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PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Pharmacotherapeutic classification: (Antifungals for dermatological/topical use; imidazole derivative.)
ATC code: D01A C02
Miconazole combines an antifungal activity against the common dermatophytes, yeasts and various other fungi with an antibacterial activity against certain gram-positive bacilli and cocci.
Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.
Miconazole has also been proven to be effective in secondarily infected mycoses.
Usually, miconazole acts very rapidly on pruritus, which frequently accompanies dermatophyte and yeast infections. This symptomatic improvement is seen before the first signs of healing are observed.
Pharmacokinetic Properties
Absorption: Miconazole remains in the skin after topical application for up to 4 days. Systemic absorption of miconazole is limited, with a bioavailability of less than 1% following topical application of miconazole. Plasma concentrations of miconazole and/or its metabolites were measurable 24 and 48 hours after application.
Systemic absorption has also been demonstrated after repeated application of miconazole to infants with diaper dermatitis. Plasma levels of miconazole were undetectable or low in all infants.
Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).
Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in feces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine.
Preclinical Safety Data
Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.
PHARMACEUTICAL PARTICULARS
List of Excipients
DAKTARIN Cream: The cream formulation consists of PEG-6 (and) PEG-32 (and) glycol stearate, oleoyl macrogolglycerides, liquid paraffin, benzoic acid, butylated hydroxyanisole, purified water.
DAKTARIN Powder: The powder formulation consists of talc, zinc oxide, colloidal silicon dioxide.
DAKTARIN Tincture: The tincture formulation consists of acrylic/acrylate copolymer, propylene glycol and alcohol.
Incompatibilities
None known.
Shelf Life
Observe expiry date on the outer carton.
Special Precautions for Storage
DAKTARIN Cream: Store between 15°C and 25°C.
DAKTARIN Powder: Store between 15°C and 30°C.
DAKTARIN Tincture: Store between 15°C and 30°C.
Keep DAKTARIN Cream, Powder and Tincture out of reach of children.
Nature and Contents of Container
DAKTARIN Cream (containing 20 mg of miconazole nitrate per g) is supplied in tubes of 15 g cream.
DAKTARIN Powder (containing 20 mg of miconazole nitrate per g) is supplied in shakers of 20 g.
DAKTARIN Tincture (containing 20 mg of miconazole nitrate per ml) is supplied in 30 ml bottles (with brush).
Instructions for Use/handling
DAKTARIN Cream: To open the tube, unscrew the cap. Then pierce the seal of the tube with the pin on the top of the cap.
DAKTARIN Powder: Not applicable.
DAKTARIN Tincture: Use the brush attached to the cap of the bottle to apply the tincture.
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