Overview
11 Description MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use.
Mechanism of Action
12 Clinical Pharmacology 12.1 Mechanism of Action Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone. Epinephrine is a vasoconstrictor added to bupivacaine to slow absorption into the general circulation and thus prolong maintenance of an active tissue concentration. 12.
Indications
- 1 Indications and Usage MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].
Common Doses
- 400 mg
- 5 mg
- 7.5 mg
- 3 mL
Dosage
2 Dosage and Administration 2.1 Important Dosage and Administration Information •MARCAINE / MARCAINE WITH EPINEPHRINE is not for intrathecal use. •Avoid use of MARCAINE / MARCAINE WITH EPINEPHRINE solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia [see Warnings and Precautions (5.4)]. •Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use.
Contraindications
- 4 Contraindications MARCAINE / MARCAINE WITH EPINEPHRINE is contraindicated in: •obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. •intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.7)]. •patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of MARCAINE / MARCAINE WITH EPINEPHRINE. Obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death.
Side Effects
- 6 Adverse Reactions The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: •Cardiac Arrest in Obstetrical Anesthesia [see Warnings and Precautions (5.1)] •Dose-Related Toxicity [see Warnings and Precautions (5.2)] •Methemoglobinemia [see Warnings and Precautions (5.3)] •Chondrolysis with Intra-Articular Infusion [see Warnings and Precautions (5.5)] •Severe, Persistent Hypertension, Cerebrovascular Accidents, and Bradycardia Due to Drug Interactions [see Warnings and Precautions (5.
Interactions
- 7 Drug Interactions 7.1 Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with MARCAINE / MARCAINE WITH EPINEPHRINE cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Dosage and Administration (2.1), Warnings and Precautions (5.2)]. 7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants The administration of MARCAINE WITH EPINEPHRINE to patients receiving monoamine oxidase inhibitors, or tricyclic antidepressants may produce severe,...