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DIFLUCAN FOR ORAL SUSPENSION 50mg/5ml

Product Information

Registration Status: Active

SIN08903P

DIFLUCAN FOR ORAL SUSPENSION 50mg/5ml is approved to be sold in Singapore with effective from 1996-04-09. It is marketed by PFIZER PTE LTD, with the registration number of SIN08903P.

This product contains Fluconazole 50mg/5ml in the form of SUSPENSION. It is approved for ORAL use.

This product is manufactured by PFIZER PGM in FRANCE.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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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.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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