Noveron

Noveron

rocuronium bromide

Manufacturer:

Novell Pharma

Distributor:

DKLL

Marketer:

Genemax Healthcare
Concise Prescribing Info
Contents
Rocuronium Br
Indications/Uses
Adjunct to general anaesth to facilitate tracheal intubation during routine or rapid sequence induction & to provide skeletal muscle relaxation during surgery. Adjunct in ICU to facilitate intubation & mechanical ventilation.
Dosage/Direction for Use
IV (as bolus inj or continuous infusion) Individualized dosage. Neuromuscular blockade (intermediate duration) during surgery & intubation Adult, neonate & childn Initial dose: 0.6 mg/kg IV inj. Maintenance dose: 0.15 mg/kg or 0.3-0.6 mg/kg/hr IV infusion. Rapid sequence induction: 1 mg/kg. Elderly Initial dose: 0.6 mg/kg IV inj. Maintenance dose: 0.75-0.1 mg/kg or up to 0.4 mg/kg/hr IV infusion. Neuromuscular blockade (intermediate duration) during intensive care Adult Initial dose: 0.6 mg/kg dose is optional by IV infusion. Maintenance dose: 0.3-0.6 mg/kg/hr IV infusion for the 1st hr then adjusted according to response. Hepatic & renal impairment Initial dose: 0.6 mg/kg IV inj. Maintenance dose: 0.075-0.1 mg/kg IV inj or 0.3-0.4 mg/kg/hr continuous infusion.
Contraindications
Hypersensitivity to rocuronium Br or Br ion.
Special Precautions
Patients w/ hypersensitivity reaction under general anaesth should be tested for cross-sensitivity to other neuromuscular blockers. Mandatory ventilatory support for patients until adequate spontaneous respiration is restored. Rocuronium may increase the heart rate. Prolonged circulation time in conditions eg, CV disease, old age & oedematous state. Use w/ extreme caution in patients w/ neuromuscular disease or after poliomyelitis, myasthenia gravis or myasthenic (Eaton-Lambert) syndrome. Obesity, hypothermia, burns, hypokalemia (eg, after severe vomiting, diarrhoea or diuretic therapy), hypermagnesaemia, hypocalcaemia (after massive transfusions), hypoproteinaemia, dehydration, acidosis, hypercapnia & cachexia. Correct severe electrolyte disturbances, altered blood pH or dehydration when possible. Prolonged paralysis &/or skeletal muscle weakness in long term use. Monitor neuromuscular transmission during therapy. Extubate only after the patient has recovered sufficiently from neuromuscular block. Delay administration if suxamethonium is used for intubation. Consider use of reversal agent in cases where residual neuromuscular blockade may occur. Myopathy after long-term therapy in the ICU in combination w/ corticosteroids. Limit use in patients receiving both neuromuscular blocking agent & corticosteroid. Hepatic &/or biliary tract & renal failure. Pregnancy & lactation. Risk of residual neuromuscular blockade after extubation in the post-op phase in geriatric patients ≥65 yr & other factors (eg, drug interactions or patient condition).
Adverse Reactions
Anaphylaxis, prolonged neuromuscular block, myopathy, local inj site pain/reaction, tachycardia, lack of efficacy, prolonged action, lowering of BP.
Drug Interactions
Increased effect/toxicity w/ aminoglycosides, certain medicines for heart disease or high BP (loop diuretics, Ca channel blockers, β-blockers & quinidine), capreomycin, colistimethate, inhalational anesth, ketorolac (nasal & systemic), lincosamide antibiotics, lithium, medicines for manic depressive illness (bipolar disorder), Mg salts, polymyxin B, procainamide, quinidine, quinine, spironolactone, tetracycline derivatives, vancomycin. Decreased effect w/ acetylcholinesterase inhibitors, loop diuretics. Increased effect of cardiac glycosides, corticosteroids (systemic), onabotulinum toxin A, rimabotulinum toxin B.
MIMS Class
Neuromuscular Blocking Agents
ATC Classification
M03AC09 - rocuronium bromide ; Belongs to the class of other quaternary ammonium-containing agents used as peripherally-acting muscle relaxants.
Presentation/Packing
Form
Noveron soln for inj 10 mg/mL
Packing/Price
5 mL x 12 × 1's
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