Cocaine

What is Cocaine and how is it used?

Cocaine is a prescription medicine used to treat the symptoms of Anesthesia of the Nasal Cavity and Mucous Membrane. Cocaine may be used alone or with other medications.

Cocaine belongs to a class of drugs called Local Anesthetics, Esters.

What are the possible side effects of Cocaine?

Cocaine may cause serious side effects including:

• fever,
• mood changes,
• drowsiness,
• confusion,
• hallucinations,
• mood swings,
• numbness in application area sever hours after procedure,
• loss of smell or taste,
• blurred vision,
• sensitivity to light,
• slow, shallow or rapid breathing,
• fainting,
• fast, slow, irregular or pounding heartbeat,
• severe headache,
• shaking,
• chest pain, and
• seizures

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Cocaine include:

• dizziness,
• nausea,
• nervousness,
• unusual feelings of well-being, and
• restlessness

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Cocaine. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Each mL contains:

Cocaine Hydrochloride topical solution) 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 (cocaine (cocaine hydrochloride topical solution) hydrochloride topical solution) USP is a crystalline, granular, or powder substance having a saline, slightly bitter taste that numbs tongue and lips. Cocaine Hydrochloride (cocaine topical solution) is a local anesthetic.

INDICATIONS

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

DOSAGE AND ADMINISTRATION

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 (cocaine (cocaine hydrochloride topical solution) hydrochloride topical solution) Topical Solution can be administered by means of cotton applicators or packs, instilled into a cavity, or as a spray.

HOW SUPPLIED

4% Cocaine Hydrochloride (cocaine (cocaine hydrochloride topical solution) hydrochloride topical solution) 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 (cocaine (cocaine hydrochloride topical solution) hydrochloride topical solution) 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.

SIDE EFFECTS

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 (cocaine hydrochloride topical solution) slow the heart rate, but after moderate doses, the rate is increased due to central sympathetic stimulation.

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

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

DRUG INTERACTIONS

No information provided.

WARNINGS

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 (cocaine hydrochloride topical solution) are not available.

Pregnancy

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

PRECAUTIONS

The safety and effectiveness of Cocaine Hydrochloride (cocaine (cocaine hydrochloride topical solution) hydrochloride topical solution) 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 (cocaine (cocaine hydrochloride topical solution) hydrochloride topical solution) 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.

OVERDOSE

The fatal dose of cocaine (cocaine hydrochloride topical solution) 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 (cocaine hydrochloride topical solution) 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 (cocaine hydrochloride topical solution) is rapid in developing.

Treatment - The specific treatment of acute cocaine (cocaine hydrochloride topical solution) 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 (cocaine hydrochloride topical solution) is eliminated fairly rapidly.

CONTRAINDICATIONS

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

CLINICAL PHARMACOLOGY

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

PATIENT INFORMATION

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