VIADERM KC Cream, Ointment Ref.[50685] Active ingredients: Gramicidin Neomycin Nystatin Triamcinolone

Adrenal suppression can occur, even without occlusion. The use of occlusive dressings should be avoided because of the increased risk of sensitivity reactions and increased percutaneous absorption. The possibility of sensitivity to neomycin should be taken into consideration especially in the treatment of patients suffering from leg ulcers.

Pregnancy

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, topical steroids should not be used extensively in pregnancy i.e. in large amounts for long periods. Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Children

In infants, long term continuous topical steroid therapy should be avoided.

No data available.

Pregnancy

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, topical steroids should not be used extensively in pregnancy i.e. in large amounts for long periods. Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Children

In infants, long term continuous topical steroid therapy should be avoided.

Not applicable.

General disorders and administration site conditions

Rebound effect – see Section 4.2 Dose and method of administration.

Triamcinolone acetonide is well tolerated. Where adverse reactions occur, they are usually reversible on cessation of therapy. However, the following side effects have been reported usually with prolonged usage.

Dermatological: Impaired wound healing, thinning of the skin, petechiae and ecchymoses, facial erythema and telangiectasia, increased sweating, purpura, striae, hirsutism, acneiform eruptions, lumps erythematosus-like lesions and suppressed reactions to skin tests. These effects may be enhanced with occlusive dressings.

Signs of systemic toxicity such as oedema and electrolyte imbalance have not been observed even when high topical dosage has been used. The possibility of the systemic effects which are associated with all steroid therapy should be considered.

Neomycin: Sensitivity reactions may occur especially with prolonged use. Ototoxicity and nephrotoxicity have been reported. Large amounts of this product should be avoided in the treatment of skin infections following excessive burns, trophic ulceration and other conditions where absorption of neomycin is possible.

Gramicidin: Sensitivity has occasionally been reported.

Nystatin: There have been no substantiated reports of sensitivity associated with topical nystatin.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

Not applicable.