(mepivacaine Hydrochloride Injection, USP)
Health Professional Information
Description
11 DESCRIPTION
CARBOCAINE contains mepivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for CARBOCAINE is by injection, for local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.3)].
Mepivacaine hydrochloride is 2-piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-methyl, monohydrochloride. It is a white crystalline odorless powder, soluble in water, but very resistant to both acid and alkaline hydrolysis. It has the following structural formula:
C15H22N2O • HCl
CARBOCAINE (mepivacaine hydrochloride) is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 10 mg, 15 mg or 20 mg of mepivacaine hydrochloride (equivalent to 8.71 mg, 13.07 mg, or 17.42 mg of mepivacaine, respectively) with the detailed composition shown in the table. Each mL of multiple-dose vial contains 10 mg or 20 mg of mepivacaine hydrochloride (equivalent to 8.71 mg or 17.42 mg of mepivacaine, respectively) with the detailed composition shown in the table.
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Composition of Available Solutions* | |||||
1% Single-Dose 30 mL Vial mg/mL | 1% Multiple-Dose 50 mL Vial mg/mL | 1.5% Single-Dose 30 mL Vial mg/mL | 2% Single-Dose 20 mL Vial mg/mL | 2% Multiple-Dose 50 mL Vial mg/mL | |
Mepivacaine | | | | |
20 |
Sodium chloride | 6.6 | 7 | 5.6 | 4.6 | 5 |
Potassium chloride | 0.3 | 0.3 | 0.3 | ||
Calcium chloride | 0.33 | 0.33 | 0.33 | ||
Methylparaben | 1 | 1 | |||
The specific gravity of CARBOCAINE 1% at 25 °C is 1.007 for the single-dose vials and 1.008 for the multiple-dose vials. The specific gravity of CARBOCAINE 1.5% and 2% at 25 °C is 1.008.
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