Cocaine

Cocaine is a prescription medication used as a local (topical) anesthetic for areas of the mouth, throat, and nasal cavities.

Cocaine belongs to a group of drugs called local anesthetics. These cause a loss of feeling or numbness to the areas it is applied and prevent pain sensations during surgical procedures.

This medication is available as a solution that is applied to the mucous membranes of the areas that require anesthesia. The topical solution cannot be injected or administered by any other route.

Common side effects of topical cocaine include nervousness, restlessness, and excitement. The use of cocaine as a local anesthetic for an examination or surgery is not likely to cause psychological dependence or other serious side effects.

Cocaine is a prescription medication used to provide anesthesia and pain relief during examinations and surgical procedures of the mouth, throat, and nasal cavities.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with cocaine. See the “Cocaine Precautions” section.

Side effects of cocaine are often due to the excessive and rapid absorption of the drug. Reactions usually involve the central nervous system and the cardiovascular system.

Common side effects of topical cocaine may include:

• nervousness, restlessness, and excitement
• tremors or seizures
• vomiting

This is not a complete list of cocaine side effects. Ask your doctor or pharmacist for more information.

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

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

almotriptan (Axert)

• amitriptyline (Elavil, Vanatrip, Sentravil)
• amoxapine (Asendin)
• desvenlafaxine (Pristiq)
• dihydroergotamine (Migranal)
• dolasetron (Azemet)
• donepezil (Aricept)
• fentanyl (Duragesic, Actiq, Abstral, Fentora, Sublimaze, Subsys, Ionsys)
• fluoxetine (Prozac, Sarafem)
• granisetron (Sancuso, Kytril, Granisol)
• hyaluronidase (Hylenex, Vitrase, Amphadase, Hydase, HyQvia)
• hydroxytryptophan
• iobenguane I 123
• levomilnacipran (Fetzima)
• lorcaserin (Belviq)
• meperidine (Demerol)
• mirtazapine (Remeron)
• palonosetron (Aloxi)
• phenelzine (Nardil)
• St John's Wort
• tramadol (Ultram, Ultram ER, ConZip, Rybix ODT, Ryzolt)
• trazodone (Desyrel, Oleptro, Trazamine, Desyrel Dividose)
• vilazodone (Viibryd)
• vortioxetine (Brintellix)
• ziprasidone (Geodon)

This is not a complete list of cocaine drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with topical cocaine including the following:

• changes in body temperature
• dilation of the pupils
• loss of sense of taste or smell
• abdominal or stomach pain
• chills
• confusion
• dizziness or lightheadedness
• excitement, nervousness, restlessness, or any mood or mental changes
• fast or irregular heartbeat
• general feeling of discomfort or illness
• hallucinations or seeing, hearing, or feeling things that are not there
• headache (sudden)
• increased sweating
• nausea
• respiratory depression

Resuscitative equipment and drugs should be immediately available when cocaine is used.

Do not use topical cocaine if you are allergic to cocaine or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of topical cocaine, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using topical cocaine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to cocaine or to any of its ingredients
• have or have had seizures
• have or have had liver problems
• have or have had heart problems, including a fast or irregular heartbeat, heart or blood vessel disease, high blood pressure, or a heart attack
• have or have had thyroid problems
• have Tourette’s syndrome
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Topical cocaine falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Cocaine should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Cocaine has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from cocaine, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Topical cocaine for anesthesia should be used exactly as prescribed.

This medication is available as a solution that is applied to the mucous membranes of the areas that require anesthesia. It can be administered by cotton applicators or packs, instilled into a cavity, or applied as a spray.

The topical solution cannot be injected or administered by any other route.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The dosage varies and depends upon the area and the type of tissue to be anesthetized, individual tolerance, and the technique of administration. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients.

If you take too much cocaine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If cocaine is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store cocaine at room temperature.
• Keep this and all medicines out of the reach of children.

NOT FOR INJECTION OR OPHTHALMIC USE.