Irunin capsules 100mg №14

Active ingredient

Irunin capsules yellow color; the contents of the capsules pellets (spherical microgranules) from light yellow to yellowish-beige.
One capsule contains 0.1 g of itraconazole.
Excipients: sucrose, starch, hydroxypropylmethylcellulose, poloxamer;
6, 10 or 14 capsules per pack.

antifungal agent

Pharmacology

Itraconazole is a triazole derivative. Irunin inhibits (disrupts) the synthesis of ergosterol, which is an important component of the cell membrane of fungi, which causes the antifungal effect of the drug.
Irunin it is active against dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), and Candida spp. (including Candida albicans, Candida glabrata, Candida krusei), mold fungi (Cryptococcus neoformans, Aspergillus spp., Histoplasma spp., Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecae spp., Cladosporium spp. spp. shepp, spp. spp. spp. spp. pepp.

Indications for use
Irunin capsules are indicated for the treatment of the following mycoses:

• dermatomycosis and dermatophytoses, including severe lesions of the hands, feet, onychomycosis, caused by dermatophytes and / or yeast, mold and dimorphic fungi
• candidomycosis (fungal infections of the skin and mucous membranes): multi-colored (pityriasis) versicolor, inguinal athlete, oral and visceral (internal organs) candidiasis, pulmonary candidiasis, vulvovaginal candidiasis, fungal keratitis;
• deep mycoses: blastomycosis, coccidioidomycosis, paracoccidioidomycosis, sporotrichosis, mycetoma of the foot, histoplasmosis, chromomycosis, penicillis
• Systemic mycoses: systemic aspergillosis and candidiasis of various localization, cryptococcosis (including cryptococcal meningitis), histoplasmosis, sporotrichosis, paracoccidioidomycosis, blastomycosis, and other rare systemic or tropical mycoses

Contraindications

Irunin capsules are contraindicated in patients with hypersensitivity to the components of the drug.

Women of childbearing age, taking Irunin, you must use adequate methods of contraception throughout the course of treatment until the first menstruation after its completion.
Pregnant women Irunin should be prescribed only if the expected benefit to the woman outweighs the potential risk to the fetus. Since a small amount of itraconazole is excreted in breast milk, the expected benefits of taking itraconazole must be compared with the risk to the baby when breastfeeding. In case of doubt, it is necessary to resolve the issue of termination of breastfeeding.

Since the clinical data on the use of Irunin capsules in children is not enough, it is recommended to use Irunin only if the possible benefit outweighs the potential risk.

Dosage and administration

For optimal absorption of the drug, it is necessary to take Irunin in capsules immediately after a meal. Capsules should be swallowed whole.

At systemic mycoses Recommended doses vary depending on the type of infection.

At onychomycosis pulse therapy is shown. One course of pulse therapy consists in taking Irunin 200 mg daily (2 capsules) 2 times / day for 1 week, followed by a three-week break.
In this case, the removal of the nail plate is required only in the case of significant keratotic masses (growths of nails affected by fungi).
For method of treating fungal infections of the nail plate brushes 2 courses recommended.
For treatment of fungal infections of the nail plate feet 3 courses recommended. The interval between courses is 3 weeks.
Clinical results appear after treatment, as nails grow.

At onychomycosis it is possible to use continuous therapy: 200 mg (2 capsules) 1 time / day for 3 months.
Removal of itraconazole from the skin and nail plate is slower than from plasma. Thus, the optimal clinical and mycological effects are achieved in 2-4 weeks. after the end of treatment for skin infections and 6–9 months after the end of the treatment of nail infections.

Adverse reactions
Gastrointestinal: often - dyspepsia, nausea, abdominal pain, constipation; possible anorexia, reversible increase in liver enzymes, cholestatic jaundice, hepatitis; in some cases - toxic damage to the liver, including case of acute liver failure with a fatal outcome.
Nervous system: possible headache, fatigue, dizziness, peripheral neuropathy.
From the reproductive system: possible violations of the menstrual cycle.
Urogenital: hypercreatininemia, dyeing urine in a dark color.
Metabolism: swelling, hyperkalemia.
Since the cardiovascular system: possible chronic heart failure and pulmonary edema.
Allergic reactions: possible itching, rash, urticaria, angioedema, Stevens-Johnson syndrome.
Dermatological reactions: possible alopecia.

No data available. In case of accidental overdose, it is necessary to wash the stomach during the first hour after ingestion, and, if necessary, to appoint activated charcoal. Symptomatic treatment.
Itraconazole is not excreted by hemodialysis.
There is no specific antidote.

Itraconazole has been found to have a negative inotropic effect. Cases of chronic heart failure associated with taking itraconazole have been reported. Irunin should not be taken in patients with chronic heart failure or with the presence of this disease in history, except when possible benefits far outweigh the potential risk. In an individual assessment of the balance between benefits and risks, factors such as the seriousness of the indications, the dosing regimen and individual risk factors for the occurrence of chronic heart failure should be taken into account. Risk factors include the presence of heart disease, (coronary heart disease or valvular lesions), chronic obstructive pulmonary disease; renal failure.

Simultaneous use of itraconazole with Calcium channel blockers may reduce their metabolism.

At low acidity of the stomach, absorption of itraconazole is impaired. Patients taking antacid preparations (for example, aluminum hydroxide) are recommended to use them no earlier than 2 hours after taking Irunin capsules. Patients with achlorhydria or using H2 blockers or proton pump inhibitors are advised to take Irunin capsules with cola or seltzer water, and in some cases dissolve the contents of the capsules in hydrochloric acid, gastric juice or along with acid pepsin and drink through a straw in order not to damage acid teeth.

In very rare cases, when itraconazole was applied, severe toxic liver damage developed, including cases of fatal liver failure. In most cases, this was observed in patients who had abnormal liver function, as well as in patients who received other drugs with a hepatotoxic effect.

In this regard, it is recommended to regularly monitor the function of the liver in patients receiving itraconazole therapy. In the event of symptoms that suggest the occurrence of hepatitis, namely anorexia, nausea, vomiting, weakness, pain in the abdomen and darkening of the urine, it is necessary to immediately stop taking the drug and conduct a study of liver function.Patients with elevated levels of liver enzymes or liver disease in the active phase should not be prescribed Irunin's treatment unless the expected benefit justifies the risk of liver damage. In these cases, it is necessary to monitor the level of liver enzymes during treatment.

Treatment should be discontinued if neuropathy occurs, which may be associated with taking Irunin capsules.

There is no data on cross-sensitivity to itraconazole and other azole antifungal agents. Irunin capsules should be used with caution in patients with hypersensitivity to other azoles.

In a dry, dark place, at a temperature not higher than 25 ° C.
Shelf life - 2 years.

On prescription