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Xylotin

Xylotin

lidocaine

Manufacturer:

Hetero Labs

Distributor:

Medicell Pharma
Concise Prescribing Info
Contents
Lidocaine HCl
Indications/Uses
Production of local or regional anaesth by infiltration, IV regional anaesth (excluding soln w/ adrenaline), peripheral nerve block (eg, intercostal block), major plexus block (eg, brachial plexus block), epidural & subarachnoid block.
Dosage/Direction for Use
Individualized dosage. Max dose: 3 mg/kg at one time. Adult Infiltration 0.5% conc 40 mg/200 mL, 1% conc 20 mg/200 mL, 2% conc 10 mg/200 mL. IV regional anaesth 0.5% conc 40 mg/200 mL w/ Bier's block. Paravertebral 1% conc 3-5 mg/30-50 mL. Pudendal (each side); paracervical 1% conc 10 mg/100 mL. Stellate ganglion block (cervical) 1% conc 5 mg/50 mL, (lumbar) 1% conc 10 mg/100 mL. Epidural anaesth (thoracic) 1% conc 10-20 mg/100-200 mL, (lumbar) 1.5% conc 5-13 mg/65-195 mL, 2% conc 5-10 mg/100-200 mL. Test dose for epidural anaesth Administer 3-5 mL of local anaesth soln preferably containing up to 15 mcg of adrenaline. Caudal 1.5% conc 5-13 mg/65-195 mL. Epidural analgesia (lumbar or caudal) 1% conc 10-20 mg/100-200 mL.
Contraindications
Hypersensitivity to amide type local anaesth. Local anaesth for epidural & spinal anaesth in patients w/ uncorrected hypotension or coagulation disorders or those receiving anti-coagulation treatment. Not to be used when there is inflammation &/or sepsis in the region of proposed inj &/or in presence of septicaemia. Not to be used in patients w/ Stokes-Adam & Wolff-Parkinson-White syndrome, or w/ severe degrees of SA, AV or intraventricular block in absence of artificial pacemaker.
Special Precautions
Patients w/ known drug sensitivities. Possible methaemoglobinaemia. Closely monitor for signs & symptoms of methaemoglobinaemia in patients w/ G6PD deficiency, congenital or idiopathic methaemoglobinaemia, cardiac or pulmonary compromise, infants <6 mth & concurrent exposure to oxidizing agents or their metabolites. Possible chondrolysis when used as IA infusions following arthroscopic & other surgical procedures. Perform aspiration before local anesth soln inj to avoid intravascular inj. Perform syringe aspirations before & during each supplemental inj when using indwelling catheter techniques. Monitor for CNS & CV toxicity as well as signs of unintended intrathecal administration after initial test dose during epidural anesth administration. Consider employing epinephrine-containing local anesth soln for test dose when clinical conditions permit. Repeated doses may cause significant increase in blood levels w/ each repeated dose; give reduced doses in debilitated, elderly, acutely ill patients & childn. Patients w/ severe shock or heart block. Extreme caution during use of lumbar & caudal epidural anesth in patient w/ existing neurological disease, spinal deformities & severe HTN. Careful & constant monitoring of CV & resp vital signs & patient's state after each local anesth inj. Patients w/ CV function impairment. Possible familial malignant hyperthermia; promptly discontinue use if early unexplained signs of tachycardia, tachypnea, labile BP & metabolic acidosis occur. Proper tourniquet technique is essential in performing IV regional anesth. Patients w/ epilepsy, impaired cardiac conduction, bradycardia, severe shock or digitalis intoxication. Central nerve blocks may cause CV depression especially in the presence of hypovolaemia. Epidural anaesth may lead to hypotension & bradycardia; promptly treat hypotension w/ IV sympathomimetic & repeat as necessary. Patients w/ pre-existing abnormal neurological pathology (eg, myasthenia gravis). Serious CNS or spinal cord diseases (eg, meningitis, spinal fluid block, cranial or spinal haemorrhage, tumours, poliomyelitis, syphilis, TB or metastatic spinal cord lesions) when used in epidural, caudal & spinal anaesth. Inadvertent intravascular or subarachnoid inj of small doses of local anaesth inj into the head & neck area, including retrobulbar, dental & stellate ganglion blocks may produce AR similar to systemic toxicity. Possible CV collapse & apnoea following local anaesth inj use for retrobulbar block. Retrobulbar inj may very occasionally reach the subarachnoid space & cause temporary blindness, CV collapse, apnoea, convulsions which must be promptly diagnosed & treated. Possible