GOPRELTO

A double-blind, multicenter, single-dose, placebo- and dose-controlled, parallel-group study was conducted in 648 subjects undergoing diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities. Subjects were randomized to receive GOPRELTO (n=278), cocaine hydrochloride solution 8% (n=275), to explore the dosing range, or placebo (n=95). Nasal endoscopy, nasal laryngoscopy, nasopharyngeal laryngoscopy, and nasal debridement comprised 88% of all procedures performed in the GOPRELTO group and 85% of all procedures performed in the placebo group. All subjects comp...

The most common adverse reactions (>0.5%) occurring in patients treated with GOPRELTO (cocaine hydrochloride) nasal solution 4% were headache and epistaxis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LXO US., INC. at 1-844-800-8007 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in ...

GOPRELTO is contraindicated in patients with a known history of hypersensitivity to cocaine hydrochloride, other ester-based anesthetics, or any other component of the product. Known hypersensitivity to cocaine hydrochloride, other ester-based anesthetics, or any other component of GOPRELTO. ( 4 )

• Seizures : GOPRELTO may lower the convulsive threshold. Monitor patients for development of seizures. ( 5.2 )
• Blood Pressure and Heart Rate Increases : Monitor vital signs, including heart rate and rhythm, in patients after receiving GOPRELTO. Avoid use of GOPRELTO in patients with a recent or active history of uncontrolled hypertension, unstable angina, myocardial infarction, coronary artery disease, or congestive heart failure. ( 5.3 ) 5.1 Potential for Abuse and Dependence Central nervous...

7 DRUG INTERACTIONS

• Disulfiram : Increases plasma cocaine exposure. Avoid using GOPRELTO in patients taking disulfiram. ( 7 )
• Epinephrine, Phenylephrine : There have been reports of myocardial ischemia, myocardial infarction, and ventricular arrhythmias with concomitant use during nasal surgery. Avoid use of additional vasoconstrictor agents with GOPRELTO. If concomitant use is unavoidable, pr...