Appendix B

Rx Betamethasone Valerate

Betamethasone is a 9α-fluorinated derivative of hydrocortisone. The addition of a 5-carbon valerate chain to the 17-hydroxy position increases its potency 300 times that of hydrocortisone for topical use. Acts to control the rate of protein synthesis, inhibit migration of polymorphonuclear leukocytes, reverse capillary permeability and stabilize cellular lysosomal membranes.

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: Use with caution in patients with heart failure, diabetes, GI diseases, hepatic impairment, myasthenia gravis, MI, patients at risk for osteoporosis, seizure disorders, or thyroid disease. Use with caution in patients with glaucoma, cataracts, latent TB, psychiatric disturbances, or secondary infection. May induce hypothalamic-pituitary-adrenal (HPA) axis suppression, particularly in patients receiving supraphysiological doses for prolonged periods. If present, withdrawal and discontinuation of prednisone should be done slowly and carefully.

Drug interactions: Barbiturates, phenytoin, and rifampin increase metabolism of betamethasone. Potassium-depleting diuretics increase potassium loss. Betamethasone may increase blood glucose levels, counteracting the actions of insulin or oral hypoglycemic agents. Salicylates may increase risk of gastric ulceration.

Dosage form – 0.1% cream, 0.1% ointment.
Topical – Apply thin coating of cream or ointment 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, candidal 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