Zuellig Pharma


Zuellig Pharma
Concise Prescribing Info
Pain management & surgical anesth in adult. Infiltration analgesia (ilioinguinal/iliohypogastric blocks) in childn.
Dosage/Direction for Use
Administer slowly in incremental doses. Surgical anesth: Epidural for surgery 10-20 mL of 0.5-0.75% soln. Epidural for cesarean section 15-30 mL of 0.5% soln. Max dose: 150 mg. Peripheral nerve 1-40 mL of 0.25-0.5% soln. Max dose: 150 mg. Intrathecal 3 mL of 0.5% soln. Ophth 5-15 mL of 0.75% soln. Local infiltration Adult 1-60 mL of 0.25% soln. Max: 150 mg. Childn <12 yr 0.25-0.5 mL/kg of 0.25-0.5% soln. Max dose: 1.25 mg/kg. Pain management: Labor analgesia Epidural bolus: 10-20 mL of 0.25% soln. Epidural infusion: 4-10 mL/hr of 0.125% soln. Post-op pain Epidural infusion: 10-15 mL/hr of 0.125% soln or 5-7.5 mL/hr of 0.25% soln. Max dose: 695 mg/24 hr (intra-op block & post-op pain management); 570 mg/24 hr (post-op epidural infusion); 300 mg as single fractionated inj (brachial plexus block).
Hypersensitivity to amide-type local anesth. Not for paracervical block in obstetrics & IV regional anesth (Bier block). Severe hypotension eg, cardiogenic or hypovolemic shock.
Special Precautions
Avoid intravascular inj. Do not inj rapidly in large doses. Patients w/ hypotension, hypovolemia, or impaired CV function especially heart block; severe hepatic disease. Severe bradycardia, hypotension & resp compromise w/ cardiac arrest may occur. Caution when using higher conc of therapy; inj into the head & neck area in small doses. Inj slowly & incrementally, w/ frequent aspirations before & during inj to avoid intravascular inj. Conditions associated w/ impaired CV function. Perform careful & constant monitoring of CV & resp vital signs & patient's state of consciousness after each inj. Not recommended to use for >24 hr. Patients receiving other local anesth or agents structurally related to amide-type local anesth. Temporary loss of sensation & motor activity may be experienced. Elderly. Pregnancy & lactation.
Adverse Reactions
Hypotension, nausea, post-op pain, fever, vomiting, anemia, pruritis, pain, headache, constipation, dizziness, fetal distress.
Drug Interactions
Additive toxic effects w/ other local anesth or agents structurally related to amide-type local anesth. Metabolism may be affected by CYP3A4 inducers (eg, phenytoin, phenobarb, rifampin), CYP3A4 inhibitors (azole, antimycotics eg, ketoconazole; certain protease inhibitors eg, ritonavir, macrolide antibiotics eg, erythromycin & Ca channel antagonists eg, verapamil); CYP1A2 inducers (omeprazole), CYP1A2 inhibitors (furafylline, clarithromycin). Antiarrhythmics w/ local anesth activity (eg, mexiletine), or class III antiarrhythmics.
MIMS Class
Anaesthetics - Local & General
ATC Classification
N01BB10 - levobupivacaine ; Belongs to the class of amides. Used as local anesthetics.
Chirocaine inj soln 5 mg/mL
(amp) 10 mL x 10 × 1's
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