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Antifungals & Antivirals

Fluconazol STADA® 150 mg

 
Pack size:

Box of 1 blister x 1 capsule. 

 

Compostion:

Each capsule contains fluconazole 150 mg.

 

Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place.  Do not store above 300C.

 

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

  • Fluconazole is a triazole antifungal used for superficial mucosal (oropharyngeal, oesophageal, or vaginal) candidiasis and for fungal skin infections.
  • It is also given for systemic infections including systemic candidiasis, coccidioidomycosis, and cryptococcosis, and has been tried in blastomycosis, chromoblastomycosis, histoplasmosis, and sporotrichosis.
  • Prophylaxis: Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
    Dosage:
  • Fluconazole 150 mg by mouth as a single dose may be used for vaginal candidiasis or candidal balanitis.
  • Dermatophytosis, pityriasis versicolor, and Candida infections of the skin may be treated with fluconazole 50 mg daily by mouth for up to 6 weeks.
  • Systemic candidiasis, cryptococcal meningitis, and other cryptococcal infections may be treated with fluconazole. The initial dose is 400 mg followed by 200 to 400 mg daily. Duration of therapy is based on clinical and mycological response, but is usually at least 6 to 8 weeks in cryptococcal meningitis. Fluconazole may also be used in daily doses of 100 to 200 mg to prevent relapse following a primary course of antifungal treatment for acute cryptococcal meningitis in patients with AIDS.
  • In immunocompromised patients at risk of fungal infections, fluconazole may be given prophylactically in a dose of 50 to 400 mg daily, although long-term prophylaxis has been associated with the emergence of resistant organisms.
    Children:
  • Doses for children over 4 weeks of age are 3 mg/kg daily for superficial infections (a loading dose of 6 mg/kg may be used on the first day if necessary), and 6 to 12 mg/kg daily for systemic infections. For prophylaxis in immunocompromised children, a dose of 3 to 12 mg/kg daily may be given.
  • For infants under 2 weeks of age, all these doses should be given once every 72 hours; for those aged between 2 and 4 weeks, the dose should be given every 48 hours.
  • A maximum dose of 400 mg daily should not be exceeded in children, or 12 mg/kg at appropriate intervals in infants.
  • Dosage may need to be reduced in patients with renal impairment.
    Administration
  • High doses: Doses of fluconazole of up to 1000 mg daily have been tried in the treatment of cryptococcal meningitis. Daily doses of up to 800 mg have been used in blastomycosis and coccidioidomycosis, and doses of 10 mg/kg daily have been tried in disseminated candidiasis.
  • Administration in renal impairment: Patients with renal impairment may require dosage reduction. Normal loading or initial doses of fluconazole should be given on the first day of treatment and subsequent doses should be adjusted according to creatinine clearance. If the creatinine clearance is more than 50 ml/minute, the standard dose can be given. If the creatinine clearance is less than 50 ml/minute and the patient is not receiving dialysis, half the standard dose can be given. Patients on regular haemodialysis should receive a standard dose of fluconazole after every dialysis session. No dosage adjustment is needed in patients with renal impairment given single-dose therapy.
  • Intermittent doses: Once-weekly treatment with fluconazole has been tried in onychomycosis and tinea capitis.
  • Leishmaniasis: Fluconazole has been tried in the treatment of cutaneous leishmaniasis caused by Leishmania major.


Or as prescribed by physicians.

 

  • Patients who have shown hypersensitivity to fluconazole or to any ingredient of the drug.
  • Coadministration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400 mg or higher based upon results of a multiple dose interaction study. Coadministration of cisapride or astemizole is contraindicated in patients receiving fluconazole.

     

  • Adverse effects reported with fluconazole most commonly affect the gastrointestinal tract and include abdominal pain, diarrhoea, flatulence, nausea and vomiting, and taste disturbance. Other adverse effects include headache, dizziness, leucopenia, thrombocytopenia, hyperlipidaemias, and raised liver enzyme values. Serious hepatotoxicity has been reported in patients with severe underlying disease such as AIDS or malignancy. Anaphylaxis and angioedema have been reported rarely.
  • Skin reactions are rare but exfoliative cutaneous reactions such as toxic epidermal necrolysis and Stevens-Johnson syndrome have occurred, more commonly in patients with AIDS.
  • Alopecia: Alopecia has occasionally been reported in patients receiving fluconazole, especially during prolonged treatment.
  • Effects on the liver: Elevation of liver enzymes is commonly encountered and there have been reports of jaundice associated with fluconazole treatment.

     

  • No studies have been performed on the effects of fluconazole on the ability to drive or use machines. Patients should be warned about the potential for dizziness or seizures while taking fluconazole and should be advised not to drive or operate machines if any of these symptoms occur.
  • There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles.
  • Fluconazole should be used with caution in patients with impaired renal or hepatic function. Abnormalities in haematological, hepatic, and renal function tests have been observed in patients with serious underlying diseases such as AIDS or malignancy.
  • Geriatric use: fluconazole is primarily cleared by renal excretion as unchanged drug. Because elderly patients are more likely to have decreased renal function, care should be taken to adjust dose based on creatinine clearance. It may be useful to monitor renal function.
  • The drug should be used with caution in driving and operating machinery.
  • Pregnancy: It is recommended that fluconazole should be avoided during pregnancy.
  • Lactation: Fluconazole is distributed into breast milk, achieving concentrations similar to those found in maternal plasma, and its use in women who are breast feeding is not recommended.
  • No studies have been performed on the effects of fluconazole on the ability to drive or use machines. Patients should be warned about the potential for dizziness or seizures while taking fluconazole and should be advised not to drive or operate machines if any of these symptoms occur.
     

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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