Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: hameln pharma limited, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Neostigmine should not be administered to patients with mechanical obstruction of gastrointestinal or urinary tracts, peritonitis or doubtful bowel viability.
Neostigmine should not be used in conjunction with depolarising muscle relaxants such as suxamethonium as neuromuscular blockade may be potentiated.
Neostigmine should be used with extreme caution in patients with asthma as the parasympathomimetic action of neostigmine may cause bronchoconstriction.
Bradycardia, with the potential for progression to asystole, may occur in patients receiving neostigmine by intravenous injection unless atropine is given simultaneously. Extreme caution should be employed when treating patients with preexisting bradycardia, cardiac arrhythmia or recent coronary occlusion.
Patients who are hyperreactive to neostigmine experience a severe cholinergic reaction to the drug. Atropine sulfate should always be available as an antagonist for the muscarinic effects of neostigmine.
Neostigmine should be used with caution in patients with epilepsy, vagotonia, hyperthyroidism, peptic ulceration or parkinsonism.
Administration of anticholinesterase agents to patients with intestinal anastomoses may produce rupture of the anastomosis or leakage of intestinal contents.
Although there are no specific dosage requirements in the elderly, these patients may be more susceptible to dysrhythmias than younger patients.
Neostigmine Methylsulfate should not be given during cyclopropane or halothane anaesthesia; although it may be used after withdrawal of these agents.
This medicine contains 3.54 mg (or 0.15 mmol) sodium per each 1 ml ampoule (i.e. less than 1 mmol sodium (23 mg) per 1 ml ampoule), that is to say essentially ‘sodium-free’.
Neostigmine effectively antagonises the effect of Non-depolarizing muscle relaxants (e.g. Tubocurarine, Gallamine or Pancuronium) and this interaction is used to therapeutic advantage to reverse muscle relaxation after surgery. Neostigmine does not antagonise, and it may in fact prolong, the phase I block of depolarizing muscle relaxants such as Succinylcholine.
Atropine antagonises the muscarinic effects of Neostigmine, the interaction is utilised to counteract the muscarinic symptoms of the Neostigmine toxicity.
Anticholinesterase agents are sometimes effective in reversing Neuromuscular Block induced by Aminoglycoside Antibiotics. However, Aminoglycoside Antibiotics and other drugs that interfere with Neuromuscular transmission should be used cautiously, if at all, in patients with Myasthenia Gravis and the dose of Neostigmine may have to be adjusted accordingly.
The use of Neostigmine Methylsulfate during pregnancy or lactation has not been established. Although the possible hazards to mother and child must be weighed against the potential benefits in every case. Experience with Myasthenia Gravis has revealed no untoward effect of the drug on the course of pregnancy. As the severity of Myasthenia Gravis often fluctuates considerably, particular care is required to avoid cholinergic crisis due to overdosage of Neostigmine.
Only negligible amounts of Neostigmine Methylsulfate are excreted in breast milk. Nevertheless, attention should be paid to possible effects on the breast-feeding infant.
Not applicable.
Adverse effects of Neostigmine are chiefly those of exaggerated response to parasympathetic stimulation.
| System Organ Class | Adverse reaction | Frequency |
|---|---|---|
| Immune system disorders | Hypersensitivity, angioedema, anaphylactic reaction. | Not known |
| Nervous system disorders | Cholinergic syndrome, especially at high doses. In patients with myasthenia gravis, cholinergic crisis may be difficult to distinguish from myasthenia crisis (see section 4.9). | Not known |
| Eye disorders | Miosis, lacrimation increased | Not known |
| Cardiac disorders | Bradycardia, decreased cardiac conduction, in severe cases possibly leading to heart block or cardiac arrest | Not known |
| Vascular disorders | Hypotension | Not known |
| Respiratory, thoracic or mediastinal disorders | Increased bronchial secretion, bronchospasm | Not known |
| Gastrointestinal disorders | Nausea, vomiting, diarrhoea, abdominal cramps, salivary hypersecretion. Increased intestinal motility may result in involuntary defecation. | Not known |
| Skin and subcutaneous tissue disorders | Hyperhidrosis | Not known |
| Musculoskeletal, connective tissue and bone disorders | Muscle spasms | Not known |
| Renal and urinary disorders | Urinary incontinence | Not known |
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Neostigmine may be diluted with Water for Injections. Stability of the injection cannot be guaranteed once it has been diluted.
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