Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Hospira™ Glycopyrrolate 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 Hospira™ Glycopyrrolate 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 Hospira™ Glycopyrrolate Injection is used for

Hospira™ Glycopyrrolate Injection may be used;

• before surgery to reduce the amount of saliva produced by your mouth, and other secretions produced in your lungs and stomach
• before or during surgery to maintain your heart’s normal beating rhythm, or
• it may also used to counter the effects of some other medicines, which can slow your heartbeat or produce excessive secretions when used during surgery.

This medicine belongs to a group of medicines called “anticholinergics” which work in the nervous system to block 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.

Your doctor may have prescribed Hospira™ Glycopyrrolate Injection for another purpose.

Ask your doctor if you have any questions about why Hospira™ Glycopyrrolate Injection has been prescribed for you.

Hospira™ Glycopyrrolate Injection is not addictive.

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

Before you are given Hospira™ Glycopyrrolate Injection

When you must not be given it

Do not have Hospira™ Glycopyrrolate Injection if you are allergic to Hospira™ Glycopyrrolate Injection 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.

Do not have Hospira™ Glycopyrrolate Injection if the packaging is torn or shows signs of tampering.

Do not have Hospira™ Glycopyrrolate 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. The pharmacist will check that the medicine is suitable for use before you are given it.

Before you are given it

Tell your doctor if you have any allergies to any other medicines, any other substances, such as foods, preservatives or dyes.

Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed. Your doctor will discuss the risks and benefits of receiving Hospira™ Glycopyrrolate Injection during pregnancy. It may also reduce your milk supply. It is not known if glycopyrrolate is found in breast milk.

Tell your doctor if you have, or have had, any other medical conditions including:

• asthma
• glaucoma, ( increased pressure in your eyes)
• diarrhea or constipation
• stomach or bowel problems
• hiatus hernia
• heart disease or high blood pressure
• hyperthyroidism
• fever
• myasthenia gravis (muscle weakness)
• kidney problems or difficulty urinating
• nerve or brain disorder, brain damage
• Down’s Syndrome.

If you have not told your doctor about any of the above, tell them before you are given Hospira™ Glycopyrrolate 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 Hospira™ Glycopyrrolate Injection. These include:

• ritodrine hydrochloride
• belladonna alkaloids
• medicines for Parkinson’s disease
• antidepressants
• phenothiazines, (used to treat mental illness or severe nausea and vomiting)
• disopyramide
• procainamide
• quinidine
• antihistamines
• narcotic pain killers (pethidine, thioxanthenes, butyrophenones or amantadine)
• digoxin (used to treat heart failure)
• any corticosterlids
• medicines used to control heart rhythm
• any other anticholinergic medicines.

These medicines may be affected by Hospira™ Glycopyrrolate Injection 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 Hospira™ Glycopyrrolate Injection.

How Hospira™ Glycopyrrolate Injection is given

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help.

How much is given

The dose of Hospira™ Glycopyrrolate Injection may be different for each person. The dose given will depend on your condition, age and body weight. The usual adult dose is 200 to 400 micrograms. Your doctor will decide the right dose for you. For children aged 1 month to 12 years, the usual dose depends on their bodyweight.

How it is given

Hospira™ Glycopyrrolate Injection will be given to you by injection into either a vein or a muscle before the anaesthetic.

How long is it given for

Hospira™ Glycopyrrolate Injection is usually given as a single dose. However, sometimes your doctor may decide you need more. Your doctor will decide how much Hospira™ Glycopyrrolate Injection you need.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre 13 11 26 for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have been given too much Hospira™ Glycopyrrolate Injection. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are having Hospira™ Glycopyrrolate Injection

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Hospira™ Glycopyrrolate Injection.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine.

Always discuss with your doctor any problems or difficulties during or after having Hospira™ Glycopyrrolate Injection.

Things you must not do

Do not drive or operate machinery, or perform hazardous work until you know how Hospira™ Glycopyrrolate Injection affects you. Hospira™ Glycopyrrolate Injection may cause drowsiness or blurred vision in some people and therefore may affect alertness.

