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Marcaine (Bupivacaine Hydrochloride) - Summary

 
 



BOX WARNING

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.

 

MARCAINE SUMMARY

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 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.


See all Marcaine indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Marcaine (Bupivacaine)

The Death of Joan Rivers: Endoscopy and Anesthesia Risks
Source: MedicineNet Heart Attack Specialty [2014.12.09]
Title: The Death of Joan Rivers: Endoscopy and Anesthesia Risks
Category: Doctor's Views
Created: 9/8/2014 12:00:00 AM
Last Editorial Review: 12/9/2014 12:00:00 AM

New clue to how anesthesia works
Source: Pain / Anesthetics News From Medical News Today [2014.11.18]
Anesthesia, long considered a blessing to patients and surgeons, has been a mystery for much of its 160-plus-year history in the operating room.

Risks From Epidural, Spinal Anesthesia Very Low, Study Says
Source: MedicineNet Pregnancy Drug Dangers Specialty [2014.10.15]
Title: Risks From Epidural, Spinal Anesthesia Very Low, Study Says
Category: Health News
Created: 10/14/2014 12:00:00 AM
Last Editorial Review: 10/15/2014 12:00:00 AM

more news >>

Published Studies Related to Marcaine (Bupivacaine)

Efficiency of bupivacaine versus lidocaine and methylprednisolone versus placebo to reduce postoperative pain and swelling after surgical removal of mandibular third molars: a randomized, double-blinded, crossover clinical trial. [2013]
swelling after surgical removal of mandibular third molars... CONCLUSIONS: Bupivacaine combined with methylprednisolone reduced the

A comparison of two different doses of bupivacaine in caudal anesthesia for neonatal circumcision. A randomized clinical trial. [2013]
anesthesia... CONCLUSIONS: Low volume high concentration caudal bupivacaine provided a similar

Spinal anaesthesia for pelvic surgery: low concentrations of lignocaine and bupivacaine are effective with less adverse events. [2013]
subarachnoid block for pelvic surgeries... CONCLUSION: [corrected] For subarachnoid block for pelvic surgeries longer than

Dexamethasone added to bupivacaine prolongs duration of epidural analgesia. [2013]
duration of postoperative analgesia via epidural catheterization... CONCLUSIONS: This study revealed that dexamethasone added to bupivacaine-fentanyl

Preoperative peritonsillar infiltration of dexamethasone and levobupivacaine reduces pediatric post-tonsillectomy pain: a double-blind prospective randomized clinical trial. [2013]
children... CONCLUSION: Addition of dexamethasone to levobupivacaine for preoperative

more studies >>

Clinical Trials Related to Marcaine (Bupivacaine)

Bupivacaine Effectiveness and Safety in SABER™ Trial [Recruiting]
This is a research study testing SABERâ„¢-Bupivacaine (an experimental pain-relieving medication). SABERâ„¢-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain.

The purpose of this study is to investigate safety (side effects) associated with the use of SABERâ„¢-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.

Epidural Fentanyl-bupivacaine Versus Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor [Not yet recruiting]
Epidural analgesia is widely regarding as the most effective analgesic strategy for labor pain. Modern practice is to utilize dilute local anesthetics as a continuous infusion along with an opioid, e. g., our common "recipe" of 12 ml/hr of 0. 0625% bupivacaine with 2 micrograms/ml fentanyl, after the initial dose to maintain patient comfort until delivery. This dose of the infusion often provides adequate comfort without interfering with the mobility of the patient and her ability to effectively push during delivery. However, this low dose epidural infusion strategy often results in recurrence of pain after an initial pain free period.

This breakthrough pain is treated by administering small boluses of analgesics via the epidural catheter. The pain occurring in labor is initially of visceral origin and is mediated by pain fibers originating from the low thoracic and upper lumbar segments of the spinal cord. As labor progresses to the late first phase (also known as transitional stage), pain sensations originating from the distension of the pelvic floor, vagina and perineum adds a somatic component to labor pain. This type of breakthrough pain is often difficult to treat.

Although requests from patients to alleviate late stage breakthrough pain are common, no one knows the most effective strategy for pain management in this stage of labor. This study is designed to compare the efficacy of two treatments for controlling late first stage breakthrough pain during labor with an epidural infusion in place: clonidine-bupivacaine versus fentanyl-bupivacaine.

Women who have labor epidural analgesia in place will be enrolled to be randomized if and when they present with breakthrough pain in the late first stage or second stage of labor (≥ 8 cm dilated). They will receive 8 ml of a solution containing 10 mg bupivacaine and 75 micrograms of either fentanyl (an opioid or "narcotic") or clonidine (an "alpha-2 agonist known to be effective as an epidural analgesic).

Pain relief, labor progress and outcome will be assessed to compare fentanyl versus clonidine.

It is the hypothesis of this study that clonidine added to bupivacaine is a better analgesic than fentanyl added to bupivacaine for breakthrough pain in advanced labor.

Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections [Recruiting]
Intrathecal (i. t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with addition of fentanyl for c-section either combined or not with administration of 10 ml of N/S 0,9% epidurally, in order to extent epidural space. Sensory and motor block profile, haemodynamics and side effects were assessed.

Plasma Concentrations of Bupivacaine After Peri-articular Injection in Total Knee Arthroplasty [Recruiting]
Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot femoral nerve block and periarticular block, so we would like to know the plasma concentration of bupivacaine in these patients.

Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain [Recruiting]
This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.

more trials >>

Reports of Suspected Marcaine (Bupivacaine) Side Effects

Cardiac Arrest (8)Anaesthetic Complication (6)Respiratory Distress (5)Brain Oedema (4)Hypoxic-Ischaemic Encephalopathy (4)Drug Ineffective (3)Anaphylactic Reaction (3)Pain (3)Anaphylactic Shock (3)Oedema Peripheral (3)more >>


Page last updated: 2014-12-09

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