Pronunciation:

koe-KANE hye-droe-KLOR-ide

Brand Names:

• Numbrino

Dosage Forms:

• Solution

Warnings:

Warning: Abuse and DependenceCNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence .

Classifications:

Therapeutic—

Anesthetic, Local

Chemical—

Cocaine

Uses of This Medicine:

Cocaine hydrochloride nasal solution is used to numb the mucous membrane inside the nose before a medical procedure or surgery. This medicine is a local anesthetic.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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:

Allergies—

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of cocaine hydrochloride nasal solution in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cocaine hydrochloride nasal solution in the elderly. However, elderly patients are more likely to have high blood pressure, which may require caution in patients receiving this medicine.

Breast-feeding—

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.

Other medicines—

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

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. Discuss with your healthcare professional the use of your medicine with 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:

• Damaged nasal mucosa—Do not use in patients with this condition.

• Heart attack, history of or
• Heart failure, history of or
• Heart or blood vessel disease, history of or
• Heart rhythm problems, history of or
• Hypertension (high blood pressure), uncontrolled, history of
• Liver disease—Avoid use in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Seizures, history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a clinic or hospital. It will be given as a solution-soaked cotton or rayon pledget, where it will be inserted into the nostril before surgery or a medical procedure.

This medicine should cause numbness only to the area where it is placed. You may experience temporary loss of sensation in the affected area. This type of numbing procedure is called local anesthesia. It is not meant to cause you to fall asleep or become unconscious.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while receiving this medicine to see if it is working properly. Blood tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may increase your risk for seizures, especially if you have a history of seizures or heart rhythm problems. Talk to your doctor if you have any concerns about this.

This medicine can increase blood pressure and heart rate. It may also increase your risk of having heart attack. Check with your doctor right away if you have blurred vision, dizziness, nervousness, headache, pounding in the ears, slow or fast heartbeat, chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, trouble with breathing, nausea, sweating, or vomiting.

This medicine may cause changes in a woman's menstrual cycle and may reduce ovulation, which can lead to fertility problems. Talk to your doctor if you have concerns.

This medicine may be habit-forming. Tell your doctor if you feel like the nasal area is not numb enough or if the nasal solution is not working well.

Cocaine and its products can be detected in the blood and urine at least 1 week after its last dose.

Check with your doctor before receiving this medicine with medicines that can affect the central nervous system (CNS). The use of stimulants, including caffeine may worsen the side effects of this medicine, such as nervousness, irritability, seizures, or heart rhythm problems. Other medicines that can affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, or muscle relaxants.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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:

More common

Blurred vision

dizziness

headache

nervousness

pounding in the ears

slow or fast heartbeat

Less common

Chest pain or discomfort

fainting

fast, pounding, or irregular heartbeat or pulse

lightheadedness

unusual tiredness

Incidence not known

Nausea

pain or discomfort in the arms, jaw, back, or neck

seizures

sweating

vomiting

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:

Incidence not known

Anxiety

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.