Marcaine

MARCAINE- bupivacaine hydrochloride injection, solution
General Injectables & Vaccines, Inc

HIGHLIGHTS OF PRESCRIBING INORMATION

These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE.

MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use
MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use
Initial U.S. Approval: 1972
WARNING: RISK OF CARDIAC ARREST WITH USE OF MARCAINE IN OBSTETRICAL ANESTHESIA
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.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% (7.5 mg/mL) 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% (7.5 mg/mL) concentration of MARCAINE is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary (5.1).

1 Indications And Usage

MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults 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. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see DOSAGE AND ADMINISTRATION (2.2)].

Limitations of Use

Not all blocks are indicated for use with MARCAINE / MARCAINE WITH EPINEPHRINE given clinically significant risks associated with use [see DOSAGE AND ADMINISTRATION (2.2), CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1, 5.4, 5.5, 5.7, 5.9)].

2 Dosage And Adminisration

2.1 Important Dosage and Administration Information

  • MARCAINE / MARCAINE WITH EPINEPHRINE is not for intrathecal use.
  • Avoid use of MARCAINE / MARCAINE WITH EPINEPHRINE solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia [see WARNINGS AND PRECAUTIONS (5.4)].
  • Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use.
  • Visually inspect this product for particulate matter and discoloration prior to administration whenever solution and container permit. MARCAINE / MARCAINE WITH EPINEPHRINE are clear, colorless solutions. Do not administer solutions which are discolored or contain particulate matter.
  • Mixing or the prior or intercurrent use of any other local anesthetic with MARCAINE / MARCAINE WITH EPINEPHRINE is not recommended because of insufficient data on the clinical use of such mixtures.

Administration Precautions

  • MARCAINE / MARCAINE WITH EPINEPHRINE are to be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed.
  • Use MARCAINE / MARCAINE WITH EPINEPHRINE only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies [see WARNINGS AND PRECAUTIONS (5.2), ADVERSE REACTIONS (6), OVERDOSAGE (10)].
  • The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with MARCAINE / MARCAINE WITH EPINEPHRINE [see WARNINGS AND PRECAUTIONS (5.2), DRUG INTERACTIONS (7.1), OVERDOSAGE (10)].
  • Aspirate for blood or cerebrospinal fluid (where applicable) prior to injecting MARCAINE / MARCAINE WITH EPINEPHRINE, both the initial dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration for blood or cerebrospinal fluid does not ensure against an intravascular or intrathecal injection [see WARNINGS AND PRECAUTIONS (5.9)].
  • Avoid rapid injection of a large volume of MARCAINE / MARCAINE WITH EPINEPHRINE and use fractional (incremental) doses when feasible.
  • During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access. The lowest dosage of MARCAINE / MARCAINE WITH EPINEPHRINE that results in effective anesthesia should be used to avoid high plasma levels and serious adverse reactions.
  • Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient’s level of consciousness after each local anesthetic injection.
  • Use MARCAINE WITH EPINEPHRINE in carefully restricted quantities in areas of the body supplied by end arteries or having otherwise compromised blood supply such as digits, nose, external ear, or penis [see WARNINGS AND PRECAUTIONS (5.12)].

2.2 Recommended Concentrations and Dosages of MARCAINE / MARCAINE WITH EPINEPHRINE

The dosage of MARCAINE / MARCAINE WITH EPINEPHRINE administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Administer the smallest dosage and concentration required to produce the desired result.

The types of block and recommended MARCAINE / MARCAINE WITH EPINEPHRINE concentrations are shown in Table 1.

Table 1. Types of Block and Recommended MARCAINE / MARCAINE WITH EPINEPHRINE

Concentrations

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✓= indicated use [see WARNINGS AND PRECAUTIONS (5.1)].*MARCAINE 0.75% (7.5 mg/mL) is not recommended for nonobstetrical surgical procedures in pregnant patients.†Avoid use of multiple-dose vials of MARCAINE and MARCAINE WITH EPINEPHRINE for caudal or epidural anesthesia [see WARNINGS AND PRECAUTIONS (5.4)].

At recommended dosages, MARCAINE / MARCAINE WITH EPINEPHRINE produces complete sensory block, but the effect on motor function differs among the three concentrations. Table 2 provides information on the expected effect on motor function for the three concentrations.

Table 2. MARCAINE / MARCAINE WITH EPINEPHRINE Concentration vs. Motor Function

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*These products include MARCAINE and MARCAINE WITH EPINEPHRINE [the epinephrine concentration (1:200,000) is not included in the table].

†These are only MARCAINE products [there is no 0.75% (7.5 mg/mL) concentration for MARCAINE WITH EPINEPHRINE].

The duration of anesthesia with MARCAINE / MARCAINE WITH EPINEPHRINE is such that for most indications, a single-dose is sufficient.

