Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: hameln pharma limited, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom
Myasthenia Gravis, antagonist to non-depolarizing neuromuscular blockade, Paralytic Ileus, Post-operative Urinary Retention; Paroxysmal Supraventricular Tachycardia.
Recommended doses are present by indication below but may be varied according to the individual needs of the patient.
| Patient population | Recommended dose (via subcutaneous or intramuscular injection) |
| Adults and Children (12 to 17 years) | 1–2.5 mg Neostigmine Methylsulfate repeated at suitable intervals throughout the day (usual total daily dose in adults is 5–20 mg). |
| Children (1 month to 11 years) | 200 to 500 micrograms Neostigmine Methylsulfate repeated at suitable intervals throughout the day |
| Neonates (up to 1 month) | 150 micrograms/kg Neostigmine Methylsulfate every 6–8 hours, to be given 30 minutes before feeds, then increased if necessary up to 300 micrograms/kg every 4 hours. Because of the self-limiting nature of the disease in neonates, the daily dosage should be reduced until the drug can be withdrawn. |
Reversal of Neuromuscular blockade with Neostigmine should not be attempted unless there is spontaneous recovery from paralysis.
Atropine and Neostigmine may be given simultaneously, but in patients with Bradycardia, the pulse rate should be increased to 80 per minute with Atropine before administering Neostigmine.
| Patient population | Recommended dose (via intravenous injection) |
| Adults | 2.5 mg Neostigmine Methylsulfate (maximum per dose 5 mg), to be given over 1 minute, after or with glycopyrronium or atropine. Repeat if necessary. |
| Children (12 to 17 years) | 50 micrograms Neostigmine Methylsulfate per kg bodyweight (maximum per dose 2.5 mg Neostigmine Methylsulfate) to be given over 1 minute after or with glycopyrronium or atropine, followed by a further dose of 25 micrograms/kg Neostigmine Methylsulfate if required. |
| Children (1 month to 11 years) | 50 micrograms Neostigmine Methylsulfate per kg bodyweight (maximum per dose 2.5 mg Neostigmine Methylsulfate) to be given over 1 minute after or with glycopyrronium or atropine, followed by a further dose of 25 micrograms/kg Neostigmine Methylsulfate if required. |
| Neonates (up to 1 month) | 50 micrograms Neostigmine Methylsulfate per kg bodyweight to be given over 1 minute after or with glycopyrronium or atropine, followed by a further dose of 25 micrograms/kg Neostigmine Methylsulfate if required. |
| Patient population | Recommended dose (via subcutaneous or intramuscular injection) |
| Adults | 0.5–2.5 mg Neostigmine Methylsulfate |
| Children | 0.125–1 mg Neostigmine Methylsulfate |
Treatment should be reserved for severe cases not responding to conventional treatment and under the close supervision of a specialist experienced with its use.
A posology for use in the paediatric population is presented above by indication.
There are no specific dosage recommendations for Neostigmine Methylsulfate in the elderly (see section 4.4).
Neostigmine Methylsulfate may be administered by IV, IM or SC injection. Please refer to the above text for the recommended route of administration according to indication.
Neostigmine Methylsulfate should be given slowly by the IV route (given over 1 minute).
A syringe of Atropine Sulfate should always be available to counteract severe cholinergic reactions should they occur.
Neostigmine Methylsulfate overdosage may include Cholinergic Crisis, which is characterised by nausea, vomiting, diarrhoea, excessive salivation and sweating, increased bronchial secretions, miosis, bradycardia or tachycardia, cardiospasm, bronchospasm, incoordination, muscle cramps, fasciculation and paralysis. Extremely high doses may produce CNS symptoms of agitation, fear or restlessness. Death may result from cardiac arrest or respiratory paralysis and pulmonary oedema. In patients with Myasthenia Gravis, in whom overdosage is most likely to occur, fasciculation and adverse parasympathomimetic effects may be mild or absent making cholinergic crisis difficult to distinguish from Myasthenia crisis.
Maintenance of adequate respiration is of primary importance. Tracheostomy, Bronchial aspiration and postural drainage may be required; Respiration can be assisted mechanically or with oxygen, if necessary.
Neostigmine Methylsulfate should be discontinued immediately and 1–4mg of Atropine Sulfate administered IV. Additional doses of Atropine may be given every 5–30 minutes as needed to control muscarinic symptoms. Atropine overdosage should be avoided as tenacious secretions and bronchial plugs may result.
36 Months.
Protect from light and store at less than 25°C.
1ml glass ampoules hermetically sealed under flame at the gauging point. The ampoules are packed in cartons to contain 10 ampoules.
Use as directed by a physician.
If only part used discard the remaining solution.
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