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Protopam Injection Generic Name & Formulations
Legal Class
Rx
General Description
Pralidoxime chloride 1000mg/vial; pwd for IV inj or infusion (IM or SC inj may be used if IV route is not feasible) after reconstitution.
Pharmacological Class
Cholinesterase reactivator.
How Supplied
Single-use vials (20mL)—6
Manufacturer
Protopam Injection Indications
Indications
Treatment of poisoning due to pesticides and chemicals (eg, nerve agents) of the organophosphate class which have anticholinesterase activity. In the control of overdosage by anticholinesterase drugs used in the treatment of myasthenia gravis.
Protopam Injection Dosage and Administration
Adult
Organophosphate poisoning: Slow IV infusion or inj: initially 1000–2000mg over 15–30min; may give second dose after about 1hr if muscle weakness has not been relieved. Additional doses may be given every 10–12hrs if muscle weakness persists. IM dosing: Mild symptoms: 600mg. Wait 15 minutes, if symptoms persist give second dose; wait another 15 minutes, if symptoms persist give third dose. If at any time after first dose, severe symptoms develop, administer two additional 600mg doses in rapid succession for total cumulative dose of 1800mg. Severe symptoms: give three 600mg IM doses in rapid succession for a total dose of 1800mg; if symptoms persist, the series may be repeated beginning approx. 1hr after giving last injection. Anticholinesterase overdosage: 1000–2000mg IV followed by increments of 250mg every 5 minutes.
Children
Organophosphate poisoning: <16yrs: IV dosing: May give loading dose of 20–50mg/kg (not to exceed 2000mg/dose) over 15–30min followed by continuous infusion of 10–20mg/kg/hr; or, give intermittent infusion of 20–50mg/kg over 15–30min, a second dose may be given after about 1 hour if muscle weakness has not been relieved. Repeat dosing every 10–12hrs if needed. IM dosing: Mild symptoms: <40kg: 15mg/kg; ≥40kg: use adult dose. Wait 15 minutes, if symptoms persist give second dose; wait another 15 minutes, if symptoms persist give third dose. If at any time after the first dose, severe symptoms develop, administer two additional weight-based doses in rapid succession. Severe symptoms: give three weight-based doses as three injections in rapid succession into anterolateral thigh (total dose per 3-inj course: 45mg/kg); if symptoms persist, the series may be repeated beginning approx. 1hr after giving last injection.
Protopam Injection Contraindications
Not Applicable
Protopam Injection Boxed Warnings
Not Applicable
Protopam Injection Warnings/Precautions
Warnings/Precautions
Not for treating poisoning due to phosphorus, inorganic phosphates, or organophosphates not having anticholinesterase activity. Not an antidote for intoxication by pesticides of the carbamate class. May precipitate myasthenic crisis when treating organophosphate overdosages in cases of myasthenia gravis. Renal insufficiency. Pregnancy (Cat.C). Nursing mothers.
Protopam Injection Pharmacokinetics
See Literature
Protopam Injection Interactions
Interactions
Concomitant atropine: atropinization may occur earlier.
Protopam Injection Adverse Reactions
Adverse Reactions
Blurred vision, diplopia, impaired accommodation, dizziness, headache, drowsiness, nausea, tachycardia, increased BP, hyperventilation, muscular weakness, inj site pain, elevated LFTS, transient elevations in creatinine phosphokinase.
Protopam Injection Clinical Trials
See Literature
Protopam Injection Note
Not Applicable
Protopam Injection Patient Counseling
See Literature