The maximum dosage limit within the recommended dosage range must be individualized in each case after evaluating the size and physical status of the patient, as well as the anticipated rate of systemic absorption from a particular injection site.

The dosages in Table 3 are recommended as a guide for use in the average adult. These doses may be repeated once every three hours. Do not exceed a total daily dosage of 400 mg in 24 hours. The duration of anesthetic effect may be prolonged by the addition of epinephrine.

Table 3. Recommended Concentrations and Doses of MARCAINE / MARCAINE WITH EPINEPHRINE in Adults

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*With continuous (intermittent) techniques, repeat doses increase the degree of motor block. The first repeat dose of 0.5% (5 mg/mL) may produce complete motor block. Intercostal nerve block with 0.25% (2.5 mg/mL) also may produce complete motor block for intra-thoracic and upper intra-abdominal surgery.†Solutions with or without epinephrine (i.e., applies to MARCAINE and MARCAINE WITH EPINEPHRINE). The MARCAINE WITH EPINEPHRINE products include epinephrine (1:200,000).‡For single-dose use; not for intermittent epidural technique. Not for obstetrical anesthesia.

2.3 Use in Epidural Anesthesia
During the administration of epidural anesthesia, it is recommended that a test dose of MARCAINE WITH EPINEPHRINE without antimicrobial preservative (0.5% bupivacaine with 1:200,000 epinephrine) be administered initially and the effects monitored before the full dose is given. When using a “continuous” catheter technique, test doses should be given prior to both the initial and all supplemental doses, because a catheter in the epidural space can migrate into a blood vessel or through the dura [see DOSAGE AND ADMINISTRATION (2.4)].

During epidural administration, administer MARCAINE / MARCAINE WITH EPINEPHRINE, 0.5% (5 mg/mL) and MARCAINE 0.75% (7.5 mg/mL) solutions in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Administer injections slowly, with frequent aspirations before and during the injection to avoid intravascular injection. Perform syringe aspirations before and during each supplemental injection in continuous (intermittent) catheter techniques. In obstetrics, use ONLY the 0.5% (5 mg/mL) and 0.25% (2.5 mg/mL) concentrations of MARCAINE / MARCAINE WITH EPINEPHRINE [see WARNINGS AND PRECAUTIONS (5.1)]; incremental doses of 3 mL to 5 mL of the 0.5% (5 mg/mL) solution not exceeding 50 mg to 100 mg at any dosing interval are recommended. Repeat doses should be preceded by a test dose containing epinephrine if not clinically contraindicated. Use only the single-dose vials for caudal or epidural anesthesia; avoid use of the multiple-dose vials for these procedures, which contain a preservative [see DOSAGE AND ADMINISTRATION (2.1, 2.4), WARNINGS AND PRECAUTIONS (5.4, 5.9)].

2.4 Test Dose for Caudal and Lumbar Epidural Blocks
Three mL of MARCAINE WITH EPINEPHRINE without antimicrobial preservative (0.5% bupivacaine with 1:200,000 epinephrine) is recommended for use as a test dose prior to caudal and lumbar epidural blocks when clinical conditions permit. This test dose may serve as a warning of unintended intravascular or intrathecal injection. Closely monitor for early clinical signs of toxicity following each test dose [see WARNINGS AND PRECAUTIONS (5.9)]. Allot adequate time for onset of spinal block to detect possible intrathecal injection. An intravascular or intrathecal injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal, or cardiovascular effects from the epinephrine [see WARNINGS AND PRECAUTIONS (5.2, 5.9), OVERDOSAGE (10)].

2.5 Use in Dentistry
MARCAINE WITH EPINEPHRINE 0.5% (5 mg/mL) is recommended for infiltration and block injection in the maxillary and mandibular area when a longer duration of local anesthesia is desired, such as for procedures generally associated with significant postoperative pain. The average dose of 1.8 mL (9 mg) per injection site will usually suffice; an occasional second dose of 1.8 mL (9 mg) may be used if necessary to produce adequate anesthesia after allowing 2 to 10 minutes for block onset [see CLINICAL PHARMACOLOGY (12.2)]. Use the lowest effective dose and allow time between injections; it is recommended that the total dose for all injection sites, spread out over a single dental sitting, not exceed 90 mg for a healthy adult patient (ten 1.8 mL injections of 0.5% (5 mg/mL) MARCAINE WITH EPINEPHRINE). Inject slowly and with frequent aspirations.

2.6 Use in Ophthalmic Surgery
When MARCAINE 0.75% (7.5 mg/mL) is used for retrobulbar block, complete corneal anesthesia usually precedes onset of clinically acceptable external ocular muscle akinesia. Therefore, presence of akinesia rather than anesthesia alone should determine readiness of the patient for surgery [see WARNINGS AND PRECAUTIONS (5.15)].

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