( ceptors in the brain resulting in the ...)Alcoholism Drug Vivitrol Approved By FDA,Health

ceptors in the brain, resulting in the blockade of the neurotransmitters that are associated with alcohol dependence. This blockade may help patients reduce alcohol consumption although the exact mechanism responsible for the reduction in alcohol consumption is not well understood.

The efficacy of Vivitrol has been tested in a six-month Phase III double-blind, placebo-controlled, randomized clinical trial of alcohol dependent patients. By the end of the trial, it was found that patients who received Vivitrol and psychosocial support experienced greater reduction in days of heavy drinking than those who received only psychosocial support and placebo injection. Heavy drinking was defined as five or more drinks per day for men and four or more drinks per day for women, according to the news release by the companies.

Among patients who abstained from drinking in the week prior to the treatment, those treated with Vivitrol were more likely to maintain complete abstinence (without relapse) and experienced a greater reduction both in drinking days and heavy drinking days, compared to the placebo-treated group over the six-month treatment period.

Vivitrol was generally well tolerated at the suggested dose, but mild to moderate adverse symptoms are observed in clinical trials. The common symptoms include nausea, vomiting, headache, dizziness, fatigue and injection site reactions, according to the companies.

Vivitrol should never be given in excessive doses, which can cause hepatocellular injury when given in excessive doses. Because of the hepatotoxic effects, use of the drug in patients with acute liver disease or liver failure should be carefully considered. Likewise, patients who experience symptoms and or signs of acute hepatitis should discontinue using the drug and seek medical attention immediately. Patients should be warned of the hepatotoxic effects associated with Vivitrol.

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