ARTG Entry
BUPIVACAINE
ARTG entry for BUPIVACAINE (bupivacaine hydrochloride), ARTG 482232 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Aborns Pharmaceuticals
- Active ingredient: bupivacaine hydrochloride
- Therapeutic area: Pain Management
What it is
BUPIVACAINE WITH ADRENALINE PHEBRA is a solution for injection containing bupivacaine hydrochloride and adrenaline (epinephrine). It is presented as a clear, colourless, or almost colourless isotonic aqueous solution for injection or infusion. Two strengths are available: Bupivacaine 0.25% with Adrenaline 1:400,000 containing bupivacaine hydrochloride 50 mg/20 mL with adrenaline 50 microgram/20 mL, and Bupivacaine 0.5% with Adrenaline 1:200,000 containing bupivacaine hydrochloride 100 mg/20 mL with adrenaline 100 microgram/20 mL. The medicine is not for intravenous administration under any circumstances. The solution contains sulfites.
Approved indications
BUPIVACAINE WITH ADRENALINE PHEBRA is indicated for the production of local or regional anaesthesia and analgesia: — Epidural block for surgery — Field block for minor and major nerve blocks and infiltration — Intermittent bolus epidural administration for analgesia in postoperative pain or labour pain — Field block for minor nerve block and infiltration
Dosing overview
The dosage of BUPIVACAINE WITH ADRENALINE PHEBRA varies and depends upon the area to be anaesthetised, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anaesthesia and degree of muscle relaxation required, individual tolerance, the technique of anaesthesia, and the physical condition of the patient, with the lowest dosage that results in effective anaesthesia used. Surgical anaesthesia requires the use of higher concentrations and doses than those required for analgesia. Studies indicate that 400 mg administered over 24 hours is well tolerated in average adults. BUPIVACAINE WITH ADRENALINE PHEBRA should not be used for epidural block in labour analgesia (apart from the use as a test dose) as the benefits from the addition of adrenaline have not been shown to outweigh the risks.
Key safety warnings
BUPIVACAINE WITH ADRENALINE PHEBRA is for single use only, to be used in one patient on one occasion only and then discarded, as it contains no antimicrobial preservative.
Regulatory history
BUPIVACAINE 0.5% WITH ADRENALINE 1:200,000 PHEBRA was first listed on the ARTG on 7 October 2022, and BUPIVACAINE 0.25% WITH ADRENALINE 1:400,000 PHEBRA was first listed on 8 February 2024.