( patients receiving opioid analgesics w...)Alcoholism Drug Vivitrol Approved By FDA,Health

patients receiving opioid analgesics, with current physiologic dependence on opioids, in acute opioid withdrawal or who have previously exhibited hypersensitivity to naltrexone, PLG or any other components of the diluent," Alkermes and Cephalon said in a statement. Patients must be opioid free for at least seven to 10 days before starting VIVITROL treatment because VIVITROL is a potent opioid antagonist. "Any attempt to overcome the opioid blockade produced by Vivitrol using exogenous opioids may result in fatal overdose," the companies said.

"Should a patient receiving Vivitrol develop progressive dyspnea and hypoxemia, the diagnosis of eosinophilic pneumonia should be considered. Patients should be advised to seek medical attention for injection site reactions such as pain, tenderness, induration or pruritus that do not improve within one month following the injection. Alcohol dependent patients, including those taking Vivitrol, should be monitored for the development of depression or suicidal thinking," Alkermes and Cephalon said.

Some 18 million Americans abuse or are dependent on alcohol, or alcoholic and approximately 2.2 million of them seek treatment for their alcohol problems, yet more than 75% of these patients receiving currently available traditional therapies relapse back to drinking within the first year of beginning treatment. Vivitrol can help these patients reduce alcohol consumption.


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