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复方酮康唑软膏
  • 复方酮康唑软膏
ENGLISH NAME: Compound Ketoconazole Ointment
SPECIFICATIONS:  (1) 10 g : Ketoconazole 100 mg : clobetasol propionate 5 mg; (2)  15 g : Ketoconazole 150 mg : clobetasol propionate 7.5 mg; (3) 10 g : Ketoconazole 200 mg : clobetasol propionate 10 mg;
LICENSE NUMBER:  H20064290
PRODUCT PACKAGING: Aluminium Tube
FORMULATION: Ointment
STORAGE CONDITION: Shading, Closed, Preservation of the Shade
SHELF LIFE: 18 Months
Description: This product is a white or almost white ointment.

Pharmacological effects: The active ingredient of Compound Ketoconazole Ointment is ketoconazole, a pyrrolidine antifungal agent. It has extremely potent anti-mycotic actions against dermatophytes and yeasts (candidiasis, Pityrosporum sabour, Torulopsis, Cryptococcus), histoplasmosis capsulalum, Eumycetes. However the product has weak inhibitory action to Aspergillus, Sporothrix schenckii, dematiaceous fungi and mucor except for Entomophthorales. Ketoconazole can selectively inhibit the cytochromes P-450 activity of fungi. Therefore, the Biosynthesis of Ergosterol on the cell membrane is inhibited. Clobetasol Propionate is a hormone of the cortex that is highly effective anti-inflammation and capillary contraction.


Pharmacokinetics: Ketoconazole which is applied to the chest, back and buttocks of the healthy volunteers can not be inspected in blood (Detectable Limit is less than 5ng/ml) during the first 72 hours. Clobetasol Propionate can be completely absorbed by derma. The administered dose is metabolized, primarily in the liver. And it is excreted by kidney.

Indications: The product is indicated for the topical treatment of fungal infections of the skin including Tinea Cruris, Tinea Corporis; tenea manus, tinea pedis, and so on.

Precautions: Avoid contacting with eyes. If your skin problem does not improve within 2~4weeks for cutaneous candidiasis, pityriasis versicolor, tinea corporis, or tinea cruris; or 4 weeks for seborrheic dermatitis; or if it becomes worse, check with your doctor.Compound Ketoconazole Ointment contains Clobetasol Propionate. If the product is administered for long term in large area or used with banding treatment it may induce the reversibility restraint of PHA axis. Cushing syndromes, hyperglycosemia, urinary glucose etc. can be occurred on some patents. So long term and large area using the product is not recommended. Banding treatments is not recommended too. Combining with other skin infection, the anti-infective drugs should be administrated. If the infection has not been controlled, stop using the product until the infection is controlled.Pregnant and lactation women should be used with caution. Large area and long term using is not recommended.

Adverse reaction: Erythema, burning, itch, sharp pain or other stimulus symptom,folliculitis, skin atrophy, capillarectasis, etc are commonly seen.  Skin dryness, pilosis polytrichia, striae atrophicae and infectious susceptibility increasing can be observed. Adrenocortical hyperfunction can be induced by long term using. The symptom includes pilosis polytrichia, acne, moon face, Osteoporosis, etc. Allergic contact dermatitis can be seen on occasion. 
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