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MARCAINE - SPINAL (bupivacaine hydrochloride injection, USP - SPINAL)
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MARCAINE - SPINAL Quick Finder
1 INDICATIONS AND USAGE
MARCAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Information
- Visually inspect this product for particulate matter and discoloration prior to...
3 DOSAGE FORMS AND STRENGTHS
MARCAINE 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. ...
4 CONTRAINDICATIONS
MARCAINE SPINAL is contraindicated in:
- intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.8)].
- ...
5 WARNINGS AND PRECAUTIONS
5.1 Use of Spinal Anesthetics During Uterine Contractions
Spinal anesthetics including MARCAINE SPINAL should not be injected during...
6 ADVERSE REACTIONS
The following clinically significant adverse reactions have been reported and described in other sections of the labeling:
- Allergic-Type Reactions [see...
7 DRUG INTERACTIONS
7.1 Local Anesthetics
The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with MARCAINE SPINAL...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
The available data on...
10 OVERDOSAGE
Clinical Presentation
Acute emergencies from MARCAINE SPINAL are generally related to hypoventilation (and perhaps apnea)...
11 DESCRIPTION
MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for MARCAINE SPINAL is by subarachnoid...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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.]...
17 PATIENT COUNSELING INFORMATION
Allergic-Type Reactions
Assess if the patient has had allergic-type reactions to amide-type local...
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