Pralidoxime chloride

DOSAGE AND ADMINISTRATION Organophosphate Poisoning Treatment should include general supportive care, atropinization, and decontamination, in addition to the use of PROTOPAM Chloride. Treatment is most effective if initiated immediately after poisoning. Administration of PROTOPAM Chloride should be carried out slowly and, preferably, by infusion.

ADULT DOSING ADULT INTRAVENOUS DOSING: Refer to the Preparation for Administration section for instructions on reconstitution and dilution of PROTOPAM Chloride that result in a 10-20 mg/mL solution for intravenous infusion. Inject an initial dose of 1000 to 2000 mg of PROTOPAM Chloride, preferably as an infusion in 100 mL of normal saline, over a 15- to 30-minute period.

If this is not practical or if pulmonary edema is present, the dose should be given slowly (over not less than five minutes) by intravenous injection, as a 50 mg/mL solution in water (e.g., 1000 mg in 20 mL). A second dose of 1000 to 2000 mg may be indicated after about one hour if muscle weakness has not been relieved.

Additional doses may be given every 10-12 hours if muscle weakness persists. Intravenous administration of PROTOPAM Chloride should be carried out slowly and, preferably, by continuous or intermittent infusion, since temporary worsening of cholinergic manifestations (i.e. tachycardia, cardiac arrest, laryngospasm, and muscle rigidity or paralysis) may occur if PROTOPAM Chloride is infused too rapidly.

The intermittent infusion rate should not exceed 200 mg/minute. If intravenous administration is not feasible, intramuscular or subcutaneous injection should be used. Evidence suggests that a loading dose followed by continuous intravenous infusion of PROTOPAM Chloride may maintain therapeutic levels longer than traditional short intermittent infusions therapy (see Pharmacokinetics ).

ADULT INTRAMUSCULAR DOSING: Refer to the Preparation for Administration section for instructions on reconstitution of PROTOPAM Chloride that result in an approximate 300 mg/mL solution for intramuscular administration. Intramuscular dosing in adults should be based on the severity of clinical symptoms. MILD SYMPTOMS If symptoms persist after administering the complete 1800 mg regimen (3 injections of 600 mg each), the series may be repeated beginning approximately 1 hour after administration of the last injection.

PEDIATRIC DOSING (FOR PATIENTS 16 YEARS AND UNDER) PEDIATRIC INTRAVENOUS DOSING: Refer to the Preparation for Administration section for instructions on reconstitution and dilution of PROTOPAM Chloride that result in 10-20 mg/mL solution for intravenous infusion. PROTOPAM Chloride can be given as intermittent intravenous infusions or as a loading dose followed by continuous intravenous infusion, depending upon the patient’s clinical condition.

The specific dose given should depend upon the severity of the symptoms. Loading Dose Following By Continuous Infusion: Administer a loading dose of 20-50 mg/kg (not to exceed 2000 mg/dose) over 15-30 minutes followed by a continuous infusion of 10-20 mg/kg/hour. Intermittent Infusion Dosing: Administer an initial intermittent infusion of 20-50 mg/kg (not to exceed 2000 mg/dose) over 15-30 minutes.

A second dose of 20-50 mg/kg may be indicated after about one hour if muscle weakness has not been relieved. Repeat dosing is permissible every 10-12 hours as needed. If it is not practical to administer intermittent or continuous intravenous infusions, or if pulmonary edema is present, the 20-50 mg/kg dose should be given slowly (over not less than five minutes) by intravenous injection as a 50 mg/mL solution in water (see Preparation for Administration section).

Additional doses may be given every 10-12 hours if muscle weakness persists. PEDIATRIC INTRAMUSCULAR DOSING: Refer to the Preparation for Administration section for instructions on reconstitution of PROTOPAM Chloride that result in an approximate 300 mg/mL solution for intramuscular administration. Intramuscular injections in children should be administered in the anterolateral aspect of the thigh to avoid the nerve, artery and vein, as well as the femur.

Preparation for Administration PROTOPAM Chloride is supplied as 1000 mg single-dose vials for injection. For INTRAVENOUS infusion: Reconstitute a single PROTOPAM Chloride 1000 mg vial by adding 20 mL of Sterile Water for Injection, USP, which results in a 50 mg/mL concentration. The solution should further be diluted with Normal Saline for Injection, USP to achieve a concentration of 10 to 20 mg/mL (e.g. 1000 mg in 100 mL or 2000 mg in 100 mL).

For fluid restricted patients or for rapid administration (over at least 5 min), a maximum concentration of 50 mg/mL may be used. For INTRAMUSCULAR injection: Reconstitute a single PROTOPAM Chloride 1000 mg vial by adding 3.3 mL of Sterile Water for Injection, USP for an approximate concentration of 300 mg/mL . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Discard unused solution after a dose has been withdrawn.