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Stieva-A Cream
Tretinoin Preparation

Stieva-A Cream contains the active ingredient tretinoin USP in 0.01%, 0.025%, 0.05% and 0.1% concentrations.

Pharmacological Action
Tretinoin is structurally and pharmacologically related to Vitamin A, which regulates epithelial cell growth and differentiation.

Tretinoin, when applied topically, acts to stimulate mitosis in the epidermis and to reduce intercellular cohesion in the stratum corneum. Tretinoin contests the hyperkeratosis characteristic of acne vulgaris and aids desquamation, preventing the formation of lesions. Tretinoin also mediates an increased production of less cohesive epidermal sebaceous cells, which consequently flow out of the follicle at a more rapid rate. This appears to promote the initial expulsion and subsequent prevention of comedones, which are composed of thickened sebaceous cellular debris.

Indications and Uses
Stieva-A is indicated for use in the treatment of acne vulgaris, in particular forms where comedones, papules and pustules predominate. It is not generally effective in most cases of severe pustular or nodulocystic acne.

Route of Administration

For topical application only.

Recommended Dosage
Stieva-A should be applied once daily before retiring to the whole area under treatment. The skin should be thoroughly cleansed and dried before application.

Therapeutic effects may not be seen until 8-10 weeks after the start of treatment. Treatment should normally be continued for three months.

Patients being treated with Stieva-A may continue to use cosmetics.

Patients with known hypersensitivity to any of the ingredients should not use Stieva-A.

Stieva-A has been reported to cause severe irritation of eczematous skin and should only be used with the utmost caution in patients with this condition.

Stieva-A should not be used in patients with a personal or family history of cutaneous epithelioma.

Use in Pregnancy and Lactation

Studies in animals have shown that oral tretinoin is foetotoxic in rats given 500 times the topical human dose and teratogenic in rats given 1000 times the topical human dose. Topical tretinoin has caused delayed ossification in a number of bones in the offspring of rats and rabbits given 100 to 320 times the topical human dose respectively. Isolated cases suggesting a possible link between use of topical tretinoin during pregnancy and birth defects have been reported, although a case-control study showed no such association. Use of topical tretinoin is not recommended during pregnancy, especially during the first trimester.

Precautions and Warnings
Avoid contact of Stieva-A with the eyes, eyelids, mouth and other mucous membranes and with the angles of the nose and nasolabular fold.

Avoid excessive application.

Studies have shown that in mice treated with tretinoin and exposed to UV light, tretinoin may speed up the appearance of tumours induced by UV light (artificial sunlight); mice treated with tretinoin but not exposed to the light did not develop tumours. The significance of these findings as related to human beings is unknown. Exposure of areas treated with Stieva-A to sunlight should be avoided or minimised. The use of sunlamps should be avoided during treatment.

Side Effects
Initial application may cause a transient stinging and feeling of warmth. The correct frequency of application will produce a slight erythema similar to sunburn. If Stieva-A is applied excessively, marked redness or peeling and irritation may occur. In such cases the frequency of application should be reduced or treatment interrupted.

Temporary hyper-pigmentation and hypo-pigmentation have been reported following the use of tretinoin preparations.

All side effects so far reported have been reversible on discontinuation of therapy and in many cases did not recur on reinstitution of treatment with Stieva-A.

Excessive topical use: Discontinue use of Stieva-A, apply emollients as necessary.
Ingestion: Unless the quantity ingested is small, gastric lavage should be used.

Drug Interactions
Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentration of alcohol, astringents, spices or lime should be used with caution because of possible interaction with tretinoin.

Particular caution should be exercised when using preparations containing a peeling agent (for example sulphur, resorcinol, benzoyl peroxide or salicylic acid). It may be advisable to 'rest' a patient's skin until the effects of previously used peeling agents subside before initiating Stieva-A therapy.

No reports on incompatibilities with this drug.

Stieva-A Cream is supplied in epoxy-lined aluminium tubes of 25g capacity. The tube is presented in a carton with a package insert.

Storage Condition
Stieva-A should be stored at temperatures not exceeding 25C.











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