Not for injection or ophthalmic use .
Cocaine is a local anesthetic. It is applied to certain areas of the body (for example, the nose, mouth, or throat) to cause loss of feeling or numbness. This allows certain kinds of procedures or surgery to be done without causing pain.
Cocaine can cause psychological dependence (a strong desire to continue using the medicine because of the "high" feeling it produces). This may lead to cocaine abuse (more frequent use and/or use of larger amounts of cocaine) and to an increased chance of serious side effects. Cocaine abuse has caused death from heart or breathing failure.
Use of cocaine as a local anesthetic for an examination or surgery is not likely to cause psychological dependence or other serious side effects. However, if cocaine is absorbed into the body too quickly, serious side effects can occur. Also, some people are especially sensitive to the effects of cocaine. Unwanted effects may occur in these people even with small amounts of the medicine. Before receiving cocaine as a local anesthetic, you should discuss its use with your doctor.
Cocaine is applied only by or under the immediate supervision of your doctor.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Cocaine can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.
Side effects, including dizziness, lightheadedness, or fast or irregular heartbeats, may be more likely to occur in elderly patients. The elderly are usually more sensitive than younger adults to the effects of cocaine.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Your doctor or nurse will apply the smallest amount of medicine that will produce the needed effect before the procedure.
Cocaine and some of its metabolites (substances to which cocaine is broken down in the body) will appear in your blood and urine for several days after you receive the medicine. Tests for possible drug use will then be "positive" for cocaine. If you must have such a test within 5 days or so after receiving cocaine, be sure to tell the person in charge that you have recently received cocaine for medical reasons. It may be helpful to have written information from your doctor stating why the medicine was used, the date on which you received it, and the amount you received.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.