CHOLSTYQ Solution for injection Ref.[115306] Active ingredients: Glycopyrronium Neostigmine

Posology

Dosage

Adults and elderly patients: 1–2 ml intravenously over a period of 10 to 30 seconds (equivalent to neostigmine metilsulfate 2,5 mg with glycopyrronium bromide 0,5 mg to neostigmine metilsulfate 5 mg with glycopyrronium bromide 1 mg). Alternatively 0,02 ml/kg intravenously over a period of 10 to 30 seconds may be used, (equivalent to neostigmine metilsulfate 0,05 mg/kg with glycopyrronium bromide 0,01 mg/kg).

These doses may be repeated if adequate reversal of neuromuscular blockade is not achieved. Total doses in excess of 2 ml are not recommended as this dose of neostigmine may produce depolarising neuromuscular block.

Paediatric population: 0,02 ml/kg intravenously over a period of 10 to 30 seconds (equivalent to neostigmine metilsulfate 0,05 mg/kg with glycopyrronium bromide 0,01 mg/kg). Alternatively, dilute to 10 ml with water for injections and administer 1 ml per 5 kg bodyweight.

Method of administration

For intravenous injection.

Symptoms

Signs of neostigmine overdosage include nausea, vomiting, eructation, increased peristalsis, diarrhoea, urination and the desire to urinate, excessive salivation and sweating, increased oropharyngeal secretions, flushing, miosis, conjunctival congestion, cilliary spasm, brow ache, nystagmus, restlessness, agitation, fear, excessive dreaming, hallucinations, convulsions, slurred speech, tight chest, wheezing, increased bronchial secretion combined with bronchoconstriction, bradycardia or tachycardia, hypotension, cardiospasm, inco-ordination, muscle cramps, scattered fasciculations and eventually severe weakness and paralysis, convulsions and coma. Paradoxical effects may also occur due to interaction between nicotinic and muscarinic actions. Accordingly there may be tachycardia and hypertension. Death may follow due to cardiac arrest or central respiratory paralysis and pulmonary oedema. In severe cases, respiratory depression may occur and artificial ventilation may be necessary in such patients. Signs of neostigmine overdose may be treated by the administration of glycopyrronium bromide injection 0,2–0,6 mg intravenously or atropine sulphate 1–2 mg intravenously, intramuscularly or subcutaneously to control the muscarinic effects.

Signs of glycopyrronium bromide overdosage include tachycardia, ventricular irritability and peripheral anticholinergic effects. Signs of glycopyrronium bromide overdose may be treated by the administration of neostigmine metilsulfate 1,0 mg for each 1,0 mg of glycopyrronium bromide known to have been administered.

Management

The treatment of overdosage depends on whether signs of anticholinesterase or anticholinergic overdosage is the predominant presenting feature. As glycopyrronium bromide is a quaternary ammonium agent, symptoms of overdosage are peripheral rather than central in nature. Centrally acting anticholinesterase medicines such as physostigmine are therefore unnecessary to treat glycopyrronium bromide overdosage.

2 years.

Cholstyq has to be used immediately after first opening.

Store at or below 30°C.

Do not freeze.

Cholstyq has to be used immediately after first opening.

Keep out of the sight and reach of children.

Cholstyq is presented in 2 ml (filled to 1 ml) Type I clear colourless glass ampoules. Ampoules are packed into outer cardboard cartons in pack sizes of 10.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.