Full Prescribing Info
Each g of Retacnyl Cream 0.05% contains 0.5 mg tretinoin as the active ingredient in a cream base containing polyethylene glycol stearate, glycerol stearate & PEG-100 stearate, cetyl alcohol, stearyl alcohol, squalane, butylhydroxyanisole, butylhydroxytoluene, propyl parahydroxybenzoate, stearic acid, carbomer 941, glycerol, methyl parahydroxybenzoate, disodium edetate, triethanolamine, isopropyl myristate, sorbic acid and purified water.
Pharmacology: Although the exact mode of action of tretinoin is unknown, current evidence suggest that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells, causing extrusion of the comedones.
This medicine is a tretinoin-based cream (all-trans retinoic acid) for topical application. It is for use in the local treatment of acne and for certain conditions which cause difficulties in the formation of the skin's stratum corneum.
Dosage/Direction for Use
Retacnyl cream 0.05% should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly.
Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment.
Alterations of vehicle, drug concentration or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance.
During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy.
Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen.
Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms.
Patients treated with tretinoin cream acne treatment may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied (see PRECAUTIONS).
If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.
Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.
Special Precautions
General: If a reaction suggesting sensitivity 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.
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: Pregnancy Category B. Reproduction studies performed in rats and rabbits at dermal doses up to 50 times the human dose (assuming the human dose to be 500 mg of gel per day) have revealed no evidence of impaired fertility or harm to the fetus due to tretinoin (retinoic acid). There was, however, a slightly higher incidence of irregularly contoured or partially ossified skull bones in some rat and rabbit fetuses. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
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.
Adverse Reactions
The skin of certain sensitive individuals may become excessively red, edematous, blistered or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper or hypopigmentation has been reported with repeated application of topical tretinoin. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with topical tretinoin. To date, all adverse effects to topical tretinoin have been reversible upon discontinuation of therapy (see DOSAGE & ADMINISTRATION).
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 cation 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.
Store at room temperature not exceeding 25°C, away from light.
MIMS Class
Acne Treatment Preparations
ATC Classification
D10AD01 - tretinoin ; Belongs to the class of topical retinoid preparations used in the treatment of acne.
Cream 0.05% x 30 g.
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