1 Name of Medicine
Clobetasol propionate.
2 Qualitative and Quantitative Composition
Each 1 g of ointment contains 0.5 mg of clobetasol propionate.
For the full list of excipients, see Section 6.1 List of Excipients.
3 Pharmaceutical Form
Clobetasol propionate 0.05% w/w ointment is a white to off-white translucent ointment.
4 Clinical Particulars
4.9 Overdose
Topically applied clobetasol may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercortisolism may occur.
In the event of overdose, clobetasol should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.
However, because of the risk of acute adrenal suppression, this should be done under medical supervision.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
5 Pharmacological Properties
5.3 Preclinical Safety Data
Genotoxicity. Clobetasol propionate did not demonstrate any genotoxic potential in vitro (Ames, fluctuation and gene conversion tests and chromosome aberration assay) or in vivo (mouse micronucleus test).
Carcinogenicity. Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.
6 Pharmaceutical Particulars
6.7 Physicochemical Properties
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCLOPRO.gif CAS number. 25122-46-7.
7 Medicine Schedule (Poisons Standard)
Schedule 4 (Prescription Medicine).
Summary Table of Changes
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/XOBETOST.gif
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