GLYCOPYRROLATE INJECTION USP 200 MICROGRAMS/ML 1ML & 3ML
Glycopyrrolate Injection U.S.P. 200 micrograms/ml
This leaflet will provide you with important information about your medicine. Please
read it carefully before your medicine is administered. The leaflet provides a summary
but not all of the information about Glycopyrrolate Injection USP. If you require any
further information or you are unsure about anything, ask your doctor or pharmacist.
WHAT'S IN YOUR MEDICINE
Glycopyrrolate Injection USP 200 microgram/ml is a clear, colourless, sterile solution.
Each lml of solution contains the active ingredient glycopyrrolate 200 micrograms
(0.2mg). Glycopyrrolate Injection is presented in clear glass ampoules containing lml or
3ml of solution.
Inactive ingredients :sodium chloride, dilute hydrochloric acid. and water for injections.
Pack sizes :Boxes of 10 X lml ampoules and 10 X 3ml ampoules.
Holder of Product Licence : Mercury Pharma International Ltd., 4045, Kingswood Road,
City West Business Park, Co Dublin, Ireland.
Manufacturer : Mercury Pharma International Ltd., 4045, Kingswood Road, City West
Business Park, Co Dublin, Ireland.
Type of Medicine :Glycopyrrolate belongs to a group of medicines called anticholinergic
or antimuscarinic drugs.
Glycopyrrolate Injection may be used
1. to protect against some of the unwanted effects of drugs such as neostigmine or
pyridostigmine, which are used to reverse the effects of certain types of muscle- relaxing
drugs (called non-depolarising muscle relaxants)
2. before an operation, to reduce saliva and other secretions and to make the stomach
contents less acid
3. before or during an operation, to reduce or prevent slowness of the heart beat during
BEFORE RECEIVING THIS MEDICINE
You must not be given Glycopyrronium Injection if:
you are allergic to glycopyrrolate or any other ingredient present in this injection
Before you are given Glycopyrronium Injection, you should tell your doctor if:
you are suffering from heart disease, heart failure, irregular heart beats or high
you have an overactive thyroid gland.
you have a high temperature (fever).
you have been administered inhalation anesthesia
you suffer from glaucoma (increased pressure in the eye)
you suffer from myasthenia gravis(leading to muscle weakness and fatiguability)
you have an enlarged prostrate gland
you suffer from obstruction of the stomach (pyloric stenosis) or bowel causing
vomiting, abdominal pain and swelling (paralytic ileus).
Tell your doctor if any of these apply to you.
Taking other medicines:
Please tell your doctor if you are taking or have recently taken any other medicines,
including medicines obtained without prescription.
A number of drugs can interact with Glycopyrronium Injection which can significantly
alter their effects.
These drugs include:
Drugs for depression known as Tricyclic antidepressants and Monoamine Oxidase
Clozapine which is used to treat severe mental disorders
Strong pain relievers such as Nefopam
Amantadine which is used to treat Parkinson’s disease or viral infection
Pregnancy and breast feeding
Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding.
Driving or operating machinery: Glycopyrrolate may cause your eyesight to become
blurred and this could interfere with your ability to drive or operate machinery safely. If
you notice any problems with your vision after you receive your injection, do not drive or
operate machinery until these effects have fully cleared. If you are in any doubt, ask your
doctor for advice.
HOW THIS MEDICINE IS ADMINISTERED
Glycopyrrolate Injection is administered by injection into a muscle or into a vein.
Dosage when used before an operation
Adults and older patients: 200 to 400 micrograms (0.2 to 0.4mg) may be injected into a
vein or into a muscle before the anaesthetic is given. Alternatively, a dose of 4 to 5
micrograms per kilogram of body weight (0.004 to 0.005mg per kg) may be used, up to a
maximum dose of 400 micrograms (0.4mg).
Children: 4 to 8 micrograms per kilogram of body weight (0.004 to 0.008mg per kg) up
to a maximum of 200 micrograms (0.2mg) may be injected into a vein or into a muscle
before the anaesthetic is given.
Dosage when used during an operation
Adults and older patients: A single dose of 200 to 400 micrograms (0.2 to 0.4mg) should
be given by injection into a vein. Alternatively, a single dose of 4 to 5 micrograms per
kilogram of body weight (0.004 to 0.005mg per kg) may be used, up to a maximum of
400 micrograms (0.4mg). This dose may be repeated if necessary.
Children: A single dose of 200 micrograms (0.2mg) should be given by injection into a
vein. Alternatively, a single dose of 4 to 8 micrograms per kilogram of body weight
(0.004 to 0.008mg per kg) may be used, up to a maximum of 200 micrograms (0.2mg).
This dose may be repeated if necessary.
Dosage when reversing the effects of non-depolarising muscle relaxants
Adults and older patients: 200 micrograms (0.2mg) per 1,000 micrograms (lmg) of
neostigmine or the equivalent dose of pyridostigmine, by injection into a vein.
Alternatively, a dose of 10 to 15 micrograms per kilogram of body weight (0.01 to
0.015mg per kg) may be injected into a vein with 50 micrograms per kg (0.05mg per kg)
of neostigmine or equivalent dose of pyridostigmine. Glycopyrrolate Injection may be
administered at the same time and from the same syringe with the neostigmine or
Children: 10 micrograms per kg of body weight (0.0lmg per kg) may be injected into a
vein with 50 micrograms per kg (0.05mg per kg) of neostigmine or the equivalent dose of
pyridostigmine. Glycopyrrolate Injection may be administered at the same time and from
the same syringe with the neostigmine or pyridostigmine.
WHAT TO DO IN CASE OF OVERDOSE
This is unlikely because the dose will be administered by a health professional.
WHILST RECEIVING THIS MEDICINE
Along with its needed effects, a medicine may cause unwanted effects. If you notice any
of the following symptoms, and if these are persistent or troublesome, tell your doctor :
difficulty in passing stools (constipation)
absence of sweating
irregular heart beat, slow heart beats followed by rapid heart beats
reduced secretions in the lungs
difficulty in passing urine
increased sensitivity towards light (photophobia)
nausea (feeling sick), vomiting
eye disorder (glaucoma)
dryness of the skin
If you notice any unwanted effects that are not mentioned here, tell your doctor.
STORING THIS MEDICINE
Do not use after the expiry date shown on the ampoule or carton.
The ampoules should be protected from light and stored below 25°C.
If only part of the contents of an ampoule is used, the remaining solution should be
Keep out of reach of children.
Marketing authorization holder
Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park,
Co Dublin, Ireland.
This leaflet was last revised in March 2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.