IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
COCAINE HYDROCHLORIDE - TOPICAL
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.
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 (especially of the face/tongue/throat), 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.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Cocaine (cocaine hydrochloride topical solution) Side Effects Center for a complete guide to possible side effects
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. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
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. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. 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.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking 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 medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson's disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
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 a poison control center or emergency room immediately. US residents can call their local poison control center 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 October 2013. Copyright(c) 2013 First Databank, Inc.