Consumer medicine information

ROBINUL Injectable

Glycopyrronium bromide (glycopyrrolate)

BRAND INFORMATION

Brand name

Robinul

Active ingredient

Glycopyrronium bromide (glycopyrrolate)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using ROBINUL Injectable.

What is in this leaflet

This leaflet answers some common questions about ROBINUL Injection. It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking ROBINUL Injection against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What ROBINUL Injection is used for

ROBINUL is used before surgery to decrease the volume of secretions from your mouth, lungs and stomach.

It can also be used either before or during surgery to maintain your heart’s normal beating rhythm.

ROBINUL is also used to counter the effects of some other medicines, which can slow your heartbeat or produce excessive secretions when used during surgery

Ask your doctor if you have any questions about why ROBINUL Injection has been prescribed for you. Your doctor, however, may have prescribed it for another purpose.

ROBINUL works in the nervous system by blocking an enzyme, which is responsible for producing saliva in your mouth and secretions in your stomach and lungs. This enzyme also slows down the heart rate. When this enzyme is blocked secretions dry up and the heart rate increases.

ROBINUL Injection is not habit forming.

This medicine is available only with a doctor’s prescription.

Before you are given it

When you must not be given it

Do not have ROBINUL Injection if:

  1. You are allergic to ROBINUL or any of the ingredients listed at the end of this leaflet.
    Some of the symptoms of an allergic reaction may include rash, itching, hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or troubled breathing.
  2. You are breastfeeding or plan to breastfeed.
    Medicines like ROBINUL may reduce your milk supply. It is not known if ROBINUL is found in breast milk.

Do not have ROBINUL Injection if the packaging is torn or shows signs of tampering.

Do not have ROBINUL Injection after the expiry date (EXP) printed on the pack. If you have it after the expiry date has passed, it may not work as well.

Before you are given it

You must tell your doctor if:

  1. You have any allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes
  • latex rubber.
  1. You are pregnant or plan to become pregnant.
    Your doctor will discuss the risks and benefits of receiving ROBINUL during pregnancy.
  2. You have or have had any other medical conditions including:
  • asthma
  • glaucoma, which is an increased pressure in your eyes
  • diarrhoea
  • problems with your heart, kidney or thyroid
  • difficulty urinating, or enlarged prostate
  • stomach or bowel problems
  • hiatus hernia that causes heartburn and belching
  • high blood pressure
  • myasthenia gravis, a muscle weakness disorder
  • nerve or brain disorder, brain damage, or Down’s Syndrome.

If you have not told your doctor about any of the above, tell them before you are given ROBINUL Injection.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with ROBINUL. These include:

  • ritodrine hydrochloride
  • medicines for Parkinson’s disease
  • phenothiazines, which are used to treat mental illness or severe nausea and vomiting
  • antidepressants
  • antihistamines
  • narcotic pain killers such as pethidine
  • medicines used to control heart rhythm
  • digoxin used to treat heart failure
  • thioxanthenes
  • butyrophenones
  • amantadine.

These medicines may be affected by ROBINUL or may effect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid when given ROBINUL Injection.

How ROBINUL Injection is given

How much is given

A doctor gives ROBINUL Injection to you.

The dose of ROBINUL may be different for each person. The dose given depends on your condition, age, body weight and your doctor. Your doctor will decide the right dose for you. For children aged 1 month to 12 years, the usual dose depends on their body weight.

When used before surgery the usual adult dose is 0.2 to 0.4mg given by injection into either a vein or a muscle. You will get ROBINUL before the anaesthetic is given.

For use during surgery, the usual adult dose is a single injection of 0.2 to 0.4mg into a vein. Sometimes the dose may need to be repeated. Your doctor will decide if this needs to happen.

To counter the effects of other medicines, the usual adult dose of ROBINUL is 0.2mg per 1mg neostigmine or the equivalent dose of pyridostigmine given by injection into a vein.

How it is given

A doctor gives ROBINUL Injection to you. The injection is usually given into a muscle or a vein.

If ROBINUL is given to counter the effects of other medicines, it may be given in the same syringe as the neostigmine or pyridostigmine.

