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US Brand Names

Description

Bupivacaine liposome injection is used to relieve pain after surgery. It belongs to the family of medicines called local anesthetics. This medicine prevents pain by blocking the signals at the nerve endings

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

This product is available in the following dosage forms:

• Suspension

Before Using

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of bupivacaine liposome injection in the pediatric population. 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 liposome injection in the elderly. However, elderly patients are more likely to have kidney or liver problems, which may require caution for patients receiving bupivacaine liposome injection.

Pregnancy

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

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.

• Hyaluronidase
• Propofol
• Propranolol
• St John's Wort
• 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:

• Bone or joint problems (e.g., chondrolysis)—May increase risk for more serious side effects.

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

• Obstetrical paracervical block (numbing procedure)—Should not be used in patients having this procedure.

Proper Use

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle injected into the surgical site (such as big toe).

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

Bupivacaine liposome injection (Exparel™) works differently with other formulations of bupivacaine, even at the same dose (number of milligrams). Do not convert or change the dosing from any other formulations of bupivacaine to Exparel™.

Precautions

Your doctor will check you closely while you are receiving this medicine. This is to check for any problems or unwanted effects that may be caused by this medicine.

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

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

Side Effects

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:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Blurred vision
• Confusion
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fast, pounding, or irregular heartbeat or pulse
• Fever
• Pale skin
• Rapid weight gain
• Sweating
• Tingling of the hands or feet
• Troubled breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain or loss

• Bleeding from the anus
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Chest pain or discomfort
• Fainting
• Lightheadedness, dizziness, or fainting
• Painful defecation
• Shortness of breath
• Slow or irregular heartbeat
• Swelling at the surgical site

• Chills
• Decrease in the frequency of urination
• Decrease in the urine volume
• Difficult or troubled breathing
• Difficulty in passing urine (dribbling)
• Extra heart beat
• Headache
• Hives
• Hoarseness
• Irregular, fast or slow, or shallow breathing
• Irritation
• Itching
• Joint pain, stiffness, or swelling
• Nervousness
• Not breathing
• Painful urination
• Pale or blue lips, fingernails, or skin
• Pounding in the ears
• Rash
• Redness of the skin
• Shakiness in the legs, arms, hands, or feet
• Shortness of breath
• Swelling at the incision site
• Tightness in the chest
• Troubled breathing or swallowing
• Weakness
• Wheezing

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:

• Back pain
• Muscle spasm
• Nausea
• Sleepiness or unusual drowsiness
• Sleeplessness
• Trouble sleeping
• Unable to sleep
• Vomiting

• Decreased appetite
• Itching in the genital or other skin areas
• Scaling
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

• Agitation
• Cold sweats
• Hives or welts
• Increased sweating
• Muscle weakness
• Pain in the neck
• Paleness of the skin
• Restlessness

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.

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