Funit Itraconazole (Generic Sporanox, Tolsura) 100 Mg 15 Capsules

Formula:
A Funit (Sporanox, Tolsura) micropellet capsule contains 100 mg itraconazole and azombine as capsule dyestuff, patent blue V, titanium dioxide and caramel colour.
Pharmacological properties:
Itraconazole, a triazole derivative, a broad-spectrum antimycotic, acts by blocking the synthesis of ergosterol in the cell membrane of fungal cells. The bioavailability of hraconazole is 55%. Oral bioavailability is maximum when taken with food. Doubling the dose results in an approximately 3-fold increase in itraconazole plasma level. Steady plasma levels are reached within 15 days following oral doses of 50-400 mg daily. Cmax = 2282 ng/ml, Cmjn = 1855 ng/ml, Tmax = 4.6 hours, AUC = 22569 ng.hour/ml, t112 = 64 hours in patients taking itraconazole 200 mg twice daily with meals for 15 days .

Itraconazole is extensively metabolized in the liver. The most important metabolite is hydroxysutraconazole. Approximately 3-18% of the dose is excreted unchanged by the faecal route and less than 0.03% renally. 40% of the dose is excreted in the urine as inactive metabolites. Plasma concentrations obtained in patients with renal impairment are similar to healthy individuals. The effect of hepatic impairment on the plasma concentration of itraconazole is unknown. Therefore, it is recommended to monitor the plasma concentrations of itraconazole in patients with hepatic impairment.

Itraconazole is 99.8% and hydroxyitraconazole is 99.5% bound to plasma proteins. Since the elimination of itraconazole is due to epidermal regeneration rather than the systemic circulation, the drug level in the skin and mucous membranes persists for 1-4 weeks after discontinuation of treatment. In animal experiments, it was determined that itraconazole showed a good distribution in lipophilic tissues. Concentrations of itraconazole in adipose tissue, omentum, liver, kidney and skin were 2-20 times higher than the plasma concentration. The drug passes into body fluids such as cerebrospinal fluid and saliva, but at negligible rates.

Indications:
Itraconazole, a triazole derivative, a broad-spectrum antimycotic, acts by blocking the synthesis of ergosterol in the cell membrane of fungal cells.

Funit (Sporanox, Tolsura) 15-30 Micropellet Capsules with superficial fungal infections such as Tinea corporis, Tinea cruris, Tinea pedis, Tinea manuum, Pityriasis versicolor, Aspergillosis, Blastomycosis, Histoplasmosis, esophageal, oropharynx, oropharynx It is indicated for the treatment of systemic fungal infections such as sporotricosis. Funit (Sporanox, Tolsura) 15-30 Micropellet Capsules are also used for the suppression of Cryptococcal meningitis and Histoplasmosis.

Contraindications:
Concomitant use of itraconazole with terfenadine and astemizole is contraindicated as it will increase the risk of cardiac arrhythmia.

Funit (Sporanox, Tolsura) micropellet capsule should be used with caution in case of hypersensitivity to azole derivatives due to insufficient information on cross-hypersensitivity reaction between itraconazole and other azole antifungals.

Funit (Sporanox, Tolsura) micropellet capsule is contraindicated in case of hypersensitivity to itraconazole and other ingredients.

Warnings/Precautions:
Since Funit (Sporanox, Tolsura) micropellet capsule is metabolized in the liver, liver function tests are recommended in patients with symptoms such as weakness, abdominal pain, nausea and vomiting after use for more than 1 month. It should not be used in people with a history of liver disease or in people who have developed liver toxicity due to other drugs.

Achlorhydria and hypochlorhydria reduce the absorption of itraconazole. Decreased stomach acid reduces the absorption of itraconazole. For this reason, drugs that reduce stomach acid should be taken at least 2 hours later. In addition, it is recommended to take drugs that reduce acid secretion with cola drinks. It should not be used in children unless the potential benefit outweighs the potential risk. The bioavailability of itraconazole may be reduced by oral administration in patients with renal impairment. Therefore, the plasma level of itraconazole should be monitored and dose adjustment should be made if necessary. In case of neuropathy that may be related to the treatment of Funit (Sporanox, Tolsura) micropellet capsule, treatment should be discontinued.

Itraconazole has been shown to cause fetal developmental abnormalities in pregnant mice at high doses. Use in pregnant women should only be started by calculating the risk of harm and benefit in life-threatening mycoses. Since it passes into breast milk, it should not be used in nursing mothers.

Side effects/Adverse effects:
The most common side effects in clinical studies were dyspepsia, nausea, abdominal pain, and indigestion. Rarely, headache, transient elevation of liver enzymes, menstrual irregularities, pruritus, skin rash, urticaria