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Bupivacaine liposome (Injection route)

Pronunciation:

bue-PIV-a-kane LYE-poh-some

Brand Names:

  • Exparel

Dosage Forms:

  • Suspension

Classifications:

Therapeutic—

Anesthetic, Local

Chemical—

Amino Amide

Uses of This Medicine:

Bupivacaine liposome injection is used to relieve pain after surgery. It is a local anesthetic that prevents pain by blocking signals at nerve endings.

This medicine is to be given only by or under the direct supervision of a 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 liposome injection 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 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—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

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

  • 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:

  • Chondrolysis (a bone or joint problem)—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.

Proper Use of This Medicine:

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

This medicine should cause numbness only to the area where it is injected. You may experience temporary loss of sensation or movement to 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.

Bupivacaine liposome injection (Exparel™) works differently than other forms of bupivacaine, even at the same dose. You should not receive another type of bupivacaine injection during the first 4 days (96 hours) after the injection of Exparel™.

Precautions While Using This Medicine:

Your doctor will check you closely after you receive this medicine. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

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. 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 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
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
Less common
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
Less common or rare
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:

More common
Back pain
muscle spasm
nausea
sleepiness or unusual drowsiness
sleeplessness
trouble sleeping
unable to sleep
vomiting
Less common
Decreased appetite
itching in the genital or other skin areas
scaling
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Less common or rare
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.


Last Updated: 11/4/2014

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