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MARCAINE AND EPINEPHRINE - VIAL (bupivacaine hydrochloride & epinephrine injection, USP - VIAL)
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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
MARCAINE AND EPINEPHRINE - VIAL Quick Finder
Highlights
Boxed Warning
WARNING: RISK OF CARDIAC ARREST WITH USE OF MARCAINE IN OBSTETRICAL ANESTHESIA
There have been reports of cardiac arrest with difficult resuscitation or death during use of MARCAINE for epidural anesthesia in obstetrical patients....
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Indications and 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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Information
- •
- MARCAINE / MARCAINE WITH EPINEPHRINE is not for intrathecal use.
- •
- ...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
MARCAINE (bupivacaine hydrochloride) injection is a clear, colorless solution available as:
- •
- 0.25% (25 mg/10 mL) (2.5 mg/mL) in single-dose vials.
- •
- 0.25% (75...
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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. ...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Cardiac Arrest with Use of MARCAINE in Obstetrical Anesthesia
There have been reports of cardiac arrest with difficult...
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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...
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Drug 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...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
MARCAINE / MARCAINE...
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Overdosage
10 OVERDOSAGE
Clinical Presentation
Acute emergencies from use of MARCAINE / MARCAINE WITH EPINEPHRINE are generally related to high...
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Description
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...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F). [See USP Controlled Room...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Allergic-Type Reactions
Assess if the patient has had allergic-type reactions to amide-type local...
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Other
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
Distributed...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.