Itrapex Capsules
Oral broad-Spectrum antifungal agent
Composition :
Each capsule contains: 100 mg Itraconazole
Pharmacology :
Itraconazole, a triazole derivative, has broad spectrum antifungal activities against infections with various fungi and yeast. In vitro,
Itraconazole inhibits the cytochrome P-450 synthesis of ergosterol which is a vital component for fungal cell membrane.
Peak plasma levels are reached 3-4 hours after an oral dose with terminal half- life of 1-1.5 days. The plasma protein binding is 99.8%
Concentrations of Itraconazole in blood are 60% of those in plasma. Uptake in keratinous tissues, especially the skin is up to 4 times higher than in plasma and therapeutic levels in the skin persist for 2-4 weeks after discontinuation of a-4 week treatment course. Itraconazole is also present in sebum and to a less extent in sweat. Concentrations in lung, kidneys, spleen, liver, stomach, bone and muscles are 2-3 times higher than the corresponding plasma
concentration. Therapeutic levels in vaginal tissue are maintained for another 3-days after discontinuation of a 1 – day course with 200 mg b.i.d, and for another 2 days after discontinuation of a 3-days course with 200 mg daily.
Indications :
– Gynaecological indications : Vulvovaginal candidosis. – Dermatological indications : Pityriasis versicolor, Dermatomycosis & Onychomycosis
– Ophthalmological indications: fungal Keratitis.
– Blastomycosis: pulmonary and extrapulmonary.
– Oral candidosis.
Dosage and Administration :
For optimal results, it is essential to swallow itrapex capsule immediately after a full meal.
Gynaecological Indications :
200 mg b.i.d for 1 day or 200 mg o.d. for 3 days.
Dermatological indications :
-Pityriasis versicolor: 200 mg o.d. for 7 days
-Dermatomycosis: 100 mg o.d. for 15 days In hyperkeratinous regions e.g. T.pedis (Plianter or Palmer) might require an additional treatment of 15 days at 100 mg daily.
Fungal Keratitis :
200 mg o.d. for 21 days.
Oral Candidosis :
100 mg o.d. for 15 days.
In some immunocompromised patients e.g. in organ transplant, the dose may need doubling. Optimal clinical and mycological response is
reached 2-4 weeks after the cessation of treatment in skin infections.
Contraindications :
– Itrapex is contraindicated in patients who have known hypersensitivity to the drug or its excipients.
– During pregnancy.
Warnings :
– it is advisable to monitor liver function in patients receiving Itraconazole continuously for more than one month.
– In patients with raised liver enzymes ,treatment should not be started unless the potential benefits exceed the potential risks
– If neuropathy occurs during ltraconazole therapy,
the treatment should be stopped
– It is preferable to swallow Itraconazole with any cola drink in patients using acid reducing drugs, and patients using antacids containing alum. hydroxide should take it at least 2 hours after the intake of Itraconazole.
– It is not advisable to be used in children.
Side Effects :
– Dyspepsia ,nausea and constipation.
– Less commonly: headache, irregular menstruation, pruritis and urticaria.
– In case of Itraconazole treatment for more than one month, rare cases of hypokalemia may occur.
Interactions :
Itrapex may interact with:
rifampicin, phenytoin, terfenadine, astemizole, cisapride, midazolam,triazolam,anticoagulants, digoxin, cyclosporin A, dihydropyridine and quinidine.
How supplied :
Capsule 100 mg Itraconazole :
Packs of 4 capsules.
Packs of 15 capsules.
I Keep medicines out of reach of children
Manufactured by :
MULTI-APEX Pharma
S.A.E” Badr City-Cairo, Egypt
