Serzone
Former NFLers at Risk for Brain, Mood Problems »
"Jan. 7, 2013 -- Problems in thinking skills and depression may be more common in former National Football League players compared with other people as they age, according to a new study.
The research suggests the problems may be linke"...
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Serzone
Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)
SERZONE®
(nefazodone hydrochloride) Tablets
Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE (nefazodone) . The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000- 300,000 patient-years of SERZONE (nefazodone) treatment. The total patient-years is a summation of each patients duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc. (See WARNINGS.)
Ordinarily, treatment with SERZONE (nefazodone) should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc) and to report them to their doctor immediately if they occur.
SERZONE (nefazodone) should be discontinued if clinical signs or symptoms suggest liver failure (see PRECAUTIONS: Information for Patients). Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels ≥ 3 times the upper limit of NORMAL, while on SERZONE (nefazodone) should be withdrawn from the drug. These patients should be presumed to be at increased risk for liver injury if SERZONE (nefazodone) is reintroduced. Accordingly, such patients should not be considered for re-treatment.
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of SERZONE (nefazodone) or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SERZONE (nefazodone) is not approved for use in pediatric patients. (See WARNINGS and PRECAUTIONS: Pediatric Use.)
Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.
DRUG DESCRIPTION
SERZONE® (nefazodone hydrochloride) is an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI).
Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl) -1-piperazinyl]propyl] -5-ethyl-2,4-dihydro-4-(2-phenoxyethyl) -3H-1,2,4-triazol-3-one monohydrochloride. The molecular formula is C25H32ClN5O2 HCl, which corresponds to a molecular weight of 506.5. The structural formula is:
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Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water.
SERZONE (nefazodone) is supplied as hexagonal tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and iron oxides (red and/or yellow) as colorants.
Last reviewed on RxList: 5/1/2008
This monograph has been modified to include the generic and brand name in many instances.
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