Pronunciation:

LYE-doe-kane

Brand Names:

• Burnamycin
• Burn-O-Jel
• Corta-Cap Needle Ease
• Lida Mantle
• Lidoderm
• LMX 4
• LMX 5
• Senatec
• Solarcaine Cool Aloe
• Topicaine
• Xylocaine
• Solarcaine First Aid Lidocaine Spray
• Solarcaine Lidocaine First Aid Spray

Dosage Forms:

• Solution
• Pad
• Gel/Jelly
• Patch, Extended Release
• Spray
• Ointment
• Cream
• Foam
• Dressing
• Aerosol Liquid
• Lotion

Classifications:

Therapeutic—

Anesthetic, Local

Chemical—

Amino Amide

Uses of This Medicine:

Lidocaine belongs to the family of medicines called local anesthetics. When lidocaine is applied to the skin, it produces pain relief by blocking the signals at the nerve endings in the skin. Lidocaine topical systems are used to relieve pain and discomfort associated with herpes zoster virus infection of the skin (shingles).

Lidocaine is available only with your doctor's prescription.

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—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of lidocaine topical systems in children with use in other age groups.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of lidocaine topical systems in the elderly with use in other age groups.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dihydroergotamine

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:

• Broken or inflamed skin, burns, or open wounds at the place of application—More of this medicine can be absorbed into the body quickly, which increases the chance of side effects
• Liver disease (severe)—The risk of side effects may be increased because of slower removal of lidocaine from the body

Proper Use of This Medicine:

Unless otherwise directed by your health care professional, do not apply this medicine to open wounds, burns or broken or inflamed skin.

Be careful not to get any of this medicine in your eyes, because it can cause severe eye irritation. If any of the medicine does get into your eye, immediately wash out the eye with water and protect the eye until sensation returns. Check with your doctor.

Use only as directed by your health care professional; avoid applying more than the recommended number of topical systems or using the topical systems for longer than the recommended wearing time.

Clothing may be worn over the area of application.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For relieving pain caused by herpes zoster virus infection of the skin (shingles) in adult patients—Remove release liner and apply topical system to skin, covering the most painful area(s). Apply no more than 3 systems at one time and do not leave on for longer than twelve hours within a twenty–four hour period. Topical systems may be cut into smaller sizes with scissors prior to removal of the release liner.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

If irritation or a burning sensation occurs during application, remove the system(s) and do not reapply until the irritation subsides.

Wash hands after handling systems.

Avoid contact with eyes.

Store and dispose of topical systems out of the reach of children and pets. Chewing or ingesting new or used topical systems could result in serious adverse effects.

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 immediately if any of the following side effects occur:

Symptoms of allergic reaction

Rare

Cough

difficulty swallowing or tongue swelling

dizziness or fainting

hives or swelling of eyelids, face or lips

itching or skin rash

stuffy nose

chest tightness, shortness of breath, troubled breathing, or wheezing

Signs of too much medicine being absorbed into the body

Rare

Blurred or double vision

confusion

dizziness, light-headedness or drowsiness

feeling hot, cold, or numb

muscle twitching or trembling

nausea or vomiting

ringing or buzzing in the ears

shortness of breath or trouble breathing

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

Note: The above side effects are not likely to occur when usual amounts of this medicine are used properly. However, they may occur if the medicine is used too often, applied to broken or inflamed skin, applied to very large areas, or kept on the skin too long.

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:

More common

Rash, hives, swelling, or abnormal sensation at the site of application

Incidence unknown

(Observed during clinical practice, estimates of frequency can not be determined )

Blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

disorientation

flushing

headache

hearing loss

increased sensitivity to pain

increased sensitivity to touch

lack or loss of strength

metallic taste

skin irritation

sleepiness or unusual drowsiness

taste alteration

tremor

visual disturbance

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.