HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BUPIVACAINE SPINAL safely and effectively. See full prescribing information for BUPIVACAINE SPINAL.
BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) for subarachnoid injection
Initial U.S. Approval: 1984
INDICATIONS AND USAGE
BUPIVACAINE SPINAL is an amide-local anesthetic indicated in adults for subarachnoid injection for the production of subarachnoid block (spinal anesthesia). (1)
DOSAGE AND ADMINISTRATION
The dosage of BUPIVACAINE SPINAL administered varies with the anesthetic procedure, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Administer the smallest dosage and concentration required to produce the desired result. The following are general dosage guidelines:
DOSAGE FORMS AND STRENGTHS
Injection: 15 mg/2 mL (7.5 mg/mL) in single-dose glass ampules. (3)
WARNINGS AND PRECAUTIONS
Most common adverse reactions are hypotension due to loss of sympathetic tone, and diaphragmatic paralysis or hypoventilation due to cephalad spread and high motor block. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1‑800‑438‑1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
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bupivacaine hydrochloride injection, USP - SPINAL Highlights
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