Hospira Inc.
Product Description:Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide
Classification:Class I
Product Quantity:40,360 vials
Reason For Recall:Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Recall Initiation Date:20131018
Report Date:20140326
Hospira Inc.
Product Description:Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide
Classification:Class I
Product Quantity:40,360 vials
Reason For Recall:Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Recall Initiation Date:20131018
Report Date:20140326
Hospira Inc.
Product Description:Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide
Classification:Class I
Product Quantity:40,360 vials
Reason For Recall:Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Recall Initiation Date:20131018
Report Date:20140326
Hospira Inc.
Product Description:Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide
Classification:Class I
Product Quantity:40,360 vials
Reason For Recall:Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Recall Initiation Date:20131018
Report Date:20140326
Hospira Inc.
Product Description:Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide
Classification:Class I
Product Quantity:40,360 vials
Reason For Recall:Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Recall Initiation Date:20131018
Report Date:20140326
Hospira Inc.
Product Description:Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide
Classification:Class I
Product Quantity:40,360 vials
Reason For Recall:Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Recall Initiation Date:20131018
Report Date:20140326

Marcaine

Marcaine

Marcaine Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

THE 0.75% CONCENTRATION OF MARCAINE IS NOT RECOMMENDED FOR OBSTETRICAL ANESTHESIA. THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATION OR DEATH DURING USE OF MARCAINE 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.

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.

Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement.

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.

MARCAINE 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 MARCAINE 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 MARCAINE in this age group is not recommended.

Mixing or the prior or intercurrent use of any other local anesthetic with MARCAINE 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 MARCAINE for intravenous regional anesthesia (Bier Block). Information on safe dosages and techniques of administration of MARCAINE in this procedure is lacking. Therefore, MARCAINE is not recommended for use in this technique.

MARCAINE 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 MARCAINE without epinephrine do not contain sodium metabisulfite.

 

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

MARCAINE 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 MARCAINE in these patients.

MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS.

The routes of administration and indicated MARCAINE concentrations are:

∙ local infiltration                                                                                 0.25%

∙ peripheral nerve block                                                                      0.25% and 0.5%

∙ retrobulbar block                                                                              0.75%

∙ sympathetic block                                                                             0.25%

∙ lumbar epidural                                                                                 0.25%, 0.5%, and 0.75%

                                                                                                          (0.75% not for obstetrical anesthesia)

∙ caudal                                                                                               0.25% and 0.5%

∙ epidural test dose                                                                              0.5% with epinephrine 1:200,000

∙ dental blocks                                                                                     0.5% 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 MARCAINE.

 

History

There is currently no drug history available for this drug.

Other Information

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:

MM1

Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. It has the following structural formula:

MM1

MARCAINE is available in sterile isotonic solutions with and without epinephrine (as bitartrate) 1:200,000 for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Solutions of MARCAINE 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.

MARCAINE — Sterile isotonic solutions containing sodium chloride. In multiple-dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4 and 6.5 with sodium hydroxide or hydrochloric acid.

MARCAINE with epinephrine 1:200,000 (as bitartrate)—Sterile isotonic solutions containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.0091 mg epinephrine bitartrate, with 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. In multiple-dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008.

 

Marcaine Manufacturers


  • Remedyrepack Inc.
    Marcaine (Bupivacaine Hydrochloride) Injection, Solution [Remedyrepack Inc. ]
  • General Injectables & Vaccines, Inc
    Marcaine (Bupivacaine Hydrochloride) Injection, Solution [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccines, Inc
    Marcaine (Bupivacaine Hydrochloride) Injection, Solution [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccines, Inc
    Marcaine (Bupivacaine Hydrochloride) Injection, Solution [General Injectables & Vaccines, Inc]
  • Hospira, Inc.
    Marcaine (Bupivacaine Hydrochloride) Injection, Solution Marcaine With Epinephrine (Bupivacaine Hydrochloride And Epinephrine Bitartrate) Injection, Solution [Hospira, Inc.]
  • Physicians Total Care, Inc.
    Marcaine (Bupivacaine Hydrochloride) Injection, Solution Marcaine With Epinephrine (Bupivacaine Hydrochloride And Epinephrine Bitartrate) Injection, Solution [Physicians Total Care, Inc.]
  • Cardinal Health
    Marcaine (Bupivacaine Hydrochloride) Injection, Solution [Cardinal Health]
  • Carestream Health Inc.
    Marcaine (Bupivacaine Hydrochloride And Epinephrine Bitartrate) Injection, Solution [Carestream Health Inc.]
  • A-s Medication Solutions Llc
    Marcaine (Bupivacaine Hydrochloride) Injection, Solution [A-s Medication Solutions Llc]
  • Remedyrepack Inc.
    Marcaine (Bupivacaine Hydrochloride) Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Marcaine (Bupivacaine Hydrochloride) Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Marcaine (Bupivacaine Hydrochloride) Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Marcaine (Bupivacaine Hydrochloride) Injection, Solution [Remedyrepack Inc. ]

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