View Drug - metronidazole
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metronidazole

Generic: METRONIDAZOLE

100%
Basic Information
Manufacturer
Mayne Pharma Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
5099691f-f216-4ac1-b057-99a845cc770f
Indications & Usage
INDICATIONS AND USAGE Metronidazole Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Adverse Reactions
ADVERSE REACTIONS In a controlled clinical trial, safety data from 141 patients who used Metronidazole Topical Lotion (n=71), or the lotion vehicle (n=70), twice daily and experienced a local cutaneous adverse event which may or may not have been related to the treatments include: local allergic reaction, Metronidazole Topical Lotion 2 (3%), lotion vehicle 0; contact dermatitis, Metronidazole Topical Lotion 2 (3%), lotion vehicle 1 (1%); pruritus, Metronidazole Topical Lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), Metronidazole Topical Lotion 1 (1%), lotion vehicle 2 (3%); erythema, Metronidazole Topical Lotion 4 (6%), lotion vehicle 0; dry skin, MetronidazoleTopical Lotion 0, lotion vehicle 1 (1%); and worsening of rosacea, Metronidazole Topical Lotion 1 (1%), lotion vehicle 7 (10%).

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.