ROBINUL

What it is

ROBINUL contains glycopyrronium bromide 0.2 mg per 1 mL ampoule and 1 mL vial , and a 2 mL vial formulation containing glycopyrronium bromide 0.2 mg . It is supplied as an injection solution . Glycopyrronium bromide is a synthetic anticholinergic agent that inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation .

Approved indications

— As a preoperative antimuscarinic to reduce salivary, tracheobronchial and pharyngeal secretions, and to reduce the acidity and volume of the gastric contents. — As a preoperative or intra-operative antimuscarinic to attenuate or prevent intra-operative bradycardia associated with the use of suxamethonium or due to cardiac vagal reflexes. — To protect against the peripheral muscarinic actions (e.g. bradycardia and excessive secretions) of anticholinesterases such as neostigmine or pyridostigmine given to reverse neuromuscular blockade produced by non-depolarising muscle relaxants.

Dosing overview

For pre-anaesthetic use in adults, 0.2 mg to 0.4 mg is given intravenously or intramuscularly before the induction of anaesthesia, or alternatively a dose of 0.004 to 0.005 mg/kg up to a maximum of 0.4 mg may be used . For children aged 1 month to 12 years, 0.004 to 0.008 mg/kg up to a maximum of 0.2 mg is given intravenously or intramuscularly before the induction of anaesthesia . For intraoperative use in adults where indicated, a single dose of 0.2 to 0.4 mg (or 0.004 to 0.005 mg/kg up to a maximum of 0.4 mg) by intravenous injection should be used, and this dose may be repeated if necessary . For children aged 1 month to 12 years, a single dose of 0.004 to 0.008 mg/kg or up to a maximum of 0.2 mg by intravenous injection should be used, and this dose may be repeated if necessary . For reversal of neuromuscular blockade in adults, 0.2 mg intravenously per 1 mg neostigmine or equivalent dose of pyridostigmine is given, or alternatively a dose of 0.01–0.015 mg intravenously with 0.05 mg/kg neostigmine or equivalent dose of pyridostigmine . For children aged 1 month to 12 years, 0.01 mg/kg intravenously with 0.05 mg/kg neostigmine or the equivalent dose of pyridostigmine is used .

Key safety warnings

ROBINUL should be used with caution, if at all, in patients with glaucoma or asthma . ROBINUL should be used with caution in patients with obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, intestinal atony, unstable cardiovascular status in acute haemorrhage, severe ulcerative colitis and toxic megacolon complicating ulcerative colitis, autonomic neuropathy and prostatic hypertrophy . In the presence of fever, as in high environmental temperature, and physical exercise, reduced sweating can occur with ROBINUL causing heat prostration; use very cautiously when the ambient temperature is high and in pyrexic patients, especially children and the elderly, who have a tendency to sweat less . Large doses of quaternary ammonium anticholinergic compounds have been shown to block end-plate nicotinic receptors, and this should be considered before using glycopyrronium bromide in patients with myaesthenia gravis . The duration of effect of ROBINUL may be prolonged in patients with renal impairment since glycopyrronium bromide is excreted mostly in urine as unchanged drug, and dosage adjustment may be needed for patients in renal failure .

Contraindications

ROBINUL is contraindicated in patients with known hypersensitivity to glycopyrronium bromide or any of the inactive ingredients .

Regulatory history

The 2 mL vial formulation (AUST R 290709) was first approved on 31 January 1994 . The 1 mL ampoule (AUST R 163586) was first approved on 20 November 2009 . The 1 mL vial (AUST R 184356) was first approved on 6 October 2011 .