Bupivacaine is an anesthetic (numbing medicine) that blocks nerve impulses in your body.

Bupivacaine liposome is used as a local (in only one area) anesthetic to numb an area of your body for a minor surgery such as bunion removal or hemorrhoid surgery.

Bupivacine liposome is also used as a nerve block after surgery on your shoulder or upper arm, to provide pain relief to the area.

Bupivacaine may also be used for purposes not listed in this medication guide.

You may still feel numb or be unable to move the numbed area for up to 5 days after you are treated with bupivacaine liposome.

Bupivacaine is given as an injection placed into an area near your surgical incision. You will receive this injection in a hospital or surgical setting.

Bupivacaine liposome can have long-lasting or delayed effects. For at least 4 days (96 hours) after your surgery, tell any doctor or dentist who treats you that you recently received a bupivacaine liposome injection.

Call your doctor if you have joint pain or stiffness, or weakness in any part of your body that occurs after your surgery, even months later.

Usual Adult Dose for Pain:

Local Analgesia via Infiltration:
-Dose will be dependent on size of surgical site, volume required to cover area, and individual patient factors that may impact the safety of an amide local anesthetic.
-Maximum infiltration dose: 266 mg (20 mL)

Regional Analgesia via Interscalene Branchial Plexus Nerve Block:
-Based upon study of patients undergoing total shoulder arthroplasty or rotator cuff repair: 133 mg (10 mg)
Maximum dose for interscalene brachial plexus nerve block: 133 mg (10 mg)

Comments:
-This drug has not been evaluated for the following uses and, therefore, is not recommended for epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, and intravascular or intra-articular use.
-Different formulations of bupivacaine are not bioequivalent.

Uses: For single-dose infiltration to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.

You should not be treated with bupivacaine if you are allergic to it.

Tell your doctor if you have ever had:

• an allergic reaction to any type of numbing medicine;

• liver disease;

• kidney disease;

• heart disease;

• a heart rhythm disorder; or

• seizures.

It is not known whether bupivacaine liposome will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Since bupivacaine liposome is used as a single dose, it does not have a daily dosing schedule.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

For at least 4 days (96 hours) after surgery, avoid using any pain or numbing medicines that contain lidocaine. This includes skin patches, sprays, creams, ointments, or gels applied to the skin. Follow your doctor's instructions.

Get emergency medical help if you have signs of an allergic reaction: hives, red rash, itching; sneezing, difficulty breathing; severe dizziness, vomiting; swelling of your face, lips, tongue, or throat.

You will be watched closely after receiving bupivacaine liposome, to make sure you do not have a reaction to the medicine. Tell your caregivers at once if you have any of these signs of a serious side effect:

• ringing in your ears;

• drowsiness, feeling restless or anxious;

• feeling like you might pass out;

• speech or vision problems, a metallic taste in your mouth;

• numbness or tingling around your mouth;

• fast or slow heart rate, feeling short of breath, feeling unusually hot or cold;

• tremors, twitching, mood changes;

• ongoing numbness, weakness, or loss of movement where the medicine was injected; or

• joint pain or stiffness, or weakness in any part of your body for months after your surgery.

You may still feel numb or be unable to move the numbed area for up to 5 days after you are treated with bupivacaine liposome.

Common side effects include:

• nausea, vomiting;

• constipation; or

• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect bupivacaine liposome, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.