Appendix E

Rx Clobetasol Propionate 0.05%

Clobetasol propionate is a very high potency analogue of prednisolone with a high degree of glucocorticoid activity and slight degree of mineralocorticoid activity. It acts to induce the production of phospholipase A2 inhibitory proteins, which control the biosynthesis of inflammatory mediators such as prostaglandins and leukotrienes.

Indications: Topical treatment of OLP, MMP, and PV.

Contraindications: Hypersensitivity to the drug or any component of the formulation. Fungal, viral or bacterial infections of the oral cavity or throat.

Warnings/Precautions: Although rare with topical use, clobetasol propionate may induce hypothalamic-pituitary-adrenal (HPA) axis suppression, particularly in patients receiving supraphysiological doses for prolonged periods. If evidence of HPA-axis suppression is present, withdrawal and discontinuation of clobetasol propionate should be done slowly and carefully.

Drug interactions: No significant drug interactions reported.

Dosage form – 0.05% cream, 0.05% ointment, 0.05% gel.
Topical – Apply thin coating of cream, ointment, or gel to lesion after meals and at bedtime. Do not eat or drink for 30 minutes.

Monitor efficacy: Improved oral comfort, lesion resolution.

Monitor toxicity: Mucosal thinning, burning, candida superinfection, perioral dermatitis, Cushing’s syndrome (hypertension, obesity, facial plethora, muscle weakness, back pain, striae, bruising, and psychological symptoms).

Length of treatment: As may be required to manage painful exacerbations of OLP.

Cessation of treatment: Topical regimens may be discontinued without tapering.

Instructions to the patient: Use only as instructed. Do not swallow.

For additional information see DailyMed