Bupivacaine

Generic name: bupivacaine
Brand names: Marcaine HCl, Marcaine Spinal, Sensorcaine, Sensorcaine-MPF, Sensorcaine-MPF Spinal, Xaracoll
Drug class: Local injectable anesthetics

What is bupivacaine?

Bupivacaine is a prescription medicine that is used to ease pain at the surgery site.

Description

Bupivacaine hydrochloride is 2-Piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula:

Dextrose is D-glucopyranose monohydrate and has the following structural formula:

Bupivacaine Hydrochloride in Dextrose Injection, USP is available in sterile hyperbaric solution for subarachnoid injection (spinal block).

Bupivacaine hydrochloride is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage.

Each mL of Bupivacaine Hydrochloride in Dextrose Injection, USP contains 7.5 mg bupivacaine hydrochloride (anhydrous) and 82.5 mg dextrose (anhydrous). The pH of this solution is adjusted to between 4.0 and 6.5 with sodium hydroxide or hydrochloric acid.

The specific gravity of Bupivacaine Hydrochloride in Dextrose Injection, USP is between 1.030 and 1.035 at 25°C and 1.03 at 37°C.

Bupivacaine Hydrochloride in Dextrose Injection, USP does not contain any preservatives.

Before taking bupivacaine, tell your doctor:

• If you are allergic to bupivacaine; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take bupivacaine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take bupivacaine?

• Tell all of your health care providers that you take bupivacaine. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may cause dizziness. If this happens, do not drive or do other tasks or actions that call for you to be alert. Talk with your doctor.
• This medicine may cause short-term loss of feeling and motor activity in the body. This may last for up to 5 days. Do not try to get out of bed or do other tasks or actions until feeling and motor activity have returned to normal.
• A severe blood problem called methemoglobinemia has happened with drugs like this one. The risk may be raised in people who have glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. The risk may also be raised while taking certain other drugs and in infants younger than 6 months of age. Tell your doctor if you have ever had methemoglobinemia.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using bupivacaine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is bupivacaine best taken?

Use bupivacaine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot.
• Your doctor will give bupivacaine.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of bupivacaine that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of methemoglobinemia like a blue or gray color of the lips, nails, or skin; a heartbeat that does not feel normal; seizures; very bad dizziness or passing out; very bad headache; feeling very sleepy; feeling tired or weak; or shortness of breath. This effect is rare but may be deadly if it happens.
• Change in balance.
• Restlessness.
• Anxiety.
• Change in speech.
• Change in taste.
• Dizziness or passing out.
• Feeling lightheaded, sleepy, confused, or having blurred eyesight.
• Ringing in ears.
• Shakiness.
• Twitching.
• Low mood (depression).
• Feeling nervous and excitable.
• Seizures.
• Upset stomach or throwing up.
• Fever or chills.
• Small pupils.
• Chest pain or pressure or a fast heartbeat.
• Slow heartbeat.
• Sneezing.
• Sweating a lot.
• Joint pain.
• Joint stiffness.
• Weakness, numbness, or tingling.
• Swelling in the arms or legs.
• Feeling very tired or weak.
• Trouble passing urine.

What are some other side effects of bupivacaine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Trouble sleeping.
• Muscle spasm.
• Back pain.
• Feeling tired or weak.
• Hiccups.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out bupivacaine?

• If you need to store bupivacaine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL