Govazol

Composition :

Each capsule GOVAZOL® contains Fluconazole 150 mg

 

Pharmacology :

Fluconazole is a triazole group anti-fungus whose mechanism of action is by inhibiting the P450 cytochrome enzyme, blocking ergosterol synthesis.

 

Indication :

Fluconazole is indicated for the treatment:

  • Cryptococcal meningitis
  • Systemic Candidiasis including: candidemia, disseminated other forms of invasive candida infections (on the peritoneum, endocardium, lung and urinary tract)
  • Candidiasis oropharyngeal and esophageal
  • Acute reccurent vaginal candidiasis

 

Dosage :

The daily dose of Fluconazole should be based on the patient’s condition and the severity of the infection. Most cases of vaginal candidiasis respond to a single dose. Treatment for the type of infection requiring dose repetition should be given until clinical or laboratory parameters indicate that active yeast infection has disappeared. Lack of inadequate treatment can lead to a recurrence of active infection. AIDS sufferers and cryptococcal meningitis or recurrent oropharyngeal candidiasis, usually requiring maintenance therapy to prevent relapse.

 

Adult :

  • For cryptococcal meningitis: the usual dose of 400 mg on the first day is continued 200-400 mg, 1 times daily. The duration of treatment depends on the mycologic and clinical responses, but generally less than 6-8 weeks.
  • For the prevention of relapse of cryptococcal meningitis (especially in people with AIDS after receiving a series of initial therapy): 200 mg of Fluconazole daily for as long as needed.
  • For candidemia, disseminated candidiasis and other invasive candida infections: the usual dose of 400 mg on the first day and then 200 mg/day. Dosage may be increased to 400 mg/day depending on the clinical response. The duration of treatment also depends on the clinical response
  • For orpharyngeal candidiasis: the usual dose of 50 mg, once daily for 7-14 days. In severe immune compromised patients, the duration of administration may be prolonged if necessary
  • For other candida infections of the mucosa, such as esophagitis (except for vaginal candidiasis): the usual prevalent dose is 50 mg/day for 14-30 days. In difficult and unusual cases, the dose may be increased to 100 mg / day
  • For vaginal candidiasis: single dose 150 mg Fluconazole (oral)

 

Children :

  • Usage in children < 16 years old is not recommended. However, if it is considered very important by the doctor, then for children aged 1 year or older (with normal kidney function) is recommended dose 1-2 mg/kg/day for systemic candida or cryptococcal infection.
  • From the data obtained, after administration of Fluconazole in children aged 5-13 years showed that the elimination of Fluconazole faster than adults. Therefore, for life-threatening infections a larger dose is required. Doses up to 12 mg/kg body weight/day have been used in some children. Dosage should not exceed 400 mg/day (maximum dose for adult).
  • For children with impaired kidney function, the dose should be adjusted (depending on the level of renal impairment)

 

Elderly :

If there is no evidence of impaired renal function, use a normal dose. For patients with impaired renal function (creatinine clearance <40 ml / minute) the dose should be adjusted, as follows:

 

 

Creatinine clearance (ml/minute)

 

  

Dose Interval (daily dose)
 

> 40

21 – 40

 

10 – 20

 

  

Every 24 hours (according to usual dose)

 

Every 48 hours (½ usual dose)

 

1 dose each after dialysis

 

Presentation and Registration Number :

GOVAZOL® Box 1 strip @ 3 capsules; DKL9608006801B1

 

ON MEDICAL PRESCRIPTION ONLY

 

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