Exparel

Exparel is a prescription medication used to prevent post-surgical pain.

Exparel belongs to a group of drugs called local anesthetics. These work by blocking the generation of nerve impulses that cause pain.

Exparel is a version of bupivacaine that is encapsulated in a fat delivery (liposomal) system that breaks down slowly in the body, which allows the extended release of the anesthetic over 48 to 96 hours.

This medication is available in an injectable form to be infiltrated directly into the surgical site by a healthcare professional.

Common side effects of Exparel include nausea, constipation, and vomiting.

Bupivacaine is a prescription medication used to prevent pain before surgical procedures and induce spinal anesthesia.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pacira Pharmaceuticals, Inc.

Serious side effects have been reported with bupivacaine. See the “Bupivacaine Precautions” section.

Common side effects of bupivacaine include the following:

• Nausea
• Constipation
• Vomiting
• Chills

This is not a complete list of bupivacaine side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Monoamine oxidase inhibitors such as rasagiline (Azilect), selegiline (Deprenyl, Eldepryl, Emsam), isocarboxazid (Marplan), isoniazid (Laniazid), phenelzine (Nardil)
• Tricyclic antidepressants such as nortiptyline (Pamelor), amitriptyline, and imipramine (Tofranil)

This is not a complete list of bupivacaine drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with bupivacaine including the following:

• Central nervous system reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of central nervous system reactions.
  • Restlessness, anxiety, dizziness, ringing in the ears, blurred vision, or tremors
  • Depression
  • Drowsiness or loss of consciousness
  • Nausea, vomiting, chills, or constriction of the pupils
• Cardiovascular system reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of cardiovascular system reactions.
  • Decreased blood pressure
  • Decreased heart rate
  • Ventricular arrhythmias
  • Cardiac arrest
• Allergic-type reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of allergic-type reactions.
  • Itching, hives, and redness
  • Swelling of the throat or face
  • Increased heart rate
  • Sneezing
  • Nausea
  • Vomiting
  • Dizziness
  • Loss of consciousness
  • Excessive sweating
  • Elevated temperature or fever
• Neurologic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of neurologic reactions.
  • Decreased heart rate
  • Urinary retention
  • Fecal and urinary incontinence
  • Persistent anesthesia
  • Tingling in the extremities
  • Weakness
  • Paralysis of the lower extremities
  • Headache
  • Backache
  • Septic meningitis

Bupivacaine can cause drowsiness, dizziness, and blurred vision. Do not drive or operate heavy machinery until you know how bupivacaine affects you.

Do not take bupivacaine if you:

• are allergic to bupivacaine or to any of its ingredients

Bupivacaine injection is contraindicated in obstetrical paracervical block anesthesia.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of bupivacaine, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking bupivacaine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to bupivacaine or to any of its ingredients
• have or have had liver problems
• have or have had heart problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Bupivacaine falls into category C.  In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Bupivacaine has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from bupivacaine, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take bupivacaine exactly as prescribed.

This medication is available in an injectable form to be administered by injection via local infiltration, peripheral nerve block, or caudal and lumbar blocks by a healthcare professional. The dose, frequency, and route of administration will vary, depending on the indication for use.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of bupivacaine at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight

The dose, frequency, and route of administration will vary, depending on the indication for use.

If you take too much bupivacaine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If bupivacaine is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Local anesthetics, including bupivacaine, should only be administered by clinicians who are experienced in the diagnosis and management of dose-relaeted toxicity and acute emergencies that might arise from the agent being used.
• Emergency resuscitative equipment and personnel should be available when local anesthetics are administered.

THE 0.75% CONCENTRATION OF BUPIVACAINE HYDROCHLORIDE IS NOT RECOMMENDED FOR OBSTETRICAL ANESTHESIA. THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATION OR DEATH DURING USE OF BUPIVACAINE HYDROCHLORIDE FOR EPIDURAL ANESTHESIA IN OBSTETRICAL PATIENTS. IN MOST CASES, THIS HAS FOLLOWED USE OF THE 0.75% CONCENTRATION. RESUSCITATION HAS BEEN DIFFICULT OR IMPOSSIBLE DESPITE APPARENTLY ADEQUATE PREPARATION AND APPROPRIATE MANAGEMENT. CARDIAC ARREST HAS OCCURRED AFTER CONVULSIONS RESULTING FROM SYSTEMIC TOXICITY, PRESUMABLY FOLLOWING UNINTENTIONAL INTRAVASCULAR INJECTION. THE 0.75% CONCENTRATION SHOULD BE RESERVED FOR SURGICAL PROCEDURES WHERE A HIGH DEGREE OF MUSCLE RELAXATION AND PROLONGED EFFECT ARE NECESSARY.