How long is it given

ROBINUL injection is usually given as a single dose, but sometimes a dose must be repeated. Your doctor will decide how many doses of ROBINUL Injection are needed.

While you are having it

Things you must do

Tell any other doctors, dentists and pharmacists who are treating you that you have had ROBINUL Injection.

Tell your doctor if you feel ROBINUL is not helping your condition.

Always discuss with your doctor any problems or difficulties during or after having ROBINUL Injection.

Things you must not do

Do not drive or operate machinery until you know how ROBINUL Injection affects you.

ROBINUL may cause drowsiness or dizziness or blurred vision in some people and therefore may affect alertness.

Make sure you know how you react to ROBINUL injection before you drive a car, operate machinery, or do anything else that could be dangerous if you are drowsy, dizzy or not alert.

Things to be careful of

Be careful if you are elderly, unwell or taking other medicines. Some people may experience side effects such as drowsiness, or blurred vision, which may increase the risk of a fall.

Be careful during warm weather and temperature, and/or with physical exercise after use of ROBINUL. It may reduce your ability to sweat and can therefore cause overheating.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after having ROBINUL Injection.

ROBINUL helps most people with your condition, but it may have unwanted side effects in some people.

All medicines may have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • fast, slow or irregular heart beats
  • flushing
  • unable to sweat
  • feeling sick or vomiting
  • dry mouth
  • dry and/or itchy skin
  • constipation
  • difficulty urinating
  • impotence
  • reduced milk supply in breastfeeding women
  • blurred vision or other problems with your eyesight
  • headache
  • nervousness, drowsiness
  • dizziness
  • unable to sleep
  • over-excitement in children
  • confusion, especially in elderly people
  • fever
  • feeling bloated
  • loss or alteration of taste.

These side effects are usually mild.

Rare side effects include: injection site reactions like itchy skin, swelling, pain

Tell your doctor immediately if you notice any of the following:

  • rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
  • cold sweat, nausea, light headedness, discomfort in chest or other areas of the upper body like pain or discomfort in one or both arms, the back, neck, jaw or stomach

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor if you notice anything else that is making you feel unwell when you are taking, or soon after you have finished taking, ROBINUL Injection. Other side effects not listed above may occur in some patients.

Ask your doctor or pharmacist if you don’t understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After having it

Storage

ROBINUL Injection will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place where the temperature stays below 25°C.

Product description

What it looks like

ROBINUL Injection comes in a clear glass 1 mL ampoule containing a clear, colourless solution. Available in packs of 5 single dose ampoules.

Ingredients

The active ingredient in ROBINUL Injection is glycopyrrolate. Each 1 mL ampoule contains 0.2 mg/mL of glycopyrrolate.

Excipients include water for injections, sodium chloride and sodium hydroxide/hydrochloride acid (for pH adjustment).

It does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

Australian Registration Number
1 mL ampoule: AUST R 163586

This leaflet was revised in July 2016.

Published by MIMS May 2017

BRAND INFORMATION

Brand name

Robinul

Active ingredient

Glycopyrronium bromide (glycopyrrolate)

Schedule

S4

 

1 Name of Medicine

Glycopyrronium bromide (glycopyrrolate).

2 Qualitative and Quantitative Composition

Robinul 1 mL ampoule and 1 mL vial contains glycopyrronium bromide (glycopyrrolate) bromide (glycopyrronium bromide (glycopyrrolate)) 0.2 mg as the active ingredient.
Robinul 2 mL vial contains glycopyrronium bromide (glycopyrrolate) bromide (glycopyrronium bromide (glycopyrrolate)) 0.2 mg as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Injection, solution.

4 Clinical Particulars

4.1 Therapeutic Indications

1. As a preoperative antimuscarinic to reduce salivary, tracheobronchial and pharyngeal secretions, and to reduce the acidity and volume of the gastric contents.
2. 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.
3. 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.

4.2 Dose and Method of Administration

For intramuscular or intravenous administration.

Pre-anaesthetic use.

Adults.

0.2 mg to 0.4 mg intravenously or intramuscularly before the induction of anaesthesia.
Alternatively, a dose of 0.004 to 0.005 mg/kg up to a maximum of 0.4 mg may be used. Larger doses may result in profound and prolonged antisialogogue effect, which may be unpleasant for the patient.

