Therapeutic Indications

Dermatop cream is also suitable for sensitive areas of skin and for repeated application and use in large areas must be under direct supervision of a doctor.

Posology and method of Administration

Dermatop cream is applied to the affected skin areas in a thin layer once daily and if possible, rubbed in gently. If necessary the frequency of use may be increased to twice daily. Long - term continuous treatment should not exceed 4 weeks.

Contra Indications

Dermatop cream must not be used on the eyes (see also under “special warnings and precautions”) and in patients with hypersensitivity to prednicarbate or any of the excipients (see under “composition”). Dermatop cream contains a paraffin, which can cause leaking or breaking of latex condoms. Contact between Dermatop 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 infections (for example chickenpox), rosacea, and perioral dermatitis, must not use topical corticosteroids such as Dermatop cream, because there is a risk that the condition may deteriorate.

Special Warnings and Precautions for Use

Dermatop cream must only be used in infants if there are compelling medical reasons, since the risk of systemic effects due to corticosteroid absorption. Over the course of time, increased intra-ocular pressure can develop if small doses of topical corticosteroids (to include Dermatop cream) come into repeated contact with the conjunctival sac. For this reason, prolonged application of Dermatop 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. Topical corticosteroids such as Dermatop cream must only be used for symptomatic therapy of bacterial and/or mycotic skin infections in combination with concomitant antibacterial or antimycotic treatment. Visual disturbance may be associated with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).

Pregnancy and Lactation

Application of Dermatop cream over extensive areas (more than 30% of the body surface) is contraindicated during the first three months of pregnancy, since systemic glucocorticoid effects cannot be excluded. However, if there are compelling medical reasons. Dermatop cream may be applied to small areas of skin. Caution should be exercised when Dermatop cream is administered to nursing women. Insufficient clinical experience is availbale on use during lactation.

Adverse effects

In approximately 2-3% of patients a burning sensation and in rare cases, itching, folliculitis or allergic skin reactions with e.g burning. Reddening or weeping may occur. Skin atrophogenic effects (such as skin thinning, skin atrophy, skin discoloration, telangiectasia) may occur with use of the Dermatop for more than three weeks. (frequency: not known). Eye disorders: blurred vision4, chorioretinopathy.

PHARMACODYNAMIC PROPERTIES

ATC Code : D07, The prednicarbate in Dermatop cream is an corticosteroid.

Reg No. DKL0121202829A1 ( Tube 5 g)

Reg.No.DKL0121202829A1 (Tube 15g)

MARKETING AUTHORISATION HOLDER

PT. Aventis Pharma, Jakarta – Indonesia

Based on approval 28 January 2019

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