Clinical Overview
Important Safety Information
- Because concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect, patients should be closely monitored.
- Oravig should be administered with caution in patients with hepatic impairment.
- There is no information regarding cross-hypersensitivity between miconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.
- Most commonly reported adverse reactions (incidence 2%) in clinical studies include diarrhea, nausea, upper abdominal pain, vomiting, headache and dysgeusia
References: 1. Vazquez JA, Patton LL, Epstein JB, et al; SMiLES Study Group. Randomized, comparative, double-blind, double-dummy, multicenter trial of miconazole buccal tablet and clotrimazole troches for the treatment of oropharyngeal candidiasis: study of miconazole Lauriad® efficacy and safety (SMiLES). HIV Clin Trials. 2010;11(4):186-196. 2. Data on file, Midatech Pharma US Inc.
Important Safety Information
- Because concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect, patients should be closely monitored.
- Oravig should be administered with caution in patients with hepatic impairment.
- There is no information regarding cross-hypersensitivity between miconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.
- Most commonly reported adverse reactions (incidence 2%) in clinical studies include diarrhea, nausea, upper abdominal pain, vomiting, headache and dysgeusia
References: 1. Bensadoun R-J, Daoud J, El Gueddari B, et al. Comparison of the efficacy and safety of miconazole 50-mg mucoadhesive buccal tablets with miconazole 500-mg gel in the treatment of oropharyngeal candidiasis: a prospective, randomized, single-blind, multicenter, comparative, phase III trial in patients treated with radiotherapy for head and neck cancer. Cancer. 2008;112:204-211. 2. Data on file, Midatech Pharma US Inc
