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bupivacaine hydrochloride injection, USP - SPINAL
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 - SPINAL Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
BUPIVACAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Information
- •
- Visually inspect this product for particulate matter and discoloration prior to...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is a clear, colorless solution available as:
- •
- 15 mg/2 mL (7.5 mg/mL) in single-dose glass ampules. ...
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Contraindications
4 CONTRAINDICATIONS
BUPIVACAINE SPINAL is contraindicated in:
- •
- intravenous regional anesthesia (Bier Block) [see Warnings and...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Use of Spinal Anesthetics During Uterine Contractions
Spinal anesthetics including BUPIVACAINE SPINAL should not be injected during...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions have been reported and described in other sections of the labeling:
- •
- Allergic-Type Reactions [see...
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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
The available data on the use of BUPIVACAINE SPINAL in pregnant women...
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Overdosage
10 OVERDOSAGE
Clinical Presentation
Acute emergencies from BUPIVACAINE SPINAL are generally related to hypoventilation (and perhaps apnea) secondary to upward extension of spinal...
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Description
11 DESCRIPTION
BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for BUPIVACAINE SPINAL is by subarachnoid...
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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
Carcinogenesis
Long-term studies in animals...
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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 Temperature.]
BUPIVACAINE SPINAL solution may be autoclaved...
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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 anesthetics or to other formulation ingredients...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety 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.