Pronunciation:

bue-PIV-a-kane hye-droe-KLOR-ide, ep-i-NEF-rin

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Anesthetic, Amino Amide Combination

Pharmacologic—

Sympathomimetic

Chemical—

Bupivacaine

Uses of This Medicine:

Bupivacaine and epinephrine combination injection is used to numb an area of your body during surgery or other procedures, childbirth, or dental work. It is a local anesthetic.

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—

Appropriate studies have not been performed on the relationship of age to the effects of bupivacaine and epinephrine combination injection in the pediatric population. Use is not recommended in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bupivacaine and epinephrine combination injection in the elderly. However, elderly patients are more likely to have low blood pressure or kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

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.

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
• Isocarboxazid
• Linezolid
• Phenelzine
• Tranylcypromine

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
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Articaine
• Benoxinate
• Benperidol
• Benzocaine
• Benzyl Alcohol
• Bromperidol
• Bucindolol
• Bupropion
• Carteolol
• Carvedilol
• Chloroprocaine
• Clomipramine
• Cocaine
• Desipramine
• Dextroamphetamine
• Dibenzepin
• Dibucaine
• Digoxin
• Dilevalol
• Dixyrazine
• Donepezil
• Doxepin
• Droperidol
• Dyclonine
• Entacapone
• Ergonovine
• Ethyl Chloride
• Etidocaine
• Fexofenadine
• Fluphenazine
• Fospropofol
• Furazolidone
• Haloperidol
• Halothane
• Hyaluronidase
• Imipramine
• Iobenguane I 123
• Iproniazid
• Levalbuterol
• Levobunolol
• Levobupivacaine
• Lidocaine
• Lisdexamfetamine
• Lofepramine
• Loxapine
• Melitracen
• Melperone
• Mepivacaine
• Methdilazine
• Methotrimeprazine
• Methylene Blue
• Methylergonovine
• Metipranolol
• Metopimazine
• Milnacipran
• Moperone
• Nadolol
• Nialamide
• Nortriptyline
• Opicapone
• Opipramol
• Oxprenolol
• Penbutolol
• Perazine
• Periciazine
• Perphenazine
• Pindolol
• Pipamperone
• Piperazine
• Pipotiazine
• Practolol
• Pramoxine
• Prilocaine
• Procaine
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Proparacaine
• Propiomazine
• Propofol
• Propranolol
• Protriptyline
• Rasagiline
• Ropivacaine
• Safinamide
• Selegiline
• Sotalol
• St John's Wort
• Terfenadine
• Tertatolol
• Tetracaine
• Thiethylperazine
• Thioproperazine
• Thioridazine
• Tianeptine
• Timolol
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimipramine
• Verapamil
• 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.

• Alacepril
• Benazepril
• Captopril
• Cilazapril
• Delapril
• Enalaprilat
• Enalapril Maleate
• Fosinopril
• Imidapril
• Labetalol
• Lisinopril
• Moexipril
• Pentopril
• Perindopril
• Quinapril
• Ramipril
• Spirapril
• Temocapril
• Trandolapril
• Zofenopril

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)—Use with caution. The chance of side effects may be increased.

• 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.

• Kidney disease or
• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• 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 sometimes given through a catheter placed into your lower back for an epidural or a spinal block. You may also receive the injection into your rib cage, chest, or other body areas. This medicine may also be injected directly into your gums for dental work.

This medicine should cause numbness only to the area where it is injected. You may experience temporary loss of sensation or movement in the injected area. This type of numbing procedure is called local anesthesia. It is not meant to cause you to fall asleep or become unconscious.

You may experience temporary loss of sensation and movement, usually in the lower half of your body, if you receive this medicine into your lower back (epidural). It may be easier to hurt yourself while your treated body area is still numb. Be careful to avoid injury until you have regained all the feeling and are no longer numb.

To avoid injury after dental work, do not chew solid foods until normal feeling has returned to the area. Do not test the feeling in your mouth by biting or poking the treated area (up to 7 hours).

If you are receiving this medicine as an epidural to ease labor pains, it may take longer than normal for you to push your baby out. It is also possible that the baby may have unwanted effects after birth (including sleepiness, slow responses). Talk to your doctor if you have questions about how this medicine might affect your baby.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while receiving this medicine to see if it is working properly. Blood tests may be needed to check for any 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 has 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.

Tell your doctor or nurse right away if you have the following symptoms with this medicine: anxiety, blurred vision, depression, drowsiness, lightheadedness, nausea or vomiting, numbness and tingling of the mouth or lips, restlessness, ringing in the ears, speech problems, or tremors.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat after receiving this medicine.

This medicine may also increase your risk of having serious heart and blood vessel problems such as a heart attack, heart rhythm changes, or low blood pressure. Check with your doctor if you have chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, dizziness, fainting, pounding, slow heartbeat, troubled breathing, or unusual tiredness or weakness.

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

Anxiety

blurred vision

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

chest pain or discomfort

cold, clammy, pale skin

confusion

continuing ringing or buzzing or other unexplained noise in the ears

cough

decrease in the frequency and amount of urine

difficulty in passing urine (dribbling)

difficulty swallowing

discouragement

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

drowsiness

excitement

false or unusual sense of well-being

fast or irregular heartbeat

feeling sad or empty

general feeling of illness

hearing loss

hives, itching, skin rash

inability to breathe without assistance

irritability

lack of appetite

loss of interest or pleasure

nausea

painful urination

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

restlessness

seizures

severe headache

shivering

slow heart rate

slowing of labor

stiff neck or back

sweating

tightness in the chest

trouble concentrating

trouble sleeping

unusual tiredness or weakness

vomiting

weakness of the muscles in your face

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

Abnormal ejaculation

decreased sexual performance or desire

feeling of heat

loss of bladder and bowel control

loss of genital sensation and sexual function

no sensation in the legs

numbness

unable to move the legs

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.