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Monitor vital signs and observe the patient for signs and symptoms of opioid withdrawalThese may includebut are not limited tonauseavomitingdysphoriayawningsweatingtearingrhinorrheastuffy nosecraving for opioidspoor appetiteabdominal crampssense of fearskin erythemadisrupted sleep patternsfidgetinguneasinesspoor ability to focusmental lapsesmuscle aches or crampspupillary dilationpiloerectionfeverchanges in blood pressurepulse or temperatureanxietydepressionirritabilitybackachebone or joint painstremorssensations of skin crawling or fasciculationsIf signs or symptoms of withdrawal appearthe test is positive and no additional naloxone should be administered.

There are no adequate and well-controlled studies in pregnant womenREVIA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Patients receiving opioid analgesicsPatients currently dependent on opioidsincluding those currently maintained on opiate agonistse.gmethadoneor partial agonistse.gbuprenorphinePatients in acute opioid withdrawalsee WARNINGSAny individual who has failed the naloxone challenge test or who has a positive urine screen for opioidsAny individual with a history of sensitivity to REVIA or any other components of this productIt is not known if there is any cross-sensitivity with naloxone or the phenanthrene containing opioids.

Although no causal relationship with REVIA is suspectedphysicians should be aware that treatment with REVIA does not reduce the risk of suicide in these patientssee PRECAUTIONS

Lethargy and somnolence have been reported following doses of REVIA and thioridazine.

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