Pronunciation:

bue-PIV-a-kane hye-droe-KLOR-ide

Brand Names:

• Marcaine HCl
• Marcaine Spinal
• Sensorcaine
• Sensorcaine-MPF

Dosage Forms:

• Solution

Warnings:

There have been reports of cardiac arrest with difficult resuscitation or death during use of bupivacaine for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of bupivacaine hydrochloride injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary .

Classifications:

Therapeutic—

Anesthetic, Local

Chemical—

Bupivacaine

Uses of This Medicine:

Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work. This medicine is also used to numb your shoulder after surgery for up to 72 hours. It is a local anesthetic.

Bupivacaine injection causes a loss of feeling and prevents pain by blocking signals at the nerve endings. It does not cause loss of consciousness.

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 injection during surgery and procedures in the pediatric population. Use is not recommended in children younger than 12 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of bupivacaine injection after shoulder surgery in the pediatric population. 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 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 bupivacaine injection.

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 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
• Articaine
• Benoxinate
• Benzocaine
• Benzyl Alcohol
• Bupropion
• Chloroprocaine
• Cocaine
• Dibucaine
• Donepezil
• Dyclonine
• Ethyl Chloride
• Etidocaine
• Fospropofol
• Hyaluronidase
• Levobupivacaine
• Lidocaine
• Mepivacaine
• Pramoxine
• Prilocaine
• Procaine
• Proparacaine
• Propofol
• Propranolol
• Ropivacaine
• St John's Wort
• Tetracaine
• Verapamil

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
• 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:

• Arthritis or
• Back pain, chronic or
• Blood clotting problems or
• Headache, before surgery or
• Mental illness (eg, psychosis) or
• Paresthesia (nerve problem), persistent or
• Pernicious anemia, history of or
• Poliomyelitis, history of or
• Spinal problems or
• Syphilis, history of or
• Tumor, history of—Use with caution. May prevent the use of bupivacaine in patients with these conditions.

• 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.

• Heart rhythm problems (eg, arrhythmia, heart block) or
• Hemorrhage (bleeding), severe or
• Hypotension (low blood pressure), severe or
• Infection at the injection site or
• Septicemia (blood infection) or
• During uterine contractions—Marcaine™ should not be used in patients with these conditions.

• Heart rhythm problems (eg, heart block) or
• Hypotension (low blood pressure)—Use with caution. Posimir® may make these conditions worse.

• Kidney disease or
• Liver 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 in a hospital. Marcaine™ is sometimes given through a catheter placed into your lower back for an epidural or a spinal block. Posimir® is usually given in the shoulder area.

Posimir® should not be used to ease labor pains during childbirth.

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.

This medicine may cause a bone or joint problem called chondrolysis. Check with your doctor right away if you or your child have bone or joint pain or stiffness or an inability to move.

This medicine may cause low blood pressure (hypotension). This is more likely in patients with blood vessel problems, including high blood pressure (hypertension) or a decrease in blood volume. Check with your doctor right away if you have confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness.

Bupivacaine injection may also cause a dangerous increase in body temperature (hyperthermia). Check with your doctor if you or your child have fast shallow breathing, a fast, weak heartbeat, headache, muscle cramps, pale, clammy skin, or an extremely high fever or body temperature.

This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor before receiving this medicine with other medicines that affect the central nervous system (CNS). The use of other medicines that affect the CNS with bupivacaine injection may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, or muscle relaxants.

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:

More common

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

change or loss of taste

chest pain or discomfort

continuing ringing or buzzing or other unexplained noise in the ears

decrease in the frequency and amount of urine

diarrhea

difficult or painful urination

dizziness

dry mouth

fever

headache

hearing loss

increased thirst

loss of appetite

mood changes

muscle pain or cramps

nausea or vomiting

seizures

sleepiness or unusual drowsiness

slow or irregular heartbeat

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Arm, leg, back, or jaw pain

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

body aches or pain

chills

cough or hoarseness

cramps

difficulty in moving

dry throat

ear congestion

fast or pounding heartbeat or pulse

increased blinking

loss of voice

muscle stiffness or twitching

nervousness

pain, cramps, or heavy menstrual bleeding

pain, swelling, or redness in the joints

pounding in the ears

runny or stuffy nose

sneezing

sore throat

swelling of the testes

tightness in the chest

twitching of the eyelids

unusual weight gain or loss

Incidence not known

Anxiety

cold, clammy, pale skin

confusion

difficulty swallowing

discouragement

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

excitement

false or unusual sense of well-being

feeling sad or empty

general feeling of illness

hives, itching, skin rash

irritability

loss of interest or pleasure

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

restlessness

shivering

slowing of labor

stiff neck or back

sweating

trouble concentrating

trouble sleeping

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:

More common

Acid or sour stomach

belching

bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

constipation

excess air or gas in the stomach or intestines

full feeling

heartburn

indigestion

passing gas

stomach discomfort, upset, or pain

Incidence not known

Abnormal ejaculation

decreased sexual performance or desire

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.