Children.

(See Section 4.3 Contraindications.)
1 month to 12 years of age 0.004 to 0.008 mg/kg up to a maximum of 0.2 mg intravenously or intramuscularly before the induction of anaesthesia. Larger doses may result in profound and prolonged antisialogogue effect which may be unpleasant for the patient.

Intraoperative use.

When used to treat arrhythmias associated with traction reflexes, the usual attempts should be made to determine the aetiology of the arrhythmia, and the surgical or anaesthetic manipulations necessary to correct parasympathetic imbalance should be performed.

Adults.

In those situations where intraoperative use is 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. This dose may be repeated if necessary.

Children (1 month to 12 years of age).

In those situations where intraoperative use is indicated, 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. This dose may be repeated if necessary.

Reversal of neuromuscular blockade.

Adults.

0.2 mg intravenously per 1 mg neostigmine or the equivalent dose of pyridostigmine. Alternatively, a dose of 0.01-0.015 mg intravenously with 0.05 mg/kg neostigmine or equivalent dose of pyridostigmine. Robinul may be administered simultaneously from the same syringe with the anticholinesterase; greater cardiovascular stability results from this method of administration.

Children (1 month to 12 years of age).

0.01 mg/kg intravenously with 0.05 mg/kg neostigmine or the equivalent dose of pyridostigmine. Robinul may be administered simultaneously from the same syringe with the anticholinesterase; greater cardiovascular stability results from this method of administration.

4.3 Contraindications

Known hypersensitivity to glycopyrronium bromide (glycopyrrolate) or any of the inactive ingredients (see Section 4.8 Adverse Effects (Undesirable Effects)).

4.4 Special Warnings and Precautions for Use

Robinul should be used with caution, if at all, in patients with glaucoma or asthma.
Robinul should be used with caution in patients with any of the following conditions: 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.
Diarrhoea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.
In the case of ulcerative colitis, large doses of Robinul may suppress intestinal motility resulting in production of paralytic ileus perhaps precipitating or aggravating toxic megacolon.
Hiatus hernia associated with reflux oesophagitis may be aggravated following administration of this medicine.
Use with caution in patients with coronary artery disease, congestive heart failure, cardiac arrhythmias, hypertension or hyperthyroidism since an increase in heart rate may occur. Investigate any tachycardia before giving glycopyrronium bromide (glycopyrrolate) as an increase in heart rate may occur.
In the presence of fever, as in high environmental temperature, and physical exercise, reduced sweating can occur with Robinul causing heat prostration (fever and heat stroke). 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. This should be considered before using glycopyrronium bromide (glycopyrrolate) in patients with myasthenia gravis.
The closure system contains dry natural rubber that may cause hypersensitivity reactions when handled by or when the product is injected in persons with known or possible latex sensitivity.

Use in hepatic impairment.

No data available.

Use in renal impairment.

The duration of effect of Robinul may be prolonged in patients with renal impairment since glycopyrronium bromide (glycopyrrolate) is excreted mostly in urine as unchanged drug. Dosage adjustment may be needed for patients in renal failure.

Use in the elderly.

Clinical studies of glycopyrronium bromide (glycopyrrolate) did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

Paediatric use.

