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NDC 63323-0462-17

BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE 5 mg/mL, .005 mg/mL INJECTION, SOLUTION

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NDC
63323-0462-17
Generic Name
BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
Brand Name
SENSORCAINE MPF
Strength
5 mg/mL, .005 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL
Package Size
Labeler
Fresenius Kabi USA, LLC

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE: Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS ). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl…

Important Warnings

WARNINGS: THE 0.75% CONCENTRATION OF SENSORCAINE INJECTION IS NOT RECOMMENDED FOR OBSTETRICAL ANESTHESIA. THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATION OR DEATH DURING USE OF BUPIVACAINE FOR EPIDURAL ANESTHESIA IN OBSTETRICAL PATIENTS. IN MOST CASES, THIS HAS FOLLOWED USE OF THE 0.75% CONCENTRATION. RESUSCITATION HAS BEEN DIFFICULT OR IMPOSSIBLE DESPITE APPARENTLY ADEQUATE…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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