Pronunciation:

LYE-doe-kane

Dosage Forms:

• Powder

Classifications:

Therapeutic—

Anesthetic, Local

Chemical—

Amino Amide

Uses of This Medicine:

Lidocaine is used to cause numbness or loss of feeling before certain painful procedures such as injections or drawing blood from a blood vessel.

Lidocaine belongs to the family of medicines called local anesthetics. This medicine prevents pain by blocking the signals at the nerve endings in the skin.

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

Lidocaine intradermal injection system (Zingo(TM)) was recalled on November 11, 2008 due to nonsafety-related regulatory compliance issues, which could affect the product shelf life. Anesiva has no plans to distribute Zingo(TM) in the future.

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—

Appropriate studies have not been performed on the relationship of age to the effects of lidocaine in children below 3 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of lidocaine have not been performed in the geriatric population. Safety and efficacy have not been established.

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—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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
• Dronedarone
• Saquinavir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide
• Amiodarone
• Amprenavir
• Arbutamine
• Atazanavir
• Bretylium
• Cobicistat
• Darunavir
• Delavirdine
• Disopyramide
• Dofetilide
• Encainide
• Etravirine
• Flecainide
• Fosamprenavir
• Fosphenytoin
• Hyaluronidase
• Ibutilide
• Lopinavir
• Metoprolol
• Mexiletine
• Moricizine
• Phenytoin
• Procainamide
• Propafenone
• Propofol
• Quinidine
• Sotalol
• St John's Wort
• Succinylcholine
• Telaprevir
• Tocainide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cimetidine
• Penbutolol
• Tocainide

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:

• Bleeding problems—May increase the risk of bleeding through the skin where the medicine is placed.

• Liver disease, severe or
• Pseudocholinesterase deficiency (a genetic disease)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given by placing a special round container on your skin. The container pushes the medicine into the skin, and does not use a needle to do this. You or your child will hear a popping noise when the medicine is given.

This medicine is for use on the skin only. It will not be used on skin areas that have cuts or scrapes. Do not get it in your eyes, nose, or mouth. If it does get on these areas, rinse it off right away.

Precautions While Using This Medicine:

Do not let your child get any of the medicine in the mouth. This medicine can cause serious side effects, especially in children, if any of it gets into the mouth and is swallowed.

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 or nurse immediately if any of the following side effects occur:

More common

Flushing, redness of the skin

small red or purple spots on the skin

swelling at the site of application

unusually warm skin

Less common

Bruising, burning, pain, or bleeding at the site of application

itching skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Change in consciousness

fainting

fast, pounding, or irregular heartbeat or pulse

loss of consciousness

no blood pressure or pulse

no breathing

stopping of the heart

unconsciousness

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:

Less common

Nausea

vomiting

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.