HSA Reclassified Drug | Exemptions For Supply of Fluconazole Without Prescription

 

Criteria

Eligible Active Ingredient: Fluconazole. As an oral preparation containing 150mg
With Effective From: 1-Jan-13
Indication Permitted: Indications: Vaginal Candidiasis
Maximum Daily Dose: 150mg
Maximum Supply per Transaction: 1 tablet
Minimum Age of User: 16 years. Not recommended in adults older than 60 years of age
Patient Information Leaflet from HSA/PSS: Download PIL (Link to HSA website)

 

Mechanism of Action of Fluconazole

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.

Additional Information of Fluconazole

Pharmacology Class: Antimycotics For Systemic Use
Therapeutic Class: Antimycotics For Systemic Use
Chemical Class: Triazole Derivatives
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


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HSA-registered therapeutic products granted exemption to supply without prescription

References

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

HSA-Registered Products Containing Fluconazole As an oral preparation containing 150mg

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This list is not exhaustive. HSA collaborates with Pharmaceurical Society of Singapore (PSS) to review the appropriate use of therapeutic products in the community from time to time. Hence, HSA may enable the supply of a Prescription Only Medicine (POM) by pharmacists without a prescription, upon review that the product can be used in a safe and effective manner under the supervision of a pharmacist. This can be effected through legislative mechanisms in the absence of an application made by the product registrant to reclassify the therapeutic product, subject to to conditions including indication, strength, maximum daily dose, maximum supply quantity, and age restriction.