(and dosage form):
Tretinoin (all-trans-retinoic acid, vitamin A acid) 0,05% by mass in a base of the oil-in-water emulsion type. The base is free from hydrocarbons and nipa esters.
A 13.12 Acne preparations
The primary target tissue for successful local acne therapy is the follicular epithelium. Consequently, a deep rather than superficial action is needed for the true effectiveness of a locally applied acne preparation. Tretinoin stimulates proliferation and modifies differentiation as well as cornification of the epidermis, the follicular epithelium and of the epithelium of the acne comedos. It increases the production of loose non-coherent horny cells in the follicular epithelium and loosens the acne comedo from its bed. The comedos are subsequently ejected by the increasing stream of loose horny cells via excretory follicular ducts. In this manner the prerequisites are met for regeneration of the follicular epithelium and for healing of acne without the formation of residual scars.
Acute dermatitis, particularly acute eczema and rosacea.
DOSAGE AND DIRECTIONS FOR USE:
Unless otherwise prescribed by the physician, ILOTYCIN-A CREAM should be applied twice daily (morning and evening) to the skin, using enough to lightly cover the entire affected area. Prior to application the skin should preferably be cleaned with lukewarm water and a mild, non-irritating soap.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
ILOTYCIN-A CREAM is for external use only.
The application of ILOTYCIN-A CREAM may cause a transitory reddening of the skin and a feeling of warmth or slight stinging. During the first weeks of therapy an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen acne comedos. The severeness of these accompanying symptoms depends on the dose and frequency of application of ILOTYCIN-A CREAM and on the patient's individual sensitivity. The symptoms usually decrease or disappear during further treatment. In cases where it is necessary temporarily to discontinue the therapy or to reduce the frequency of application, regular treatment may be resumed when the patient is again able to tolerate the treatment.
Therapeutic results are noticed as a rule after two to three weeks of treatment; optimal results (complete disappearance of acne comedos and efflorescences) may be expected after approximately six to seven weeks of therapy.
ILOTYCIN-A CREAM should be kept away from the eyes, the mouth and mucous membranes.
Concomitant topical medication with other drugs should be used with caution because of possible interactions with tretinoin.
Particular caution should be exercised in using preparations containing peeling agents (such as sulphur, resorcinol, benzoyl peroxide or salicylic acid). Extensive exposure to sunlight, including sun lamps, should be avoided during use of ILOTYCIN-A CREAM.
Medicated or abrasive soaps or cleansers as well as cosmetics that have a strong drying effect or products with high concentrations of alcohol or astringents (shaving lotions) should not be used during treatment with ILOTYCIN-A CREAM.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms mentioned under Side-Effects and Special Precautionsmay occur. Treatment is supportive and symptomatic.
ILOTYCIN-A CREAM is a light yellow cream with a pleasant odour.
Tubes of 20 g.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
308427 030707 Harrys Printers-K30922 K03
Updated on this site: April 2005
Source: Hospital Pharmacy
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