Retacnyl Special Precautions

General: If a reaction suggesting sensivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during the use of Retacnyl cream, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Use of sunscreen products and protective clothing over treated areas may be prudent when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin. Retacnyl cream acne treatment should be kept away from the eyes, the mouth, angles of the nose and mucous membranes. Topical use may induce severe local erythema and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use the medication less frequently, discontinue use temporarily, or discontinue use altogether. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.
Drug Interactions: Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices or lime should be used with caution because of possible interaction with tretinoin. Particular caution should be exercised in using preparations containing sulfur, resorcinol or salicylic acid with Retacnyl cream. It is also advisable to "rest" a patient's skin until the effects of such preparations subside before use of Retacnyl cream is begun.
Carcinogenesis: Long-term animal studies to determine the carcinogenic potential of tretinoin have not been performed. Studies in hairless albino mice suggest that tretinoin may accelerate the tumorigenic potential of ultraviolet radiation. Although the significance to man is not clear, patients should avoid or minimize exposure to sun.
Use in Pregnancy: Studies in animal have shown that oral tretinoin is fetotoxic in rats given 500 times the topical human dose and teratogenic in rats given 1,000 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. There has been increasing incidence of foetal malformation following topical administration of tretinoin. Orally administered retinoids have been associated with congenital abnormalities. Use of topical tretinoin is not recommended during pregnancy, especially in the first trimester. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result in low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure. Retacnyl cream is contraindicated in pregnancy, or in women planning a pregnancy. If the product is used during pregnancy, or if the patient becomes pregnant while using this drug, treatment should be discontinued.
Use in Lactation: It is not known whether this drug is excreted in human milk. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.
Use in Children: Safety and efficacy have not been established.