To protect against the peripheral muscarinic actions of anticholinesterases such as Neostigmine and Pyridostigmine, used to reverse residual neuromuscular blockade produced by non-depolarising muscle relaxants.
As a pre-operative antimuscarinic agent to reduce salivary tracheobronchial and pharyngeal secretions and to reduce the acidity of the gastric contents.
As a pre-operative or intra-operative antimuscarinic to attenuate or prevent intra-operative bradycardia associated with the use of Suxamethonium or due to cardiac vagal reflexes.

Glycopyronium Bromide Injection is a sterile solution for intravenous or intramuscular administration.
Premedication
Adults and older patients:
200 to 400 micrograms (0.2mg to 0.4mg) intravenously or intramuscularly before the induction of anaesthesia. Alternatively, a dose of 4 to 5 micrograms/kg (0.004 to 0.005mg/kg) up to a maximum of 400 micrograms (0.4mg) may be used. Larger doses may result in profound and prolonged antisialogogue effect which may be unpleasant for the patient.

Children:
4 to 8 micrograms/kg (0.004 to 0.008mg/kg) up to a maximum of 200 micrograms (0.2mg) 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.
Intra-operative use
Adults and older patients:
A single dose of 200 to 400 micrograms (0.2 to 0.4mg) by intravenous injection should be used. Alternatively, a single dose of 4 to 5 micrograms/kg
(0.004 to 0.005mg/kg) up to a maximum of 400 micrograms (0.4mg) may be used. This dose may be repeated if necessary.
Children:
A single dose of 200 micrograms (0.2mg) by intravenous injection should be used. Alternatively, a single dose of 4 to 8 micrograms/kg by intravenous injection (0.004 to 0.008mg/kg) up to a maximum of 200 micrograms (0.2mg) may be used. This dose may be repeated if necessary.
Reversal of residual non-depolarising neuromuscular block
Adults and older patients:
200 micrograms (0.2mg) intravenously per 1000 micrograms (1mg) of Neostigmine or the equivalent dose of Pyridostigmine. Alternatively, a dose of 10 to 15 micrograms/kg (0.01 to 0.015mg/kg) intravenously with 50 micrograms/kg (0.05mg/kg) Neostigmine or equivalent dose of pyridostigmine. Glycopyrronium Bromide Injection may be administered simultaneously from the same syringe with the anticholinesterase; as there are greater cardiovascular stability results from this method of administration. Children:
10 micrograms/kg (0.01mg/kg) intravenously with 50 micrograms/kg (0.05mg/kg) Neostigmine or equivalent dose of pyridostigmine. Glycopyrronium Bromide Injection may be administered simultaneously from the same syringe with the anticholinesterase; as there are greater cardiovascular stability results from this method of administration.

Because of the increase of heart rate produced by the administration of anticholinergics, use with caution in patients with coronary artery disease; congestive heart failure; cardiac arrhythmias, hypertension and thyrotoxicosis.
This product should be used very cautiously in pyrexial patients due to inhibition of sweating.
Large doses of quaternary ammonium anticholinergic compounds have been shown to block end plate nicotinic receptors. This should be considered before using Glycopyrronium Bromide in patients with myasthenia gravis.
It is known that the administration of anticholinergic agents during inhalation anaesthesia can result in ventricular arrhythmias.
This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially ‘sodium free’.

Anticholinergic agents may delay absorption of other medicaments given concomitantly.
Excessive cholinergic blockade can occur if Glycopyrronium Bromide 0.2mg/ml Solution for Injection is given concomitantly with belladonna alkaloids or other synthetic anticholinergic agents (such as antiparkinsonism agents), phenothiazines, tricyclic antidepressants, disopyramide, procainamide, quinidine, antihistamines, or narcotic analgesics such as meperidine.
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.

Although reproduction studies in rats and rabbits revealed no teratogenic effects from Glycopyrronium Bromide, safety in human pregnancy and lactation has not been established. Diminished rates of conception and of survival at 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. The significance of this for man is not clear.

Do not operate or drive heavy machinery until instructed by a physician.

Glycopyrronium Bromide Injection may produce the following effects which are extensions of its fundamental pharmacological actions: dry mouth, difficulty in micturition, disturbances in visual accommodation, tachycardia, palpitations and inhibition of sweating.
However, the use of Glycopyrronium Bromide Injection as a preoperative anticholinergic is associated with less effect on the cardiovascular system compared to Atropine.

Symptoms
Since Glycopyrronium Bromide is a quaternary ammonium agent, symptoms of overdosage are peripheral rather than central in nature.
Treatment
To combat the peripheral anticolinergic effects of Glycopyrronium Bromide anticholinergic effects, a quaternary ammonium anticholinesterase such as Neostigmine methylsulphate may be given in a dose of 1000 micrograms (1.0mg) for each 1000 micrograms (1.0mg) of glycopyrrolate known to have been administered by the parenteral route.
- To reports any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
• Fax: +966-11-205-7662
• Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
• Toll free phone: 8002490000
• E-mail: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc

Glycopyrronium Bromide is a quaternary ammonium antimuscarinic agent and like other anticholinergic 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. Glycopyrronium
Bromide antagonises muscarinic symptoms (e.g. bronchorrhea, bronchospasm, bradycardia and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases.
The highly polar quaternary ammonium group of Glycopyrronium Bromide limits its passage across lipid membranes, such as the blood-brain barrier, in
contrast to Atropine Sulphate and Scopolamine Hydrobromide, which are non- polar tertiary amines which penetrate lipid barriers easily.
Glycopyrronium Bromide Injection has been used successfully as an adjunct to reversal by Neostigmine when Atropine has been used as the preoperative anticholinergic. The use of Glycopyrronium Bromide Injection as an adjunct to reversal by Neostigmine of non-depolarising muscle relaxants is associated with less initial tachycardia and better protection against the cholinergic effects of Neostigmine compared to reversal with a mixture of Neostigmine and Atropine.

Glycopyrronium Bromide is rapidly diminished and/or excreted after intravenous administration. The terminal elimination phase is relatively slow with quantifiable levels remaining up to 8 hours after administration. Peak effects occur approximately 30 to 45 minutes after intramuscular administration. The vagal blocking effects persist for 2 to 3 hours and the antisialagogue effects persist up to 7 hours, periods longer than for atropine. With, intravenous injection, the onset of action is generally evident within one minute.

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

Sodium Chloride
Dilute Hydrochloric Acid

Water for Injections

Glycopyrronium Bromide Injection has been shown to be physically compatible with the following agents commonly used in anaesthetic practice: Butorphanol, Lorazepam, Droperical and Fentanyl Citrate, Levorphanol Tartrate, Pethidine Hydrochloride, Morphine Sulphate, Neostigmine, Promethazine and Pyridostigmine.
Glycopyrronium Bromide Injection has been shown to be physically
incompatible with the following agents commonly used in anaesthetic practice: Diazepam, Dimenhydrinate, Methohexital Sodium, Pentazocine, Pentobarbital Sodium and Thiopental Sodium.

This medicinal product does not require any special storage conditions.

Glycopyrronium Bromide Injection is presented in clear Type I ampoules of neutral glass containing 10 x 1ml ampoules or 10 x 3ml ampoules packed in a cardboard carton.

Keep out of the reach and sight of children.
If only part of an ampoule is used, discard the remaining solution.