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A dose of 50 mg once a day will produce adequate clinical blockade of the actions of parenterally administered opioidsAs with many non-agonist treatments for addictionREVIA is of proven value only when given as part of a comprehensive plan of management that includes some measure to ensure the patient takes the medication.

REVIA is a pure opioid antagonistIt does not lead to physical or psychological dependenceTolerance to the opioid antagonist effect is not known to occur.

This could result in potentially life-threatening opioid intoxicationrespiratory compromise or arrestcirculatory collapseetcif the patient uses previously tolerated doses of opioidsCases of opioid overdose with fatal outcomes have been reported in patients after discontinuing treatment.

There is limited clinical experience with REVIA overdosage in humansIn one studysubjects who received 800 mg daily REVIA for up to one week showed no evidence of toxicity.

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Get emergency medical help if you have any of these signs of an allergic reactionhivesdifficulty breathingswelling of your facelipstongueor throat.

Clinicians are reminded that there is no completely reliable method for determining whether a patient has had an adequate opioid-free periodA naloxone challenge test may be helpful if there is any question of occult opioid dependenceIf signs of opioid withdrawal are still observed following naloxone challengetreatment with REVIA should not be attemptedThe naloxone challenge can be repeated in 24 hours.

There are no systematically collected data that specifically address the switch from buprenorphine or methadone to REVIAhoweverreview of postmarketing case reports have indicated that some patients may experience severe manifestations of precipitated withdrawal when being switched from opioid agonist therapy to opioid antagonist therapysee WARNINGSPatients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as 2 weeksHealthcare providers should be prepared to manage withdrawal symptomatically with non-opioid medications.

Allodynic TherapeuticsLLC1785 NE 123rd StreetNorth MiamiFL 33181-2537.

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