Dosage Form: Cream
For topical application within the treatment of skin break out vulgaris in which comedones, papules and pustules prevail,
Although the exact mode of action of Tretinoin is unknown, current evidence suggests that topical Tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally Tretinoin stimulates mitotic activity and increases turnover of follicular epithelial cells, causing extrusion of the comedones, papules and pustules.
This cream should be applied sparingly to the whole affected area once or twice daily. The skin should be thoroughly cleaned and dried before application. Patient should be advised that 6 to 8 weeks of treatment may be required before a therapeutic effect is observed. Moisturizers and cosmetics may be used during treatment with Tretinoin cream but should not be applied to the skin at the same time. Astringent toiletries should be avoided.
Route of administration: Topical.
Other topical acne treatments should be used with caution during treatment with Tretinoin. Particular caution should be exercised when using preparation containing a peeling agent for example benzoyl peroxide. It is also possible to apply Tretinoin and benzoyl peroxide alternately. The suggested regimens are either Tretinoin in the morning and benzoyl peroxide in the evening or the preparations should be used on alternate days.
Tretinoin is contraindicated to those who are highly sensitive to any of the ingredients. This cream should not be used in patients with a personal or family history of cutaneous epithelioma (skin cancer).
Initial external application of Tretinoin generally may cause burning or slight irritation, erythema and peeling at the site of application may also occur. If irritation becomes severe and persists, discontinue application and consult your physicians, if necessary.
Pregnancy & Lactation:
There is an inadequate evidence of the safety of topically applied Tretinoin in human pregnancy. Tretinoin has been associated with teratogenicity in human when administered systemically. So the cream should not be used during pregnancy and lactation.
Precautions & Warnings:
Avoid contact of Tretinoin with lips, mouth, eyes, eyelids, nostrils or another mucous membrane. If contact in these areas occurs, careful washing with water is recommended. Apply the cream to sensitive areas of skin, such as the neck, with caution. Do not use it on broken, eczematous or sun burned skin.
Topical retinoid and related preparations
Keep out of the reach of children. Keep in a cool & dry place, protect from light.
Manufactured by: Beximco Pharmaceuticals Ltd.