Enstilar Dosage/Direction for Use

betamethasone + calcipotriol


LEO Pharma


Full Prescribing Info
Dosage/Direction for Use
Posology: Flare treatment: Enstilar foam should be applied to the affected area once daily. The recommended treatment period is 4 weeks. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular supervision.
Long-term maintenance treatment: Patients who have responded at 4 weeks' treatment using Enstilar once daily are suitable for long-term maintenance treatment. Enstilar should be applied twice weekly on two non-consecutive days to areas previously affected by psoriasis vulgaris. Between applications there should be 2-3 days without Enstilar treatment. If signs of a relapse occur, flare treatment, as described previously, should be re-initiated.
Maximum dose: The daily maximum dose of Enstilar should not exceed 15 g, i.e. one 60 g can should last for at least 4 days of treatment. 15 g corresponds to the amount administered from the can if the actuator is fully depressed for approximately one minute. A two-second application delivers approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of skin roughly corresponding to the surface area of an adult hand.
If using other topical products containing calcipotriol in addition to Enstilar, the total dose of all calcipotriol containing products should not exceed 15 g per day.
The total body surface area treated should not exceed 30%.
Special populations: Renal and hepatic impairment: The safety and efficacy of Enstilar foam in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Paediatric population: The safety and efficacy of Enstilar foam in children below 18 years have not been established. Currently available data in children aged 12 to 17 years are described in Adverse Reactions and Pharmacology: Pharmacodynamics under Actions, but no recommendation on a posology can be made.
Method of administration: For cutaneous use.
The can should be shaken for a few seconds before use. Enstilar should be applied by spraying holding the can at least 3 cm from the skin. The foam can be sprayed holding the can in any orientation except horizontally.
Enstilar should be sprayed directly onto each affected skin area and rubbed in gently.
If used on the scalp, Enstilar should be sprayed into the palm of the hand and then applied to affected scalp areas with the fingertips. Hair washing instructions are provided in the package leaflet.
The hands should be washed after using Enstilar (unless Enstilar is used to treat the hands) to avoid accidentally spreading to other parts of the body as well as unintended drug absorption on the hands. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. It is recommended not to take a shower or bath immediately after application of Enstilar. Let the foam remain on the scalp and/or skin during the night or during the day.
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