Composition
EPISTIGMIN Ampoules:
Each 1 ml ampoule contains:
Neostigmine methylsulfate ......................................................... 0.5 mg
EPISTIGMIN Vials:
Each 5 ml vial contains:
Neostigmine methylsulfate ......................................................... 2.5 mg/ml
Inactive ingredients:
EPISTIGMIN Ampoules: Sodium chloride, sodium hydroxide, water for injection.
EPISTIGMIN Vials: Sodium chloride, phenol, sodium hydroxide, water for injection.
Therapeutic Indications
Myasthenia gravis.
Antagonist to non-depolarizing neuromuscular blockade.
Paralytic Ileus.
Post-operative Urinary Retention.
Paroxysmal Supraventricular Tachycardia.
Dosage and Administration
Routes of Administration: EPISTIGMIN may be administered by IV, IM or SC injection.
EPISTIGMIN should be given very slowly by the IV route. A syringe of atropine sulphate should always be available to counteract severe cholinergic reactions should they occur.
Myasthenia gravis:
1-2.5 mg by IM or SC injection at intervals throughout the day, when maximum strength is needed. The usual duration of action of a dose is two to four hours.
The total daily dose is usually 5-20 mg by injection, but higher doses may be needed by some patients.
Neonatal Myasthenia gravis:
May be treated with 0.1 mg EPISTIGMIN IM initially. Thereafter, the dose must be titrated individually. But is usually 0.05-0.25 mg IM or 0.03 mg/kg IM, every two to four hours. Because of the self-limiting nature of the disease in neonates, the daily dosage should be reduced until the drug can be withdrawn.
Older Children (Under 12 years of age):
May be given 0.2-0.5 mg by injection as required. Dosage requirements should be adjusted according to the response of the patient.
Antagonist to Non-depolarizing Neuromuscular Blockade:
Reversal of neuromuscular blockade with EPISTIGMIN should not be attempted unless there is spontaneous recovery from paralysis.
Adults and Children:
A single dose of EPISTIGMIN 0.05-0.07 mg/kg body-weight and atropine 0.02-0.03 mg/kg body weight, by slow IV injection over one minute is usually adequate for complete reversal of non-depolarizing muscle relaxants within 5-15 minutes.
The maximum recommended dose of EPISTIGMIN in adults is 5 mg and in children 2.5 mg.
Atropine and EPISTIGMIN may be given simultaneously, but in patients with bradycardia, the pulse rate should be increased to 80 per minute with atropine before administering EPISTIGMIN.
Other Indications:
Adults:
0.5-2.5 mg EPISTIGMIN by SC or IM injection.
Children:
0.125-1 mg by injection. Doses may be varied according to the individual needs of the patient.
Elderly:
There are no specific dosage recommendations for EPISTIGMIN in the elderly.

Contraindications
Use of EPISTIGMIN is contraindicated in patients with hypersensitivity to neostigmine or to any of the excipients in this injection.
EPISTIGMIN should not be administered to patients with mechanical obstruction of gastrointestinal or urinary tracts, peritonitis or doubtful bowel viability.
EPISTIGMIN should not be used in conjunction with depolarising muscle relaxants such as suxamethonium as neuromuscular blockade may be potentiated.

Warnings and Precautions
EPISTIGMIN should be used with extreme caution in patients with asthma as its parasympathomimetic action may cause bronchoconstriction.
Bradycardia, with the potential for progression to asystole, may occur in patients receiving EPISTIGMIN by intravenous injection unless atropine is given simultaneously. Extreme caution should be employed when treating patients with pre-existing bradycardia, cardiac arrhythmia or recent coronary occlusion.
Patients who are hyperreactive to EPISTIGMIN experience a severe cholinergic reaction to the drug. Atropine sulphate should always be available as an antagonist for the muscarinic effects of EPISTIGMIN.
EPISTIGMIN 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.
Elderly:
Although there are no specific dosage requirements in the elderly, these patients may be more susceptible to dysrhythmias than younger patients.
Inhaled anaesthetics:
EPISTIGMIN should not be given during cyclopropane or halothane anaesthesia; although it may be used after withdrawal of these agents.
Excipients:
EPISTIGMIN contains sodium. This should be taken into consideration by patients on a controlled sodium diet.
Special Precautions for Disposal and other Handling:
Use as directed by a physician.
If only part has been used, discard the remaining solution.
Incompatibilities:
EPISTIGMIN may be diluted with Water for Injection. Stability of the injection cannot be guaranteed once it has been diluted.