FLUCONAZOLE KABI SOLUTION FOR INFUSION 2MG/ML

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.

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 |

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.

Pharmacodynamics

Fluconazole, a synthetic antifungal agent of the imidazole class, is used to treat vaginal candidiasis. It inhibits the fungal lanosterol 14 alpha-demethylase which thereby prevents the formation of ergosterol which is an essential component in the fungal cell membrane.

Pharmacokinetics

Absorption:

90%

Distribution:

Not Available

Metabolism:

Hepatic

Elimination:

In normal volunteers, fluconazole is cleared primarily by renal excretion, with approximately 80% of the administered dose appearing in the urine as unchanged drug.

Half-life

30 hours (range 20-50 hours)

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.

References

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

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Approval Information

FLUCONAZOLE KABI SOLUTION FOR INFUSION 2MG/ML was registered with Health Science Authority of Singapore by FRESENIUS KABI (SINGAPORE) PTE LTD. It is marketed with the registration number of SIN15044P with effective from 2016-07-04.

This product contains 2mg/ml of Fluconazole in the form of INTRAVENOUS INFUSION, SOLUTION.

The medicine was manufactured by Fresenius Kabi Poland Sp. Z o.o. in POLAND

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

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: J02AC01

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