This paper from Hospital Pharmacy is giving a guarded approval for the use of Oxymetazoline topically for the redness of rosacea. Even though the FDA has not approved Oxymetazoline as a topical skin treatment, it is approved as a nasal decongestant.
Doctors are able to prescribe drugs for off-label use, that is once a drug has been approved for one condition, there is some freedom for doctors to propose it for other conditions.
What is Oxymetazoline
Oxymetazoline is the active ingredient in decongestant products like Afrin, Sudafed OM and Vicks Sinex as well as in eye drops like Visine LR.
A well known side effect of Visine is rebound redness, where continued use leads to the redness that you were originally treating. Extended usage of Afrin can also lead to rebound nasal congestion.
Oxymetazoline 0.05% solution, as mentioned in this paper is available as TopCare Sinus Nasal Spray and also Afrin Nasal Spray.
We know that Allergan are conducting trials to establish the best amount of active ingredient to include in their Oxymetazoline Cream.
Given the question hanging over the rebound redness issues with Mirvaso, one should also be careful with products like Afrin as rebound issues may well arise.
Hosp Pharm. 2013 Jul-Aug; 48(7): 558–559.
Joyce A. Generali, RPh, MS, FASHP, (Editor) and Dennis J. Cada, PharmD, FASHP, FASCP
Dosage and Duration
Intranasal oxymetazoline 0.05% solution applied topically once daily to affected facial areas for up to 17 months.
The topical use of oxymetazoline 0.05% solution in the management of rosacea has been primarily limited to data from case series involving fewer than 10 patients and demonstrating sustained improvements in both erythema and flushing. Alhough oxymetazoline is not recognized in national guidelines, an international consensus statement recognizes the possible therapeutic role of oxymetazoline in the management of rosacea, despite the limited evidence.
For symptoms of periodic flushing, vasoactive drugs are also recommended, including topical oxymetazoline and oral nadolol, ondansetron, or clonidine, despite limited evidence. The FDA-approved topical therapies are suggested as first-line treatment for persistent erythema or rosacea characterized by papules and pustules.
In 2 case reports of adults (aged 55 and 70 years) with a history of refractory erythema and flushing related to rosacea for several years, topical oxymetazoline 0.1% solution was applied once daily to affected facial areas. A decrease in facial erythema was noted within 1 hour after application, and a dramatic improvement was observed within 2 to 3 hours. The effects were sustained throughout the day. Continued use for several months was associated with marked improvement in erythema without episodes of flushing or flares. Both patients experienced sustained effects with prolonged use of 8 and 17 months.
This is a limited safety profile. Refer to package labeling for complete prescribing information (eg, warnings/precautions, adverse reactions, drug interactions).
Concerns with the use of intranasal alpha-agonist decongestants include the loss of efficacy with prolonged use (tachyphylaxis) and possible rebound vasodilation, although these effects have not occurred in the limited number of patients studied.
No stinging or burning was noted with application
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