Each mL contains:

Cocaine Hydrochloride 40 mg or 100 mg

As aqueous solution.

The topical solution contains the following inactive ingredients: citric acid, D and C Yellow No. 10, FD and C Green No. 3, sodium benzoate, and water.

NOTE (for Glass Bottle): External surface of unopened bottle may be sterilized by ethylene oxide only. Do not steam autoclave. Cocaine Hydrochloride USP is a crystalline, granular, or powder substance having a saline, slightly bitter taste that numbs tongue and lips. Cocaine Hydrochloride is a local anesthetic.

Last updated on RxList: 3/19/2009

Cocaine Hydrochloride Topical Solution is indicated for the introduction of local (topical) anesthesia of accessible mucous membranes of the oral, laryngeal and nasal cavities.

The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Cocaine Hydrochloride Topical Solution can be administered by means of cotton applicators or packs, instilled into a cavity, or as a spray.

4% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.

NDC 0054-8163-02: Unit-of-use Glass Bottle filled to contain 4 mL, one 4 mL bottle per carton.
NDC 0054-3154-40: Multi-Dose Bottle of 10 mL.

10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.

NDC 0054-8164-02: Unit-of-use Glass Bottle filled to contain 4 mL, one 4 mL bottle per carton.
NDC 0054-3155-40: Multi-Dose Bottle of 10 mL.

DEA Order Form Required.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Avoid freezing.

Keep out of reach of children.

Boehringer lngelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216. Revised February 2006.

Last updated on RxList: 3/19/2009

Adverse reactions may be due to high plasma levels as a result of excessive and rapid absorption of the drug. Reactions are systemic in nature and involve the central nervous system and/or the cardiovascular system. A small number of reactions may result from hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.

CNS reactions are excitatory and/or depressant, and may be characterized by nervousness, restlessness and excitement. Tremors and eventually clonictonic convulsions may result. Emesis may occur. Central stimulation is followed by depression, with death resulting from respiratory failure.

Small doses of cocaine slow the heart rate, but after moderate doses, the rate is increased due to central sympathetic stimulation.

Cocaine is pyrogenic, augmenting heat production in stimulating muscular activity and causing vasoconstriction which decreases heat loss. Cocaine is known to interfere with the uptake of norepinephrine by adrenergic nerve terminals, producing sensitization to catecholamines, causing vasoconstriction and mydriasis.

Cocaine causes sloughing of the corneal epithelium, causing clouding, pitting, and occasionally ulceration of the cornea. The drug is not meant for ophthalmic use.

No information provided.

Last updated on RxList: 3/19/2009

RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHEN ANY LOCAL ANESTHETIC IS USED.

Carcinogenesis, Mutagenesis

Long-term studies to determine the carcinogenic and mutagenic potential of cocaine are not available.

Pregnancy

Teratogenic Effects-Pregnancy Category C: Animal reproduction studies have not been conducted with cocaine. It is also not known whether cocaine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cocaine should be given to a pregnant woman only if needed.

The safety and effectiveness of Cocaine Hydrochloride Topical Solution depends on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Standard textbooks should be consulted for specific techniques and precautions for various anesthetic procedures.

The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status.

Cocaine Hydrochloride Topical Solution should be used with caution in patients with severely traumatized mucosa and sepsis in the region of the proposed application. Use with caution in persons with known drug sensitivities.

Last updated on RxList: 3/19/2009

The fatal dose of cocaine has been approximated at 1.2 g., although severe toxic effects have been reported from doses as low as 20 mg.

Symptoms - The symptoms of cocaine poisoning are referable to the CNS, namely the patient becomes excited, restless, garrulous, anxious and confused. Enhanced reflexes, headache, rapid pulse, irregular respiration, chills, rise in body temperature, mydriasis, exophthalmos, nausea, vomiting and abdominal pain are noticed. In severe overdoses, delirium, Cheyne-Stokes respiration, convulsions, unconsciousness, and death from respiratory arrest result. Acute poisoning by cocaine is rapid in developing.

Treatment - The specific treatment of acute cocaine poisoning is the intravenous administration of a short-acting barbiturate or diazepam. Artificial respiration may be necessary. It is important to limit absorption of the drug. If entrance of the drug into circulation can be checked, and respiratory exchange maintained, the prognosis is favorable since cocaine is eliminated fairly rapidly.

Cocaine Hydrochloride is contraindicated in patients with a known history of hypersensitivity to the drug or to the components of the topical solution.

Last updated on RxList: 3/19/2009

Cocaine blocks the initiation or conduction of the nerve impulse following local application, thereby effecting local anesthetic action. Cocaine is absorbed from all sites of application, including mucous membranes and the gastrointestinal mucosa. Cocaine is degraded by plasma esterses, with the half-life in the plasma being approximately one hour.

Last updated on RxList: 3/19/2009

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 3/19/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

COCAINE HYDROCHLORIDE - TOPICAL

(KOE-kane)

USES: Cocaine is used by health care professionals to temporarily numb the lining of the mouth, nose, and throat (mucous membranes) before certain medical procedures (e.g., biopsy, stitches, wound cleaning). It is an anesthetic that works quickly to numb the area about 1-2 minutes after application. Cocaine also causes blood vessels to narrow, an effect that can decrease bleeding and swelling from the procedure.

HOW TO USE: This medication is applied directly to the inside of the mouth, nose, or throat by a health care professional, usually right before your procedure. It may be poured, sprayed, or applied with a cotton swab directly to the area. When using this medication in the nose, your health care professional may soak absorbent material with the solution, then insert it into the nose. The dosage and application method depends on your condition and response to the drug. Do not give this medication by injection or use in the eye.

This medication numbs the mouth, nose, and throat. This effect will make swallowing difficult and increase your risk of choking or swallowing the wrong way. Do not eat or chew gum for 1 hour after this product is used or until your mouth/throat is no longer numb. It is especially important to make sure children do not eat or chew gum for at least 1 hour after their procedure. Be careful not to accidentally bite your tongue or mouth.

Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Use this medication exactly as prescribed. Do not use more of this medication, use it more frequently, or use for a longer period of time than prescribed.

SIDE EFFECTS: Dizziness, nausea, nervousness, unusual feelings of well-being, or restlessness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fever, mental/mood changes (e.g., drowsiness, confusion, hallucinations, mood swings), numbness in application area several hours after procedure, loss of smell or taste, vision problems (e.g., blurred vision, sensitivity to light).

Tell your doctor immediately if any of these rare but very serious side effects occur: slow/shallow/rapid breathing, fainting, fast/slow/irregular/pounding heartbeat, severe headache, shaking (tremors).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before your procedure, tell your doctor or pharmacist if you are allergic to cocaine; or to other ester-type anesthetics (e.g., benzocaine); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease (e.g., chest pain, heart attack, irregular heartbeat), overactive thyroid (hyperthyroidism), seizures, infection/sores/injury in the area of the application site (e.g., mouth, nose, throat).

This drug may make you dizzy. Use caution while driving, using machinery, or doing any activity that requires alertness. Avoid alcoholic beverages.

Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially restlessness/excitement.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially irregular heartbeat and chest pain.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before and during treatment with this medication. In some cases, a serious (possibly fatal) drug interaction may occur.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before using this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: stimulant-type drugs (e.g., catecholamines such as norepinephrine or epinephrine, ephedrine, pseudoephedrine, amphetamines).

Also report the use of drugs that might increase seizure risk when combined with cocaine such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting, stomach/abdominal pain, severe headache, irregular breathing, seizures, fainting.

NOTES: Do not share this medication with others. It is against the law.

MISSED DOSE: Not applicable.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.