Cocaine

GOPRELTO (cocaine hydrochloride) nasal solution is indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. GOPRELTO (cocaine hydrochloride) nasal solution is an ester local anesthetic indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.

Cocaine hydrochloride is a local anesthetic of the ester type. Cocaine hydrochloride prevents conduction in nerve fibers by reversibly blocking sodium channels and preventing the transient rise in sodium conductance necessary for generation of an action potential.

• For intranasal use only. • Recommended dose: two pledgets, each containing 40 mg of cocaine hydrochloride,applied to each nasal cavity. • Do not apply to damaged nasal mucosa. • Preparation and Application: – In a small container, soak four pledgets in the full contents (4 mL) of one bottle of GOPRELTO until the solution is fully absorbed. Each pledget absorbs 1 mL of solution, equivalent to 40 mg cocaine hydrochloride. – Following soaking, place two pledgets in each nasal cavity against the septum. – Leave pledgets in p lace for up to 20 minutes.

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.

Boxed warning (abuse and dependence cns): stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence WARNING: ABUSE AND DEPENDENCE CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence. • Seizures: GOPRELTO may lower the convulsive threshold. Monitor patients for development of seizures. • 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.

The most common adverse reactions (>0.5%) occurring in patients treated with GOPRELTO (cocaine hydrochloride) nasal solution 4% were headache and epistaxis.

• Disulfiram: Increases plasma cocaine exposure. Avoid using GOPRELTO in patients taking disulfiram. • 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, prolonged vital sign and ECG monitoring may be required.

Store upright at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Avoid freezing.