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Pralidoxime Injection (Pralidoxime Chloride Injection) - Warnings and Precautions

 
 



WARNINGS

Pralidoxime is not effective in the treatment of poisoning due to phosphorus, inorganic phosphates or organophosphates not having anticholinesterase activity.

PRECAUTIONS

General:

Pralidoxime has been very well tolerated in most cases, but it must be remembered that the desperate condition of the organophosphate-poisoned patient will generally mask such minor signs and symptoms as have been noted in normal subjects.

Because pralidoxime is excreted in the urine, a decrease in renal function will result in increased blood levels of the drug. Thus, the dosage of pralidoxime should be reduced in the presence of renal insufficiency.

Information for Patients:

The pralidoxime chloride auto-injector should be self- or buddy- administered by military personnel or administered by qualified civilian emergency responders only after the following events have occurred:

  • -individual has donned his mask subsequent to recognizing the existence of a chemical agent hazard in his area
  • -some or all of the symptoms of nerve agent poisoning cited below are present:
  •  unexplained runny nose
  •  tightness of chest with difficulty in breathing
  •  pinpointed pupils of the eye resulting in blurred vision
  •  drooling, excessive sweating
  •  nausea, vomiting, and abdominal cramps
  •  involuntary urination and defecation
  •  jerking, twitching, and staggering
  •  headache, drowsiness, coma, convulsions
  •  stoppage of breathing

Appropriate steps must be taken to insure that personnel equipped with auto-injectors understand their indications and use including review of symptoms of poisoning and operation of the auto-injector.

Laboratory Tests:

Treatment of organophosphate poisoning should be instituted without waiting for the results of laboratory tests. Red blood cell, plasma cholinesterase, and urinary paranitrophenol measurements (in the case of parathion exposure) may be helpful in confirming the diagnosis and following the course of the illness. A reduction in red blood cell cholinesterase concentration to below 50% of normal has been seen only with organophosphate ester poisoning.

Drug Interactions:

When atropine and pralidoxime are used together, the signs of atropinization (flushing, mydriasis, tachycardia, dryness of the mouth and nose) may occur earlier than might be expected when atropine is used alone. This is especially true if the total dose of atropine has been large and the administration of pralidoxime has been delayed.2, 3, 4

The following precautions should be kept in mind in the treatment of anticholesterinase poisoning, although they do not bear directly on the use of pralidoxime; since barbiturates are potentiated by the anticholinesterases, they should be used cautiously in the treatment of convulsions; morphine, theophylline, aminophylline, succinylcholine, reser-pine, and phenothiazine-type tranquilizers should be avoided in patients with organophosphate poisoning.

Carcinogenesis, Mutagensis, Impairment of Fertility:

Since the pralidoxime chloride auto-injector is indicated for short-term emergency use only, no investigations of its potential for carcinogenesis, mutagenesis, or impairment of fertility have been conducted by the manufacturer, or reported in the literature.

Pregnancy Category C:

Animal reproduction studies have not been conducted with pralidoxime. It is also not known whether pralidoxime can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pralidoxime should be given to a pregnant woman only if clearly needed.

Nursing Mother:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pralidoxime is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children have not been established.

Page last updated: 2008-06-18

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