Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Glycopyrrolate Accord. It does not contain all 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 Glycopyrrolate Accord 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 Glycopyrrolate Accord Injection is used for

When you must not be given it

Do not have Glycopyrrolate Accord if:

You are allergic to Glycopyrrolate Accord 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.

You are breastfeeding or plan to breastfeed.

Medicines like Glycopyrrolate Accord may reduce your milk supply. It is not known if Glycopyrrolate Accord is found in breast milk.

Do not have Glycopyrrolate Accord if the packaging is torn or shows signs of tampering.

Do not have Glycopyrrolate Accord 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

2. You are pregnant or plan to become pregnant.

Your doctor will discuss the risks and benefits of receiving Glycopyrrolate Accord during pregnancy.

3. 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 Glycopyrrolate Accord.

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 Glycopyrrolate Accord. 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 Glycopyrrolate Accord or may affect 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 Glycopyrrolate Accord.

How Glycopyrrolate Accord Injection is given

How much is given

A doctor gives Glycopyrrolate Accord to you.

The dose of Glycopyrrolate Accord 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 bodyweight.

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

For use during surgery, the usual adult dose is a single injection of 0.2 to 0.4 mg 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 Glycopyrrolate Accord is 0.2 mg per 1 mg neostigmine or the equivalent dose of pyridostigmine given by injection into a vein.

How it is given

A doctor gives Glycopyrrolate Accord to you. The injection is usually given into a muscle or a vein. If GLYCOPYRROLATE ACCORD 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

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

While you are having Glycopyrrolate Accord Injection

Things you must do

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

Tell your doctor if you feel Glycopyrrolate Accord is not helping your Condition

Always discuss with your doctor any problems or difficulties during or after having Glycopyrrolate Accord.

Things you must not do

Do not drive or operate machinery until you know how Glycopyrrolate Accord affects you.

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

Make sure you know how you react to Glycopyrrolate Accord 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 Glycopyrrolate Accord. Glycopyrrolate Accord 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 while you are having Glycopyrrolate Accord.

Glycopyrrolate Accord 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.

Other side effects not listed above may occur in some patients. 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, Glycopyrrolate Accord.

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.

Storage

Glycopyrrolate Accord 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

Glycopyrrolate Accord comes in a clear glass ampoule containing a clear, colourless solution. Each ampoule is for single use in one patient only. Discard any remaining residue.

Glycopyrrolate Accord is available in the following strengths and pack sizes:

• 0.2 mg/1 mL, packs of 5 and 10 ampoules
• 0.6 mg/3 mL, packs of 5 and 1 ampoules.

Not all presentations may be marketed.

Ingredients

The active ingredient in Glycopyrrolate Accord is glycopyrronium bromide (glycopyrrolate). Each ampoule contains 0.2 mg/mL of glycopyrronium bromide (glycopyrrolate).

Glycopyrrolate Accord also contains:

• sodium chloride
• hydrochloric acid
• water for injections.

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

Name and Address of the Sponsor

Accord Healthcare Pty Ltd
Level 24, 570 Bourke Street
Melbourne, VIC, 3000
Australia

Australian Registration Numbers

0.2 mg/1 mL: AUST R 237760

0.6 mg/3 mL: AUST R 237403

Date of Preparation

This leaflet was prepared on 11 May 2020.

Published by MIMS June 2020

1 Name of Medicine

Glycopyrronium bromide (glycopyrrolate).

2 Qualitative and Quantitative Composition

1 mL contains 0.2 mg glycopyrronium bromide (glycopyrrolate).
1 ampoule of 1 mL solution for injection contains 0.2 mg glycopyrronium bromide (glycopyrrolate).
1 ampoule of 3 mL solution for injection contains 0.6 mg glycopyrronium bromide (glycopyrrolate).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Glycopyrrolate Accord is supplied as a clear, colourless sterile solution for injection, practically free from visible particles, with a pH of 2.0 - 3.0.

4 Clinical Particulars

4.1 Therapeutic Indications

Glycopyrrolate Accord is indicated for:
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.

4.2 Dose and Method of Administration

For intramuscular or intravenous administration.
Glycopyrrolate Accord contains no antimicrobial preservative and is for single use in one patient on one occasion only. Discard any remaining residue.

Pre-anaesthetic use.

Adults.

Children (see Section 4.3 Contraindications).

Intraoperative use.

Adults.

Children (1 month to 12 years of age).

Reversal of neuromuscular blockade.

Adults.

Children (1 month to 12 years of age).

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

Glycopyrrolate Accord should be used with caution, if at all, in patients with glaucoma or asthma.
Glycopyrrolate Accord 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 Glycopyrrolate Accord 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 Glycopyrrolate Accord 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 myaesthenia gravis.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

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 Glycopyrrolate Accord 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 Glycopyrrolate Accord 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.
Glycopyrrolate Accord is compatible for mixing and injection with pethidine hydrochloride; morphine sulfate; droperidol plus fentanyl citrate; hydroxyzine; neostigmine; promethazine and pyridostigmine. Glycopyrrolate Accord 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 ringers solution.
Since the stability of glycopyrronium bromide (glycopyrrolate) is questionable above a pH of 6.0, do not inject Glycopyrrolate Accord 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 ringers solution will result in a pH higher than 6.0.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

In the ambulatory patient, Glycopyrrolate Accord 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)

The following reported adverse reactions are extensions of Glycopyrrolate Accord's fundamental pharmacological actions:

Cardiovascular.

Dermatological.

Gastrointestinal.

Genitourinary.

Ocular.

Nervous system.

Pregnancy and perinatal.

Respiratory system.

General.

Reporting suspected adverse effects.

4.9 Overdose

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.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution and metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, hydrochloric acid (for pH adjustment), water for injections.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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

Glycopyrrolate Accord is available in two strengths: 0.2 mg/1 mL and 0.6 mg/3 mL in Type I clear glass ampoules in packs of 5 or 10.
Not all presentations may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

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.
The chemical name(s) for glycopyrronium bromide (glycopyrrolate) is: Pyrrolidinium, 3-[(SR)-(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-, [RS-] bromide; (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate.
Molecular formula: C₁₉H₂₈BrNO₃.
Molecular mass: 398.33.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes