Schedule H

Intravenous (IV)

• Injection: 10 mg/mL in 5 mL vial (50 mg per vial)

• Injection: 10 mg/mL in 10 mL vial (100 mg per vial)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Endotracheal Intubation — Rapid Sequence Induction (RSI)

Parameter Details

Starting dose 0.9–1.2 mg/kg IV bolus (for RSI conditions)

Titration Not applicable — single bolus for intubation

Usual maintenance dose Not applicable for induction

Maximum dose 1.2 mg/kg per intubation dose

Clinical Notes:

High-dose rocuronium (1.2 mg/kg) provides intubating conditions comparable to succinylcholine

Preferred when succinylcholine is contraindicated (malignant hyperthermia risk, hyperkalaemia risk, neuromuscular disorders)

Sugammadex allows rapid reversal if needed — essential backup for “cannot intubate, cannot ventilate” scenario

1. Endotracheal Intubation — Routine Induction

Parameter Details

Starting dose 0.6 mg/kg IV bolus

Titration Not applicable — single bolus for intubation

Usual maintenance dose Not applicable for induction

Maximum dose 0.6 mg/kg for routine intubation

Clinical Notes:

Lower dose (0.45 mg/kg) may be used when shorter duration desired

Dose based on actual body weight in non-obese patients

In morbidly obese patients, use ideal body weight for dosing

1. Maintenance of Neuromuscular Blockade During Surgery

Intermittent Bolus Dosing:

Parameter Details

Starting dose Initial intubating dose as above

Titration Administer maintenance boluses based on train-of-four (TOF) response

Usual maintenance dose 0.1–0.2 mg/kg IV bolus when T1 returns to 25% of control

Maximum dose Titrate to clinical effect; no fixed maximum

Continuous Infusion:

Parameter Details

Starting dose 0.3–0.6 mg/kg/hour IV infusion

Titration Adjust based on TOF monitoring to maintain 1–2 twitches

Usual maintenance dose 0.3–0.6 mg/kg/hour

Maximum dose Titrate to effect; reduce rate if T1 suppressed >90%

Clinical Notes:

Neuromuscular monitoring (peripheral nerve stimulator/TOF) mandatory for dosing guidance

Reduce infusion rate by 30–50% after first hour due to drug accumulation

Volatile anaesthetics potentiate blockade — reduce rocuronium dose by 25–40%

1. Facilitation of Mechanical Ventilation in ICU

(Short-term use — Specialist only)

Parameter Details

Starting dose 0.6 mg/kg IV bolus

Titration Initiate infusion at 0.3–0.6 mg/kg/hour; titrate to TOF monitoring

Usual maintenance dose 0.3–0.6 mg/kg/hour

Maximum dose Titrate to maintain 1–2 twitches on TOF

Clinical Notes:

Must be used with adequate sedation and analgesia — patient aware but paralysed is catastrophic

Limit duration to ≤48–72 hours when possible; risk of ICU-acquired weakness with prolonged use

Daily sedation vacation and neuromuscular assessment essential

Document indication clearly; specialist (Intensivist) supervision mandatory

Secondary Indications — Adults Only (Off-label)

Not applicable — No established off-label indications for rocuronium in adults.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Endotracheal Intubation

Term neonates (≥37 weeks GA) 0.45–0.6 mg/kg IV 60–90 seconds 40–60 minutes (prolonged vs older children)

Infants (1 month – 1 year) 0.6 mg/kg IV 60–90 seconds 30–40 minutes

Children (1–12 years) 0.6–1.0 mg/kg IV 60–90 seconds 25–35 minutes (shorter than adults)

Adolescents (>12 years) 0.6–1.2 mg/kg IV (adult dosing) 60–90 seconds 30–45 minutes

Parameter Details

Starting dose 0.6 mg/kg IV (standard); 1.0 mg/kg for RSI

Titration Not applicable — single bolus for intubation

Usual maintenance dose Not applicable for intubation

Maximum dose 1.2 mg/kg per intubation

1. Maintenance of Neuromuscular Blockade

Age Group Maintenance Bolus Continuous Infusion

Neonates 0.1 mg/kg when T1 at 25% 0.3–0.4 mg/kg/hour

Infants (1 month – 1 year) 0.1–0.15 mg/kg 0.4–0.6 mg/kg/hour

Children (1–12 years) 0.1–0.2 mg/kg 0.5–0.8 mg/kg/hour

Adolescents Adult dosing Adult dosing

Monitoring:

• Continuous ECG — bradycardia possible, especially in infants

• SpO₂ and end-tidal CO₂

• Peripheral nerve stimulator/TOF monitoring essential

• Temperature — hypothermia prolongs duration

Clinical Notes:

• Children (1–12 years) have faster clearance — may require higher infusion rates and more frequent boluses than adults

• Neonates have immature neuromuscular junction — prolonged duration; use lower end of dose range

• Infants more sensitive than older children — careful titration required

Secondary Indications — Paediatric (Off-label)

Indication Age Dose Remarks

Facilitation of mechanical ventilation in PICU — OFF-LABEL All ages 0.3–0.6 mg/kg/hour infusion Specialist only (Paediatric Intensivist); used with sedation/analgesia; limit duration; PICU protocols

⚠️ Not recommended in preterm neonates (<37 weeks gestational age) except under neonatal/paediatric anaesthesiology specialist supervision with documented justification. Prolonged duration and unpredictable response in preterm infants.

50 No dose adjustment required

30–50 No initial dose adjustment; may have slightly prolonged duration

<30 Prolonged duration expected; use lower maintenance doses; monitor TOF closely

Haemodialysis/ESRD Prolonged effect likely; reduce maintenance dose by 25–50%; sugammadex reversal unaffected

Note: Rocuronium is primarily eliminated via hepatobiliary excretion; renal impairment has modest effect on duration. Active metabolite (17-desacetyl-rocuronium) may accumulate with prolonged use in renal failure.

Note: Rocuronium undergoes hepatic uptake and biliary excretion — hepatic impairment significantly prolongs duration of action.

• Known hypersensitivity to rocuronium bromide

• History of anaphylaxis to any aminosteroid neuromuscular blocking agent (rocuronium, vecuronium, pancuronium)

• Known cross-reactivity with other neuromuscular blockers

• Neuromuscular disorders (myasthenia gravis, Eaton-Lambert syndrome) — markedly increased sensitivity; use 10–25% of normal dose if essential

• Electrolyte imbalances — hypokalaemia, hypocalcaemia, hypermagnesaemia potentiate blockade

• Burns >10% BSA (>10 days post-injury) — resistance to non-depolarising NMBAs; may require higher doses

• Hypothermia — prolongs duration of action

• Acidosis — may potentiate blockade

• Obesity — dose based on ideal body weight to avoid overdosing

• Chronic anticonvulsant therapy (phenytoin, carbamazepine) — resistance may develop; higher doses often required

• Prolonged ICU use (>48–72 hours) — risk of ICU-acquired weakness and myopathy

• Concurrent use with other drugs affecting neuromuscular function — adjust doses accordingly

• Must be used only with capability for mechanical ventilation and airway management

Parameter Details

Safety Category Limited human data; animal studies do not suggest teratogenicity

Pharmacokinetics Minimal placental transfer due to quaternary ammonium structure; high molecular weight

Preferred alternatives Succinylcholine traditionally used for obstetric RSI; rocuronium acceptable when succinylcholine contraindicated

When to use May be used for caesarean section under general anaesthesia; single-dose exposure acceptable

Monitoring Maternal neuromuscular function; uterine tone (theoretical concern); neonatal muscle tone and respiration if delivery occurs close to administration

Parameter Details

Compatibility Likely compatible with breastfeeding

Drug levels in milk Expected to be negligible — quaternary ammonium compound with poor oral bioavailability; rapid elimination

Preferred alternatives Not applicable — rocuronium is appropriate for indicated anaesthetic use

Infant monitoring Routine monitoring; no specific concerns if breastfeeding resumes after maternal recovery from anaesthesia

Parameter Recommendation

Starting dose 0.6 mg/kg IV for intubation (can reduce to 0.45 mg/kg if prolonged effect undesirable)

Titration Reduce maintenance doses by 25%; anticipate slower recovery

Special considerations Reduced organ reserve (hepatic, renal) may prolong duration; increased sensitivity to residual paralysis

Additional risks Higher risk of postoperative residual curarisation (PORC); ensure complete reversal before extubation; neuromuscular monitoring essential

Drug Mechanism Clinical Effect Recommendation

Aminoglycosides (gentamicin, amikacin, tobramycin) Pre- and post-synaptic neuromuscular blockade Enhanced and prolonged paralysis Monitor TOF closely; anticipate prolonged block; reduce rocuronium dose

Polymyxins (colistin) Neuromuscular blocking effect Marked potentiation of blockade Avoid if possible; prolonged ventilation may be required

Magnesium sulfate Pre-synaptic inhibition of acetylcholine release Significant potentiation of blockade Common in obstetrics (pre-eclampsia); reduce rocuronium dose by 25–50%; monitor TOF

Volatile anaesthetics (sevoflurane, isoflurane, desflurane) Enhanced neuromuscular blockade Prolonged duration; reduced dose requirements Reduce maintenance rocuronium dose by 25–40%

Chronic phenytoin, Carbamazepine Upregulation of acetylcholine receptors Resistance to rocuronium; shorter duration May require 25–50% higher doses; anticipate faster recovery

Sugammadex Specific encapsulation of rocuronium Rapid reversal of neuromuscular blockade Use 2 mg/kg at moderate block (T2); 4 mg/kg at deep block (1–2 PTC); 16 mg/kg for immediate reversal after 1.2 mg/kg dose

