Levica

Levica

levobupivacaine

Manufacturer:

Dexa Medica
Concise Prescribing Info
Contents
Levobupivacaine
Indications/Uses
Surgical anesth in adults for major epidural (in obstetric procedures including caesarean section), intrathecal, or peripheral nerve block. Surgical anesth in adults for minor local infiltration & peribulbar block in ophth surgery. Pain management in adults as a continuous infusion or single/multiple bolus administration for post-op, labor or chronic pain; continuous epidural analgesia in combination w/ epidural fentanyl, morphine or clonidine. Infiltration analgesia in childn (ilioinguinal/iliohypogastric blocks).
Dosage/Direction for Use
Epidural for surgery 50-150 mg/10-20 mL of 0.5-0.75% conc for moderate to complete motor block. Epidural for caesarian section 75-150 mg/15-30 mL of 0.5% conc for moderate to complete motor block. Peripheral nerve Max: 150 mg/1-40 mL of 0.25-0.5% conc for moderate to complete motor block. Intrathecal 15 mg/3 mL of 0.5% conc for moderate to complete motor block. Ophth 37.5-112.5 mg/5-15 mL of 0.75% conc for moderate to complete motor block. Local infiltration Adult Max: 150 mg/1-60 mL of 0.25% conc. Childn 1.25 mg/kg/side or 0.5 mL/kg/side of 0.25% conc, <12 yr 1.25 mg/kg/side or 0.25 mL/kg/side of 0.5% conc. Max: 1.25 mg/kg/side. Labor analgesia (epidural bolus) 25-50 mg/10-20 mL of 0.25% conc for min to moderate motor block. Labor analgesia (epidural infusion) 5-12.5 mg hrly or 4-10 mL hrly of 0.125% conc for min to moderate motor block. Post-op pain (epidural infusion) 12.5-18.75 mg hrly or 10-15 mL hrly of 0.125% conc for min to moderate motor block. Or 12.5-18.75 mg hrly or 5-7.5 mL hrly of 0.25% conc for min to moderate motor block. Max: 570 mg daily.
Contraindications
Hypersensitivity to local anesth amide agents. Severe hypotension eg, cardiogenic or hypovolemic shock. IV regional anesth eg, Bier block. Obstet procedures or paracervical blocks in obstet.
Special Precautions
Unintended IV inj is possible & may result in cardiac arrest when performing levobupivacaine HCl monohydrate blocks. Severe bradycardia, hypotension, resp compromise w/ cardiac arrest. Not to be injected rapidly in large doses & not for emergency situations where a fast onset of surgical anesth is necessary. Ensure availability of O2, other resuscitative drugs, cardiopulmonary resuscitative equipment & personnel resources needed for proper management of toxic reactions & related emergencies. Lowest effective anesth dose should be used to avoid high plasma or dermatomal levels & serious adverse effects. Inj slowly & incrementally w/ frequent aspirations before & during the inj to avoid intravascular inj. Perform syringe aspirations before & during inj when a continuous catheter technique is used. Patients w/ hypotension, hypovolemia, impaired CV function especially heart block; receiving other local anesth or agents structurally related to amide-type local anesth. Monitor CV & resp vital signs & patient's state of consciousness after each local anesth inj. Administer epidural ansesth in incremental vol of 3-5 mL w/ sufficient time between doses to detect toxic manifestations. A test dose of a short-acting amide anesth eg, 3 mL lidocaine is recommended to detect unintentional intrathecal administration. Cauda equina syndrome & events indicative of neurotoxicity. Not recommended for use >24 hr. Blood or CSF aspiration should be done prior to inj of any local anesth to avoid intravascular or intrathecal inj. Use in head & neck area require utmost care. Severe hepatic disease. Pregnancy & lactation.
Adverse Reactions
Asthenia, edema; postural hypotension; hypokinesia, involuntary muscle contraction, spasm (generalized), tremor, syncope; arrhythmia, extrasystoles, fibrillation (atrial), cardiac arrest; ileus; elevated bilirubin; confusion; apnea, bronchospasm, dyspnea, pulmonary edema, resp insufficiency; increased sweating, skin discoloration.
Drug Interactions
Additive effects w/ other local anesth or agents structurally related to amide-type local anesth; antiarrhythmic agents w/ local anesth activity eg, mexiletine or class III antiarrhythmic agents. Metabolism may be affected by CYP3A4 inducers (eg, phenytoin, phenobarb, rifampin), CYP3A4 inhibitors (azole antimycotics eg, ketoconazole; certain PIs eg, ritonavir; macrolide antibiotics eg, erythromycin & Ca channel antagonists eg, verapamil), CYP1A2 inducers (eg, omeprazole), CYP1A2 inhibitors (eg, furafylline & clarithromycin).
MIMS Class
Anaesthetics - Local & General
ATC Classification
N01BB10 - levobupivacaine ; Belongs to the class of amides. Used as local anesthetics.
Presentation/Packing
Form
Levica soln for inj 5 mg/mL
Packing/Price
10 mL x 5 × 1's
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