BUPIVACAINE HYDROCHLORIDE

Manufacturer: Hospira, Inc.

Score: 144.0

Quick Summary

Bupivacaine Hydrochloride is a local anesthetic used 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. The drug has a boxed warning for the risk of cardiac arrest with use in obstetrical anesthesia and has several contraindications, including obstetrical paracervical block anesthesia and intravenous regional anesthesia. The recommended concentrations and dosages vary depending on the type of block and the patient's physical status. Special population considerations include use in pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures
Production of local or regional anesthesia or analgesia

Important Safety Information

Warning

Risk of cardiac arrest with use in obstetrical anesthesia

Contraindications

Obstetrical paracervical block anesthesia
Intravenous regional anesthesia
Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of Bupivacaine Hydrochloride injection

Adverse Reactions

Cardiac arrest
Dose-related toxicity
Methemoglobinemia
Chondrolysis with intra-articular infusion
Cardiac arrest with intravenous regional anesthesia use
Systemic toxicities with unintended intravascular or intrathecal injection
Respiratory arrest following retrobulbar block

Dosing Recommendations

General Guidance

The dosage of Bupivacaine Hydrochloride injection administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient

Local infiltration

Adult Dose

0.25% (2.5 mg/mL) up to 70 mL (without epinephrine) or up to 175 mL (without epinephrine)

Pediatric Dose

Not recommended for pediatric patients younger than 12 years

Peripheral nerve block

Adult Dose

0.5% (5 mg/mL) 5-35 mL (without epinephrine) or 25-175 mg (without epinephrine)

Pediatric Dose

Not recommended for pediatric patients younger than 12 years

Special Population Considerations

Pregnancy

Bupivacaine Hydrochloride injection is contraindicated for obstetrical paracervical block anesthesia
The use of Bupivacaine Hydrochloride injection in pregnant women has resulted in fetal bradycardia and death

Nursing Mothers

No information available

Pediatric Use

Administration of Bupivacaine Hydrochloride injection in pediatric patients younger than 12 years is not recommended
Continuous infusions of bupivacaine in pediatric patients have been reported to result in high systemic levels of bupivacaine and seizures

Geriatric Use

Patients 65 years and over, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing anesthesia with Bupivacaine Hydrochloride injection
Elderly patients may require lower doses of Bupivacaine Hydrochloride injection