Itrapex for vulvovaginal candidosis and fungal keratitis and oral candidosis

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 :

S.A.E” Badr City-Cairo, Egypt

اترابكس عقار مضاد للفطريات واسع المدى لعلاج كانديدا المهبل و الفم و حالات العدوى الفطرية فى الجلد