NUMBRINO (cocaine hydrochloride)

NUMBRINO is an aqueous solution of cocaine hydrochloride for topical use only.

AbsorptionApplication of NUMBRINO for 20 minutes by pledget administration to the nasal mucosa in healthy adults may reduce the systemic absorption of the applied dose of cocaine hydrochloride compared to the systemic absorption after non-pledget administration. The estimated mean systemic absorption of cocaine from a single 160 mg dose (4 mL, 4%) was 23.44% of the topically applied dose. ( Table 2 ). Table 2. System...

Efficacy was demonstrated in one multicenter, randomized, double-blind, placebo-controlled, parallel-arm, clinical trial comparing a single-dose of 4% and 10% NUMBRINO and placebo applied to pledgets and delivered to the nasal mucosa in patients requiring a diagnostic or surgical procedure on or through accessible mucous membranes of the nasal cavities. One trial was terminated early in order to update the trial to refine its operation. The primary endpoint was nasal anesthetic success, defined as immediate anesthesia based on a numeric pain rating score (NPRS) of 0 (no pain, 0 to 10 scale) 20...

The following treatment-emergent adverse events are discussed in more detailed in other sections of the labeling: Increases in Blood Pressure and Heart Rate [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (> 1%) occurring in patients treated with NUMBRINO were hypertension, tachycardia, and sinus tachycardia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Omnivium Pharmaceuticals LLC at 1-888-807-1048 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical...

NUMBRINO is contraindicated in: patients with a known history of hypersensitivity to cocaine hydrochloride, other ester-based local anesthetics, or any other component of the nasal solution [see Warnings and Precautions ( 5.5 )] . Hypersensitivity to cocaine, or any component of NUMBRINO. ( 4 )

NUMBRINO is for TOPICAL USE ONLY. NOT FOR INJECTION OR OPHTHALMIC USE. ( 5 ) Seizures: NUMBRINO 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 NUMBRINO. Avoid use of NUMBRINO in patients with a recent or active history of myocardial infarction, coronary artery disease, congestive heart failure, irregular heart rhythm, abnormal ECG, uncontro...

7 DRUG INTERACTIONS 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 NUMBRINO. If concomitant use is unavoidable, prolonged vital sign and ECG monitoring may be required. ( 5.3 , 7.2 ) Disulfiram: Disulfiram treatment increases...