BUPIVACAINE- bupivacaine hydrochloride injection, solution
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE- bupivacaine hydrochloride and epinephrine bitartrate injection, solution
General Injectables & Vaccines, Inc
Bupivacaine in Dextrose
Bupivacaine HCl 0.75% in Dextrose
Sterile Hyperbaric Solution for
Bupivacaine hydrochloride is 1-Butyl-2? 6?-pipecoloxylidide monochloride, 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:
structural formula bupivacaine hydrochloride
(click image for full-size original)
Dextrose is D-glucopyranose monohydrate and has the following structural formula:
structural formula dextrose
Bupivacaine Spinal (Bupivacaine in Dextrose Injection, USP) is available in sterile, hyperbaric solution for subarachnoid injection (spinal block).
Bupivacaine hydrochloride 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.
Each 1 mL of Bupivacaine Spinal contains 7.5 mg bupivacaine hydrochloride, anhydrous and 82.5 mg dextrose, anhydrous. The pH of this solution is adjusted to 5.5 (4.0 to 6.5) with sodium hydroxide and/or hydrochloric acid.
The specific gravity of Bupivacaine Spinal is between 1.030 and 1.035 at 25°C and 1.03 at 37°C.
Bupivacaine Spinal does not contain any preservatives.
Solutions of bupivacaine hydrochloride may be autoclaved if they do not contain epinephrine.
Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception and (5) skeletal muscle tone.
Systemic absorption of local anesthetics produces effects on the cardiovascular and central nervous system (CNS). At blood concentrations achieved with normal therapeutic doses, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. However, toxic blood concentrations depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias and cardiac arrest, sometimes resulting in fatalities. In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure. Recent clinical reports and animal research suggest that these cardiovascular changes are more likely to occur after unintended direct intravascular injection of bupivacaine. Therefore, when epidural anesthesia with bupivacaine is considered, incremental dosing is necessary.
INDICATIONS AND USAGE
Bupivacaine Spinal is indicated for the production of subarachnoid block (spinal anesthesia).
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of spinal anesthesia.
Bupivacaine Hydrochloride and Epinephrine Indications and Usage
Bupivacaine Hydrochloride 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 0.75% concentration of Bupivacaine Hydrochloride in these patients.
Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia (Bier Block