Lidocaine Viscous (patient information)

IMPORTANT WARNING

[Posted 02/06/2007] FDA informed consumers and healthcare professionals of the potential hazards of using skin numbing products containing topical anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. Numbing products are widely used to numb the skin for medical and cosmetic procedures, and to relieve pain, burning and itching due to a variety of medical conditions. FDA has approved many of these products for these uses. Some of these products must be prescribed by a doctor, others may be purchased without a prescription. FDA is aware that use of these products before a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, a patient may apply large amounts of the numbing product to their skin, which can cause life-threatening side effects and death. If a skin numbing product is prescribed or recommended for a procedure, consumers should do the following:

use a topical anesthetic approved by the FDA. use a topical anesthetic that contains the lowest amount of anesthetic drugs possible that will relieve pain. ask for instructions from your doctor on how to safely use the topical anesthetic. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Anesthetics and http://www.fda.gov/cder/drug/advisory/topical_anesthetics.htm.

Why this medication is prescribed

Lidocaine viscous, a local anesthetic, is used to treat the pain of a sore or irritated mouth and throat often associated with cancer chemotherapy and certain medical procedures. Lidocaine viscous is not normally used for sore throats due to cold, flu, or infections such as strep throat.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How this medication should be used

Lidocaine viscous comes as a thick liquid and should be shaken well before using. Lidocaine viscous usually is used as needed but not more frequently than every 3 hours, with a maximum of eight doses in 24 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use lidocaine exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

For a sore or irritated mouth, the dose should be placed in the mouth, swished around until the pain goes away, and spit out.

For a sore throat, the dose should be gargled and then may be swallowed. To avoid or decrease side effects, use the minimum amount of drug needed to relieve your pain.

Because lidocaine viscous decreases the feeling in your mouth and/or throat, it may affect your ability to swallow. Avoid eating for at least 1 hour after you have used this drug. You should also avoid chewing gum while using this medication.

Special precautions

Before using lidocaine viscous:

• tell your doctor and pharmacist if you are allergic to lidocaine, anesthetics, or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, including vitamins.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking lidocaine, call your doctor.

What to do if you forget a dose

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Side Effects

Lidocaine viscous may cause side effects. If you experience any of the following symptoms, call your doctor immediately:

• drowsiness
• blurred or double vision
• shakiness
• irregular heartbeat
• vomiting
• seizures or convulsions
• ringing in the ears
• rash
• severe itching or burning

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

Other information

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Xylocaine Viscous®