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.

Renal impairment

Dose reduction should be considered in patients with renal impairment (see sections 4.4 and 5.2).

4.3 Contraindications

Hypersensitivity to Glycopyrronium Bromide or to any of the excipients listed in section 6.1.

In common with other antimuscarinics: angle-closure glaucoma; myasthenia gravis (large doses of quaternary ammonium compounds have been shown to block end plate nicotinic receptors); paralytic ileus; pyloric stenosis; prostatic enlargement.

Anticholinesterase-antimuscarinic combinations such as neostigmine plus glycopyrronium should be avoided in patients with a prolonged QT interval.

4.4 Special warnings and precautions for use

Antimuscarinics should be used with caution (due to increased risk of side effects) in Down's syndrome, in children and in the elderly.

They should also be used with caution in gastro-oesophageal reflux disease, diarrhoea, ulcerative colitis, acute myocardial infarction, thyrotoxicosis, hypertension, congestive heart failure, conditions characterised by tachycardia (including hyperthyroidism, cardiac insufficiency, cardiac surgery) because of the increase in heart rate produced by their administration, coronary artery disease and cardiac arrhythmias, pyrexia (due to inhibition of sweating), pregnancy and breast feeding. As glycopyrronium inhibits sweating, patients with increased temperature (especially children) should be observed closely.

Because of prolongation of renal elimination, repeated or large doses of glycopyrronium should be avoided in patients with uraemia. Anticholinergic drugs can cause ventricular arrhythmias when administered during inhalation anaesthesia especially in association with the halogenated hydrocarbons.

Unlike atropine, glycopyrronium bromide is a quaternary ammonium compound and does not cross the blood-brain barrier. It is therefore less likely to cause postoperative confusion which is a particular concern in the elderly patients. Compared to atropine, glycopyrronium has reduced cardiovascular and ocular effects.

This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially 'sodium free'.

The duration of effect of Glycopyrronium Bromide Injection may be prolonged in patients with renal impairment since glycopyrrolate is excreted mostly in urine as unchanged drug. Dosage adjustment may be needed for patients with renal impairment.

The injection can increase the tachycardia effect of sympathomimetic medicinal products

4.5 Interaction with other medicinal products and other forms of interaction

Many drugs have antimuscarinic effects; concomitant use of two or more of such drugs can increase side-effects such as dry mouth, urine retention and constipation. Concomitant use can also lead to confusion in the elderly.

Anticholinergic agents may delay absorption of other medication given concomitantly.