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The first and only FDA approved 4% cocaine hydrochloride nasal solution (CII), clinically proven to be safe and effective1


from wholesalers at a comparable price to the unapproved product.


Indications: Induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. Cocaine hydrochloride nasal solution is a Scheduled II Controlled substance.1


Quality tested with 18 months’ dating Eligible for reimbursement by payers, including Medicare and Medicaid Available in single use 4 mL bottles1 Wholesaler


Order Numbers 4% (4 mL)


Amerisource Bergen 10189060 Cardinal Health McKesson Corp.


5455753 393240


New Order Numbers Please forward this important information to the staff member(s) that place orders for cocaine hydrochloride nasal solution 4% (CII)


14% cocaine hydrochloride nasal solution (CII), package insert, 3/2018 Important Safety Information


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.


CONTRAINDICATIONS


Known hypersensitivity to cocaine hydrochloride, other ester-based anesthetics, or any other component of cocaine hydrochloride nasal solution 4%.


WARNINGS AND PRECAUTIONS


• Seizures: Cocaine hydrochloride nasal solution 4% 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 cocaine hydrochloride nasal solution. Avoid use of cocaine hydrochloride nasal solution in patients with a recent or active history of uncontrolled hypertension, unstable angina, myocardial infarction, coronary artery disease, or congestive heart failure.


ADVERSE REACTIONS


The most common adverse reactions (>0.5%) occurring in patients treated with cocaine hydrochloride nasal solution 4% were headache and epistaxis.


DRUG INTERACTIONS


Disulfiram: Increases plasma cocaine exposure. Avoid using cocaine hydrochloride nasal solution 4% in patients taking disulfiram. 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 cocaine hydrochloride nasal solution. If concomitant use is unavoidable, prolonged vital sign and ECG monitoring may be required.


USE IN SPECIFIC POPULATIONS


Pregnancy: May cause fetal harm. Lactation: Avoid breastfeeding for 48 hours after treatment. Hepatic Impairment: Monitor for adverse reactions such as headache, epistaxis, and clinically relevant increases in heart rate or blood pressure. Do not administer a second dose within 24 hours of the first dose.


OVERDOSAGE


No cases of overdose with cocaine hydrochloride nasal solution 4% were reported in clinical trials. Blood pressure and heart rate increases were greater with cocaine hydrochloride solution 8% than with cocaine hydrochloride nasal solution 4%. In the case of an overdose, consult with a certified poison control center (1-800-222-1222) for up-to-date guidance and advice for treatment of overdosage. Individual patient response to cocaine varies widely. Toxic symptoms may occur idiosyncratically at low doses. Manifestations of cocaine overdose associated with illicit use of cocaine reported in literature and based on reports in FDA’s Adverse Events Reporting System (AERS) database include death, cardio-respiratory arrest, cardiac arrest, respiratory arrest, tachycardia, myocardial infarction, agitation, aggression, restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia, and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Other reactions include arrhythmias, hypertension or hypotension, circulatory collapse, nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma. Because cocaine is significantly distributed to tissues and rapidly metabolized, dialysis and hemoperfusion are not effective. Acidification of the urine does not significantly enhance cocaine elimination.


To report SUSPECTED ADVERSE REACTIONS, contact Pharm- Olam at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.


See full Prescribing Information for cocaine hydrochloride nasal solution 4% (CII).


Copyright 2018 Genus Lifesciences, Inc. All rights reserved.


, is now available as an authorized generic


, facilitating inventory management (NDC 64950-362-04)


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