Each g of Retacnyl Cream 0.025% and Retacnyl Cream 0.05% contains respectively 0.25 mg and 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: Pharmacodynamics: Tretinoin applied to the skin is responsible for a variety of effects on cellular systems. It stimulates mitosis and the renewal of epidermal cells, inhibits the formation of keratin, promotes repair of conjunctive tissue and can avert and even achieve regression of cutaneous tumours induced by various carcinogenic agents. These properties form the basis for the use of tretinoin in dermatology in the treatment of cutaneous disorders such as acne, psoriasis, ichthyosis and actinic keratosis.
In acne, tretinoin acts on one of the essential aetiological factors which is the keratinisation of the lower part of the pilosebaceous follicle. The keratinised cells adhere strongly to each other, obstructing the pilosebaceous orifice which dilates, forming the microcomedone. The sebaceous gland, plugged by the effect of sebum production, becomes encysted, forming a microcyst or closed comedone. This closed comedone may evolve into an open comedo or blackhead. The microcysts are the site of a microbial pullulation of Staphylococcus albus and Propionibacterium acnes.
These organisms liberate lipases which prematurely transform triglycerides into free fatty acids which emerge in the dermis through the follicle wall, giving rise to an inflammatory reaction with a degree of suppuration, corresponding to the formation of papules and pustules. In the course of this suppurative phase, deep cystic nodules can be formed. Their evolution is prolonged, interspersed with inflammatory phenomena. The activity of tretinoin is based on a mechanism of action which has an application at every state in the pathogenesis of acne.
Tretinoin opposes and averts the formation of those elements which cause acne: by stimulation of the follicular epithelium, the increased proliferation of non-coherent keratinised cells is intensified. These unattached corneal cells are evacuated together with sebum towards the surface of the skin. The corneal plug cannot evolve and the formation of new elements is thus forestalled.
Tretinoin provokes the expulsion of retentive elements (open comedones, microcysts). Beyond the superficial desquamation of the epidermis, tretinoin exerts a deep action at the level of the follicular epithelium: it stimulates the proliferation of free corneal cells which, in association with the reduction in coherence of the corneal plug, lead to the expulsion of microcysts or of the comedone.
Tretinoin accelerates the evolution of inflammatory elements (papules, pustules). Applied at the onset of the inflammatory phase, tretinoin increases the permeability of the follicular wall to irritants responsible for inflammatory phenomena (fragments of keratin, free fatty acids) and equally accelerates the evolution of papules and pustules and their elimination. It thus prevents the transformation of these lesions into cystics nodules.
Pharmacokinetics: Absorption of tretinoin through intact human skin is low and it is not known whether it is absorbed from denuded skin, wounds, or mucous membranes. Tretinoin is rapidly absorbed but equally rapidly eliminated by metabolism and excretion. Cutaneously a small percentage passes the stratum corneum, in the order of 0.6% to 6% of the applied dose.
This medicine is a tretinoin-based cream (all-trans retinoic acid) for topical application. It is for the topical treatment of acne vulgaris, in which comedones, papules and pustules predominate.
Retacnyl cream 0.025% or 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.
Do not use in pregnancy or in women planning a pregnancy. See Use in Pregnancy & Lactation.
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.
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.
Nursing Mothers: 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.
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).
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.
Store at room temperature not exceeding 25°C, away from light.
D10AD01 - tretinoin ; Belongs to the class of topical retinoid preparations used in the treatment of acne.
Retacnyl cream 0.025%
30 g x 1's
Retacnyl cream 0.05%
30 g x 1's
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