Levobupivacaine hydrochloride monohydrate solution for injection is indicated in adults for:
Adults: Surgical anesthesia
Epidural, intrathecal, peripheral nerve block. For obstetric procedures, including Caesarean section, concentrations higher than 0.5% are not recommended, see Contraindications, Warnings and Precautions, Pregnancy and Lactation.
Local infiltration, peribulbar block in ophthalmic surgery.
Adults: Pain management
Continuous epidural infusion, single or multiple bolus administration for postoperative, labor or chronic pain. For continuous epidural analgesia, levobupivacaine hydrochloride monohydrate may be administered in combination with epidural fentanyl, morphine, or clonidine.
Levobupivacaine hydrochloride monohydrate is indicated in children for infiltration analgesia (ilioinguinal/iliohypogastric blocks).
Levobupivacaine 50 mg
0 to 12 Years Old
- Local infiltration (0.25%) 0.50 ml/kg/side or (0.5%) 0.25 ml/kg/side
The maximum recommended dose for infiltration analgesia (ilioinguinal-iliohypogastric block) is 1.25 mg/kg/side.
12 Years Old and Above
- Epidural for surgery (0.5-0.75%) 10-20 ml [50-150 mg]
- Epidural for Caesarean section (0.5%) 15-30 ml [75-150 mg]
- Peripheral nerve (0.25-0.5%) 1-40 ml [maximum 150 mg]
- Intrathecal (0.5%) 3 ml [15 mg]
- Ophtalmic (0.75%) 5-15 ml [37.5-112.5 mg]
- Local infiltration (0.25%) 1-60 ml [maximum 150 mg]
- Labor analgesia (epidural bolus with 0.25%) 10-20 ml [25-50 mg]
- Labor analgesia (epidural infusion with 0.125%) 4-10 ml/hour [5-12.5 mg/hour]
- Postoperative pain (epidural infusion with 0.125%) 10-15 ml/hour or (0.25%) 5-7.5 ml/hour [12.5- 18.75 mg/hour]
Epidural doses up to 375 mg have been administered incrementally to patients during a surgical procedure.
The maximum dose in 24 hours for intraoperative block and postoperative pain management was 695 mg.
The maximum dose administered as a postoperative epidural infusion over 24 hours was 570 mg.
The maximum dose administered to patients as a single fractionated injection was 300 mg for brachial plexus block.
For Caesarean section, the maximum recommended dose is 150 mg.
The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used. The smallest dose and concentration required to produce the desired result should be administered. The use of levobupivacaine hydrochloride monohydrate is not recommended for more than 24 hours.