DESCRIPTION SECTION
BUPIVACAINE HYDROCHLORIDE injection, solution
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (bupivacaine hydrochloride and epinephrine bitartrate) injection, solution
[Hospira, Inc.]
Rx only
THE 0.75% CONCENTRATION OF BUPIVACAINE HYDROCHLORIDE IS NOT RECOMMENDED FOR OBSTETRICAL ANESTHESIA.
THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATION OR DEATH DURING USE OF BUPIVACAINE HYDROCHLORIDE 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 PREPARATION AND APPROPRIATE MANAGEMENT. CARDIAC ARREST HAS OCCURRED AFTER CONVULSIONS RESULTING FROM SYSTEMIC TOXICITY, PRESUMABLY FOLLOWING UNINTENTIONAL INTRAVASCULAR INJECTION. THE 0.75% CONCENTRATION SHOULD BE RESERVED FOR SURGICAL PROCEDURES WHERE A HIGH DEGREE OF MUSCLE RELAXATION AND PROLONGED EFFECT ARE NECESSARY.
DESCRIPTION
Bupivacaine Hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula:
bupivacaine hydrochloride 1
Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. It has the following structural formula:
bupivacaine hydrochloride 2
infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Solutions of Bupivacaine Hydrochloride may be autoclaved if they do not contain epinephrine. Solutions are clear and colorless.
Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage.
Bupivacaine Hydrochloride Injection, USP is available in sterile, isotonic solutions containing bupivacaine hydrochloride in water for injection with characteristics as follows:
| Concentration | Bupivacaine Hydrochloride mg/ml | Sodium Chloride mg/ml | |
| 0.25% | 2.5 | 8.6 | |
| 0.5% | 5 | 8.1 | |
| 0.75% | 7.5 | 7.6 |
May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. (See HOW SUPPLIED section for pH information.) Multiple-dose vials contain methylparaben 1 mg/mL added as a preservative.
Bupivacaine and Epinephrine Injection, USP is available in sterile, isotonic solutions containing bupivacaine hydrochloride and epinephrine 1:200,000 with characteristics as follows:
| Concentration (Bupivacaine HCL) | Bupivacaine Hydrochloride (mg/ml) | Epinephrine 1:2000,000 (mcg/ml) | Sodium Chloride (mg/ml) |
| 0.25% | 2.5 | 5 | 8.5 |
| 0.5% | 5 | 5 | 8.5 |
| 0.75% | 7 |
Sodium metabisulfite 0.1 mg/mL added as antioxidant and edetate calcium disodium, anhydrous 0.1 mg/mL added as stabilizer. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. (See HOW SUPPLIED section for pH information.) Multiple-dose vials contain methylparaben 1 mg/mL added as a preservative.
Single-dose solutions contain no added bacteriostat or anti-microbial agent and unused portions should be discarded after use.
CLINICAL PHARMACOLOGY SECTION
INDICATIONS & USAGE SECTION
CONTRAINDICATIONS SECTION
WARNINGS SECTION
DOSAGE & ADMINISTRATION SECTION
PRECAUTIONS SECTION
ADVERSE REACTIONS SECTION
OVERDOSAGE SECTION
HOW SUPPLIED SECTION
0.25% 30ML Ampule
