Generic Name


Therapeutic Category



Itraconazole 100mg Capsules




    Each capsule contains:

    Itraconazole Pellets eq. to Itraconazole           100mg

    Size '0' plain hard gelatin capsule with blue colored cap and yellow colored body. 




    • Absorption of capsule enhanced by acidic gastric environment or when taken with food.
    • Bioavailability is increased when taken with FDA standard high fat meal.

    Pregnancy: Category C

    Nursing mother: ITRATIME is excreted in breast milk.

    Pediatric: The efficacy and safety have not been established.

    Storage: Store tablets at room temperature (15-25°C); Protected from light, heat and moisture; Keep out of reach of children.

    Missed dose: Take the missed dose as soon as you remember; Skip the missed dose if it is almost time for your next scheduled dose; Do not take extra medicine to make up the missed dose.


    Pharmacotherapeutic Group: Anti-fungal agent

     Pharmacodynamic properties: ITRATIME (Itraconazole) inhibits 14α-demethylase, an enzyme necessary to convert lanosterol to ergosterol. This results in a depletion of ergosterol and causes disruption of fungal cell membrane synthesis.

     Pharmacokinetic properties:

    Absorption: Absorbed from the GIT; Absolute bioavailability: 55%; Time to peak plasma concentrations: 3-4 hr.

    Distribution: Itraconazole is extensively bound (99.8%) to plasma protein; widely distributed in skin, sebum, pus and other tissues and organs; small amounts are distributed in CSF and breast milk.

    Metabolism: Undergoes saturable hepatic metabolism; converted to hydroxyitraconazole (antifungal activity comparable to the parent drug) and other metabolites.

    Excretion: Excreted via urine (35%) or bile (as inactive metabolites); via faeces (3-18% as unchanged); not removed by dialysis


    Candidiasis; Dermatophytosis; Aspergillosis; Histoplasmosis; Tinea infection; Onychomycosis; Sporotrycosis; Cryptococcosis.


    Oropharyngeal candidiasis:  100 mg daily for 15 days. Vulvovaginal candidiasis: 200 mg twice daily as a single dose.

    Skin Infection: 100 mg daily for 15 days or 200 mg daily for 7 days.

    Nail fungal infections: 200 mg daily for 3 month. Systemic fungal infections: 100-200 mg once daily, increased to 200 mg bid for invasive or disseminated infections.

    Prophylaxis of infections in neutropenic or AIDS patients: 200 mg daily increased to 200 mg bid if necessary.


    Hypersensitivity to azole antifungals; Pregnancy and lactation; Hepatic disease; Ventricular dysfunction such as Chronic Heart Failure (CHF) or history of CHF.


    Renal insufficiency; Cardiac Dysrhythmias, Cardiac Disease; Chronic Obstructive Pulmonary Disease.


    Dyspepsia, abdominal pain, nausea, vomiting, diarrhoea; menstrual disorders; constipation, rash, pruritus, urticaria; angioedema, anaphylaxis. Increased liver enzyme values, jaundice, Stevens-Johnson syndrome, hypokalaemia. Potentially Fatal: Liver failure; heart failure; pulmonary oedema; CV disease.


    Concentration increased by: clarithromycin, erythromycin, HIV protease inhibitors; Concentration decreased by: carbamazepine, phenobarbital, phenytoin, isoniazid, rifabutin, rifampin, nevirapine; Capsule absorption may be decreased by antacids, H2-receptor antagonists, proton pump inhibitors.


    Each box contains 10 strip packs of 4 tablets per strip (Inner catch cover per strip).