OGB

 

Cream

Composition:
Each gram of DESOXIMETASONE cream contain:
Desoximetasone 2.5 mg

Pharmacology:
It is an active corticosteroid specially developed for topical application. It has pronounced anti-inflammatory, antiallergic, antiexudative, antiproliferative and antipruritic effects.

Indication:
Relief inflammatory and pruritic manifestation of corticosteroid responsive dermatoses.

Contraindications:
- Must not be used on the eyes.
- In patients with hypersensitivity to desoximetasone, other corticosteroid of the betamethasone type.
- Desoximetasone cream contains a paraffin, which can cause leaking or breaking of latex condoms. Contact between desoximetasone cream 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 infection (for example chicken pox), rosacea, and perioral dermatitis, must not be use topical corticosteroids, because there is a risk that the condition may deteriorate.
- During pregnancy or lactation, application over extensive areas is contraindicated due to the risk of absorption desoximetasone. However, if there are compelling medical reasons, desoximetasone cream may be applied to small areas of skin.

Dosage and administration:
Dosage is generally based on the following guidelines and is determined by the physician in accordance with individual requirements: Desoximethasone cream should be applied sparingly to affected skin areas once or twice daily. If possible, desoximetasone cream should be rubbed gently into the skin. After skin lesions have improved, the frequency of application may be reduced, for example from twice to once daily. Applications 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.

Dosage mistakes: short-term deviations from the scheduled dose (application over too large areas 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.

Side 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 dressing is used.
- Desoximetasone cream leads to local hypersensitivity reactions of the skin in rare cases only.
- Systemic corticosteroid effects may occur if desoximetasone cream 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 effect listed in this package insert or any other undesired effects or any other undesired effects or unexpected changes (for example new skin change).

Warnings and precautions:
- Desoximetasone cream 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 desoximetasone cream over large areas of skin. In such cases, particularly in prolonged use, the possibility of adrenal suppression must be taken into account. Therefore patient should be evaluated periodically for evidence of HPA (hypothalamic-pituitary-adrenal) axis supression by using the urinary free cortisol and ACTH stimulation test. If this occurs, it may be necessary to discontinue desoximetasone cream gradually or to substitute a less potent steroid.
- Over the course of time, increased intraocular pressure can develop if small doses of topical corticosteroids come into repeated contact with the conjunctival sac. For this reason, prolonged application of desoximetasone cream in the immediate vicinity of the eyes, must be preceded by a careful risk-benefit assessment and must only be performed under medical supervision. If irritation develops, topical corticosteroid should be discontinued and appropriate therapy instituted.
- Desoximetasone cream must only be used for symptomatic therapy for 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.

Overdosage: Due to the absorption of large amounts of desoximetasone, systemic corticosteroid effect may occur. Particularly after application of desoximetasone cream, to large areas of skin or for prolonged periods. In such cases, the dose must be reduced or treatment halted altogether. If adrenal suppression is suspected, a gradual discontinuation of treatment must be considered.

Presentation and registration number:
Box, tube @ 15 g;

ON MEDICAL PRESCRIPTION ONLY

STORE AT TEMPERATURE BELOW 30°C

Manufactured by:
PT Ferron Par Pharmaceuticals

Cikarang-Indonesia

For:
PT Dexa Medica