Marcaine with Epinephrine 5 mg/mL
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE · INJECTION, SOLUTION · Hospira, Inc.
Marcaine with Epinephrine is a injection, solution containing bupivacaine hydrochloride and epinephrine bitartrate at 5 mg/mL, taken epidural. Manufactured by Hospira, Inc..
Key Facts
- Brand Name
- Marcaine with Epinephrine
- Generic Name
- BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
- NDC Code (Product)
0409-1749- Manufacturer
- Hospira, Inc.
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- EPIDURAL, INTRACAUDAL, PERINEURAL
- Marketing Status
- Application #
- NDA016964
- Marketing Start
- 09/12/2005
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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) ]. MARCAINE contains bupivacaine, an amide local anesthetic, and MARCAINE WITH EPINEPHRINE is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. 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. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. ( 1 , 2.2 ) Limitations of Use Not all blocks are indicated for use with MARCAINE / MARCAINE WITH EPINEPHRINE given…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Not for intrathecal use. ( 2.1 ) • Avoid use of solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia. ( 2.1 , 5.4 ) • Three mL of MARCAINE WITH EPINEPHRINE without antimicrobial preservative (0.5% bupivacaine with 1:200,000 epinephrine ) is recommended for use as a test dose prior to caudal and lumbar epidural blocks when clinical conditions permit. ( 2.4 ) • See full prescribing information for: - Recommended concentrations and dosages of MARCAINE / MARCAINE WITH EPINEPHRINE according to type of block. ( 2.2 ) - Additional dosage and administration information pertaining to use in epidural anesthesia, test dose for caudal and lumbar epidural blocks, use in dentistry, and use in ophthalmic surgery. ( 2.3 , 2.4 , 2.5 , 2.6 ) 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 pre…
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. ( 4 ) • Intravenous regional anesthesia (Bier Block). ( 4 ) • Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of MARCAINE / MARCAINE WITH EPINEPHRINE. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Local Anesthetics : The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. ( 7.1 ) • Monoamine Oxidase Inhibitors and Tricyclic Antidepressants : Administration of MARCAINE WITH EPINEPHRINE to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. ( 5.6 , 7.2 ) • Ergot-Type Oxytocic Drugs : Concurrent administration of MARCAINE WITH EPINEPHRINE and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. ( 5.6 , 7.3 ) • Nonselective Beta-Adrenergic Antagonists : Administration of MARCAINE WITH EPINEPHRINE (containing a vasoconstrictor) in patients receiving nonselective beta-adrenergic antagonists may cause severe hypertension and bradycardia. Concurrent use of these agents should generally be avoided. ( 5.6 , 7.4 ) • Drugs Associated with Methemoglobinemia : Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates, nitrites, local anesthetics, antineopla…
Adverse Reactions
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 (5.6) ] • Cardiac Arrest with Intravenous Regional Anesthesia Use [see Contraindications (4) , Warnings and Precautions (5.7) ] • Allergic-Type Reactions [see Warnings and Precautions (5.8) ] • Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see Warnings and Precautions (5.9) ] • Respiratory Arrest Following Retrobulbar Block [see Warnings and Precautions (5.15) ] The following adverse reactions from voluntary reports or clinical studies have been reported with bupivacaine or bupivacaine and epinephrine. Because many of these reactions were reported voluntarily from a population of u…
Frequently Asked Questions
What is Marcaine with Epinephrine used for?
Marcaine with Epinephrine contains BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE. It is a injection, solution taken epidural. Consult your doctor for specific uses.
Is Marcaine with Epinephrine a controlled substance?
Marcaine with Epinephrine is not classified as a controlled substance by the DEA.
What is the generic name for Marcaine with Epinephrine?
The generic name for Marcaine with Epinephrine is BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE. There are 8 other brand versions of BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE.
What is the NDC code for Marcaine with Epinephrine 5 mg/mL?
The NDC (National Drug Code) for Marcaine with Epinephrine 5 mg/mL is 0409-1749, listed by Hospira, Inc..