Drug Interaction Recommendation

Loop diuretics (furosemide) Electrolyte disturbances (hypokalaemia) may potentiate blockade Monitor electrolytes; correct hypokalaemia

Calcium channel blockers May enhance neuromuscular blockade Monitor for prolonged duration

Lithium May prolong or shorten duration (unpredictable) Monitor neuromuscular function carefully

Clindamycin, Lincomycin Neuromuscular blocking properties Enhanced blockade possible; monitor TOF

Corticosteroids (prolonged ICU use) Risk of critical illness myopathy Limit duration of concurrent use; monitor for weakness

Propofol, Thiopental, Ketamine No significant pharmacodynamic interaction Ensure adequate depth of anaesthesia before neuromuscular blockade

Quinidine, Procainamide May potentiate neuromuscular blockade Monitor for prolonged duration

• Injection site pain/reaction

• Transient tachycardia

• Transient hypotension or hypertension

• Bronchospasm (usually mild)

• Residual neuromuscular blockade postoperatively (postoperative residual curarisation — PORC)

• Hiccups

• Anaphylaxis/Anaphylactoid reactions — rocuronium has highest incidence of anaphylaxis among neuromuscular blockers; presents with bronchospasm, hypotension, rash, cardiovascular collapse; requires immediate discontinuation, adrenaline, supportive care

• Prolonged paralysis/Delayed recovery — particularly in hepatic/renal impairment, hypothermia, drug interactions; requires continued mechanical ventilation

• Critical illness polyneuromyopathy (CIPNM) — with prolonged ICU use; presents as generalised weakness, difficulty weaning from ventilator

• Residual curarisation leading to respiratory failure — incomplete reversal before extubation; risk of aspiration, hypoxia, reintubation

• Bradycardia — more common in paediatric patients; may require anticholinergic treatment

• Malignant hyperthermia — NOT directly triggered by rocuronium, but may occur if concurrent trigger agents (volatile anaesthetics, succinylcholine) used

⚠️ Ensure complete neuromuscular recovery (TOF ratio ≥0.9) before extubation. Have sugammadex available for emergency reversal.

Phase Parameters

Baseline Renal function, hepatic function; serum electrolytes (K⁺, Mg²⁺, Ca²⁺); history of neuromuscular disorders; medication review for interactions

Intraoperative Continuous ECG, SpO₂, blood pressure; neuromuscular monitoring (peripheral nerve stimulator — TOF or PTC) mandatory; end-tidal CO₂

Before extubation Confirm TOF ratio ≥0.9 (quantitative monitoring preferred); clinical signs of recovery (sustained head lift ≥5 seconds, strong hand grip, adequate tidal volumes)

ICU use Daily assessment of neuromuscular function; daily sedation vacation; monitor for ICU-acquired weakness; limit duration of paralysis

• Esmeron® (Organon/MSD)

• Rocuron® (Neon)

• Neoroc® (Themis)

• Myoblock® (Intas)

• Rocuronium Bromide Injection (multiple generic manufacturers)

Note: Not included in NLEM 2022; not NPPA price-controlled; prices vary by institution and procurement.

• Succinylcholine alternative: Rocuronium (1.0–1.2 mg/kg) provides RSI intubating conditions comparable to succinylcholine and is preferred when succinylcholine is contraindicated (malignant hyperthermia susceptibility, hyperkalaemia risk, neuromuscular disorders)

• Sugammadex availability critical: High-dose rocuronium for RSI should ideally be backed by sugammadex availability for immediate reversal in "cannot intubate, cannot ventilate" emergencies — 16 mg/kg sugammadex reverses 1.2 mg/kg rocuronium within 3 minutes

• Neuromuscular monitoring mandatory: Never redose without TOF assessment — visual or tactile evaluation alone is insufficient; quantitative monitoring (acceleromyography) preferred

• Residual paralysis prevention: Ensure TOF ratio ≥0.9 before extubation — residual curarisation is common cause of postoperative respiratory complications; neostigmine/glycopyrrolate reversal or sugammadex should be routine

• Obesity dosing: Use ideal body weight (IBW) for dosing in morbidly obese patients — dosing on actual body weight leads to overdosing and prolonged paralysis

• ICU caution: Limit neuromuscular blockade to shortest duration necessary; daily sedation vacation; document indication; monitor for ICU-acquired weakness with prolonged use

rocuronium; neuromuscular blocker; non-depolarising; aminosteroid; RSI; intubation; anaesthesia; sugammadex reversal; train-of-four; TOF monitoring; ICU paralysis; paediatric; Schedule H; India

RxIndia v1.0 — 07 May 2025

• CDSCO approved product information

• Indian Pharmacopoeia

• AIIMS Anaesthesiology Protocols

• Indian Society of Anaesthesiologists Practice Guidelines

• ICMR Critical Care Guidelines

• API Textbook of Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• WHO Model Formulary (supportive paediatric dosing)