SPL Set ID: bcaab86f-20f0-4482-8d73-e29b36dced58
1 drug(s) with this SPL Set ID
Bupivacaine hydrochloride injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection (without epinephrine) is by injection, for infiltration, perineural, or retrobulbar use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)] . Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl- N -(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 96 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula: Bupivacaine hydrochloride is a clear and colorless sterile isotonic solution. Each mL of multiple-dose vial contains 2.5 mg or 5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Image