Arrythmias associated with the use of glycopyrronium bromide (glycopyrrolate) intravenously as a premedication or during anaesthesia appear to be more likely in paediatric patients than in adults.
Infants, patients with Down's Syndrome, and paediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects.
A paradoxical reaction characterised by hyperexcitability may occur in paediatric patients taking large doses of anticholinergics including glycopyrronium bromide (glycopyrrolate). Infants and young children are especially susceptible to the toxic effects of anticholinergics.
Safety and effectiveness of long-term IV use has not been established in paediatric patients. Long-term use of Robinul is therefore not recommended in paediatric patients.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The use of glycopyrronium bromide (glycopyrrolate), like atropine, with or within several hours of ritodrine hydrochloride administration may result in a drug interaction causing tachycardia.
The intravenous administration of any anticholinergic in the presence of cyclopropane anaesthesia can result in ventricular arrhythmias; therefore, caution should be observed if Robinul is used during cyclopropane anaesthesia. If the drug is given in small incremental doses of 0.1 mg or less, the likelihood of producing ventricular arrhythmias is reduced.
Anticholinergic agents may delay absorption of other medications given concomitantly.
Excessive cholinergic blockade can occur if Robinul is given concomitantly with belladonna alkaloids or other synthetic anticholinergic agents (such as antiparkinsonism agents), phenothiazines, tricyclic antidepressants, disopyramide, procainamide, quinidine, some antihistamines, narcotic analgesics such as pethidine, thioxanthenes, butyrophenones or amantadine.
Concurrent administration of anticholinergics and corticosteroids may result in increased intraocular pressure.
Concurrent use of anticholinergic agents with slow-dissolving tablets of digoxin may cause increased serum digoxin levels.
Robinul is compatible for mixing and injection with pethidine hydrochloride; morphine sulfate; droperidol plus fentanyl citrate; hydroxyzine; neostigmine; promethazine and pyridostigmine. Robinul may be mixed with 4%-10% glucose in water or saline, or it may be administered via the tubing of a running infusion of physiological saline, glucose, or lactated Ringer's solution.
Since the stability of glycopyrronium bromide (glycopyrrolate) is questionable above a pH of 6.0, do not inject Robinul at the same intramuscular site or combine it in the same syringe with: thiopentone sodium; chloramphenicol; diazepam; dimenhydrinate; methohexitone sodium; pentazocine lactate; pentobarbitone sodium; quinalbarbitone; or sodium bicarbonate. A gas will evolve or a precipitate may form.
Mixing with dexamethasone, sodium phosphate or a buffered solution of lactated Ringer's solution will result in a pH higher than 6.0.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Long-term studies in animals have not been performed to evaluate the mutagenic potential of glycopyrronium bromide (glycopyrrolate).
(Category B2)
Clinically, the safe use of glycopyrronium bromide (glycopyrrolate) has not been established. Single-dose studies in humans found that only very small amounts of glycopyrronium bromide (glycopyrrolate) passed the placental barrier. Therefore, the drug should not be used in pregnant women or those likely to become pregnant, unless the expected benefits outweigh any potential risk.
Reproduction studies in rats and rabbits did not reveal any teratogenic effects from glycopyrronium bromide (glycopyrrolate). Diminished rates of conception and of survival of weaning were observed in rats, in a dose-related manner. Studies in dogs suggest that this may be due to diminished seminal secretion, which is evident at high doses of glycopyrronium bromide (glycopyrrolate). The significance of this for humans is not clear.
 Anticholinergic agents may suppress lactation. It is not known whether glycopyrronium bromide (glycopyrrolate) is excreted in human milk.
Therefore, it is not recommended for nursing mothers unless the expected benefits outweigh any potential risk.

4.7 Effects on Ability to Drive and Use Machines

In the ambulatory patient Robinul may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.
The following reported adverse reactions are extensions of Robinul's fundamental pharmacological actions:

Cardiovascular.

Tachycardia, ventricular fibrillation, bradycardia, palpitation and arrhythmia, hypertension, hypotension, cardiac arrest, heart block, prolonged QTc interval.

Dermatological.

Flushing and inhibition of sweating. Severe allergic reactions or drug idiosyncrasies including urticaria and other dermal manifestations, pruritus, dry skin.

Gastrointestinal.

Nausea, vomiting, dry mouth, constipation, taste alterations, including loss of taste.

Genitourinary.

Urinary hesitancy and retention, impotence.

Ocular.

Blurred vision due to mydriasis, cycloplegia, photophobia, increased ocular tension.

Nervous system.

Inhibition of transmission at neuromuscular junction, headache, nervousness, drowsiness, dizziness, seizure, insomnia, some degree of mental confusion, especially in the elderly, hyperexcitability in children.

Pregnancy and perinatal.

Suppression of lactation.

Respiratory system.

Respiratory arrest.

General.

