Cocaine Hydrochloride Nasal
Generic Name: cocaine hydrochloride nasal
Brand Names:
Numbrino
11 DESCRIPTION NUMBRINO TM (cocaine hydrochloride) nasal solution is a clear, blue-green, aqueous solution, available in 4% strength. Each 1 mL contains cocaine hydrochloride 40 mg, equivalent to 35.7 mg of cocaine free base; 4% as 160 mg/4 mL or 400 mg/10 mL. Cocaine, (1R,2R,3S,5S) methyl 3-(benzoyloxy)-8-methyl-8-azabicyclo[3.2.1]octane-2-carboxylate hydrochloride, is a synthetic tropane alkaloid ester, local anesthetic, which occurs as colorless to white crystals or white crystalline powder.
Overview
11 DESCRIPTION NUMBRINO TM (cocaine hydrochloride) nasal solution is a clear, blue-green, aqueous solution, available in 4% strength. Each 1 mL contains cocaine hydrochloride 40 mg, equivalent to 35.7 mg of cocaine free base; 4% as 160 mg/4 mL or 400 mg/10 mL. Cocaine, (1R,2R,3S,5S) methyl 3-(benzoyloxy)-8-methyl-8-azabicyclo[3.2.1]octane-2-carboxylate hydrochloride, is a synthetic tropane alkaloid ester, local anesthetic, which occurs as colorless to white crystals or white crystalline powder.
Uses
1 INDICATIONS AND USAGE NUMBRINO (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. NUMBRINO (cocaine hydrochloride) nasal solution is an ester local anesthetic indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION For intranasal use only. ( 2.1 ) Do not apply to damaged nasal mucosa. ( 2.1 ) NUMBRINO should not be substituted for other nasal cocaine products unless determined by FDA to be substitutable. ( 2.1 ) The recommended dose of NUMBRINO ranges from 40 mg to 160 mg, depending on the nasal surface area to be anesthetized and the procedure to be performed. ( 2.2 ) NUMBRINO should be administered by means of cotton or rayon applicator pledgets applied to the nasal mucosa. ( 2 ) One pledget will absorb one mL of NUMBRINO nasal solution. ( 2.2 ) Preparation and Application: Draw up 4 mL NUMBRINO 4% nasal solution into a syringe calibrated in mL. Apply 2 mL NUMBRINO nasal solution to the top of four stacked pledgets.
Side Effects
6 ADVERSE REACTIONS 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.
Interactions
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 plasma cocaine exposure. Avoid using NUMBRINO in patients taking disulfiram. ( 7.3 ) CNS stimulants: Concomitant administration may result in nervousness, irritability, or possibly convulsions. ( 7.1 ) Cholinesterase inhibitors: Concomitant administration may increase the risk of cocaine toxicity.
Warnings
WARNING: ABUSE AND DEPENDENCE CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence. ( 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 ) 5 WARNINGS AND PRECAUTIONS 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, uncontrolled hypertension, or thyrotoxicosis. 5.1 Potential for Abuse and Dependence Central nervous system (CNS) stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence [see Drug Abuse and Dependence ( 9.2 , 9.3 )] . 4 CONTRAINDICATIONS 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 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on the use of NUMBRINO in pregnant women to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Adverse maternal and fetal/neonatal outcomes have been seen in women with chronic cocaine abuse during pregnancy ( see Data ) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied NUMBRINO TM (cocaine hydrochloride) nasal solution is a clear, blue-green solution available as follows: 4% (40 mg/ mL) Nasal Solution NDC 81665-300-02: 4mL Single-use Bottles NDC 81665-300-03: 10mL Multi-use Bottles 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° and 30°C (59° and 86° F) [see...
Frequently Asked Questions
What is Cocaine Hydrochloride Nasal used for?▼
1 INDICATIONS AND USAGE NUMBRINO (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. NUMBRINO (cocaine hydrochloride) nasal solution is an ester local anesthetic indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults. ( 1 )
What are the side effects of Cocaine Hydrochloride Nasal?▼
6 ADVERSE REACTIONS 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.
Can I take Cocaine Hydrochloride Nasal during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on the use of NUMBRINO in pregnant women to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Adverse maternal and fetal/neonatal outcomes have been seen in women with chronic cocaine abuse during pregnancy ( see Data ) .
What are the important warnings for Cocaine Hydrochloride Nasal?▼
WARNING: ABUSE AND DEPENDENCE CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence. ( 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 ) 5 WARNINGS AND PRECAUTIONS 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, uncontrolled hypertension, or thyrotoxicosis. 5.1 Potential for Abuse and Dependence Central nervous system (CNS) stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence [see Drug Abuse and Dependence ( 9.2 , 9.3 )] . 4 CONTRAINDICATIONS 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.