Dexa Medica


Averroes Pharma
Concise Prescribing Info
Levobupivacaine HCl
Anesth in adults for major surgery eg, epidural (obstetric procedures eg, Caesarean section), intrathecal, peripheral nerve block & minor surgery eg, local infiltration, peribulbar block in ophth surgery. Pain management for post-op, local or chronic pain as single or multiple bolus continuous epidural infusion. In combination w/ fentanyl, morphine or clonidine for continuous epidural analgesia. Infiltration analgesia in childn >6 mth.
Dosage/Direction for Use
Moderate to complete motor block: Epidural for surgery 10-20 mL (50-150 mg). Max: 300 mg as single fractionated inj for brachial plexus block. Epidural for caesarean section 15-30 mL (75-150 mg). Max: 150 mg. Peripheral nerve 1-40 mL. Max: 150 mg. Intrathecal 3 mL (15 mg). Max: 695 mg in 24 hr for intra-op block. Ophth 5-15 mL (37.5-112.5 mg). Local infiltration Adult 1-60 mL. Max: 150 mg. Childn <12 yr 0.25 or 0.5 mL/kg/side (1.25 mg/kg/side). Max: 1.25 mg/kg/side. Min to moderate motor block: Labor analgesia Epidural bolus: 10-20 mL (25-50 mg). Epidural infusion: 4-10 mL/hr (5-12.5 mg/hr). Max: 570 mg in 24 hr. Post-op pain Epidural infusion: 10-15 mL/hr or 5-7.5 mL/hr (12.5-18.75 mg/hr). Max: 695 mg in 24 hr.
Hypersensitivity to levobupivacaine HCl or local amide-type anesth. Severe hypotension eg, cardiogenic or hypovolemic shock. Paracervical block in obstet, IV regional anesth (eg, Bier's block).
Special Precautions
Not recommended for emergency situations & >24 hr use. Not to be inj rapidly in large doses. Severe bradycardia, hypotension & resp compromise w/ cardiac arrest; malignant hyperthermia. Patients w/ hypotension, hypovolemia or impaired CV function, heart block. Temporary loss of sensation & motor activity. Monitor for CNS & CV toxicity; respirations & cirulation if used in head & neck area. Ensure immediate availability of O2, other resuscitative drugs, cardiopulmonary resuscitative equipment, personnel resources needed for proper management of toxic reactions & related emergencies. Perform constant monitoring of CV & resp vital signs, adequate ventilation & state of consciousness after each inj. Frequent aspirations before & during inj to avoid intravascular inj. Large vol or doses. Not to be used w/ disinfecting agents containing heavy metals eg, Hg, Zn, Cu. Concomitant use w/ other local or amide-type local anesth. May affect ability to drive & use machines. Hepatic & renal impairment. Pregnancy & lactation. Childn <6 yr.
Adverse Reactions
Anemia; allergic reactions, hypersensitivity; dizziness, headache, convulsion, loss of consciousness, somnolence, syncope, paresthesia, paraplegia, paralysis; blurred vision, ptosis, miosis, enophthalmos; AV block, cardiac arrest, ventricular tachyarrhythmia, tachycardia, bradycardia; hypotension, flushing; resp arrest; laryngeal edema, apnea, sneezing; nausea, vomiting, oral hypoesthesia, loss of sphincter control; angioedema, urticaria, pruritus, hyperhidrosis, anhidrosis, erythema; back pain, muscle twitching, muscular weakness; bladder dysfunction; fetal distress syndrome; priapism; pyrexia; decreased cardiac output, ECG change; procedural pain.
Drug Interactions
Additive toxic effects w/ other local or amide-type anesth; class III antiarrhythmics or mexiletine. Affected metabolism w/ CYP3A4 inducers eg, phenytoin, phenobarb, rifampin; CYP3A4 inhibitors eg, azole antimycotics (eg, ketoconazole), certain PIs (eg, ritonavir), macrolides (eg, erythromycin), Ca-channel antagonists (eg, verapamil); CYP1A2 inducers eg, omeprazole; CYP1A2 inhibitors eg, furafylline, clarithromycin. Increased levels w/ CYP3A4 & CYP1A2 inhibitors.
MIMS Class
Anaesthetics - Local & General
ATC Classification
N01BB10 - levobupivacaine ; Belongs to the class of amides. Used as local anesthetics.
L-Ascain soln for inj 5 mg/mL
10 mL x 5 × 1's
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