THERAPEUTIC INDICATIONS

For the relief of the inflammatory and pruritic manifestation of corticosteroid responsive dermatoses.

POSOLOGY AND METHOD OF ADMINISTRATION

Dosage is generally based on the following guidelines and is determined by the physician in accordance with individual requirements: Esperson Ointment should be applied sparingly to affected skin areas once or twice, or if necessary three times daily. If possible, Esperson Ointment should be rubbed gently into the skin. After skin lesions have improved, the frequency of application may be reduced, for example, from twice to one daily. Application over large areas (more than approximately 10% of body surface) and prolonged therapy (longer than approximately 4 weeks) should be avoided. Both carry a risk of systemic corticosteroid effects; in addition, prolonged therapy is also associated with a risk of more pronounced local effects.

CONTRAINDICATIONS

Patient with hypersensitivity to desoximetasone/other corticosteroids of the betamethasone type, or any of excipients. Patients with skin reactions resulting from vaccinations, cutaneous manifestations of tuberculosis, syphilis, viral infections (e.g. chickenpox), rosacea, and perioral dermatitis (risk of deterioration). Do not use on the eyes. Avoid contact between Esperson and latex condoms (protection afforded by the condoms may be lost).

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Visual disturbance, if symptoms such as blurred vision or other visual disturbances are present, consider referral to an ophthalmologist for evaluation of possible causes. Use in infants or children <6 years with compelling medical reasons only, If use is unavoidable, application must be limited to the minimum dose required for successful treatment. Use of Esperson over large area of skin, particularly in prolonged use, the possibility of HPA axis suppression must be taken into account, if this occurs, discontinue Esperson gradually. If small doses of topical corticosteroids come into repeated contact with the conjunctival sac, increased intra-ocular pressure can develop. For this reason, prolonged application of Esperson in the immediate vicinity of the eyes. If irritation develops, discontinue treatment and appropriate therapy instituted. Esperson must only be used for symptomatic therapy of bacterial and/or mycotic skin infections in combination with antibacterial or antimycotic treatment. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

PREGNANCY AND LACTATION

Application over extensive areas is contraindicated during pregnancy or lactation. If there are compelling medical reasons, Esperson may be applied to small areas of skin.

UNDESIRABLE EFFECTS

Folliculitis, hypertrichosis, acne, hyper-or-hypopigmentation, telangiectases, striae distensae, skin atrophy and skin maceration, burning, itching, irritation, dryness, perioral dermatitis, allergic contact dermatitis and secondary infection may develop in the region of treated skin areas. These effects occur particularly when treatment is prolonged and occlusive dressings are used, (including systemic effect).

PHARMACODYNAMIC PROPERTIES

ATC Code: D07AC03, corticosteroids, dermatological preparations

Presentation

Tube containing 5 g and 15 g ointment (DKL0121203030A1)

Date of revision: 9-Apr-2018 (based on BPOM approval 19-Mar-2018)

This information is intended for Health Care Professional only. See local product information for full details information

ESPERSON