Numbrino Dosage

2.1 Important Dosage and Administration Instructions

• NUMBRINO (cocaine hydrochloride) is for intranasal use only.
• Do not apply NUMBRINO to damaged nasal mucosa.
• Unless the FDA has determined that these products can be substituted, do not substitute NUMBRINO for other intranasal cocaine products because this may result in different local and/or systemic exposures.

2.2 Dosing Recommendations

The recommended dose of NUMBRINO ranges from 40 mg to 160 mg, depending on the nasal mucosal area to be anesthetized and the procedure to be performed. Each pledget absorbs one mL of NUMBRINO nasal solution. A maximum of two soaked cotton or rayon pledgets may be placed in each nasal cavity, for a total dose of 160 mg for NUMBRINO nasal solution 4%.

The total dose for any one procedure or surgery should not exceed 3 mg/kg cocaine hydrochloride.

The recommended size of the cotton or rayon pledgets for use with NUMBRINO measure ½ inch x 3 inch (sold separately).

2.3 Preparation and Administration of NUMBRINO via Pledgets

Draw up 4 mL NUMBRINO into a syringe calibrated in mL. Stack four pledgets and apply 2 mL of solution to the top of the stacked pledgets. Turn the stacked pledgets over and apply 2 mL of solution to the other side. NUMBRINO should be evenly distributed on all pledgets.

Following NUMBRINO application to pledgets, place One (1) or two (2) pledgets in each nasal cavity, for a maximum of 2 pledgets used per nostril.

Leave pledgets in place for up to 20 minutes. Remove pledgets and continue with the procedure. Discard pledgets, and dispose of any unused pledgets and remaining solution in accordance with institutional procedures for CII products.

Pledgets should be removed immediately upon any sign or symptom of an adverse event.