Product Information
Registration Status: ActivePRISTINEX CREAM 2% W/W is approved to be sold in Singapore with effective from 1999-01-21. It is marketed by APEX PHARMA MARKETING PTE LTD, with the registration number of SIN10695P.
This product contains Ketoconazole 2% w/w in the form of CREAM. It is approved for TOPICAL use.
This product is manufactured by XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD in MALAYSIA.
It is a Pharmacy Only Medicine that can be obtained from a pharmacist at a retail pharmacy.
Description
Broad spectrum antifungal agent used for long periods at high doses, especially in immunosuppressed patients. It is a racemate consisting of equimolar amounts of (2R,4S)- and (2S,4R)-ketoconazole with the chiral centers on the acetal ring.
Indication
For the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis.
Mechanism of Action
Ketoconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary for the conversion of lanosterol to ergosterol. This results in inhibition of ergosterol synthesis and increased fungal cellular permeability. Other mechanisms may involve the inhibition of endogenous respiration, interaction with membrane phospholipids, inhibition of yeast transformation to mycelial forms, inhibition of purine uptake, and impairment of triglyceride and/or phospholipid biosynthesis. Ketoconazole can also inhibit the synthesis of thromboxane and sterols such as aldosterone, cortisol, and testosterone.
Pharmacokinetics
- Absorption
- Moderate
- Distribution
- Metabolism
- Hepatic
- Elimination
Toxicity
Hepatotoxicity, LD50=86 mg/kg (orally in rat)
Active Ingredient/Synonyms
Ketoconazol | Ketoconazole | Ketoconazolum | Ketozole | Ketoconazole |
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.