ROCURONIUM KABI SOLUTION FOR INJECTION/INFUSION 10MG/ML

Rocuronium

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

Rocuronium | Rocuronium |

Description

Rocuronium (rapid onset-curonium) is a desacetoxy analogue of vecuronium with a more rapid onset of action. It is an aminosteroid non-depolarizing neuromuscular blocker or muscle relaxant used in modern anaesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Introduced in 1994, rocuronium has rapid onset, and intermediate duration of action. It is marketed under the trade name of Zemuron in the United States and Esmeron in most other countries. There is considered to be a risk of allergic reaction to the drug in some patients (particularly those with asthma), but a similar incidence of allergic reactions has been observed by using other members of the same drug class (non-depolarizing neuromuscular blocking drugs). The γ-cyclodextrin derivative sugammadex (trade name Bridion) has been recently introduced as a novel agent to reverse the action of rocuronium.

Indication

For inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Mechanism of Action

Rocuronium acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium. Rocuronium acts by competitively binding to nicotinic cholinergic receptors. The binding of vecuronium decreases the opportunity for acetylcholine to bind to the nicotinic receptor at the postjunctional membrane of the myoneural junction. As a result, depolarization is prevented, calcium ions are not released and muscle contraction does not occur. Evidence also suggests that nondepolarizing agents can affect ACh release. It has been hypothesized that nondepolarzing agents bind to postjunctional ("curare") receptors and may therefore interfere with the sodium and potassium flux, which is responsible for depolarization and repolarization of the membranes involved in muscle contraction.

Pharmacodynamics

Neuromuscular blocking agents are drugs that cause skeletal muscle relaxation primarily by causing a decreased response to the neurotransmitter acetylcholine (ACh) at the myoneural (neuromuscular) junction of skeletal muscle. At that site, ACh normally produces electrical depolarization of the postjunctional membrane of motor end-plate, which leads to conduction of muscle action potential and subsequently induces skeletal muscle contraction. Neuromuscular agents are classified as depolarizing or nondepolarizing. Rocuronium is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium, like vecuronium is longer acting in infants than in children. However, unlike vecuronium, rocuronium retains the characteristics of an intermediate-acting NMBD in infants.

Pharmacokinetics

Absorption:

Poorly absorbed from the GI tract.

Distribution:

* 0.3 L/kg [3 to <12 mos] * 0.26 L/kg [1 to <3 yrs] * 0.21 L/kg [3 to <8 yrs]

Metabolism:

Rocuronium is metabolized to a less active metabolite, 17-desacetyl-rocuronium, and is eliminated primarily by the liver.

Elimination:

Studies of distribution, metabolism, and excretion in cats and dogs indicate that rocuronium is eliminated primarily by the liver.

Half-life

The rapid distribution half-life is 1-2 minutes and the slower distribution half-life is 14-18 minutes. Renal impairment has no net effect on half-life, however, half-life is almost doubled in patients with impaired liver function.

Clearance

* 0.25 L/kg/hr [Adults (Ages 27 to 58 years)] * 0.21 L/kg/hr [Geriatrics (>=65 yrs)] * 0.16 L/kg/hr [Normal ewnal and hepatice function] * 0.13 L/kg/hr [Renal transplant patients] * 0.13 L/kg/hr [Hepatic dysfunction patients] * 0.35 +/- 0.08 L/kg/hr [Pediatric Patients 3 to <12 mos] * 0.32 +/- 0.07 L/kg/hr [Pediatric Patients 1 to 3 yrs] * 0.44 +/- 0.16 L/kg/hr [Pediatric Patients 3 to 8 yrs]

Toxicity

No cases of significant accidental or intentional overdose have been reported. Overdosage with neuromuscular blocking agents may result in neuromuscular block beyond the time needed for surgery and anesthesia.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

ROCURONIUM KABI SOLUTION FOR INJECTION/INFUSION 10MG/ML was registered with Health Science Authority of Singapore by FRESENIUS KABI (SINGAPORE) PTE LTD. It is marketed with the registration number of SIN15106P with effective from 2016-10-25.

This product contains 10mg/ml of Rocuronium in the form of INTRAVENOUS INJECTION, SOLUTION.

The medicine was manufactured by Fresenius Kabi Austria GmbH in AUSTRIA

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: M03AC09

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