of the patient, having only one course of therapy, although it is rather an exception to the rule.

If we talk about this preparation, the reviews Rumikoz thrush, with pityriasis versicolor, with nail fungus and other fungal infections   mostly positive, although with reference to various side effects.

It should be remembered that antifungals They have many side effects and the most severe of which may be from the liver. In this regard, the passage antifungal therapy , You need to constantly monitor her condition.

Price Rumikoza where to buy

Average price Rumikoza on the pharmaceutical market of Russia:

• Capsules №6 - 350 rubles;
• capsules №15 - 800 rubles.

Recall that in selecting analogues Rumikoza price tablet with a similar effect may be lower, as well as their quality and effectiveness. In any case, though the choice of drug is yours, should take into account the recommendation of a physician.

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