Product Information
Registration Status: ActiveSIN13329P
APO-FLUCONAZOLE 150MG CAPSULE is approved to be sold in Singapore with effective from 2007-03-08. It is marketed by PHARMAFORTE SINGAPORE PTE LTD, with the registration number of SIN13329P.
This product contains Fluconazole 150mg per capsule in the form of CAPSULE. It is approved for ORAL use.
This product is manufactured by Apotex Inc in CANADA.
It is a has been granted the exemption for supply without a presciption if it met certain criteria.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Triazole antifungal agent that is used to treat oropharyngeal candidiasis and cryptococcal meningitis in AIDS. [PubChem]
Indication
For the treatment of fungal infections.
Mechanism of Action
Fluconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Fluconazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis.
Pharmacokinetics
- Absorption
- 90%
- Distribution
- Metabolism
- Hepatic
- Elimination
Clearance
* 0.23 mL/min/Kg [adults] * 0.18 mL/min/Kg [In premature newborns within 36 hours of birth] * 0.22 mL/min/Kg [In premature newborns 6 days old] * 0.33 mL/min/Kg [In premature newborns 12 days old] * 0.4 mL/min/kg [9 Months-13 yearsreceiving single-oral 2 mg/kg] * 0.51 mL/min/Kg [9 Months-13 yearsreceiving single-oral 8 mg/kg] * 0.49 mL/min/Kg [5-15 yearsreceiving multiple IV 2 mg/kg] * 0.59 mL/min/Kg [5-15 yearsreceiving multiple IV 4 mg/kg] * 0.66 mL/min/Kg [5-15 yearsreceiving multiple IV 8 mg/kg]
Toxicity
Symptoms of overdose include hallucinations and paranoid behavior.
Active Ingredient/Synonyms
2-(2,4-DIFLUOROPHENYL)-1,3-di(1H-1,2,4-triazol-1-yl)propan-2-ol | 2,4-Difluoro-alpha,alpha-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol | Biozole | Elazor | Fluconazol | Fluconazolum | Triflucan | Fluconazole |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.