DailyMed Label: Bupivacaine Hydrochloride

DailyMed Label: Bupivacaine Hydrochloride

2024

DailyMed Prescription

Bupivacaine Hydrochloride

Bupivacaine Hydrochloride

Hikma Pharmaceuticals USA Inc.

NDC: 0143-9328

NDC: 0143-9328

NDC: 0143-9329

NDC: 0143-9329

Bupivacaine hydrochloride injection, USP 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. 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 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 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.

Bupivacaine Hydrochloride injection 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 Bupivacaine Hydrochloride injection 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 Bupivacaine Hydrochloride injection 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 )] .

Bupivacaine hydrochloride injection, USP is a clear, colorless solution available as: 0.25% (125 mg/50 mL) (2.5 mg/mL) in multiple-dose vials. 0.5% (250 mg/50 mL) (5 mg/mL) in multiple-dose vials.

Bupivacaine Hydrochloride injection is contraindicated in: obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.7) ] . patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of Bupivacaine Hydrochloride injection.

The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling:

Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 ° F to 86 °F). [See USP Controlled Room Temperature.] Bupivacaine hydrochloride injection, USP ―Solutions of Bupivacaine hydrochloride injection, USP may be autoclaved. Autoclave at 15-pound pressure, 121 °C (250 °F) for 15 minutes. Protect from light. This product is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate. NDC No. Container Fill Quantity 0.25% — Contains 2.5 mg bupivacaine hydrochloride per mL. 0143-9328-10 Multiple Dose Vial 50 mL Carton of 10 vials 0.5% — Contains 5 mg bupivacaine hydrochloride per mL. 0143-9329-10 Multiple Dose Vial 50 mL Carton of 10 vials

Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone. Epinephrine is a vasoconstrictor added to bupivacaine to slow absorption into the general circulation and thus prolong maintenance of an active tissue concentration.

NDC 0143- 9328 -01     Rx only 50 mL Multiple-Dose Vial Bupivacaine HCl Injection, USP      0.25% 125 mg per 50 mL (2.5 mg/mL) For Infiltration and Nerve Block Not for Caudal, Epidural, or Spinal Anesthesia Preservative Added NDC 0143- 9328 -10     Rx only Bupivacaine HCl Injection, USP      0.25% 125 mg per 50 mL (2.5 mg/mL) For Infiltration and Nerve Block Not for Caudal, Epidural, or Spinal Anesthesia Preservative Added 10 x 50 mL Multiple-Dose Vials