SPL Set ID: dec92845-e713-42a3-83a7-3a48920b7eed

Bupivacaine Hydrochloride Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. [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 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula: Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 5 mg of bupivacaine hydrochloride (equivalent to 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. Chemical Structure DESCRIPTION Methylprednisolone acetate injectable suspension, USP is a sterile anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in 40 mg/mL strength: Each mL of these preparations contains: Methylprednisolone acetate..................................40 mg Polyethylene glycol 3350...................................29.1 mg Polysorbate 80................................................ 1.94 mg Monobasic sodium phosphate monohydrate........ 6.8 mg Dibasic sodium phosphate anhydrous USP............1.42 mg Benzyl alcohol added as a preservative............... 9.16 mg Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range (e.g., 3.5 to 7.0). The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20- dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11β) and 11β,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione 21-acetate the molecular weight is 416.51. The structural formula is represented below: Methylprednisolone acetate sterile aqueous suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water. image description