INFORMATION FOR HEALTH PROFESSIONALS
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Cream: Triamcinolone acetonide, 0.02% and 0.05% in Aquatain base, a water miscible base containing Polawax (cetostearyl alcohol and a polysorbate), isopropyl palmitate, glycerol, sorbitol, lactic acid, 2% benzyl alcohol.
Ointment: Triamcinolone acetonide 0.02% and 0.05% in a white soft paraffin base.
Anti-inflammatory topical agent.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.
Absorption, distribution and excretion of triamcinolone acetonide (TA) following topical application were studied using 3H-labelled substance in rats and dogs. Detectable blood levels (>0.02 mcg/mL) of radioactivity were demonstrated in rats but not in dogs following a single dose of approximately 1mg/kg of 3H-TA. In rats, peak blood levels of radioactivity occurred six hours after the dose, suggesting a very slow rate of absorption from the skin. Tissue distribution of topically applied 3H-TA was similar to the distribution following other routes of administration; initially fairly evenly distributed throughout the body, with subsequent, higher concentrations in the organs associated with elimination (kidney, liver and gastrointestinal tract). Data resulting from studies in the rat and dog indicate 3H-TA is mainly excreted in the bile and subsequently eliminated in the faeces.
No studies have been conducted on binding of TA per se to plasma proteins. However, in studies with binding of 3H-triamcinolone (free alcohol) to plasma proteins of dogs and humans, 40% of the substance was bound to albumin and only very slightly bound to transcortin.
Radiolabelled studies showed that metabolism of TA in the rat, rabbit, dog and monkey is extensive. Only small amounts of unchanged TA were excreted. The major metabolites of TA found in urine and faeces were identified as 6B-hydroxy-triamcinolone acetonide, 6B-hydroxy-triamcinolone acetonide-21-carboxylic acid and triamcinolone acetonide-21-carboxylic acid. No differences in metabolic pattern related to route of administration were detected.
In the treatment of the following dermatoses; atopic dermatitis, eczematous dermatitis, nummular eczema, contact dermatitis, pruritus vulvae and ani, external otitis, seborrhoeic dermatitis, eczematised psoriasis, neuro-dermatitis.
Apply in small quantities to the affected areas three or four times daily. Some cases of eczematised psoriasis may be treated more effectively by the application of ARISTOCORT under an occlusive nonpermeable dressing.
Tuberculosis of the skin, fungus infections and viral diseases of the skin (Herpes simplex, chickenpox and vaccinia) perioral dermatitis, rosacea and ulcerative conditions. Allergy to any of the components.
If reactions or idiosyncrasies are encountered, ARISTOCORT should be discontinued.
The use of steroids on infected areas should be attended with caution and careful observation, bearing in mind the potential spreading of infections by anti-inflammatory steroids and the possible advisability of discontinuing steroid therapy and/or initiating antibacterial measures. If infection of the tissues is present, the use of a systemic broad spectrum antibiotic may be desirable.
Generalised dermatological conditions may require systemic, corticosteroid therapy.
It must be remembered that steroid therapy, although responsible for remissions of dermatoses, especially of allergic origin, should not be used prophylactically. With exposure to an allergen, flare up of allergic dermatoses may occur even while an ARISTOCORT preparation is being used.
The use of steroids over extensive body areas, with or without occlusive nonpermeable dressings may result in systemic absorption of the corticosteroid being used and the physician should be aware of such possible absorption and appropriate precautions should be taken.
These preparations are not to be used in the eye as there is a potential risk of glaucoma and cataract.
When steroids are applied for long periods of time (more than 4 weeks) the occurrence of atrophic striae is likely. Prolonged use on flexures and intertriginous areas is undesirable.
Children may absorb proportionately larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. In infants, long term continuous topical steroid therapy should be avoided. Adrenal suppression can occur even without occlusion.
The use of ARISTOCORT cream or ointment should be limited during pregnancy because of possible teratogenic effects. Caution should be exercised when topical corticosteroids are administered to a nursing woman.
Local intolerance to ARISTOCORT is rare, but may be manifested by itching and/or irritation at the site of application. Local intolerance may result from idiosyncratic reaction to components other than the triamcinolone acetonide.
Where occlusive, nonpermeable dressings are used, miliaria, folliculitis and pyodermas will sometimes develop beneath the occlusive material. Localised atrophy and striae have been reported with the use of steroids by the occlusive technique.
Nil
Not applicable but see "Adverse Effects" for statement concerning use with occlusive material.
Store below 25°C.
Avoid freezing.
Prescription Medicine.
| Cream | 0.02% 100g 0.05% 30g |
| Ointment | 0.02% 100g 0.05% 30g |
Nil
Zuellig Pharma Limited
54 Carbine Road
Mt Wellington
Auckland
Telephone: (09) 570 1080
19 May 2002