TRACHON Capsule

Itraconazole 100 mg

Category:

COMPOSITION :

Trachon® Capsule, each capsule contains: Itraconazole pellet equivalent to Itraconazole 100 mg.

 

DESCRIPTIONS :

Trachon® containing Itraconazole pellet (equivalent to Itraconazole) is available as capsule 100 mg.

 

INDICATIONS :

Trachon® is indicated for treatment of :

  • Gynaecological : Vulvovaginal candidacies.
  • Dermatological/Opthalmological :
    1. Pityriasis versicolor, dermatomycosis, fungal keratitis and oral candidacies.
    2. Onychomycosis caused by dermatofit and/or yeast.
  • Systemic mycosis : Systemic aspergillosis and candidacies, cryptococcosis (including cryptococcal meningitis), histoplasmosis, sporotrichosis, paracoccidioidomycosis, blastomycosis and other systemic tropic mycosis.


DOSAGE AND ADMINISTRATIONS :

Taking immediately after a full meal is essential to ensure optimal absorption. Capsules must be swallowed whole.

  • Blastomycosis = 100 mg once daily until 200 mg twice a day during 6 months.
  • Gynaecological : Vulvovaginal candidacies = 200 mg twice a day during one day or 200 mg once a day during 3 days.
  • Dermatological/Opthalmological :
    1. Pityriasis versicolor = 200 mg once day during a week.
    2. Dermatomycosis = 200 mg once a day or 100 mg once a day during 7 days or 15 days.
  • Area with highly keratinisation such as tinea pedis and tinea manus need the dose about 200 mg twice a day during 7 days or 100 mg per day during 30 days.
  • Oral candidacies = 100 mg once a day during 15 days.
  • Some patients with immunocompromized such as neutropenia, AIDS or organ transplanted patient have lower level of oral bioavailability. Therefore, the dose should be given 2 times higher than usual.
  • Fungal keratitis = 200 mg once a day during 21 days.
  • Other systemic mycoses :
Other Systemic Mycoses Dose and Duration of Therapy
Indication Dose Median duration
Aspergillosis

 

 200 mg once daily

 

 2 – 5 months

If the case is invasive or disseminated, the dose should be increased twice daily.
Non-meningeal cryptococcosis 200 mg once daily 2 months – 1 year

Supported treatment (meningeal case) 200 mg once daily.
Cryptococcal meningitis 200 mg twice daily
Histoplasmosis 200 mg once daily or 200 mg twice daily 8 months
Sporotrichosis 100 mg once daily 3 months
Paracoccidioidomycosis 100 mg once daily 6 months
Blastomycosis 100 mg once a day 200 mg twice a day 6 months

 

 
  • Onycomycosis : 200 mg twice daily for 7 days. Treatment with 2 one-week courses is recommended for fingernail infections and 3 one weeks courses for toenail infections. The one-week courses are always separated by a 3-week drug-free interval. Clinical response will become evident as the nail regrows, following discontinuation of the treatment.

Intraconazole Onychomycosis Dosing Schedule

Pulse 11 Pulse 21 Pulse 31
Site of Onychomycosis Week

1

 Week

2

 Week

3

 Week

4

 Week

5

 Week

6

 Week

7

 Week

8

 Week

9
Toenails with/without fingernail involvement 200 mg BID for 7 days Itraconazole – free weeks 200 mg BID for 7 days Itraconazole – free weeks 200 mg BID for 7 days
Fingernails only 200 mg BID for 7 days Itraconazole – free weeks 200 mg BID for 7 days

A pulse = 1 week couse of treatment

 

CONTRAINDICATIONS :

Itraconazole is contraindicated for :

  • Patients who have shown hypersensitivity to Itraconazole or its excipients. Use with caution in prescribing to patients with hypersensitivity to other azoles.
  • Treatment in pregnant women or in women contemplating pregnancy. If Itraconazole is given to women of childbearing potential, she must prevent pregnancy, effective contraception should be continued until one menstruation cycle following the end of treatment.
  • Coadministration of Pimozide, Quinidine, Dofetilide, Cisapride, Mizolastine, Astemizole, Terfenadine, Triazolam or oral Midazolam.
  • HMG-CoA reductase inhibitors metabolized by the CYP3A4 enzyme system (e.g., Lovastatin, Simvastatin) during Itraconazole therapy.

 

WARNINGS AND PRECAUTIONS :

  • Itraconazole has been shown to have a negative inotropic effect and has been associated with reports of CHF (Congestive Heart Failure). Itraconazole should not be given to patients with evidence of ventricular dysfunction such as CHF or a history of CHF except its benefit is much greater than its risk and still concerning in disease, regimen dose and the risk factor of CHF. These risk factors include cardiac disease such as ischemic and valvular disease, significant pulmonary disease such as chronic obstructive pulmonary disease, renal failure and other edematous disorders. Such patients should be informed of the signs and symptoms of CHF, should be freated with caution, and should be monitored for signs and symptoms of CHF during treatment. If signs or symptoms of CHF appear during administration of Itraconazole, discontinue administration.
  • Itraconazole is metabolized in the liver. The terminal half-life of Itraconazole in cirrhotic patients is somewhat prolonged. A decrease in the oral bioavailability of Itraconazole from Itraconazole capsules was observed in cirrhotic patient; this can also be expected with the oral solution. It is advisable to monitor Itraconazole plasma concentrations and to adapt the dose when necessary. In patients with raised liver enzymes or an active liver disease or who have experienced liver toxicity with other drugs, do not start treatment unless the expected benefit exceeds the risk of hepatic injury. In such cases, liver enzyme monitoring is necessary.
  • It is advisable to monitor liver function in patients receiving continuous treatment of more than 1 month and promptly in patients developing symptoms suggestive of hepatitis (e.g., anorexia, nausea, vomiting, fatigue, abdominal pain, dark urine). If signs or symptoms appear, discontinue administration.
  • Discontinue if neuropathy occurs that may be attributable to Itraconazole capsules.
  • Absorption of Itraconazole from the capsules is impaired when gastric acidity is decrease. In patients also receiving acid-neutralizing medicines (e.g., Aluminium hydroxide), these should be given at least 2 hours after the intake of Itraconazole capsules. In patients with achlorhydria, such as certain AIDS patients on acid secretion suppressors (e.g., H2 antagonists, Proton Pump Inhibitors), it is advisable to give Itraconazole capsules with a cola beverage.
  • Itraconazole is excreted in breast milk, therefore it is not recommended to use this drug during lactation except its benefit exceed the risk or advise the patient to discontinue nursing while taking Itraconazole.
  • Safety and efficacy in children have not been established. Therefore, not recommended to be given to children except its benefit is much greater than the risk.
  • Renal insufficient : Bioavailability of Itraconazole is lower than normal patient. Monitoring of plasma concentration and dose adjustment may be needed.
  • There is no information regarding hypersensitivity interactions of Itraconazole and another azole antifungal. Use with caution for patients with hypersensitivity of another.

 

PRESENTATION :

Trachon® Capsule 100 mg                    Box, 1 strip @ 10 capsules                                Reg. No. DKL9902328301A1

 

STORAGE :

STORE BELOW 30ºC, PROTECT FROM LIGHT

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

PT. BERNOFARM

Sidoarjo – Indonesia

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