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Sergivell Plain/Sergivell Iso

Sergivell Plain/Sergivell Iso

bupivacaine

Manufacturer:

HBM Pharma

Distributor:

Generics Pharmacal

Marketer:

Ambica
Concise Prescribing Info
Contents
Bupivacaine HCl
Indications/Uses
For local anesth by percutaneous infiltration, peripheral nerve block, & central neural block (caudal or epidural) where prolonged anesth is required because sensory nerve block is more marked than motor block. Relief of pain eg, during labor. Surgical anesth in adults & childn >12 yr. Management of acute pain in adults & childn >1 yr.
Dosage/Direction for Use
Sergivell Plain Intrathecal anesth for surgery Adult & childn >12 yr 2-4 mL (10-20 mg). Neonate, infant & childn 15-40 kg 0.25-0.30 mg/kg, 5-15 kg 0.30-0.40 mg/kg, <5 kg 0.40-0.50 mg/kg. Sergivell Iso Adult Surgery & cesarean section (Lumbar epidural) 75-150 mg. Thoracic epidural 25-50 mg. Caudal epidural block 100-150 mg. Major nerve block (eg, brachial plexus, femoral, sciatic nerve) 50-175 mg. Field block (eg, minor nerve blocks and infiltrations) <150 mg. Acute pain management (lumbar epidural) 15-37.5 mg every 30 min as intermittent injections or 12.5-18.8 mg/hr as continuous infusion. Labor pain relief (lumbar epidural) 6.25-12.5 mg/hr as continuous infusion. Thoracic epidural 6.3-12.5 mg/hr (0.125%) or 10-18.8 mg/hr (0.25%) as continuous infusion. Max: 400 mg/24 hr. IA block (eg, single inj following knee arthroscopy) ≤100 mg/hr (0.25%). If other means of bupivacaine administration is used, over all dose should not >150 mg. Field block (eg, minor nerve block & infiltration) ≤150 mg/hr (0.25%). Childn 12-1 yr Pre & post-op acute pain management (Caudal, lumbar, & thoracic epidural) 1.5-2 mg/kg. Field block (eg, blockades of minor nerves & infiltration), peripheral nerve block (eg, ilioinguinal iliohypogastric) 0.5-2 mg/kg.
Contraindications
Hypersensitivity to bupivacaine & local anesth of the amide type. Active disease of the CNS eg, meningitis, poliomyelitis, intracranial hemorrhage, sub-acute combined degeneration of the spinal cord due to pernicious anemia & cerebral & spinal tumors; pyogenic infection of the skin or adjacent to the site of puncture; cardiogenic or hypovolemic shock; coagulation disorders or ongoing anticoagulation therapy. Sergivell Plain Spinal stenosis & active disease (eg, spondylitis, TB, tumor) or recent trauma (eg, fracture) in the vertebral column; septicemia. Sergivell Iso IV regional anesth (Bier's block) may caused unintentional leakage into systemic circulation. TB of the spine.
Special Precautions
May cause acute toxicity effects on the central nervous & CV systems if utilized for local anesth procedures. Ventricular arrhythmia, ventricular fibrillation, sudden CV collapse & death may occur w/ high systemic conc. Adequate resuscitation equipment should be available whenever local or general anesth is administered. Before any nerve block is attempted, IV access for resuscitation purposes should be established. Patients w/ hypovolemia can develop sudden & severe hypotension during epidural/intrathecal anesth. May cause hypotension & bradycardia, intercostal paralysis during epidural/intrathecal anesth. Septicemia can increase the risk of intraspinal abscess formation in the post-op period. Reduced doses in elderly & patients in poor general condition to commensurate w/ their physical status. Patients w/ partial or complete heart block; advanced liver disease & severe renal dysfunction. Close surveillance & ECG monitoring in patients treated w/ anti-arrhythmic agents class III (eg, amiodarone). May affect the ability to drive & use machine. Pregnancy (late stages). Sergivell Plain Immediately stop inj if signs of acute systemic toxicity or total spinal block appears. Increased risk of high or total spinal blockade, resulting in CV & resp depression in elderly & pregnant women (late stage). Neurologic injury may occur. Sergivell Iso Cardiac arrest or death during the use of bupivacaine for epidural anesth or peripheral nerve blockade may occur. Inj of repeated doses may cause significant increases in blood levels w/ each repeated dose due to the slow accumulation of the drug. Impaired CV function; untreated hypovolemia or significantly impaired venous return. Retro- & peribulbar inj may cause a low risk of persistent ocular muscle dysfunction. May aggravate tissue reactions w/ vasoconstrictors. Inj into the head & neck, including retrobulbar dental & stellate ganglion blocks, may produce systemic toxicity. Chondrolysis in patients receiving post-op IA continuous infusion. Suspected recent major IA trauma or extensive raw surfaces w/in the joint have been created by a surgical procedure may increase absorption of anesth. Patients w/ pleural effusions may suffer resp embarrassment. Paracervical block may have a greater adverse effect on the fetus than other nerve blocks. Childn; childn 1-12 yr (IA block major nerve blocks); give gradual dose corresponding w/ their age & body wt to avoid severe hypotension & resp impairment.
Adverse Reactions
Hypotension; nausea. Vomiting, urinary retention. Sergivell Plain Bradycardia. Postdural puncture headache; urinary incontinence. Sergivell Iso Paresthesia, dizziness; bradycardia; HTN.
Drug Interactions
Increase toxic effects w/ local anesth or agents structurally related to amide type local anesth, eg, certain anti-arrhythmics such as lidocaine & mexiletine.
MIMS Class
Anaesthetics - Local & General
ATC Classification
N01BB01 - bupivacaine ; Belongs to the class of amides. Used as local anesthetics.
Presentation/Packing
Form
Sergivell Iso soln for inj 5mg/mL
Packing/Price
10 mL x 5 × 1's
Form
Sergivell Plain soln for inj 5 mg/mL
Packing/Price
5 mL x 5 × 1's
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