Retigel0.05%

For the treatment of acne vulgaris in which comedones, papules and pustules predominate. For the treatment of hyperpigmentation, roughness and fine wrinkling of photodamaged skin due to chronic sun exposure. For the treatment of Acute promyelocytic leukaemia

Topical retinoid and related preparations

Retigel 0.05% is structurally and pharmacologically related to vitamin A. Current evidence suggests that topical Retigel 0.05% decreases cohesiveness of follicular epithelial cells with decreased microcomedone formation. Additionally, Retigel 0.05% stimulates mitotic activity and increases turnover of follicular epithelial cells, causing extrusion of the comedones

Retigel 0.05% cream: Retigel 0.05% 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.Retigel 0.05% gel: Retigel 0.05% gel should be applied once or twice a day, before retiring, to the skin where lesions appear, using enough to cover the entire affected area lightly. The frequency of application can be adjusted to obtain maximum clinical efficacy with minimal erythema and scaling.If Retigel 0.05% gel is applied excessively, no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur. Should this occur accidentally or through over-enthusiastic use, application should be discontinued for few days.Patience is needed in this treatment, since the therapeutic effects will not usually be observed until after 6-8 weeks of treatment. During the early weeks of treatment, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen comedones and papules. Once the acne lesions have responded satisfactorily, it should be possible to maintain the improvement with less frequent applications.Moisturizers and cosmetics may be used during treatment with Retigel 0.05% gel but should not be applied to the skin at the same time. The skin should be thoroughly washed before application of Retigel 0.05% gel. Astringent toiletries should be avoided.Capsule: The recommended dose is 45 mg/m2/day administered as two evenly divided doses until complete remission is documented. Therapy should be discontinued 30 days after achievement of complete remission or after 90 days of treatment, whichever occurs first.If after initiation of treatment of Retigel 0.05% the presence of the translocation is not confirmed by cytogenetics and/or by polymerase chain reaction studies and the patient has not responded to Retigel 0.05%, alternative therapy appropriate for acute myelogenous leukemia should be considered.

Particular caution should be exercised in using preparations containing peeling agents (i.e. sulfur, resorcinol, benzoyl peroxide or salicylic acid). Use of topical preparations with high concentrations of alcohol, menthol, spices or lime- such as shaving lotions, astringents and perfume- should be avoided, especially during initial therapy.

Retigel 0.05% is contraindicated in patients who are allergic to this drug. It is contraindicated in pregnancy or suspected pregnancy. It is also contraindicated in personal or familial history of cutaneous epithelioma.Local irritation: The presence of cutaneous irritative signs (e.g. erythema, peeling, pruritus, sunburn, etc.) should prohibit initiation or recommencement of treatment with Retigel 0.05% until the symptoms resolve. Retigel 0.05% has been reported to cause severe irritation on eczematous skinand should be used with caution in patients with this condition.Exposure to sunlight: Exposure to sunlight, including ultraviolet sun-lamps, should be avoided or minimised during the use of Retigel 0.05%.General precaution: Before application of Retigel 0.05%, areas to be treated should be cleansed thoroughly. Abstain from washing the treated area frequently; twice daily is sufficient. Use of mild soap is recommended. Dry the skin without rubbing.Avoid contact with eyes, eyelids, nostrils, mouth and mucous membranes. If contact in these areas occurs, careful washing with water is recommended.

True allergic contact dermatitis is rare but a primary irritant dermatitis, manifesting itself as irritation, erythema, peeling and sensation of warmth, is common. Slight stinging is common as a mild reaction in many people but usually settles with continuous use and/or reduction in the frequency of application of the drug.

Retigel 0.05% is contraindicated in pregnancy or suspected pregnancy. The drug should be avoided by breast feeding mothers.

Store in a cool and dry place, away from light. Keep out of reach of children.