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Numbrino Generic Name & Formulations
Legal Class
CII
General Description
Cocaine HCl 4% (40mg/mL); aqueous nasal soln.
Pharmacological Class
Local anesthetic.
How Supplied
Nasal soln (4mL, 10mL)—1
Manufacturer
Generic Availability
NO
Numbrino Indications
Indications
Local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities.
Numbrino Dosage and Administration
Adult
For intranasal use only. Do not apply to damaged nasal mucosa. ≥18yrs: 40–160mg based on the nasal mucosal area and procedure; max 2 pledgets per nasal cavity (total dose of 160mg). Each pledget (recommended size is ½ inch x 3 inch) absorbs 1mL. Do not exceed 3mg/kg for any one procedure/surgery.
Children
<18yrs: not established.
Numbrino Contraindications
Contraindications
Hypersensitivity to other ester-based local anesthetics.
Numbrino Boxed Warnings
Boxed Warning
Abuse and dependence.
Numbrino Warnings/Precautions
Warnings/Precautions
High potential for abuse and dependence. History of seizures. Prior EEG abnormalities without seizures. Monitor vital signs (eg, HR and rhythm) and for seizure development. Avoid in patients with history of MI, coronary artery disease, CHF, irregular heart rhythm, abnormal ECG, or uncontrolled hypertension. Pseudocholinesterase deficiency, renal impairment; monitor. Hepatic impairment: avoid. Elderly. Pregnancy. Nursing mothers: not recommended (during and for 48hrs after the last dose).
Numbrino Pharmacokinetics
See Literature
Numbrino Interactions
Interactions
Avoid concomitant other vasoconstrictor agents (eg, epinephrine, phenylephrine); if unavoidable, prolonged vital sign and ECG may be needed. Avoid use with disulfiram; consider alternative local anesthesia. Concomitant other CNS stimulants may cause excessive stimulation (eg, nervousness, irritability, possibly convulsions). May be potentiated by cholinesterase inhibitors (eg, certain MAOIs, oral contraceptives, glucocorticoids, neostigmine, cyclophosphamide, thiotepa, echothiophate, organophosphate insecticides, certain antineoplastic agents); monitor. May increase risk of hypertension and cardiac arrhythmias with sympathomimetics, postganglionic blocking agents (eg, reserpine), and TCAs. May potentiate MAOIs. May be detected in plasma for up to 1 week and urine toxicology for >1 week after administration.
Numbrino Adverse Reactions
Adverse Reactions
Hypertension, tachycardia, sinus tachycardia.
Numbrino Clinical Trials
See Literature
Numbrino Note
Not Applicable
Numbrino Patient Counseling
See Literature
