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A yellow emollient cream with floral odour containing tretinoin 500 mcg/g (0.05% w/w) in a water-in-oil emulsion for topical use only. Each aluminium tube is lined and contains 20g of RETINOVA Cream.
The mechanism of action of topical tretinoin as a treatment for photodamage is not completely understood. However, it is known that tretinoin activates gene transcription for many important proteins by binding to specific retinoid receptors in the cell nucleus. Studies employing light microscopy show an increase in Type I collagen, while ultrastructural studies show an increased number of anchoring fibrils in the papillary dermis of tretinoin-treated photodamaged skin. These molecular events, coupled with the characteristic histological effects of tretinoin, i.e. increased epidermal and granular layer thickness with changes in stratum corneum morphology, indicate a specific effect rather than one induced by irritation, as has been previously suggested.
In clinical trials involving 349 Caucasians, 30-50 years of age, treated with RETINOVA tretinoin or its vehicle, three primary efficacy variables were assessed at the end of the 6-month, double-blind treatment period: investigator's global evaluation at the end of therapy, the change from baseline to the end of therapy in the investigator's evaluation of the overall severity of photodamage, and the overall patient self-assessment at the end of therapy. For each of the primary efficacy variables, a significantly greater percentage of patients improved with RETINOVA than with the vehicle.
Upon topical application of RETINOVA, tretinoin penetrates both the epidermis and dermis. Percutaneous absorption of tretinoin in an emollient cream formulation was assessed in healthy male subjects after a single application and after repeated daily applications. The mean percutaneous absorption was less than 2% and physiological concentrations of tretinoin and its major metabolites were unaltered.
Topical treatment of photodamaged skin secondary to chronic sun exposure, including a reduction of mottled hyperpigmentation, roughness, and fine wrinkling.
RETINOVA should be applied once daily in the evening in only a sufficient quantity to lightly cover the entire affected areas (face or arms).
Application of RETINOVA may cause transitory stinging and a feeling of warmth. When RETINOVA is administered, it normally produces a slight, transient erythema similar to that of mild sunburn. More frequent application or use of larger quantities of RETINOVA will not improve the outcome of treatment, and may induce marked skin irritation, e.g. erythema, peeling, pruritus, etc.
Improvements in signs of photodamage with RETINOVA are not immediate but occur gradually over the course of therapy. The onset of visible improvements varied across clinical studies, however, in general, effects emerged within 3-4 months of initiating treatment. Six months of treatment may be required before definite beneficial effects are seen.
Once the maximum beneficial effects have been achieved, they can be maintained with application of RETINOVA one or three times weekly. If maintenance therapy is not used, the beneficial effect achieved will diminish over time.
Cosmetics and moisturisers may be used concurrently throughout the duration of RETINOVA therapy. The skin should be thoroughly washed before application of RETINOVA. (See also General Precautions for Use).
A history of sensitivity / hypersensitivity to any of the components of the product.
The presence of skin irritation (e.g. erythema, peeling, pruritus, sunburn, etc.) should prohibit initiation or recommencement of treatment with RETINOVA until the symptoms subside. If the degree of local irritation warrants, a patient should be directed to apply the medication less frequently or discontinue its use temporarily.
Use of RETINOVA in certain sensitive individuals (e.g. patients with eczema, sunburn, etc.) may induce severe local erythema, swelling, pruritus, warmth, burning or stinging, blistering, crusting and/or peeling at the site of application. Tretinoin has been reported to cause severe irritation to eczematous skin and should be used with utmost caution in patient's having this condition. If a patient experiences severe or persistent irritation, the patient should be advised to discontinue application of RETINOVA completely and, if necessary, consult a physician. Caution should be exercised during concomitant therapy with other local irritants, especially those having an abrasive, drying, or desquamative effect.
Weather extremes, such as wind, cold and low humidity may also be irritating to skin treated with RETINOVA and may increase its dryness.
Exposure to sunlight, including ultraviolet (UVB) sunlamps, should be avoided or minimised during the use of tretinoin. Patients with sunburn should be advised not to use the product until fully recovered because of potential severe irritation to sensitive skin. A patient who experiences considerable sun exposure due to occupational duties and/or anyone inherently sensitive to the sun should exercise particular caution. When exposure to sunlight cannot be avoided, use of sunscreen products and protective clothing over treated areas is recommended.
RETINOVA should be used under medical supervision as part of a comprehensive skin care programme, including patient education regarding sun avoidance and general skin care, use of sunscreens and moisturising products, and protective clothing.
Care should be taken to avoid contact with the eyes, eyelids, angles of the nose, mouth, mucous membranes or other areas where treatment is not intended, in order to minimise the potential for additional skin irritation.
Areas to be treated with RETINOVA should be cleansed thoroughly. Use of a mild, non-medicated soap is recommended. Pat the skin dry without rubbing. Allow area to dry for at least 20-30 minutes before application of RETINOVA to the skin. Twice daily washing of the treated area is more than sufficient.
In clinical trials with RETINOVA, the topical human dose used in a 50kg adult applying a maximum volume of 500mg of 0.05% cream was 0.005mg/kg. In animal reproductive studies, oral tretinoin is known to be teratogenic and has been shown to be fetotoxic in rats when given in doses 500 times the topical human dose. In reproduction studies in rats and rabbits, topical tretinoin, when used at doses 1000 times the topical human dose, induced minor skeletal abnormalities, e.g. irregularly contoured or partially ossified skull bones. These changes may be considered variants of normal development and are usually corrected after weaning.
There are no adequate and well-controlled studies in pregnant women. Accordingly, RETINOVA should not be used by pregnant women or those planning to become pregnant during treatment.
It is not known whether tretinoin is excreted in human milk. Therefore, caution should be exercised when RETINOVA is administered to a nursing mother.
Safety and effectiveness of RETINOVA use in children have not been established.
Local reactions frequently reported during therapy include: dry or peeling skin, burning, stinging, warmth, erythema, pruritus, and temporary hypo- and hyperpigmentation. These skin reactions were usually mild to moderate and were generally well-tolerated. They usually occurred early in therapy and, except for dry or peeling skin which persisted during therapy, generally decreased over the course of treatment.
Clinical studies with RETINOVA showed no incidence of true allergic contact sensitivity. Heightened susceptibility to either sunlight or other sources of UVB light has been reported.
Excessive application of RETINOVA does not improve the results of treatment and may induce marked irritation, e.g. erythema, peeling, pruritus, etc. Oral ingestion of tretinoin may lead to similar side effects as those associated with excessive oral intake of Vitamin A (e.g. pruritus, dry skin, arthralgias, anorexia, vomiting).
Prescription Medicine.
20g per tube.
RETINOVA also contains: Paraffin light liquid, Sorbital Solution, Edetate Disodium, Methylparahydroxybenzoate, Dimethicone, Quaternium-15, Hydroxyoctacosanyl Hydroxystearate, Methoxy PEG-22/Dodecyl Glycol Copolymer, PEG-45/Dodecyl Glycol Copolymer, Stearoxytrimethylsaline and Stearyl Alcohol, Citric Acid Monohydrate, Butylated Hydroxytoluene, Fragrance and Purified water.
Store below 25°C. Do not freeze.
Janssen-Cilag Pty Ltd
P O Box 9222
Newmarket
AUCKLAND 1
Phone: (09) 524.5012
Fax: (09) 523.1646
11 April 2000