Cosmotrin®
(Tretinoin Cream )
Description
Cosmotrin cream is a topical anti-acne preparation containing Tretinoin
USP 0.025%. 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.
Indications
For topical application in the treatment of acne vulgaris in which
comedones, papules and pustules predominate.
Dosage and Administration
Cosmotrin 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.
Moisturisers and cosmetics may be used during treatment with Cosmotrin
cream but should not be applied to the skin at the same time. Astringent
toiletries should be avoided.
Contraindications
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).
Precautions
Avoid contact of Tretinoin with lips, mouth, eyes, eyelids, nostrils or
other mucous membrane. If contact in these areas occur, 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.
Drug Interactions
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.
Side Effects
Initial external application of Tretinoin generally may cause burning or
slight irritation. Erythema and peeling at the site of application. If
irritation becomes severe and persists, application should be discontinued
and consultation with physician is required, if necessary.
Use in Special Population
Pregnancy and lactation : There is an inadequate evidence of the safety of
topically applied Tretinoin cream during pregnancy. Tretinoin has been
associated with teratogenicity in human when administered systemically.
So, the cream should not be used during pregnancy and lactation.
Commercial Pack
Cosmotrin® Cream : Tube containing 10 g cream, each gram contains
Tretinoin USP 0.25 mg.