Marcaine HCl (Injection)

Bupivacaine injection is used to numb a part of your body during or after surgery, 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.

It is very important for your doctor to closely monitor your or your child's progress while using this medicine to ensure 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 higher in children younger than 6 months, elderly patients, or patients with certain genetic defects. It is more likely to happen if you receive too much of the medicine, but it can also occur with small amounts. Contact your doctor immediately if you or your child experience any of 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 lead to a bone or joint issue called chondrolysis. Contact your doctor right away if you or your child experience bone or joint pain, stiffness, or difficulty moving.

This medicine may cause low blood pressure (hypotension). This is more likely in patients with blood vessel problems, including high blood pressure (hypertension) or reduced blood volume. Contact your doctor immediately if you experience confusion, dizziness, faintness, or lightheadedness when rising suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness.

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

This medicine may cause dizziness or drowsiness. Do not drive or engage in any activities that could be dangerous until you know how this medicine affects you.

Consult 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 along with bupivacaine injection may increase side effects like dizziness, poor concentration, drowsiness, unusual dreams, and sleep issues. Some examples of medicines that affect the CNS include antihistamines or medicines for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicines for depression, anxiety, prescription pain medicines or narcotics, medicines for attention deficit and hyperactivity disorder, medicines for seizures or barbiturates, or muscle relaxants.

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

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how bupivacaine injection affects children during surgery and procedures. It is not recommended for children younger than 12 years old. Safety and effectiveness have not been established.

There have not been appropriate studies on how bupivacaine injection affects children after shoulder surgery. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems that would limit the use of bupivacaine injection in older adults. However, older patients are more likely to experience low blood pressure or kidney issues, which may require caution and a dose adjustment for those receiving bupivacaine injection.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor may need to adjust the dose or take other precautions. When you are receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant but not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both 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 increase the risk of certain side effects, but using both may be the best option 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

Some medicines should not be taken around meal times or with certain types of food, as interactions may occur. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect your use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Arthritis or
• Chronic back pain or
• Blood clotting issues or
• Headaches before surgery or
• Mental illness (e.g., psychosis) or
• Persistent nerve problems (paresthesia) or
• History of pernicious anemia or
• History of poliomyelitis or
• Spinal problems or
• History of syphilis or
• History of tumors—Use with caution. This 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 issues or
• Hereditary or idiopathic methemoglobinemia (blood disorder)—Use with caution. May increase the risk of methemoglobinemia.

• Heart rhythm issues (e.g., arrhythmia, heart block) or
• Severe bleeding (hemorrhage) or
• Severe low blood pressure (hypotension) or
• Infection at the injection site or
• Blood infection (septicemia) or
• During uterine contractions—Marcaine™ should not be used in patients with these conditions.

• Heart rhythm issues (e.g., heart block) or
• Low blood pressure (hypotension)—Use with caution. Posimir® may worsen these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger because the body may remove the medicine more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Change or loss of taste
• Chest pain or discomfort
• Ongoing ringing, buzzing, or other unexplained sounds in the ears
• Decrease in how often and how much urine you pass
• 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, 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.

In the U.S.

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

Available Dosage Forms:

• Solution

Therapeutic Class: Anesthetic, Local

Chemical Class: Bupivacaine

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.