Itracon 10 mg/ml Oral Solution

Itracon | 10 mg/ml Oral Solution
Price: 0.00
Generic: Itraconazole
Manufactured By: Navana Pharmaceuticals Ltd.
Variant: Tablet 200 mg

COMPOSITION

Itracon 100 Capsule : Each capsule contains Itraconazole BP 100 mg.
Itracon 200 Tablet : Each film coated tablet contains Itraconazole BP 200 mg.
Itracon Oral Solution: Each ml solution contains Itraconazole BP 10 mg.

PHARMACOLOGY

Itracon is an orally active triazole antifungal drug that has demonstrated a broad spectrum of activity & favorable pharmacokinetic profile. Itraconazole inhibits Cytochrome P-450 dependent enzymes resulting in impairment of the biosynthesis of ergosterol, a major component of the cell membrane of yeast and fungal cells. Being integral to the proper functioning of the cell membrane, inhibition of the synthesis of
ergosterol leads to a cascade of abnormalities in permeability, membrane bound enzyme activity, and coordination of chitin synthesis leading to inhibition of growth, abnormal cell wall formation and accumulation of
intracellular lipids and membranous vesicles.

INDICATION

Itracon is used for the treatment of oropharyngeal candidiasis, vulvovaginal candidiasis, pityriasis versicolor, tinea pedis, tinea cruris, tinea corporis, tinea manuum, onychomycosis, histoplasmosis. It is indicated in
the treatment of systemic candidiasis, aspergillosis, and cryptococcosis (including cryptococcal meningitis). It is also used for maintenance therapy in AIDS patients to prevent relapse of underlying fungal infections and in
the prevention of fungal infection during prolonged neutropenia.

ADVERSE EFFECT

Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, menstrual disorders, allergic reactions (including pruritus, rash, urticaria and angioedema), hepatitis and cholestatic jaundice,
peripheral neuropathy and Stevens-Johnson syndrome reported. On prolonged use, hypokalemia, oedemic and hair loss reported.

CONTRAINDICATION

Itracon is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation. Patients who have severe hepatic disease are not advised to take Itracon. It is not advisable to
use the drug in patients taking rifampin, which appears to initially inhibit and then enhance the metabolism of Itracon.

PRECAUTION

Absorption is impaired when gastric acidity is reduced. In patients receiving acid neutralizing medicines (e.g. aluminum hydroxide), these should be administered at least 2 hours after the intake of Itracon. The
drug should be administered after a full meal. Rarely, cases of hepatitis and jaundice have been reported mainly in patients treated for longer than one month. It is therefore, advised to monitor liver function in patients
receiving continuous treatment of more than one month.

DRUG INTERACTION

Drugs like terfenadine, astemizole, cisapride, HMG-CoA reductase inhibitors such as simvastatin, oral midazolam or triazolam should not be observed during co-administration of rifampin, phenytoin, phenobarbital,
digoxin, and calcium channel blockers.

USE IN PREGNANCY & LACTATION

Itracon is contraindicated in pregnancy. Breast feeding while receiving Itraconazole is not recommended.

STORAGE CONDITION

Store below 250 C. Do not freeze. Keep all medicines out of reach of children.

HOW SUPPLIED

Itracon 100 Capsule : Each box containing 28 capsules in Alu-Alu blister pack.
Itracon 200 Tablet: Each box containing 18 tablets in Alu-Alu blister pack.
Itracon Oral Solution: Each bottle contains 100 ml solution with a measuring cup.

Dosage & Administration

100 & 200 mg preparation:
For non-systemic fungal disease-

Vulvovaginal candidiasis: 200 mg twice daily for 01 day
Pityriasis versicolor: 200 mg once daily for 07 days
Tinea corporis, tinea cruris: 100 mg once daily for 15 days or 200 mg once daily for 7 days
Tinea pedis, tinea manuum: 100 mg once daily for 30 days
Oropharyngeal candidiasis: 100 mg once daily for 15 days, Increase dose to 200 mg once daily for 15 days in AIDS or neutropenic patients because of impaired absorption in these groups.
Onychomycosis (toenails with or without fingernail involvement): Either 200 mg daily for 3 months or course (pulse) of 200 mg twice daily for 7 days, subsequent courses repeated after 21 days' interval. Fingernails two courses, toenails three courses.

For systemic fungal disease-

Aspergillosis: 200 mg once daily for 2-5 months Increase dose to 200 mg twice daily in case of invasive or disseminated disease
Candidiasis: 100-200 mg once daily for 3 weeks-7 months. Increase dose to 200 mg twice daily in case of invasive or disseminated disease
Non-meningeal Cryptococcosis: 200 mg once daily for 10 weeks
Cryptococcal meningitis: 200 mg twice daily for 2-6 months
Histoplasmosis: 200 mg once daily twice daily for 8 months
Maintenance in AIDS: 200 mg once daily until immune recovery
Prophylaxis in neutropenia: 200 mg once daily until immune recovery
The dose and duration of treatment for systemic antifungal disease should be adjusted depending on the clinical response.

65 mg & 130 mg preparation:
For non-systemic fungal disease-

Vulvovaginal candidiasis: 130 mg twice daily for 1 day
Pityriasis versicolor: 65 mg twice daily for 7 days
Tinea corporis and tinea cruris: 65 mg daily for 15 days OR 65 mg twice daily for 7 days
Tinea pedis and tinea manuum: 65 mg once daily for 30 days
Oropharyngeal Candidiasis: 65 mg once daily for 15 days, increase dose to 65 mg twice daily for 15 days in AIDS or neutropenic patients because of impaired absorption in these groups.
Onychomycosis (toenails with or without fingernail involvement): Either 65 mg twice daily for 3 months or course (pulse) of 130 mg twice daily for 7 days, subsequent courses repeated after 21 days interval. Fingernails two courses, toenails three courses.

For systemic fungal disease-

Aspergillosis: 65 mg twice daily for 2-5 months. Increase dose to 130 mg twice daily in case of invasive or disseminated disease
Candidiasis: 65-130 mg once daily for 3 weeks-7 months. Increase dose to 65 mg twice daily in case of invasive or disseminated disease
Non-meningeal Cryptococcosis: 65 mg twice daily for 10 weeks
Cryptococcal meningitis: 130 mg twice daily for 2-6 months
Histoplasmosis: 130 mg once daily-twice daily for 8 months
Maintenance in AIDS: 65 mg twice daily until immune recovery
Prophylaxis in neutropenia: 65 mg twice daily until immune recovery
The dose and duration of treatment for systemic anti-fungal disease should be adjusted depending on the clinical response.

Pediatric use: The efficacy and safety of the Itracon capsule have not been established in pediatric patients.

* রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'