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Antifungals & Antivirals

Itranstad

 

Pack size:

Box of 1 blister x 6 capsules.

 

Composition:

Each capsule contains itraconazole 100 mg

(as itraconazole pellets 22%)


Shelf-life:

36 months from the date of the manufacturing.

Store in a well-closed container, in a dry place, protect from light. Do not store above 30oC.

 

 
  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Itranstad is administered orally and should be swallowed whole immediately after a meal.

Adults

Short-term therapy:

  • Oropharyngeal candidosis.
    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.
  • Vulvovaginal candidosis.
    200 mg twice daily for 1 day or 200 mg once daily for 3 days.
  • Pityriasis versicolor.
    200 mg once daily for 7 days.
  • Dermatophytosis caused by organisms susceptible to itraconazole (Trichophyton spp., Microsporum spp., Epidermophyton floccosum) e.g. tinea pedis, tinea cruris, tinea corporis, tinea manuum.
    100 mg once daily for 15 days. In highly keratinized regions: Require an additional treatment of 15 days at 100 mg daily.

Long-term therapy (for systemic fungal infections) should be dictated by the mycological and clinical response to therapy:

  • Onychomycosis (tinea unguium).
    200 mg once daily for 3 months.
  • Blastomycosis (pulmonary and extrapulmonary).
    200 mg once daily or twice daily for 8 months.
  • Histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis).
    200 mg once daily or twice daily for 8 months.
  • Aspergillosis (pulmonary and extrapulmonary in patients who do not respond to or cannot tolerate amphotericin B).
    200 mg once daily for 2 - 5 months; increase dose to 200 mg twice daily in case of invasive or disseminated disease.
  • Maintenance therapy in AIDS patients to prevent relapse of underlying fungal infection.
    200 mg once daily.
  • Itraconazole is also indicated in the prevention of fungal infection during prolonged neutropenia when standard therapy is considered inappropriate.
  • Non-meningeal cryptococcosis: 200 mg once daily, for 2 months to 1 year.
    Meningeal cryptococcosis: 200 mg twice daily. Maintenance dose: 200 mg once daily.
    Prophylaxis in neutropenia: 200 mg once daily.

Children

  • Safety and efficacy of itraconazole in children younger than 18 years of age have not been established.

 

Or as prescribed by physicians.

 

  • Patients with known hypersensitivity to itraconazole and other azoles or any ingredient in the formulation.
  • The patients are ongoing treatment with terfenadine, astemizole, oral triazolam, oral midazolam and cisapride.
  • Use of itraconazole for the treatment of onychomycosis in pregnant women or to women contemplating pregnancy.

     


Common:

  • Vertigo, headache.
  • Nausea, abdominal pain, constipation, dyspepsia.

Less common:

  • Allergic reactions, such as itch, exanthema, urticaria and angioedema; Stevens-Johnson syndrome.
  • Menstruation disturbances.
  • Reversible liver enzyme elevation, hepatitis, especially after long-term treatment.
     

Especially after long-time treatment (> 1 month), there is risk of hepatitis, hypokalemia, edema and alopecia. In rare cases there has also been reported cases of peripheral neuropathy.

 

  • Itraconazole should not be used for the treatment of onychomycosis in patients with evidence of ventricular dysfunction, such as congestive heart failure or history of congestive heart failure; should be discontinued in patients who develop congestive heart failure while receiving the drug.
  • Itraconazole therapy should not be used in patients with increased serum hepatic enzymes, active liver disease, or a history of liver toxicity with other drugs unless the potential benefits exceed the risks. In addition, serum hepatic enzyme monitoring should be considered for all patients receiving itraconazole, especially those who receive itraconazole therapy continuously for longer than 1 month.
  • If neuropathy occurs that may be attributable to itraconazole, the drug should be discontinued.
  • In systemic candidosis, if fluconazole-resistant strains of Candida species are suspected, it cannot be assumed that these are sensitive to itraconazole. Hence sensitivity should be tested before start of itraconazole therapy.
  • Pregnancy: Itraconazole has caused abnormalities in foetal development in rats. There is no studies in pregnant women, itraconazole should be used in pregnancy only if the benefit outweighs the potential risk.
  • Lactation: Breast feeding while receiving itraconazole is not recommended.
  • No studies on the effects on the ability to drive and use machines have been performed. When driving vehicles and operating machinery the possibility of adverse reactions such as dizziness, visual disturbances and hearing loss, which may occur in some instances, must be taken into account.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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