Hyperpyrexia, bloated feeling, anaphylaxis/ anaphylactoid reaction, hypersensitivity. Injection site reactions, including pruritus, oedema, erythema, pain have been reported rarely.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
The signs and symptoms of overdosage reflect the pharmacological effects of glycopyrronium bromide (glycopyrrolate). These may include hypotension, respiratory failure and a curare-like action, i.e. neuromuscular blockade leading to muscular weakness and possibly paralysis.
Treatment should be symptomatic.
Dialysis is of no value because of low plasma concentrations of the drug.
To combat peripheral anticholinergic effects a quaternary ammonium anticholinesterase such as neostigmine methylsulfate may be given intravenously in increments of 0.25 mg in adults.
This dosage may be repeated every five to ten minutes until anticholinergic over-activity is reversed or up to a maximum of 2.5 mg. Proportionately smaller doses should be used in children. Indication for repetitive doses of neostigmine should be based on close monitoring of the decrease in heart rate and the return of bowel sounds.
In the unlikely event that CNS symptoms (excitement, restlessness, convulsions, psychotic behaviour) occur, physostigmine (which does cross the blood-brain barrier) should be used. Physostigmine 0.5 to 2.0 mg should be slowly administered intravenously and repeated as necessary up to a total of 5 mg in adults. Proportionately smaller doses should be used in children.
Fever should be treated symptomatically. In the event of a curare-like effect on respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Glycopyrronium bromide (glycopyrrolate) is a synthetic anticholinergic agent. Like other anticholinergic (antimuscarinic) agents, it inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, exocrine glands, and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal and bronchial secretions. Doses which produce marked antisialogogue actions have little effect on heart rate, visual accommodation, or pupil size.
Glycopyrronium bromide (glycopyrrolate) antagonises muscarinic symptoms (e.g. bronchorrhoea, bronchospasm, bradycardia and intestinal hypermotility) induced by cholinergic drugs such as anticholinesterases.
The highly polar quaternary ammonium group of glycopyrronium bromide (glycopyrrolate) limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and hyoscine hydrobromide, which are non-polar tertiary amines that penetrate lipid barriers easily.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Peak effects occur approximately 30 to 45 minutes after intramuscular administration. The vagal blocking effects persist for 2 to 3 hours and the antisialogogue effects persist up to 7 hours; periods longer than for atropine. With intravenous injection, the onset of action is generally evident within one minute.

Distribution.

Pharmacokinetic studies in normal volunteers given a single intravenous infusion of 0.4 mg glycopyrronium bromide (glycopyrrolate) showed that the drug undergoes a rapid distribution/ elimination phase (t1/2 = 5 min) followed by a more prolonged termination elimination phase (t1/2 = 1.7 hour). The peak plasma concentration immediately following the end of the infusion was 26.4 mg/mL (± 7.6), and the volume of distribution was 0.158 ± 0.28 L/kg, which suggests that glycopyrronium bromide (glycopyrrolate), is not widely distributed to the tissues.

Metabolism.

No data available.

Excretion.

Excretion is via the urine and bile. Radioactivity studies have shown that 85% is excreted in the urine within 48 hours, over 80% of this being unchanged drug.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of glycopyrronium bromide (glycopyrrolate).

6 Pharmaceutical Particulars

6.1 List of Excipients

Excipients include water for injections, sodium chloride and sodium hydroxide/hydrochloric acid (for pH adjustment).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Robinul is a clear, colourless sterile solution with a pH of 2.5-4.0.

1 mL single dose vial.

A clear, colourless solution free of visible suspended particles in a clear glass vial. (Pack sizes of 5 and 25 vials - not currently commercialized).

2 mL single dose vial.

A clear, colourless solution free of visible suspended particles in a clear glass vial. Pack size of 5, 20 and 25 vials*.

1 mL single dose ampoule.

A clear, colourless solution free of visible suspended particles in a clear glass ampoule. Pack size of 5 ampoules.
* Not all pack sizes are commercialised.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

[596-51-0].
Molecular formula: C19H28BrNO3. Molecular mass: 398.33.
The chemical name(s) for glycopyrronium bromide (glycopyrrolate) is: Pyrrolidinium, 3- [(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl- bromide. 3-Hydroxy-1,1-dimethylpyrrolidinium bromide α-cyclopentylmandelate.
Glycopyrronium bromide (glycopyrrolate) is a white, odourless, crystalline powder with a bitter taste. It is a quaternary ammonium compound. It is soluble in water and alcohol and practically insoluble in chloroform and ether.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes