Bupivacaine injection

In the U.S.

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

Available Dosage Forms:

• Solution
• Kit
• Injectable

Therapeutic Class: Anesthetic, Local

Chemical Class: Bupivacaine

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 bupivacaine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bupivacaine 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.

Pediatric

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

Geriatric

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.

Pregnancy

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.

Interactions with 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 bupivacaine, 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 bupivacaine 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.

• Bupropion
• Donepezil
• Fospropofol
• Hyaluronidase
• Propofol
• Propranolol
• St John's Wort
• Verapamil

Using bupivacaine 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

Interactions with Food/Tobacco/Alcohol

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 bupivacaine. 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.

• 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 —Should not be used in patients with these conditions.

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

A nurse or other trained health professional will give you bupivacaine in a hospital. It is sometimes given through a catheter placed into your lower back for an epidural or a spinal block.

bupivacaine 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.

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.

If you are receiving bupivacaine 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 bupivacaine might affect your baby.

It is very important that your doctor check your progress closely after you receive bupivacaine to see if it is working properly and to check for any unwanted effects.

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

bupivacaine 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 have fast shallow breathing, a fast, weak heartbeat, headache, muscle cramps, pale, clammy skin, or an extremely high fever or body temperature.

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

Check with your doctor before receiving bupivacaine 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 bupivacaine, 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.

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:

• Anxiety
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• cold, clammy, pale skin
• confusion
• cough
• difficulty swallowing
• discouragement
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• excitement
• fast or irregular heartbeat
• feeling sad or empty
• general feeling of illness
• hives, itching, skin rash
• inability to breathe without assistance
• irritability
• lack of appetite
• loss of interest or pleasure
• nausea
• 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:

• Abnormal ejaculation
• continuing ringing or buzzing or other unexplained noise in the ears
• decrease in frequency and amount of urine
• decreased sexual performance or desire
• difficulty in passing urine [dribbling]
• hearing loss
• no sensation in the legs
• numbness
• painful urination
• 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.