Lidocaine Transdermal (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 patches are used to relieve the pain of post-herpetic neuralgia (the burning, stabbing pains, or aches that may last for months or years after a shingles infection). Lidocaine is in a class of medications called local anesthetics. It works by stopping nerves from sending pain signals.

How this medication should be used

Lidocaine comes as a patch to apply to the skin. It is applied only once a day as needed for pain. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use lidocaine patches exactly as directed.

Your doctor will tell you how many lidocaine patches you may use at one time and the length of time you may wear the patches. Never apply more than three patches at one time, and never wear patches for more than 12 hours per day. Using too many patches or leaving patches on for too long may cause serious side effects.

To apply the patches, follow these steps:

1. Look at the skin that you plan to cover with a lidocaine patch. If the skin is broken or blistered, do not apply a patch to that area.
2. Use scissors to remove the outer seal from the package. Then pull apart the zipper seal.
3. Remove up to three patches from the package and press the zipper seal tightly together. The remaining patches may dry out if the zipper seal is not tightly closed.
4. Cut patch(es) to the size and shape that will cover your most painful area.
5. Peel the transparent liner off the back of the patch(es).
6. Press the patch(es) firmly onto your skin. If you are applying a patch to your face, be careful not to let it touch your eyes. If you do get lidocaine in your eye, wash it with plenty of water or saline solution.
7. Wash your hands after handling lidocaine patches.
8. Do not reuse lidocaine patches. After you are finished using a patch, remove it and dispose of it out of reach of children and pets. Used patches contain enough medication to seriously harm a child or pet.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special Precautions

Before using lidocaine patches:

• tell your doctor and pharmacist if you are allergic to lidocaine; other local anesthetics such as bupivacaine (Marcaine), etidocaine (Duranest), mepivacaine (Carbocaine, Prolocaine), or prilocaine (Citanest); or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: disopyramide (Norpace), flecainide (Tambocor), medications applied to the skin or mouth to treat pain, mexiletine (Mexitil), moricizine (Ethmozine), procainamide (Procanabid, Pronestyl), propafenone (Rhythmol), quinidine (Quinidex), and tocainide (Tonocard). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using lidocaine patches, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using lidocaine patches.

Special dietary instructions

Unless your doctor tells you otherwise, continue your normal diet.

What to do if you forget a dose

This medication is usually taken as needed. If your doctor has told you to use lidocaine patches regularly, use the missed patch as soon as you remember it. However, if it is almost time for the next dose, skip the missed patch and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side Effects

Minor Side Effects

Lidocaine patches may cause side effects. If any of these symptoms occur, remove your patch and do not put it back on until the symptoms go away. Tell your doctor if any of these symptoms are severe or do not go away:

• burning or discomfort in the place you applied the patch
• redness or swelling of the skin under the patch

Severe Side Effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• hives
• skin rash
• itching
• diffiiculty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• cool, moist skin
• fast pulse or breathing
• unusual thirst
• upset stomach
• vomiting
• confusion
• weakness
• dizziness
• fainting

Lidocaine patches may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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.

In case of emergency/overdose

If you wear too many patches or wear patches for too long, too much lidocaine may be absorbed into your blood. In that case, you may experience symptoms of an overdose.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• lightheadedness
• nervousness
• inappropriate happiness
• confusion
• dizziness
• drowsiness
• ringing in the ears
• blurred or double vision
• vomiting
• feeling hot, cold, or numb
• twitching or shaking that you cannot control
• seizures
• loss of consciousness
• slow heartbeat

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

• Lidoderm®