Home » Drug Information » FDA-Approved Drugs » 1998
Medical Areas: Dermatology/Plastic Surgery
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Galderma Laboratories
Approval Status: Approved November 1998
Treatment Area: Dermatology
Treatment of inflammatory papules and pustules of rosacea.
A controlled clinical study was conducted in 144 patients with
moderate to severe rosacea, in which MetroLotion Topical Lotion was
compared with its vehicle. Applications were made twice daily for
12 weeks during which patients were instructed to avoid spicy
foods, thermally hot foods and drinks, alcoholic beverages, and
caffeine. Patients were also provided samples of a soapless
cleansing lotion and, if requested, a moisturizer. MetroLotion
Topical Lotion was significantly more effective than its vehicle in
the mean percent reduction of inflammatory lesions associated with
rosacea and in the investigators’ global assessment of
improvement.
MetroLotion Topical Lotion is contraindicated in individuals
with a history of hypersensitivity to metronidazole or to other
ingredients of the formulation.
Also local allergic reaction, contact dermatitis, skin
discomfort (burning and stinging), erythema and the following
additional adverse experiences have been reported with the topical
use of metronidazole: skin irritation, transient redness, metallic
taste, tingling or numbness of extremities, and nausea.
The mechanisms by which metronidazole acts in the treatment of
rosacea are unknown, but appear to include an anti-inflammatory
effect.
