WARNING: ABUSE AND DEPENDENCE CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence [see Warning and Precautions (5.1) . ] WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence. (5.1)
Adult Dosing
General dosing
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. ( 2.2 , 2.3 ) – Following soaking, place two pledgets in each nasal cavity against the septum. – Leave pledgets in p lace for up to 20 minutes. 2.1 ImportantInstructions • GOPRELTO is for intranasal use only. • Do not apply GOPRELTO to damaged nasal mucosa. 2.2 Dosing Recommendation for Adults The recommended dose of GOPRELTO is two soaked cottonoid pledgets placed in each nasal cavity, equivalent to 40 mg cocaine hydrochloride per pledget, for a total dose of 160 mg for four pledgets. The total dose for any one procedure or surgery should not exceed 160 mg, or 3 mg/kg, cocaine hydrochloride. The recommended size of cottonoid pledgets for use with GOPRELTO measure 1.3 cm x 4 cm (sold separately).
Max: 160 mg, or 3 mg/kg, cocaine hydrochloride
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