Product Description:

TRAZOL is indicated for the following:

1. Vulvovaginal candidosis


2. Pityriasis versicolor


3. Dermatophytoses caused by organisms susceptible to itraconazole


4. Oral Candidosis


5. Fungal keratitis


6. Systemic mycoses


7. Onychomycosis

Dosage and Administration

• ITRAZOL must be taken immediately after a meal for maximal absorption. Dosage recommended according to the infection.

Contraindications

ITRAZOL is contra-indicated in patients with known hypersensitivity to itraconazole or to any of the excipients.

Co-administration of the following drugs is contraindicated with ITRAZOL:

• CYP3A4 metabolised substrates that can prolong the QT-interval e.g. astemizole, bepridil, cisapride, dofetilide, levacetylmethadol (levomethadyl), mizolastine, pimozide, quinidine, sertindole and terfenadine are contraindicated with ITRAZOL capsules. Co-administration may result in increased plasma concentrations of these substrates, which can lead to QT prolongation and rare occurrences oftorsades de pointes


• CYP3A4 metabolized HMG-CoA reductase inhibitors such as atorvastatin, lovastatin and simvastatin


• Triazolam and oral Midazolam


• Ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine)


• Eletriptan


• Nisoldipine

ITRAZOL should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF except for the treatment of life-threatening or other serious infections.

Pregnancy and Lactation

Pregnancy:

ITRAZOL must not be administered during pregnancy except for life-threatening cases.

In animal studies Itraconazole has shown reproduction toxicity.

There is limited information on the use of ITRAZOL during pregnancy. During post-marketing experience, cases of congenital abnormalities have been reported.

Women of pregnancy potential taking ITRAZOL capsules should use contraceptive precautions. Effective contraception should be continued until the menstrual period following the end of ITRAZOL therapy.

Lactation:

A very small amount of Itraconazole is excreted in human milk. The expected benefits of ITRAZOL therapy should be weighed against the risks of breast feeding. In case of doubt, the patient should not breast feed.