Product Description

Indications

Nocandia SB 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 ... Read more

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Pharmacology

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 co-ordination of chitin synthesis leading to inhibition of growth, abnormal cell wall formation and accumulation of intracellular lipids and membranous vesicles.

SUBA (Super Bio-available) technology is a novel technology for enhancing the bioavailability of poorly soluble drugs. This technology utilizes a solid dispersion of drug in a polymer that improves the dissolution of poorly soluble drugs compared to their normal crystalline form. SUBA technology Itraconazole is an orally active triazole antifungal drug that has demonstrated a broad spectrum of activity and favorable pharmacokinetic profile.

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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.

50 mg capsule-

For non-systemic fungal disease:

Indication Dose & Duration

Pityriasis versicolor Treatment doses:

Children >4 weeks to <12 years old:

Usual dose: 1.25-2 mg/kg/dose (to a maximum initial dose of 100 mg) given twice daily. Dose should be adjusted based on therapeutic drug monitoring.

The dose may be increased to 5 mg/kg/dose (to a maximum initial dose of 100 mg) given twice daily for severe infections. The maximum daily dose may be increased based on therapeutic drug monitoring in discussion with the physicians.

The dose should be rounded to the nearest 50 mg to facilitate administration.

Children ≥12 years old: Usual dose: 50 mg to 100 mg once daily. Dose may be increased to 100 mg twice daily in severe infections.

Prophylaxis doses:

Children ≥2 years old: 2.5 mg/kg/dose given once daily (to a maximum initial dose of 200 mg daily). Dose should be adjusted based on therapeutic drug monitoring.

Tinea corporis and tinea cruris

Tinea pedis and tinea manuum

Oropharyngeal Candidiasis

Onychomycosis (toenails with or without fingernail involvement)

For systemic fungal disease:

Indication Dose & Duration

Aspergillosis Treatment doses:

Children >4 weeks to <12 years old:

Usual dose: 1.25-2 mg/kg/dose (to a maximum initial dose of 100 mg) given twice daily. Dose should be adjusted based on therapeutic drug monitoring.

The dose may be increased to 5 mg/kg/dose (to a maximum initial dose of 100 mg) given twice daily for severe infections. The maximum daily dose may be increased based on therapeutic drug monitoring in discussion with the physicians.

The dose should be rounded to the nearest 50 mg to facilitate administration.

Children ≥12 years old: Usual dose: 50 mg to 100 mg once daily. Dose may be increased to 100 mg twice daily in severe infections.

Prophylaxis doses:

Children ≥2 years old: 2.5 mg/kg/dose given once daily (to a maximum initial dose of 200 mg daily). Dose should be adjusted based on therapeutic drug monitoring.

Candidiasis

Non-meningeal Cryptococcosis

Cryptococcal Meningitis

Histoplasmosis

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Interaction

The drugs like terfenadine, astemizole, cisapride, HMG-CoA reductase inhibitors such as simvastatin, oral midazolam or triazolam should not be given concurrently with Nocandia SB. Significant interactions also observed during co-administration of rifampin, phenytoin, phenobarbital, digoxin, and calcium channel blockers. There is no experience of overdosage with Nocandia SB.

Contraindications

Itraconazole 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 Itraconazole. It is not advisable to use the drug in patients taking rifampin, which appears to initially inhibit and then enhance the metabolism of Itraconazole.

Side Effects

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 hypokalaemia, oedema and hair loss reported.

Pregnancy & Lactation

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

Precautions & Warnings

Absorption is impaired when gastric acidity is reduced. In patients receiving acid neutralizing medicines (e.g. aluminium hydroxide), these should be administered at least 2 hours after the intake of Nocandia SB. 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.

Therapeutic Class

Drugs for subcutaneous and mycoses

Storage Conditions

Store below 25°C, in a cool & dry place. Keep away from light. Keep all the medicine out of the reach of children.

Common Questions about Nocandia SB 65 mg Capsule

What is Nocandia SB 65 mg Capsule?

Nocandia SB 65 mg Capsule is an antifungal medication that inhibits Cytochrome P-450 dependent enzymes.

What is Nocandia SB 65 mg Capsule used for?

Nocandia SB 65 mg Capsule is used to treat fungal infections.

How long is the duration of effect?

The effect of Nocandia SB 65 mg Capsule lasts up to 16 to 28 hours.

What is the onset of action?

The peak effect of Nocandia SB 65 mg Capsule is observed to be in 2 hours.

Are there any pregnancy warnings?

Nocandia SB 65 mg Capsule is not recommended to pregnant women. In the case of absolute necessity, one must consult the doctor and discuss its pros and cons.

Is it habit forming?

Nocandia SB 65 mg Capsule is not reported to be a habit forming drug.

Are there any breast-feeding warnings?

Nocandia SB 65 mg Capsule is not recommended for breastfeeding women. In the case of absolute necessity, one must consult the doctor and discuss its pros and cons.

Quick Tips

Nocandia SB 65 mg Capsule helps treat fungal infections of mouth, skin, vagina or any other parts of the body.

Do not skip any doses and finish the full course of treatment even if you feel better.

Take Nocandia SB 65 mg Capsule with food, preferably at the same time everyday.

Use a reliable method of contraception to prevent pregnancy while taking Nocandia SB 65 mg Capsule.

Do not take indigestion remedies (antacids) within two hours of taking Nocandia SB 65 mg Capsule.

Your doctor may check your liver function before starting treatment and regularly thereafter. Inform your doctor if you notice yellowing of eyes or skin, dark urine, or stomach pain.

Inform your doctor if you develop allergic reactions, nerve pain, or hearing loss.

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