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bupivacaine hydrochloride injection, USP
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
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.
bupivacaine hydrochloride injection, USP Quick Finder
Highlights
Boxed Warning
WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA
There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride...
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Indications and Usage
1 INDICATIONS AND USAGE
Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Information
- •
- Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Bupivacaine Hydrochloride Injection, USP is a clear, colorless solution available as:
- •
- 0.25% (25 mg/10 mL) (2.5 mg/mL) in single-dose teartop vials.
- •
- 0.25% (...
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Contraindications
4 CONTRAINDICATIONS
Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is contraindicated in:
- •
- obstetrical paracervical block anesthesia. Its use in this technique has...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Cardiac Arrest with Use of Bupivacaine Hydrochloride Injection in Obstetrical Anesthesia
There have been reports of cardiac...
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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 Bupivacaine...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Bupivacaine...
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Overdosage
10 OVERDOSAGE
Clinical Presentation
Acute emergencies from use of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and...
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Description
11 DESCRIPTION
Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of...
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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.