Marcaine with Epinephrine

Marcaine with Epinephrine is part of the drug classes:

• Amides

• Adrenergic and dopaminergic agents

• Inhaled alpha and beta adrenoreceptor agonists

• Local hemostatics

• Other agents for local oral treatment

• Sympathomimetics in glaucoma therapy

• Sympathomimetics, plain

• If you have an allergy to bupivacaine, epinephrine, or any other part of Marcaine with Epinephrine (bupivacaine and epinephrine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are taking any of these drugs: Dihydroergotamine, ergonovine, ergotamine, or methylergonovine.

This is not a list of all drugs or health problems that interact with this medicine.

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 Marcaine with Epinephrine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Marcaine with Epinephrine affects you.
• If you have a sulfite allergy, talk with your doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Do not give to a child younger than 12 years of age.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Marcaine with Epinephrine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Mouth:

• Do not eat while your mouth feels numb. You may bite your tongue.

Spinal:

• This medicine may cause short-term loss of feeling and motor activity in the lower half of your body. Do not try to get out of bed or do other tasks or actions until feeling and motor activity have returned to normal.

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 you have any side effects that bother you or do not go away.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Bupivacaine hydrochloride is (±) -1-Butyl-2´, 6´-pipecoloxylidide 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:

Molecular Weight - 342.90            C18 H28 N2O • HCl • H2O

Epinephrine is (-)-3, 4-Dihydroxy-α-[(methylamino)-methyl] benzyl alcohol. It has the following structural formula:

Molecular Weight - 183.20            C9 H13 NO3

Bupivacaine is available in a sterile isotonic solution with epinephrine 1:200,000 (as bitartrate). Solutions of bupivacaine containing epinephrine may not be autoclaved.

Bupivacaine 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.

Bupivacaine stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia.

The onset of action following dental injections is usually 2 to 10 minutes and anesthesia may last two or three times longer than lidocaine and mepivacaine for dental use, in many patients up to 7 hours. The duration of anesthetic effect is prolonged by the addition of epinephrine 1:200,000.

It has also been noted that there is a period of analgesia that persists after the return of sensation, during which time the need for strong analgesic is reduced.

After injection of bupivacaine for caudal, epidural or peripheral nerve block in man, peak levels of bupivacaine in the blood are reached in 30 to 45 minutes, followed by a decline to insignificant levels during the next three to six hours. Because of its amide structure, bupivacaine is not detoxified by plasma esterases but is detoxified, via conjugation with glucuronic acid, in the liver. When administered in recommended doses and concentrations, bupivacaine does not ordinarily produce irritation or tissue damage, and does not cause methemoglobinemia.

Systemic absorption of local anesthetics produces effects on the cardiovascular and central nervous systems (CNS). At blood concentrations achieved with normal therapeutic doses, changes in cadiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. However, toxic blood concentrations depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities. In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure. Recent clinical reports and animal research suggest that these cardiovascular changes are more likely to occur after unintended intravascular injection of bupivacaine. Therefore, incremental dosing is necessary.

Following systemic absorption, local anesthetics can produce central nervous system stimulation, depression, or both. Apparent central stimulation is manifested as restlessness, tremors and shivering progressing to convulsions, followed by depression and coma progressing ultimately to respiratory arrest. However, the local anesthetics have a primary depressant effect on the medulla and on higher centers. The depressed stage may occur without a prior excited state.

Cook-Waite

NDC 31382-557-05

Marcaine® 0.5% with epinephrine 1:200,000 injection (as bitartrate)

(bupivacaine hydrochloride and epinephrine Injection, USP)

WARNINGS: CONTAINS SULFITES

Rx Only

FOR DENTAL USE

Carton contains 50 cartridges. Each cartridge contains 1.8 mL

Marketed by Carestream Health, Inc.

Manufactured for Carestream Health, Inc.
by NOVOCOL Pharmaceutical of Canada, Inc.,
Cambridge, Ontario, Canada, N1R6X3

Applies to bupivacaine / epinephrine: injection solution