SIGMACORT

What it is

SIGMACORT contains hydrocortisone acetate. The cream formulation contains 10 mg/g (1.0% w/w) microfine hydrocortisone acetate in a water miscible, lanolin free cetomacrogol base. The ointment formulation contains 10 mg/g (1.0% w/w) microfine hydrocortisone acetate in a paraffin base. On topical application, corticosteroids produce anti-inflammatory, antipruritic and vasoconstrictor actions, thought to result at least in part from binding with a steroid receptor and by decreasing inflammation through stabilising leukocyte lysomal membranes, preventing release of destructive acid hydrolyses from leukocytes, inhibiting macrophage accumulation in inflamed areas, reducing leukocyte adhesion to capillary endothelium, reducing capillary wall permeability and oedema formation, decreasing complement components, and antagonising histamine activity.

Approved indications

— Topical corticosteroid therapy for noninfective inflammatory conditions of the skin such as eczema and dermatitis.

Dosing overview

Apply a thin smear to affected areas 2 to 4 times daily, reducing the number of applications as the disorder subsides.

Key safety warnings

Prolonged and heavy doses of hydrocortisone may have an immunosuppressant effect and thus decrease resistance to infection as well as mask signs of it. Where very large areas are treated for long periods, such as in atopic dermatitis, the possibility of systemic absorption exists, particularly if an occlusive dressing is applied. Chronic topical corticosteroid therapy may interfere with growth and development in children. Long term therapy in infants should be avoided as adrenal suppression may occur. An itching or burning sensation may be experienced when using this medication. Atrophy of the epidermis, subcutaneous tissue and dermal collagen; drying and cracking or tightening of the skin may occur, as well as epidermal thinning, telangiectasia, increased fragility of cutaneous blood vessels, purpura and atrophic striae. Adverse dermatological effects usually improve when the drug is discontinued but may persist for long periods; atrophic striae may be permanent. Visual disturbance may be reported with systemic and topical corticosteroid use, and 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.

Contraindications

SIGMACORT is contraindicated in tuberculous and fungal conditions of the skin, acute Herpes simplex, vaccinia, varicella and all viral infections. Hypersensitivity to any component of the cream or ointment is a contraindication. SIGMACORT is not to be used in the eye. Topical steroids should not be used in patients with markedly impaired circulation since skin ulceration has occurred in these patients following the use of corticosteroids.

Regulatory history

SIGMACORT 1% hydrocortisone acetate cream was first listed on the ARTG on 14 October 1991, as was the ointment formulation. The product was initially approved on 7 January 2003.