Cocaine hydrochloride (Nasal)

Cocaine hydrochloride (Nasal) is used to numb the inside of 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.

It is very important that your doctor checks your progress closely while you are using 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 this 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 a 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 the last dose.

Check with your doctor before using this medicine with other 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 include antihistamines or medicines for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicines for depression, medicines for anxiety, prescription pain medicines or narcotics, medicines for attention deficit and hyperactivity disorder, medicines for seizures or barbiturates, or muscle relaxants.

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

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it will provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how cocaine hydrochloride nasal solution affects children. Its safety and effectiveness in this age group have not been confirmed.

Geriatric

Current studies have not shown any specific problems for older adults that would limit the use of cocaine hydrochloride nasal solution. However, older patients are more likely to have high blood pressure, which may require caution when using this medicine.

Breast Feeding

Research on women who are breastfeeding has shown harmful effects on infants. You should be prescribed an alternative medication or stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should never be used together, while others may be safe to use at the same time, even if there is a chance of an interaction. In these cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with specific medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to 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 stronger because the body removes the medicine more slowly.

• Seizures, history of—Use with caution. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used 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, 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.

In the U.S.

• Numbrino

Available Dosage Forms:

• Solution

Therapeutic Class: Anesthetic, Local

Chemical Class: Cocaine

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.