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Product Name
:
INTESTIGMIN
Chemical Name
:
Neostigmine (Methyl Sulfate)
Therapeutic Category
:
Neuromuscular drugs
Pharmacologic Category
:
Acetylcholinesterase Inhibitor
Pharmaceutical Form
:
Ampoule
Composition
:
Neostigmine (Methyl Sulfate) 0.5mg/ 2.5mg
Monitoring Parameters
Dosing
 
Dosing: Adult
Myasthenia gravis, diagnosis: I.M.: 0.02 mg/kg as a single dose; Note: In the diagnosis of myasthenia gravis, all anticholinesterase medications should be discontinued for at least 8 hours before administering neostigmine.
Myasthenia gravis, treatment:
I.M., I.V., SubQ: 0.5-2.5 mg every 1-3 hours up to 10 mg/24 hours maximum
Reversal of nondepolarizing neuromuscular blockade after surgery in conjunction with atropine: I.V.: 0.5-2.5 mg; total dose not to exceed 5 mg; must administer atropine several minutes prior to neostigmine
Bladder atony: I.M., SubQ:
Prevention: 0.25 mg every 4-6 hours for 2-3 days
Treatment: 0.5-1 mg every 3 hours for 5 doses after bladder has emptied

Dosing: Pediatric

Myasthenia gravis, diagnosis: I.M.: Children: 0.04 mg/kg as a single dose; Note: In the diagnosis of myasthenia gravis, all anticholinesterase medications should be discontinued for at least 8 hours before administering neostigmine.
Myasthenia gravis, treatment: Children:
I.M., I.V., SubQ: 0.01-0.04 mg/kg every 2-4 hours
Reversal of nondepolarizing neuromuscular blockade after surgery in conjunction with atropine (must administer atropine several minutes prior to neostigmine): I.V.:
Infants: 0.025-0.1 mg/kg/dose
Children: 0.025-0.08 mg/kg/dose

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

Clcr 10-50 mL/minute: Administer 50% of normal dose.
Clcr <10 mL/minute: Administer 25% of normal dose.
Use
 
Reversal of the effects of nondepolarizing neuromuscular-blocking agents; treatment of myasthenia gravis; prevention and treatment of postoperative bladder distention and urinary retention
Adverse Reactions
 
Frequency not defined.
Cardiovascular: Arrhythmias (especially bradycardia), AV block, cardiac arrest, flushing, hypotension, nodal rhythm, nonspecific ECG changes, syncope, tachycardia
Central nervous system: Convulsions, dizziness, drowsiness, dysarthria, dysphonia, headache, loss of consciousness
Dermatologic: Skin rash, thrombophlebitis (I.V.), urticaria
Gastrointestinal: Diarrhea, dysphagia, flatulence, hyperperistalsis, nausea, salivation, stomach cramps, vomiting
Genitourinary: Urinary urgency
Neuromuscular & skeletal: Arthralgias, fasciculations, muscle cramps, spasms, weakness
Ocular: Lacrimation, small pupils
Respiratory: Bronchiolar constriction, bronchospasm, dyspnea, increased bronchial secretions, laryngospasm, respiratory arrest, respiratory depression, respiratory muscle paralysis
Miscellaneous: Allergic reactions, anaphylaxis, diaphoresis increased
Contraindications
 
Hypersensitivity to neostigmine, bromides, or any component of the formulation; GI or GU obstruction
Warnings / Precautions Drug
 
Concerns related to adverse effects:
• Anticholinesterase insensitivity: For brief or prolonged periods, anticholinesterase insensitivity can develop.
• Cholinergic effects: Discontinue if symptoms of excess cholinergic activity (eg, salivation, sweating, urinary incontinence); overdosage may result in cholinergic crisis, which must be distinguished from myasthenic crisis.
• Hypersensitivity reactions: Have atropine and epinephrine ready to treat hypersensitivity reactions.
Disease-related concerns:
• Asthma: Use with caution in patients with asthma.
• Cardiovascular disease: Use with caution in patients with bradycardia and cardiac arrhythmias.
• GI disease: Use with caution in patients with GI disease, including peptic ulcer disease.
• Hyperthyroidism: Use with caution in patients with hyperthyroidism.
• Myasthenia gravis: Adequate facilities should be available for cardiopulmonary resuscitation when testing and adjusting dose for myasthenia gravis.
• Seizure disorder: Use with caution in patients with a history of seizure disorder.
• Vagotonia: Not generally recommended for use in patients with vagotonia.
Concurrent drug therapy issues:
• Muscle relaxants: Does not antagonize and may prolong the Phase I block of depolarizing muscle relaxants (eg, succinylcholine).
Interactions
 
Beta-Blockers: Acetylcholinesterase Inhibitors may enhance the bradycardic effect of Beta-Blockers. Exceptions: Levobunolol; Metipranolol. Risk C: Monitor therapy
Cholinergic Agonists: Acetylcholinesterase Inhibitors may enhance the adverse/toxic effect of Cholinergic Agonists. Risk C: Monitor therapy
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor therapy
Neuromuscular-Blocking Agents (Nondepolarizing): Acetylcholinesterase Inhibitors may diminish the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor therapy
Succinylcholine: Acetylcholinesterase Inhibitors may increase the serum concentration of Succinylcholine. Management: Consider alternatives to this combination due to a risk of prolonged neuromuscular blockade. Risk D: Consider therapy modification
Pregnancy
 
C
Lactation
 
Excretion in breast milk unknown/not recommended
Mechanism of Action
 
Inhibits destruction of acetylcholine by acetylcholinesterase which facilitates transmission of impulses across myoneural junction
Pharmacodynamics / Kinetics
 
Onset of action: I.M.: 20-30 minutes; I.V.: 1-20 minutes
Duration: I.M.: 2.5-4 hours; I.V.: 1-2 hours
Metabolism: Hepatic
Half-life elimination: Normal renal function: 0.5-2.1 hours; End-stage renal disease: Prolonged
Excretion: Urine (50% as unchanged drug)
 
   
 
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