Unitrac^TM is a synthetic triazole antifungal agent.

Composition

Each capsule contains Itraconazole 100 mg.

Pharmacology
Itraconazole, a triazole derivative, is active against infection with Dermatophytes, Aspergillus and Histoplasma spp, Paracococcidioides brasiliensis, Sporotrhrix schenckii, Fonsecaea and Cladosporium spp, Blastomyces dermatidis and various other yeast and fungi. In vitro studies have demonstrated that itraconazole inhibits the cytochrome P-450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes.
The oral bioavailability of itraconazole is maximal when itraconazole capsules is taken with a full meal. Itraconazole is extensively metabolized by the liver into a large number of metabolites, including hydroxyitraconazole, the major metabolite. Fecal excretion of the parent drug varies between 3-18% of the dose. Renal excretion of the parent drug is less than 0.03% of the dose. About 40% of the dose is excreted as inactive metabolites in the urine.
Plasma concentrations of itraconazole in subjects with renal insufficiency were comparable to those obtained in healthy subjects. The effect of hepatic impairment on the plasma concentration of itraconazole is unknown. It is recommended that plasma concentrations of itraconazole in patients with hepatic impairment be carefully monitored.
The plasma protein binding of itraconazole is 99.8% and that of hydroxyitraconazole is 99.5%. Itraconazole is not removed by hemodialysis. In animal studies, itraconazole is extensively distributed into lipophilic tissues. Concentrations of itraconazole in fatty tissues, omentum, liver, kidney and skin tissues are 2-20 times the corresponding plasma concentrations. Aqueous fluids such as cerebrospinal fluid and saliva contain negligible amounts of the drug.

Indication

• Dermatophytosis

• Pityriasis versicolor

• Vaginal candidiasis

• Onychomycosis

• Oral candidiasis

• Fungal keratitis

Contra Indication

• UnitracTM is contraindicated in patients with a hypersensitivity to itraconazole and triazole antifungals.
• UnitracTM is contraindicated in pregnancy.
   

Warning

• UnitracTM should not be administered to nursing women.
• The efficacy and safety of itraconazole have not been established in pediatric patients.
• Caution should be exercised when prescribing UnitracTM in patients with history of hepatic or renal disease
   

Adverse Reaction
Transient , mild to moderate severity
Most frequently reported :

• gastrointestinal disturbances
• dizziness
• pruritus
• headache
   

Dosage

Disorder	Dose	Interval	Duration
-         Tinea corporis & tinea cruris -         Tinea pedis & tinea manum -         Tinea capitis -         Pityriasis versicolor -         Acute vaginal candidiasis -         Chronic vaginal candidiasis -         Oral candidiasis -         Onychomycosis -         Fungal keratitis	100 mg 100 mg 100 mg 200 mg 200 mg 200 mg 100 mg 100 mg 200 mg	1 x/day 1 x/day 1 x/day 1 x/day 2 x/day 1 x/day 1 x/day 1 x/day 1 x/day	15 days 30 days 4-8 weeks 5-7 days 1 day 3 days 15 days 3-6 months 3 weeks

Stability
Store at room temperature (15-30 ºC). Protect from light and moisture.

Presentation
Box @ 3 strips @ 10 capsules @ 100 mg.