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Tydineal Cream

Osworth Nigeria Limited
3/5 Sapara Street, Industrial Estate Ikeja, Lagos
Email: Osworthnigeria@yahoo.com
Tel: 07098005296, 08087189930

Brand Name

Tydineal Cream

Manufacturer

Tydipacks Nig. Ltd. 3/5 Sapara Street Industrial Estate, Ikeja, Lagos, Nigeria

Therapeutic Class

Anti-infective/Corticosteroid combinations, Skin

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Cream (NRN: A4-9674): Ketoconazole 10 mg B.P, Neomycin Sulfate 5000 IU B.P. and Clobetasol propionate 0.25 mg B.P

Pack Size: presented in a 20 g tube

Pharmacology

A white or off-white cream with an emulsive base.

CLINICAL PHARMACOLOGY:

Ketoconazole is a broad-spectrum antifungal agent that acts on the cell membranes of fungi by changing its permeability; Pharmacological studies have shown that Ketoconazole has extremely potent antimycotic actions against dermatophytes (such as Trichophyton sp., Microsporom sp. and epidermophton sp.), saccharomyces and candida albicans.

Strains of fungi are unlikely to have a natural resistance to Ketoconazole. Clobetasol is a cortex hormone that is highly effective against Gram-positive cocci and Gram-negative bacilli. As a result, this compound cream is jointly effective against fungi, bacteria, inflammation and pruritis.

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 5 ng/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 has ulcer or breakages, it can be absorbed increasingly.

Indications

Tydineal cream is indicated for topical application in the treatment of fungal infections of the skin, such as tinea manus, tinea corporis, tinea cruris and tinea versicolor. It is has also proved effective in the treatment of many kinds of dermatitis, eczema and pruritis.

Contra-indications

Tydineal cream is contraindicated in patients with known hypersensitivity to any of its ingredients. It is not for ophthalmic use. Take special precautions in usage during pregnancy and on infants.

Precautions/Warnings

PRECAUTIONS

Tydineal should be used under a Doctor’s supervision when applied on the face or on a large area of skin for a long period of time. Avoid contact with eyes and mucous membranes.

SPECIAL PRECAUTIONS:

For external use only Avoid contact with eyes Keep out of reach of children Do not exceed prescribed dosage Read carefully before using This drug should be used under a doctor’s prescription

Interactions

Not Known

Adverse Effects

Tydineal cream has few side effects when used topically. A few instances of irritation, itching or burning sensation may be observed occasionally during the treatment. It should be discontinued if this is severe.

Dosage & Administration

FOR EXTERNAL USE ONLY

Apply externally to the affected area twice daily. It is suggested to use Tydineal® for two (2) weeks on tinea corporis and tinea cruris and for four (4) weeks on tinea pedis and tinea manus.

Storage/Handling Recommendations

Preserve in a well-closed container, below 25°C and protected from light.

Review Date

2016-08-16 04:41:12