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Basic Drug Info
Drug Name:Bupivacaine Hydrochloride
Manufacturer:Hospira, Inc.
Other Info:

LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES WHICH MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED, AND THEN ONLY AFTER INSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY RESUSCITATIVE EQUIPMENT, AND THE PERSONNEL RESOURCES NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES. (See also ADVERSE REACTIONS, PRECAUTIONS, and OVERDOSAGE.) DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE, AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.Local anesthetic solutions containing antimicrobial preservatives, i.e., those supplied in multiple-dose vials, should not be used for epidural or caudal anesthesia because safety has not been established with regard to intrathecal injection, either intentionally or unintentionally, of such preservatives.It is essential that aspiration for blood or cerebrospinal fluid (where applicable) be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does not ensure against an intravascular or subarachnoid injection.Bupivacaine Hydrochloride with epinephrine 1:200,000 or other vasopressors should not be used concomitantly with ergot-type oxytocic drugs, because a severe persistent hypertension may occur.

Likewise, solutions of Bupivacaine Hydrochloride containing a vasoconstrictor, such as epinephrine, should be used with extreme caution in patients receiving monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe prolonged hypertension may result.Until further experience is gained in pediatric patients younger than 12 years, administration of Bupivacaine Hydrochloride in this age group is not recommended.Mixing or the prior or intercurrent use of any other local anesthetic with Bupivacaine Hydrochloride cannot be recommended because of insufficient data on the clinical use of such mixtures.

There have been reports of cardiac arrest and death during the use of Bupivacaine Hydrochloride for intravenous regional anesthesia (Bier Block).

Information on safe dosages and techniques of administration of Bupivacaine Hydrochloride in this procedure is lacking.

Therefore, Bupivacaine Hydrochloride is not recommended for use in this technique.Bupivacaine Hydrochloride with epinephrine 1:200,000 contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.

The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.

Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Single-dose ampuls and single-dose vials of Bupivacaine Hydrochloride without epinephrine do not contain sodium metabisulfite.



Clinical Trials:


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).

(See WARNINGS.) The routes of administration and indicated Bupivacaine Hydrochloride concentrations are: • local infiltration 0.25% • peripheral nerve block 0.25% and 0.5% • retrobulbar block 0.75% • sympathetic block 0.25% • lumbar epidural0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia) • caudal0.25% and 0.5% • epidural test dose0.5% with epinephrine 1:200,000 (See DOSAGE AND ADMINISTRATION for additional information.)Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Bupivacaine Hydrochloride.
Absence of pain sensation --

Contraindications

Bupivacaine Hydrochloride is contraindicated in obstetrical paracervical block anesthesia.

Its use in this technique has resulted in fetal bradycardia and death.Bupivacaine Hydrochloride is contraindicated in patients with a known hypersensitivityto it or to any local anesthetic agent of the amide-type or to other components of Bupivacaine Hydrochloride solutions.
SPONDYLOMETAEPIPHYSEAL DYSPLASIA, SHORT LIMB-HAND TYPE --

Warnings

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.
Branded Drugs
The following US Branded drugs contain Bupivacaine Hydrochloride


BUPIVACAINE HYDROCHLORIDE KIT -- HOSPIRA INC

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE -- INTERNATIONAL MEDICATED SYSTEMS LTD

MARCAINE HYDROCHLORIDE -- HOSPIRA INC

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE -- HOSPIRA INC

SENSORCAINE -- ABRAXIS BIOSCIENCE INC

SENSORCAINE -- APP PHARMACEUTICALS LLC

BUPIVACAINE -- HOSPIRA INC

MARCAINE -- HOSPIRA INC

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE -- HOSPIRA INC

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE -- SEPTODONT INC

BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE -- HOSPIRA INC

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE -- HOSPIRA INC

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE -- HOSPIRA INC

DUOCAINE -- AMPHASTAR PHARMACEUTICALS INC


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