persistent ocular muscle dysfunction; use the lowest effective conc & dose of local anesth in retro- & peribulbar inj; vasoconstrictors may aggravate tissue reactions & use only when indicated. Close surveillance & monitor ECG in patients being treated w/ anti-arrhythmic drug class III (eg, amiodarone). Patients w/ acute porphyria. Patients w/ severe hepatic disease. Women of childbearing potential. Pregnancy (especially during early pregnancy). Possible maternal hypotension; elevate patient's legs & position her on left side to prevent BP decrease. Monitor fetal heart rate continuously & electronic fetal monitoring is highly advisable. Epidural, spinal, paracervical, or pudendal anesth may alter parturition forces. Possible prolonged 2nd stage of labor in spinal & epidural anesth. Obstetrical anesth use may increase need for forceps assistance. Use during labor & delivery may be followed by diminished muscle strength & tone for the 1st day or two of life. Fetal bradycardia may occur & may be associated w/ fetal acidosis. Promptly use supportive measures combined w/ forced urinary excretion of local anesth in babies presenting w/ unexplained neonatal depression at birth & often manifest seizures w/in 6 hr. Possible maternal convulsion & CV collapse following use for paracervical block in early pregnancy; inj should be made slowly w/ frequent aspiration & allow 5-min interval between sides. Lactation. Childn; infant <6 mth. Elderly.
Adverse Reactions
Lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, hyperacusis, blurred or double vision, vomiting, heat sensations, cold or numbness, twitching, tremors, convulsions, unconsciousness, resp depression & arrest, agitation, difficulty swallowing, paraesthesia circumoral, tongue numbness & slurred speech; bradycardia, hypotension, CV collapse, cardiac arrhythmias, HTN; maternal hypotension; cutaneous lesions, urticaria, edema or anaphylactoid reactions; peripheral nerve injury & arachnoiditis. IV: Methaemoglobinaemia. Regional nerve blocks: Persistent numbness, paraesthesia & other sensory disturbances. Spinal anesth: Positional headaches & backache, shivering, peripheral nerve symptoms, nausea, resp inadequacy & double vision. Caudal or lumbar epidural block: Spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, bladder & bowel control loss, perineal sensation & sexual function loss.
Drug Interactions
Potentiation of cardiac effects may occur w/ other local anaesth or agents structurally related to amide type local anaesth eg, certain anti-arrhythmics (eg, disopyramide, procainamide, mexiletine). Reduced clearance & possible precipitation of seizures led to severe sinus bradycardia & long SA arrest w/ amiodarone; carefully monitor patient receiving the combination. Reduced metabolism of lidocaine IV w/ β-adrenoreceptor antagonists (eg, propranolol & metoprolol). Reduced clearance of lidocaine IV w/ cimetidine. Enhanced lidocaine metabolism w/ phenytoin & other antiepileptics (eg, phenobarb, primidone, carbamazepine). Additive cardiac depressant effects w/ phenytoin. Decreased min effective conc of inhalational anaesth (eg, nitrous oxide). Excessive neuromuscular blockade w/ skeletal muscle relaxants (eg, suxamethonium). Patients receiving agents structurally related to local anaesth. Possible increased risk of methaemoglobinaemia when concurrently exposed to nitrates/nitrites (eg, nitroglycerin, nitroprusside, nitric oxide, nitrous oxide); local anaesth (eg, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine); antineoplastic agents (eg, cyclophosphamide, flutamide, rasburicase, isofamide, hydroxyurea); antibiotics (eg, dapsone, sulphonamides, nitrofurantoin, para-aminosalicylic acid); antimalarials (eg, chloroquine, primaquine); anticonvulsants (eg, phenytoin, Na valproate, phenobarb); other drugs [eg, acetaminophen, metoclopramide, sulfa drugs (ie, sulfasalazine), quinine]. Possible higher creatinine measurements when measured by an enzymatic method vs Jaffé method. Lidocaine IM may result in increased creatine kinase levels for up to 48 hr.
MIMS Class
Anaesthetics - Local & General
ATC Classification
N01BB02 - lidocaine ; Belongs to the class of amides. Used as local anesthetics.
Presentation/Packing
Form
Xylotin soln for inj 50 mg/5 mL
Packing/Price
1's
Form
Xylotin soln for inj 300 mg/30 mL
Packing/Price
1's
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