Bupivacaine

BUPIVACAINE

Manufacturer: Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Score: 141.0

Quick Summary

Bupivacaine liposome injectable suspension is a local anesthetic used for postsurgical pain management. It is indicated for local analgesia via infiltration in adults and regional analgesia via an interscalene brachial plexus nerve block in adults. The recommended dose for local infiltration is up to 266 mg, and for nerve block is 133 mg. Bupivacaine liposome injectable suspension is not substitutable with other bupivacaine products, and its use is contraindicated in obstetrical paracervical block anesthesia. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Local analgesia via infiltration in adults
Regional analgesia via an interscalene brachial plexus nerve block in adults

Important Safety Information

Warning

Bupivacaine liposome injectable suspension is not substitutable with other bupivacaine products, and its use is contraindicated in obstetrical paracervical block anesthesia.

Contraindications

Obstetrical paracervical block anesthesia

Adverse Reactions

Nausea
Constipation
Vomiting
Pyrexia
Headache
Dizziness
Somnolence

Dosing Recommendations

General Guidance

No dose adjustments are recommended for patients with renal impairment, but monitoring for adverse reactions is recommended.

Local analgesia via infiltration

Adult Dose

Up to 266 mg

Pediatric Dose

Not established for pediatric patients aged less than 6 years old

Regional analgesia via an interscalene brachial plexus nerve block

Adult Dose

133 mg

Pediatric Dose

Not established for pediatric patients

Special Population Considerations

Pregnancy

There are no studies conducted with bupivacaine liposome injectable suspension in pregnant women.
Adverse reactions in the parturient, fetus, and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function.

Nursing Mothers

No information is available on the use of bupivacaine liposome injectable suspension in nursing mothers.

Pediatric Use

Safety and effectiveness of bupivacaine liposome injectable suspension have not been established to produce postsurgical local analgesia via infiltration in pediatric patients aged less than 6 years old.
Safety and effectiveness of bupivacaine liposome injectable suspension have not been established to produce postsurgical regional analgesia via interscalene brachial plexus nerve block in pediatric patients.

Geriatric Use

Of the total number of patients in the bupivacaine liposome injectable suspension local infiltration clinical studies, 171 patients were greater than or equal to 65 years of age and 47 patients were greater than or equal to 75 years of age.
No overall differences in safety or effectiveness of bupivacaine liposome injectable suspension have been observed between patients 65 years of age and older and younger adult patients.