Effectiveness of levodropropizine on post-operative sore throat after endotracheal intubation for head and neck surgery: A double-blind randomized controlled trial

@#Objective: To determine the effectiveness of levodropropizine in reducing the incidence of post-operative sore throat (POST) among ear, nose, throat, head and neck (ENT-HNS) patients undergoing general endotracheal anesthesia. Methods: Design: Double-Blind, Randomized, Placebo Controlled Trial Setting: Tertiary Government Training Hospital Participants: Sixty (60) ENT-HNS patients aged between 19 to 60 years old admitted to the Southern Philippines Medical Center from January to March 2019 for surgeries on benign thyroid tumors, benign submandibular gland tumors and tonsils requiring orotracheal intubation were randomized into control and treatment groups of 30 patients each. Results: There was a statistically significant difference (p=.0016) in the incidence of POST 6 hours after surgery between control (25/30; 83%) and treatment (16/30; 53.33%) groups. However, confounders such as length and type of surgery (more females and tonsillectomy cases in the control group) were not fully eliminated by randomization. Conclusion: Perioperative levodropropizine significantly decreases the incidence of moderate (as well as mild) postoperative sore throat. It was not shown to decrease the incidence of severe sore throat. A larger cohort (adjusted for other confounders) may better describe the benefit of this treatment.

A Case of Immunoglobulin E Mediated Anaphylaxis to Levodropropizine

We experienced a case of immunoglobulin E (IgE) mediated anaphylaxis to levodropropizine. The patient was an 18-year old Korean woman. After taking the common cold medication including acetaminophen, domperidone, and levodropropizine, skin rash, angioedema and anaphylaxis were developed immediately. As she was tolerable to acetaminophen alone, we thought the culprit agent was maybe a levodropropizine tablet. To confirm the culprit, she underwent skin prick test and oral drug provocation test with the suspected one. Finally we detected levodropropizine specific IgE and confirmed the specificity by inhibition enzyme-linked immunosorbent assay (ELISA).

Pharmacokinetics and Safety of Levodropropizine Controlled Release Tablet after Repeated Dosing in Healthy Male Volunteers

BACKGROUND: Levodropropizine is non-opioid agent whose peripheral antitussive action may result from its modulation of sensory neuropeptide levels. Currently, levodropropizine 60 mg is taken three-times daily. A controlled release formulation of levodropropizine (levodropropizine CR) 90 mg was developed, which can be taken twice daily. The aim of this study was to evaluate the safety and pharmacokinetic characteristics after multiple oral administrations of levodropropizine CR 90 mg tablets in healthy male volunteers. METHODS: A randomized, open-label, cross-over study was conducted in 24 healthy male volunteers. Each subject received levodropropizine syrup 60 mg three times daily or levodropropizine CR 90 mg twice daily for 3 days. Blood samples for pharmacokinetic analysis were collected pre-dose and up to 24 hours on day 4. Pharmacokinetic analysis was conducted by non-compartmental method. Safety assessments including monitoring adverse events, laboratory tests, vital signs, physical examinations and ECGs were performed throughout the study. RESULTS: A total of 20 male volunteers completed the study. The maximum steady-state plasma concentration (Css,max) of levodropropizine syrup and levodropropizine CR were 313.28 ng/mL and 285.31 ng/mL and time to reach Css,max (Tmax,ss) were 0.48 hr and 0.88 hr, respectively. The area under the concentration-time curve to the last measured concentration of two groups were 2345.36 hr x ng/mL and 2553.81 hr x ng/mL, respectively. There was no serious adverse event. CONCLUSION: Levodropropizine CR 90 mg tablet was safe and well-tolerated when administered twice daily for 3 days. No statistically significant differences were seen in Css,max and AUCss,24hr between the two formulations. This study provided pharmacokinetic evidences that the twice-daily dosing regimen of levodropropizine 90 mg may substitute the conventional 3-times-daily regimen of levodropropizine 60 mg.