Vusion ointment, Astelin nasal spray.
* Recommended Dosage: Gently apply a thin layer of Vusion ointment to the affected area at each diaper change. Continue use for 7 days, even if improvement is noted.
* Special Considerations: Use only for diaper dermatitis complicated by documented candidiasis (verified with microscopic testing, for example).
Do not use Vusion ointment for the prevention of diaper dermatitis. Discontinue use of the ointment if irritation develops or if the disease worsens. Do not rub the ointment into the skin because this may cause additional irritation. For external use only.
* Comment: Efficacy was determined on the basis of an intent-to-treat study of 236 infants and toddlers who had diaper dermatitis and confirmed Candida infection. This double-blind, multicenter trial compared application of Vusion ointment or zinc oxide/white petrolatum at every diaper change for a period of 7 days. The primary end point was an "overall cure," defined as both clinical and microbiologic resolution.
At day 7, 7% of 112 patients in the Vusion group achieved an overall cure, compared with 0.8% of 124 patients in the vehicle group.
At follow-up on day 14, 23% of Vusion patients and 10% of vehicle patients achieved the primary outcome.
Instruct parents to gently cleanse skin with lukewarm water and pat dry with a soft towel before each use. In addition, they should thoroughly wash their hands after each application.
"One of the problems is it's somewhat difficult to distinguish candidal dermatitis from irritant dermatitis--and the candidal dermatitis is often secondary to an irritant dermatitis," said Dr. Amy Pallet, chair of the department of dermatology and professor of pediatrics at Northwestern University in Chicago.
"I really like the idea of combining an anticandidal agent and protection against irritation. In the past we prescribed a topical antifungal and had the parent then apply zinc oxide paste over it. This [combination product] is easier for parents."
A requirement to use the product only in laboratory-confirmed cases of candidiasis may not be realistic for most pediatricians, Dr. Paller said. Most pediatricians may not be approved under the Clinical Laboratory Improvement Amendments to perform KOH tests in their offices. "To do just cultures can be very misleading--many infants are colonized with Candida," she said.
Dr. Paller is a consultant for Barrier Therapeutics but was not involved in clinical studies for Vusion.
Astelin Nasal Spray (azelastine hydrochloride nasal spray, 137 mcg; MedPointe Pharmaceuticals) The FDA approved a new dosing regimen for Astelin nasal spray, 137 mcg, for patients 12 years and older with seasonal allergic rhinitis.
* Recommended Dosage: One spray twice daffy is the dosing approved in this supplemental new drug approval.
* Special Considerations: Somnolence was reported in Astelin clinical trials, so instruct patients to exercise caution if they will be driving or operating heavy machinery.
Caution is advised with concurrent use of other antihistamines. Carefully consider the risk-benefit ratio when prescribing Astelin to patients who are or may become pregnant and those who may be breast-feeding.
* Comment: "I think it's important. With any nasal spray, a decrease in the frequency is a pretty big deal," said Dr. Sai R. Nimmagadda of the division of allergy, Children's Memorial Hospital, Chicago.
"One benefit is you can get the same product to last twice as long. Also, this tells us the efficacy is still there at the lower dose.
"Cutting the dose in half is huge--especially in the pediatric population because trying to get two sprays at once is difficult. It can drip and this leads to discomfort from postnasal drip," Dr. Nimmagadda said.
For patients suffering from seasonal allergic rhinitis, "I use an intranasal corticosteroid spray first. If there is a vasomotor component or a failure to control symptoms, I would switch to Astelin," Dr. Nimmagadda said.
"The product also works for acute exposures." For example, it is worth trying Astelin before exposure to a cat in someone who has pet allergies, Dr. Nimmagadda added.
Astelin nasal spray was previously approved for adults and children 12 years and older with seasonal allergic rhinitis as one or two sprays per nostril twice daffy. The agent is also approved for use in children who are 5-11 years old with seasonal allergic rhinitis as one spray per nostril twice daily.
BY ELIZABETH MECHCATIE, SENIOR WRITER
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|Title Annotation:||New & Approved|
|Date:||Apr 1, 2006|
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