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Compound Ketoconazole Cream

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Indication: 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. 
Usage volume: Apply to the affected area two or three times daily......
Product specifications: A tube containing 10 g.

Product introduction

Product name: Compound Ketoconazole Cream
Composition: Every tube (10g) of Compound Ketoconazole Cream contains Ketoconazole 0.1g, Clobetasol Propionate 2.5mg, Neomycin Sulfate 50,000units;
Description: a white or almost white cream.
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.
Specification: 10g: Ketoconazole 0.1g, Clobetasol Propionate 2.5mg, Neomycin Sulfate 50,000units;
Dosage and Administration: Apply to the affected area two or three times daily. Generally, the duration of application depends on the type of infecting organism. Treat as below for the following:
Tinea Corporis                 2 weeks
Tinea Cruris                   2 weeks
Tinea Manus                   4 weeks
Tinea Pedis                    4 weeks
Adverse Reactions:
(1) Erythema, burning, itch, sharp pain or other stimulus symptom, folliculitis, skin atrophy, capillarectasis, etc are commonly seen.
(2) Skin dryness, pilosis polytrichia, striae atrophicae and infectious susceptibility increasing can be observed.
(3) Adrenocortical hyperfunction can be induced by long term using. The symptom includes pilosis polytrichia, acne, moon face, Osteoporosis, etc.
(4) Allergic contact dermatitis can be seen on occasion.
Contraindications: Compound Ketoconazole Cream is contra-indicated in the patients with known hydpersensitivity to any of its active ingredients pyrrolidine drugs, Ampyrimine drugs and adrenocorticoids.
Precautions:
(1) Avoid contacting with eyes.
(2) Patients with tinea cruris avoid wearing underwear that is tight-fitting or made from synthetic materials (e.g., rayon, nylon). Instead, wear loose-fitting, cotton underwear.
(3) Patient with tinea pedis avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if your feet sweat a lot. Wear well-ventilated shoes.
(4) 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.
(5) Compound Ketoconazole Cream 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.
(6) The product can be used in the cockled skin of the face, armpit and groin under the supervision of a medical doctor.
(7) 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.
(8) When the local Ulcer and damage occur, Neomycin Sulfate is absorbed increasingly. The adverse reaction of aminoglycoside drug should be observed.
Pregnancy and lactation
(1)Pregnant and lactation women should be used with caution.
(2)Large area and long term using is not recommended.
Children: wean is forbidden.
The elderly: Nil.
Over dosage: Nil.
Drug interactions Nil.
Pharmacology and Toxicology: The active ingredient of Compound Ketoconazole Cream 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.
Action mechanism of Ketoconazole: it 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.
Neomycin Sulfate, external use aminoglycoside antibiotics, can treat local infection.
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.
Neomycin Sulfate can be rarely absorbed by derma. However when the skin is ulcer and breakage it can be absorbed increasingly.
Storage: Preserve in closed containers, store below 20°C
Package:  A tube containing 10 g.
Shelf life:  24 months
Registration number : Guo-Yao-Zhun-Zi H20043453