NIZORAL CREAM 2%

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.

Active Ingredient / Synonyms

Ketoconazol | Ketoconazole | Ketoconazolum | Ketozole | Ketoconazole |

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.

Pharmacodynamics

Ketoconazole, like clotrimazole, fluconazole, itraconazole, and miconazole, is an imidazole antifungal agent.

Pharmacokinetics

Absorption:

Moderate

Distribution:

Not Available

Metabolism:

Hepatic

Elimination:

Not Available

Half-life

2 hours

Clearance

Not Available

Toxicity

Hepatotoxicity, LD50=86 mg/kg (orally in rat)

References

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

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Approval Information

NIZORAL CREAM 2% was registered with Health Science Authority of Singapore by JOHNSON & JOHNSON PTE LTD. It is marketed with the registration number of SIN01117P with effective from 1988-05-13.

This product contains 20mg/g of Ketoconazole in the form of CREAM.

The medicine was manufactured by JANSSEN PHARMACEUTICA NV in BELGIUM

It is a an Over-the-counter Medicine which can be freely obtained from any retailer

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: D01AC08

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