Things to be careful of

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

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Be careful during warm weather and higher temperature, and/or with physical exercise after use of Hospira™ Glycopyrrolate Injection. 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 Hospira™ Glycopyrrolate Injection.

Hospira™ Glycopyrrolate Injection 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 skin, or inability to sweat
• dry and/or itchy skin
• feeling sick or vomiting
• Nausea, vomiting
• dry mouth, constipation
• taste alterations, or loss of taste
• difficulty urinating
• impotence
• blurred vision, other problems with eyes
• dizziness
• seizures
• insomnia (inability to sleep)
• headache, nervousness, drowsiness
• mental confusion in elderly
• over-excitement in children
• reduced milk supply in breastfeeding women
• headache
• nervousness, drowsiness
• fever or feeling hot
• bloated feeling
• muscular weakness or possibly paralysis
• injection site reactions like itchy skin, swelling, pain.

These side effects are usually mild.

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
• muscular weakness or possibly paralysis.

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.

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 Hospira™ Glycopyrrolate Injection

Storage

Hospira™ Glycopyrrolate Injection will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, stored below 25°C.

Disposal

The hospital staff will dispose of any leftover product.

Product description

What it looks like

Hospira™ Glycopyrrolate Injection comes as a clear, colourless solution in a clear glass ampoule.

Ingredients

Each ampoule of Hospira™ Glycopyrrolate Injection contains glycopyrrolate as the active ingredient.

Each 1 mL ampoule contains 200 micrograms of glycopyrrolate. It also contains:

• Water for Injections
• Sodium Chloride and
• Hydrochloric acid

Hospira™ Glycopyrrolate Injection does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Hospira™ Glycopyrrolate Injection is supplied by:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

Hospira™ Glycopyrrolate Injection is available in the following strengths:

• 200 micrograms/mL
  AUST R 220016

This leaflet was prepared November 2019.

Published by MIMS January 2020

1 Name of Medicine

Glycopyrronium bromide (glycopyrrolate).

2 Qualitative and Quantitative Composition

Each 1 mL ampoule contains glycopyrronium bromide (glycopyrrolate) 200 microgram, water for injections q.s., sodium chloride 9 mg and hydrochloric acid (for pH adjustment).

3 Pharmaceutical Form

Solution for injection.
Hospira Glycopyrrolate Injection is a clear, colourless sterile solution with a pH of 2.5-4.0.

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 intra­operative 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

Dosage.

Adults.

Children.

Adults.

Children.

Adults.

Children (1 month to 12 years of age).

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

Glycopyrronium bromide (glycopyrrolate) should be used with caution, if at all, in patients with glaucoma or asthma.
Glycopyrronium bromide (glycopyrrolate) 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 glycopyrronium bromide (glycopyrrolate) 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 glycopyrronium bromide (glycopyrrolate) 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.

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 glycopyrronium bromide (glycopyrrolate) is used during cyclopropane anaesthesia. If the drug is given in small incremental doses of 100 microgram 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 glycopyrronium bromide (glycopyrrolate) 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.
Glycopyrronium bromide (glycopyrrolate) is compatible for mixing and injection with pethidine hydrochloride; morphine sulfate; droperidol plus fentanyl citrate; hydroxyzine; neostigmine; promethazine and pyridostigmine. Glycopyrronium bromide (glycopyrrolate) may be mixed with 4% to 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 glycopyrronium bromide (glycopyrrolate) 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 glycopyrronium bromide (glycopyrrolate) 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 effects are extensions of glycopyrronium bromide (glycopyrrolate)'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 overactivity 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

See Section 2 Qualitative and Quantitative Composition.

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

1 mL single dose glass ampoules in packs of 5's.

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

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.
Chemical name: pyrrolidinium-3[(cyclopentylhydroxyphenylacetyl)oxy]-1,-dimethyl-bromide; 3-hydroxy-1,1-dimethylpyrrolidinium bromide α-cyclopentylmandelate.
Molecular formula: C₁₉H₂₈BrNO₃.
Molecular mass: 398.33.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes