Compound Ketoconazole Cream:
Ketoconazole+ Clobetasol Propionate + Neomycin Sulfate Cream
COMPOSITION
Each gram of cream contains:
Ketoconazole 10 mg Clobetasol Propionate 0.25 mg Neomycin sulfate 5000IU
DESCRIPTION
20g tubes of a white to off-white cream with an emulsive base.
CLINICAL PHARMACOLOGY
The active ingredient of Compound Ketoconazole Cream is ketoconazole, an antifugal agent with a broad-spectrum of activity from the Imidazole group. Compound Ketoconazole Cream has extremely potent anti-mycotic actions against dermatophytes, its spectrum of activity normally against following: Candida Albicans, Toulopsis, Cryptococcus, Pityrosporium.
Clobelasol Propionate is a homone of the cortex that is highly effective as an anti-inflammatory and anti-allergenic agent with little or no side effects.
Neomycin is known to be effective against gram-positive cocci and gram-negative bacilli. The synergies obtained in the composition of the compound results in the cream being highly effective against fungi, bacteria, inflammation and pruritus.
INDICATIONS
Compound Ketoconazole Cream is indicated for topical treatment of fungal infections of the skin including: Tinea Manus, Tinea Pedis, Tinea Corporis, Tinea Cruris, Tinea Cersicolor, Dermatitis, Allergic reactions such as Eczema, Pruritus.
CONTRAINDICATIONS
Compound Ketoconazole Cream is contradicted in patients with known hypersensitivity to any of its ingredients.
Compound Ketoconazole Cream is for topical use only and can not be internal or ophthalmic use. Special precautions must beobserved during use on pregnant women and children.
INTERACTIONS
Compound Ketoconazole Cream as a topical cream dose not interact with any other product.
WARNINGS
For external use only. B) Avoid contact eyes. C) Do not exceed prescribed dosage. D) Read carefully before using.
PRECAUTIONS
Clinical studies of transcutaneous absorption conducted on animals and hum ans have proved that the reabsorption rate of ketoconazole cream is negligible; as such Compound Ketoconazole Cream can be used in pregnancy under the supervision of a medical doctor. Application to the face or on large areas for longer periods of time than recommended in leaflet should be under a medical doctor's supervision.
ADVERSE REACTIONS
Compound Ketoconazole Cream is topical antifungal cream that is well tolerated and has little or no side effects when used properly. On occasion, irritation or burning sensation may occur during treatment. However it is unnecessary to discontinue treatment with Compound Ketoconazole Cream. In severe or extreme cases you may contact the doctor.
SYMPTOMS OF OVERDOSE AND TREATMENT
Compound Ketoconazole Cream is well tolerated, no adverse effect has been observed in the event of over dosage.
DOSAGEAND ADMINISTRATION
Apply to the affected area once a day, depending on the severity of the infection, the cream may be applied on the affected area twice daily when necessary. Generally, the duration of application depends on the type of infecting organism: treat as bellows for the following:
Tinea Corporis 2 weeks Tinea Cruris 2 weeks Tinea Pedis 4weeks Tinea Manus 4 weeks
Infection normally resistant to anlifungal agents 4-6 weeks
STORAGE
Store in a cool dry place away from sunlight.
CHILDREN'S WARNING
Keep out of reach of children.
EXPIRATION DATE
Indicated on the tube and box. Three years from the date of manufacture.
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