TY - JOUR
T1 - Safety and Tolerability of Topical Clonazepam Solution for Management of Oral Dysesthesia.
AU - Villa, Alessandro
AU - Kuten-Shorrer, M.
AU - Treister, N. S.
AU - Stock, S.
AU - Kelley, J. M.
AU - Ji, Y. D.
AU - Woo, S. B
AU - Lerman, M. A.
AU - Palmason, S.
AU - Sonis, S. T.
N1 - 1 Department of Oral Medicine, Infection, and Immunity, Harvard School of Dental Medicine, Boston, MA, USA. Electronic address: [email protected]. 2 Department of Oral Medicine, Infection, and Immunity, Harvard School of Dental Medicine, Boston, MA, USA; Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA.
PY - 2017/8
Y1 - 2017/8
N2 - Objectives: The aim of the study was to determine the absolute and relative safety of treatment with 2 concentrations of topical clonazepam solution (0.1 mg/mL, 0.5 mg/mL) for management of oral dysesthesia. Study design: The study was a retrospective chart review of patients diagnosed with oral dysesthesia and managed with topical clonazepam solution (swish and spit) between 2008 and 2015. The relative safety of the 2 concentrations was evaluated in terms of occurrence of adverse drug reactions (ADRs) and occurrence of change to treatment plan secondary to ADRs. Results: For the study, 162 patients were included-84 patients in the 0.1 mg/mL cohort and 78 in the 0.5 mg/mL cohort, who were evaluated for a median follow-up period of 6 weeks. Thirty-eight (23%) patients developed ADRs. The most frequently reported ADR was sedation (62% of ADRs), followed by altered mental status and dizziness (7% each). Dose adjustments were required in 9 patients (6%) and treatment discontinuation in 13 (8%). ADRs were more frequently reported in the 0.5 mg/mL cohort, but no significant difference was found in terms of occurrence of ADRs, change to treatment plan secondary to ADRs, or types of ADRs (P > .05). Conclusions: Treatment with topical clonazepam solution in either 0.5 mg/mL or 0.1 mg/mL concentration appears to be safe and well-tolerated. Future prospective studies are needed to confirm this finding.
AB - Objectives: The aim of the study was to determine the absolute and relative safety of treatment with 2 concentrations of topical clonazepam solution (0.1 mg/mL, 0.5 mg/mL) for management of oral dysesthesia. Study design: The study was a retrospective chart review of patients diagnosed with oral dysesthesia and managed with topical clonazepam solution (swish and spit) between 2008 and 2015. The relative safety of the 2 concentrations was evaluated in terms of occurrence of adverse drug reactions (ADRs) and occurrence of change to treatment plan secondary to ADRs. Results: For the study, 162 patients were included-84 patients in the 0.1 mg/mL cohort and 78 in the 0.5 mg/mL cohort, who were evaluated for a median follow-up period of 6 weeks. Thirty-eight (23%) patients developed ADRs. The most frequently reported ADR was sedation (62% of ADRs), followed by altered mental status and dizziness (7% each). Dose adjustments were required in 9 patients (6%) and treatment discontinuation in 13 (8%). ADRs were more frequently reported in the 0.5 mg/mL cohort, but no significant difference was found in terms of occurrence of ADRs, change to treatment plan secondary to ADRs, or types of ADRs (P > .05). Conclusions: Treatment with topical clonazepam solution in either 0.5 mg/mL or 0.1 mg/mL concentration appears to be safe and well-tolerated. Future prospective studies are needed to confirm this finding.
KW - Management
KW - Oral Dysesthesia
KW - Safety
KW - Tolerability
KW - Topical Clonazepam Solution
UR - https://pubmed.ncbi.nlm.nih.gov/28606830/
U2 - 10.1016/j.oooo.2017.05.470
DO - 10.1016/j.oooo.2017.05.470
M3 - Article
VL - 124
JO - Oral Surgery, Oral Medicine, Oral Pathology, and Oral Radiology
JF - Oral Surgery, Oral Medicine, Oral Pathology, and Oral Radiology
ER -