Esperson

Esperson^® 
Desoximethasone
0.25 %
sanofi aventis

COMPOSITION
Each gram of Esperson Ointment contains, as active ingredient, 2.5 mg desoximetasone in a water-in-oil emulsion.
Excipients: Isopropyl myristate, wool alcohol ointment (consisting of wool alcohol, cetyl stearyl alcohol and white petrolatum), purified water.

PROPERTIES
The desoximetasone in Esperson Ointment is an active corticosteroid specially developed for topical application. It has pronounced anti-inflammatory, anti-allergic antiexudative antiproliferative and antipruritic effects.

INDICATIONS
Esperson ointment are indicated for the relief of the inflammatory and pruritic manifestation of corticosteroid responsive dermatoses.

CONTRAINDICATIONS
Esperson Ointment must not be used on the eyes (see also under "Special warnings and precautions") and in patients with hypersensitivity to desoximetasone, other corticosteroids of the betamethasone type, or any of the preservatives or excipients (see under "Composition"). Esperson Ointment contains a paraffin which can cause leaking or breaking of latex condoms. Contact between Esperson Ointment and latex condoms must, therefore, be avoided, because the protection afforded by the condoms may otherwise be lost. Patients with skin reactions resulting from vaccinations, cutaneous manifestations of tuberculosis, syphilis, viral infections (for example chickenpox), rosacea, and perioral dermatitis, must not use topical corticosteroids such as Esperson Ointment, because there is a risk that the condition may deteriorate.
Pregnancy and lactation: Due to the risk of absorption of desoximetasone, application of Esperson Ointment over extensive areas is contraindicated during pregnancy or lactation.
However, if there are compelling medical reasons, Esperson Ointment may be applied to small areas of skin.

SPECIAL WARNING AND PRECAUTIONS
Esperson Ointment must only be used in infants or children under six years of age if there are compelling medical reasons, since in these age groups the risk of systemic effects due to corticosteroid absorption (for example growth retardation) is increased. If use is unavoidable, application must be limited to the minimum dose required for successful treatment.
In adult, it may in exceptional circumstances be necessary to apply Esperson Ointment over large areas of skin. In such cases, particularly in prolonged use, the possibility of adrenal suppression must be taken into account. Therefore patients should be evaluated periodically for evidence of HPA (hypothalamic-pituitary-adrenal) axis suppression by using the urinary free cortisol and ACTH stimulation test. If this occurs, it may be necessary to discontinue Esperson Ointment gradually or to substitute a less potent steroid.
Over the course of time, increased intra-ocular pressure can develop if small doses of topical corticosteroids (to include Esperson Ointment) come into repeated contact with the conjunctival sac. For this reason, prolonged application of Esperson Ointment in the immediate vicinity of the eyes. If irritation develops, topical corticosteroid should be discontinued and appropriate therapy instituted. Topical corticosteroids such as Esperson Ointment must only be used for symptomatic therapy of bacterial and/or mycotic skin infections in combination with concomitant antibacterial or antimycotic treatment. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

ADVERSE EFFECTS
Folliculitis, hypertrichosis, acne, hyperor-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.
Esperson Ointment leads to local hypersensitivity reactions of the skin in rare cases only.
Systemic corticosteroid effects may occur if Esperson Ointment is used over large areas, for prolonged periods (see also under "Dosage and administration") or under occlusive dressings.
Please consult a physician if you notice any of the adverse effects listed in this package insert or any other undesired effects or unexpected changes (for example new skin changes).

DOSAGE AND 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 (see "Adverse effects").

Dosage mistakes: Short-term deviations from the scheduled dose (application over too large an ares or in excessive amounts, too frequent application, or a single missed dose) will not lead to harmful effects. Please consult your physician if these occur.

Storage
Store below 25°C.

Expiry date
Do not use later than the date of expiry

Keep medicines out of the reach of children.

This package insert is continually updated:

please read carefully before using a new pack!

Presentation
Tube containing:
5 g   Reg. No. DKL0121203030Al
15 g Reg. No. DKL0121203030Al

HARUS DENGAN RESEP DOKTER
ON MEDICAL PRESCRIPTlON ONLY

Manufactured by:
PT Aventis Pharma, Jakarta, Indonesia

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