CARBOCAINE contains mepivacaine, an amide local anesthetic. CARBOCAINE is indicated in adults and pediatric patients for the production of local or regional analgesia and/or anesthesia by administration of local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. (1, 2.2)

Limitations of Use

CARBOCAINE is not intended for spinal anesthesia or dental use. (1)

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Not for intrathecal use. (2.1)

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CARBOCAINE is supplied both with (multiple-dose vials) and without (single-dose vials) antimicrobial preservatives. (2.1)

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Avoid use of solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia. (2.1, 5.3)

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CARBOCAINE without antimicrobial preservative is recommended for use as a test dose with epinephrine prior to caudal and lumbar epidural blocks when clinical conditions permit. (2.4)

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See full prescribing information for:

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Adults: Recommended concentrations and dosages of CARBOCAINE according to type of block. (2.2)

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Pediatric patients: Recommended concentrations and dosages of CARBOCAINE according to age group and weight. (2.2)

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Additional dosage and administration information pertaining to use in epidural anesthesia and test dose for caudal and lumbar epidural blocks. (2.3, 2.4)

Injection:

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1% (300 mg/30 mL) (10 mg/mL) single-dose vials. (3)

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1% (500 mg/50 mL) (10 mg/mL) multiple-dose vials. (3)

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1.5% (450 mg/30 mL) (15 mg/mL) single-dose vials. (3)

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2% (400 mg/20 mL) (20 mg/mL) single-dose vials. (3)

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2% (1,000 mg/50 mL) (20 mg/mL) multiple-dose vials. (3)

Known hypersensitivity to mepivacaine or to any local anesthetic agent of the amide-type or to other components of CARBOCAINE. (4)

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Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after injection of CARBOCAINE. (5.1)

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Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. See full prescribing information for more detail on managing these risks. (5.2)

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Chondrolysis with Intra-Articular Infusion: Intra-articular infusions of local anesthetics including CARBOCAINE following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. (5.4)

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Risk of Systemic Toxicities with Unintended Intravascular or Intrathecal Injection: Unintended intravascular or intrathecal injection may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Aspirate for blood or cerebrospinal fluid (where applicable) prior to each dose and consider using a test dose. (5.5)

Most common adverse reactions are related to the central nervous system and the cardiovascular system. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Local Anesthetics: The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. (7.1)

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Drugs Associated with Methemoglobinemia: Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates or nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other drugs. (7.2)

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Geriatric Use: Clinical studies and other reported clinical experience indicate that use of the drug in elderly patients requires a decreased dosage. Consider adjustment of dose. (8.5)

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Moderate to Severe Renal and/or Hepatic Impairment: Consider reduced dosage and increased monitoring for mepivacaine systemic toxicity. (8.6, 8.7)