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Indications/Uses
Skin infections due to dermatophytes or yeasts and other fungi eg, Tinea capitis, Tinea corporis, Tinea manuum, Tinea barbae, Tinea cruris, Tinea pedis (athlete's foot).
Used in mycoses secondarily infected with such bacteria (eg, in napkin dermatitis) since miconazole nitrate has an antibacterial effect on gram-positive bacteria.
Used in mycoses secondarily infected with such bacteria (eg, in napkin dermatitis) since miconazole nitrate has an antibacterial effect on gram-positive bacteria.
Dosage/Direction for Use
Apply some cream to the lesions twice daily. Rub the cream into the skin with finger until it has fully penetrated the skin.
If the powder is used with the cream, a once daily application of both formulation is recommended.
The duration of therapy varies from 2-6 weeks depending on the localization and the severity of the lesion.
Treatment should be continued at least 1 week after disappearance of all signs and symptoms.
If the powder is used with the cream, a once daily application of both formulation is recommended.
The duration of therapy varies from 2-6 weeks depending on the localization and the severity of the lesion.
Treatment should be continued at least 1 week after disappearance of all signs and symptoms.
Overdosage
Symptoms: Topical Use: Excessive use can result to skin irritation, which usually disappears after discontinuation of therapy.
Treatment: Accidental Ingestion: Daktarin Cream is intended for topical use, not for oral use. Should accidental oral ingestion of large quantities of Daktarin Cream occurs, use appropriate supportive care.
Treatment: Accidental Ingestion: Daktarin Cream is intended for topical use, not for oral use. Should accidental oral ingestion of large quantities of Daktarin Cream occurs, use appropriate supportive care.
Contraindications
Daktarin is contraindicated in individuals with a known hypersensitivity to miconazole, another ingredient of the formulation, or other imidazole derivatives.
Special Precautions
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin and with other miconazole topical formulations (see Adverse Reactions). If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued.
Daktarin must not come into contact with the eyes.
Use in pregnancy: Daktarin Cream applied topically are minimally absorbed into the systemic circulation (bioavailability <1%). Although there is no evidence that miconazole is embryotoxic or teratogenic in animals, potential hazards of prescribing Daktarin Cream during pregnancy should always be weighed against the expected therapeutic benefits.
Use in lactation: Topically applied miconazole is minimally absorbed into the systemic circulation and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation. (See Interactions.)
Daktarin must not come into contact with the eyes.
Use in pregnancy: Daktarin Cream applied topically are minimally absorbed into the systemic circulation (bioavailability <1%). Although there is no evidence that miconazole is embryotoxic or teratogenic in animals, potential hazards of prescribing Daktarin Cream during pregnancy should always be weighed against the expected therapeutic benefits.
Use in lactation: Topically applied miconazole is minimally absorbed into the systemic circulation and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation. (See Interactions.)
Caution For Usage
Instructions for Use and Handling: To open the tube, unscrew the cap. Then pierce the seal of the tube with the pin on the top of the cap.
Storage
Store at temperature not exceeding 25°C.
Action
Pharmacology: Pharmacodynamics: 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.
Usually, miconazole acts very rapidly on pruritus, which frequently accompanies dermatophyte and yeast infections. This symptomatic improvement is seen before the 1st signs of healing are observed.
Miconazole has also been proven to be effective in secondary infected mycoses.
Pharmacokinetics: Absorption: Miconazole remains in the skin after topical application for up to 4 days. Systemic absorption of miconazole is limited, with a bioavailability of <1% following topical application of miconazole. Plasma concentrations of miconazole and/or its metabolites were measurable 24 and 48 hrs 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 Elimination: The small amount of miconazole that is absorbed is eliminated predominantly in feces as both unchanged drug and metabolites over a 4-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in the urine.
Toxicology: Non-clinical information: 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.
Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.
Usually, miconazole acts very rapidly on pruritus, which frequently accompanies dermatophyte and yeast infections. This symptomatic improvement is seen before the 1st signs of healing are observed.
Miconazole has also been proven to be effective in secondary infected mycoses.
Pharmacokinetics: Absorption: Miconazole remains in the skin after topical application for up to 4 days. Systemic absorption of miconazole is limited, with a bioavailability of <1% following topical application of miconazole. Plasma concentrations of miconazole and/or its metabolites were measurable 24 and 48 hrs 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 Elimination: The small amount of miconazole that is absorbed is eliminated predominantly in feces as both unchanged drug and metabolites over a 4-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in the urine.
Toxicology: Non-clinical information: 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.
MedsGo Class
Topical Antifungals & Antiparasites
Features
Brand
Daktarin
Full Details
Dosage Strength
20mg / g
Drug Ingredients
- Miconazole
Drug Packaging
Cream 5g
Generic Name
Miconazole Nitrate
Dosage Form
Cream
Registration Number
DR-XY14359
Drug Classification
Over-The-Counter (OTC)