CORTIC-DS

What it is

Cortic-DS is a hydrocortisone acetate cream and ointment. The cream contains 10 mg/g (1.0% w/w) microfine hydrocortisone acetate in a water miscible, lanolin free cetomacrogol base. The ointment 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 through binding with a steroid receptor and by 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, antagonising histamine activity and reducing fibroblast proliferation and collagen deposition.

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 2–4 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. If infection of the skin is present suitable antifungal or antibacterial agents should be used first. Any occlusive dressings should be discontinued. If the infection does not respond promptly to therapy, corticosteroid therapy should be discontinued until the infection has been controlled. Where very large areas are treated for long periods, the possibility of systemic absorption exists, particularly if an occlusive dressing is applied. Prolonged use of large quantities of topical corticosteroids may result in atrophic striae or acne eruptions. Due to the possible systemic absorption of topical steroids, there may be a need for periodic evaluation of hypothalamo-pituitary-adrenal (HPA)-axis suppression. Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development. 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. Topical corticosteroids may cause adverse dermatological effects, most likely to occur in intertriginous and facial areas. Local adverse corticosteroid effects occur most frequently with occlusive dressings, especially with prolonged therapy. Atrophy of the epidermis, subcutaneous tissue and dermal collagen; drying and cracking or tightening of the skin may occur. Epidermal thinning, telangiectasia, increased fragility of cutaneous blood vessels, purpura and atrophic striae are also reported.

Contraindications

Cortic-DS is contraindicated in tuberculous and fungal conditions of the skin, acute Herpes simplex, vaccinia, varicella and all viral infections. It is contraindicated in patients with hypersensitivity to any component of the cream or ointment. It should not 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.

PBS listing

The cream containing hydrocortisone acetate 10 mg per gram in a 50 g pack is listed on the PBS with 2 items, restriction type restricted, at an ex-manufacturer price of A$2.50. The ointment containing hydrocortisone acetate 10 mg per gram is listed in both 50 g and 30 g packs. The 50 g ointment has 2 PBS items at an ex-manufacturer price of A$2.50, while the 30 g ointment has 1 PBS item at an ex-manufacturer price of A$4.81. All items have a restriction type of restricted.

Regulatory history

Cortic-DS was first registered on the ARTG on 7 January 2003 in two formulations: the 1% hydrocortisone acetate cream and ointment, each in tube packaging.