Cepacol Viractin (Topical application)

Tetracaine is used in various areas of the body to create numbness or a loss of feeling in some patients before a medical test or procedure.

Tetracaine is part of a group of medicines called topical local anesthetics. It numbs the nerve endings in the skin. This medicine does not make you unconscious like general anesthetics used during surgery.

This medicine is available only with your doctor's prescription.

It is very important that your doctor monitors you closely for any issues or side effects that may arise from this medicine.

Stop using this medicine and contact your doctor immediately if you experience a skin rash, burning, stinging, swelling, or irritation of your skin.

Do not use cosmetics or other skin care products on the areas of skin that have been treated.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know about any other allergies you have, including to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no information available about how tetracaine affects children. Its safety and effectiveness have not been established.

Geriatric

There is no information available about how tetracaine affects older adults.

Breast Feeding

Studies in women suggest that this medication is likely safe for infants when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together, but your doctor may need to 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

Some medicines should not be taken around meal times or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine in relation to food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect how this medicine works. Be sure to tell your doctor if you have any other medical problems, especially:

• Brain or spinal problems or
• Eye problems or
• Heart and blood vessel problems—Use with caution. May worsen these conditions.

• Infection at or near the application site or
• Large sores, broken skin, or severe injury in the area of application—This may increase the chance of side effects.

Along with its necessary effects, a medicine may cause some unwanted effects. While not all of these side effects may happen, if they do, they might need medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

Incidence not known

• Blurred vision
• chest pain or discomfort
• confusion
• dizziness
• dizziness, faintness, or lightheadedness when suddenly getting up from a lying or sitting position
• fainting
• fast or irregular heartbeat
• lightheadedness or fainting
• no blood pressure or pulse
• no breathing
• numbness
• seizures
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• slow or irregular heartbeat
• stopping of heart
• sweating
• trembling or shaking of the hands or feet
• unconsciousness
• unusual tiredness or weakness

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 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

• Continuing ringing or buzzing or other unexplained noise in the ears
• fear or nervousness
• hearing loss
• restlessness
• sleepiness

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.

• Cepacol Viractin
• Pontocaine

In Canada

• Supracaine

Available Dosage Forms:

• Solution

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Ester

A nurse or other trained health professional will give you this medicine. This medicine is for use on the skin only.

Be careful not to get any of this medicine in your nose, mouth, and especially in your eyes, because it can cause severe eye irritation. If any of the medicine does get into these areas especially the eyes, wash it with water and check with your doctor right away.