Valeant Canada Limited

Valeant Canada Limited Drugs

• Pyridostigmine Bromide
  

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  Pyridostigmine Bromide

  

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  PYRIDOSTIGMINE BROMIDE IS FOR USE AS A PRETREATMENT FOR EXPOSURE TO THE CHEMICAL NERVE AGENT SOMAN. PYRIDOSTIGMINE ALONE WILL NOT PROTECT AGAINST EXPOSURE TO SOMAN. THE EFFICACY OF PYRIDOSTIGMINE IS DEPENDENT UPON THE RAPID USE OF ATROPINE AND PRALIDOXIME (2-PAM) AFTER SOMAN EXPOSURE.

  PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE AGENTS IS THE WEARING OF PROTECTIVE GARMENTS INCLUDING MASKS, HOODS AND OVERGARMENTS DESIGNED SPECIFICALLY FOR THIS USE.

  INDIVIDUALS MUST NOT RELY SOLELY UPON PRETREATMENT WITH PYRIDOSTIGMINE, AND THE ANTIDOTES ATROPINE AND PRALIDOXIME (2-PAM) TO PROVIDE COMPLETE PROTECTION FROM POISONING BY THE CHEMICAL NERVE AGENT SOMAN.

  PYRIDOSTIGMINE MUST NOT BE TAKEN AFTER EXPOSURE TO SOMAN. IF PYRIDOSTIGMINE IS TAKEN IMMEDIATELY BEFORE EXPOSURE (E.G., WHEN THE GAS ATTACK ALARM IS GIVEN) OR AT THE SAME TIME AS POISONING BY SOMAN, IT IS NOT EXPECTED TO BE EFFECTIVE, AND MAY EXACERBATE THE EFFECTS OF A SUB-LETHAL EXPOSURE TO SOMAN [See Clinical Pharmacology (12.2)].

  The dose of pyridostigmine is one 30 mg tablet every 8 hours, started at least several hours prior to exposure to Soman. At the first sign of nerve agent poisoning, pyridostigmine should be discontinued and treatment with atropine and pralidoxime should be instituted immediately.

  There is no known advantage to taking pyridostigmine just prior to or concurrent with Soman exposure. According to the mechanism of action of pyridostigmine described below [See Clinical Pharmacology (12.2)], pyridostigmine should be effective when it is given sufficiently in advance of Soman poisoning to provide a pool of protected enzyme. Therefore, it is expected that pyridostigmine will not be effective if administered just prior to or during exposure to Soman.

  The benefits and risks of use beyond 14 consecutive days have not been definitively established, therefore, continued use beyond 14 consecutive days should be evaluated in the context of the likelihood of exposure to Soman nerve agent.

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