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.
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.
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.
ADVERSE DRUG REACTIONS
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).