Pronunciation:

LYE-doe-kane, ep-i-NEF-rin

Classifications:

Pharmacologic—

Sympathomimetic

Chemical—

Amino Amide

Uses of This Medicine:

Lidocaine and epinephrine combination injection is used to cause numbness or loss of feeling for patients having certain medical procedures (by blocking certain nerves using the brachial plexus, intercostal, lumbar, or epidural blocking techniques).

This medicine is to be given only by or under the direct supervision of your doctor.

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—

Because of this medicine's toxicity, it should be used with extreme caution in children younger than 6 months of age. Recommended doses should not be exceeded, and the patient should be carefully monitored during treatment.

Older adults—

No information is available on the relationship of age to the effects of lidocaine and epinephrine combination injection in geriatric patients. However, because of this medicine's toxicity, it should be used with caution. Recommended doses should not be exceeded, and the patient should be carefully monitored during treatment.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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
• Isocarboxazid
• Linezolid
• Phenelzine
• Saquinavir
• Tranylcypromine
• Vernakalant

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.

• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Amprenavir
• Arbutamine
• Atazanavir
• Benperidol
• Bromperidol
• Bucindolol
• Bupivacaine
• Bupivacaine Liposome
• Bupropion
• Carbamazepine
• Carteolol
• Carvedilol
• Clomipramine
• Cobicistat
• Darunavir
• Dasabuvir
• Delavirdine
• Desipramine
• Dextroamphetamine
• Dibenzepin
• Digoxin
• Dilevalol
• Disopyramide
• Dixyrazine
• Donepezil
• Doxepin
• Droperidol
• Encainide
• Entacapone
• Ergonovine
• Etravirine
• Fexofenadine
• Flecainide
• Fluphenazine
• Fosamprenavir
• Fosphenytoin
• Fospropofol
• Furazolidone
• Haloperidol
• Halothane
• Hyaluronidase
• Imipramine
• Iobenguane I 123
• Iproniazid
• Lacosamide
• Levalbuterol
• Levobunolol
• Lisdexamfetamine
• Lofepramine
• Lopinavir
• Loxapine
• Melitracen
• Melperone
• Methdilazine
• Methotrimeprazine
• Methylene Blue
• Methylergonovine
• Metipranolol
• Metopimazine
• Metoprolol
• Mexiletine
• Milnacipran
• Moperone
• Moricizine
• Nadolol
• Nialamide
• Nortriptyline
• Ombitasvir
• Opicapone
• Opipramol
• Oxprenolol
• Paritaprevir
• Penbutolol
• Perazine
• Periciazine
• Perphenazine
• Phenytoin
• Pindolol
• Pipamperone
• Piperazine
• Pipotiazine
• Practolol
• Procainamide
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propafenone
• Propiomazine
• Propofol
• Propranolol
• Protriptyline
• Quinidine
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• St John's Wort
• Succinylcholine
• Telaprevir
• Terfenadine
• Tertatolol
• Thiethylperazine
• Thioproperazine
• Thioridazine
• Tianeptine
• Timolol
• Tocainide
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimipramine
• Viloxazine
• Zavegepant

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
• Labetalol
• Penbutolol

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:

• Blood vessel disease or
• Heart disease or
• Hypertension (high blood pressure) or
• Liver disease—Use with caution. The chance of side effects may be increased.

• Brain or nerve disease or
• Heart block or
• Hypertension (high blood pressure), severe or
• Sepsis or
• Shock, severe or
• Spine problems—Use with caution.

• Glucose-6-phosphate dehydrogenase deficiency (G6PD) or
• Heart problems or
• Lung or breathing problems or
• Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause)—Use with caution. May increase risk of having methemoglobinemia.

• Sulfite allergy—Lidocaine with epinephrine injection contains sodium metabisulfite, which may cause allergic reactions.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins, into your upper arm, into the head and neck area, or into the space around the spinal nerves in your lower back.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause a rare, but serious blood problem called methemoglobinemia. The risk may be increased in children younger than 6 months of age, elderly patients, or patients with certain inborn defects. It is more likely to occur in patients receiving too much of the medicine, but can also occur with small amounts. Check with your doctor right away if you or your child have the following symptoms after receiving this medicine: pale, gray, or blue-colored skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.

If you receive this medicine into your lower back (epidural), you may experience temporary loss of sensation and movement, usually in the lower half of your body. Talk with your doctor if you have concerns.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

Incidence not known

Bluish-colored lips, fingernails, or palms blurred or double vision

chest pain or discomfort

cold, clammy, pale skin

confusion

continuing ringing or buzzing or other unexplained noise in the ears

cough

dark urine

difficulty breathing

difficulty swallowing

dizziness or lightheadedness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

fast heartbeat

fever

headache

hearing loss

hives, itching, skin rash

irregular heartbeat

irregular, fast or slow, or shallow breathing

loss of consciousness

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid or slow heart rate

seizures

slow or irregular heartbeat

sore throat

sweating

tightness in the chest

tremor

twitching

unusual bleeding or bruising

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 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:

Incidence not known

Cold or numb feeling

false or unusual sense of well-being

feeling of heat

loss of bladder and bowel control

loss of genital sensation and sexual function

nervousness

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.