Betamethasone Valerate 0.025%
Description: Betamethasone is a synthetic glucocorticoid, appearing as a white to almost-white, odorless crystalline powder. It is practically insoluble in water, soluble 1 in 16 of alcohol, 1 in less than 10 of chloroform, and 1 in 400 of ether; freely soluble in acetone and in dichloromethane. The molecular weight is 476.6.
Clinical Pharmacology: The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory, anti-pruritic and/or immunosuppressive effects. The anti-inflammatory activity of betamethasone is nonspecific because it is exhibited against most causes of inflammation, whether mechanical, chemical, microbiological or immunological. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well-known, the exact mechanism of their actions in each disease are uncertain.
Pharmacodynamics: Betamethasone valerate can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. The rate limiting step for penetration is skin transport. This is either transepidermal or transfollicular, with penetration of the stratum corneum occurring, probably by passive diffusion. Compared to the 1% absorption in the forearm, the scalp absorbs approximately 4%. It is metabolized primarily in the liver and excreted in the kidneys.
Contraindications: Xandrox topical solutions are contraindicated in patients who are hypersensitive to betamethasone, to other corticosteroids, or to any ingredient in these preparations
Precautions: Although extremely unlikely, indiscriminate use of Xandrox topical solutions well above the recommended dosages can produce reversible adrenal axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include application over large surface areas, prolonged use, and the use of occlusive dressings.
Considerations: Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Long term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topically applied corticosteroids. Xandrox solutions are not recommended for pediatric use.
Adverse Reactions: The following adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.
Let me assure you that although there are risks associated with any medicatons, the 'risks' associated with using Xandrox are negligible. The issue of incorporating betamethasone in the formulation was very thoroughly researched and I knew that it could or would be used as an issue of controversy by those who do not fully understand how it works, why it works, and where it works. That's why 5% Xandrox solutions with betamethasone valerate are only available when specifically requested.
