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Serax
Generic Name: Oxazepam
Drug Category: Benzodiazepine
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 6 years old for a maximum duration of 4 months.
| Approved Uses |
|
Indicated for: • The management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. • Anxiety associated with depression is also responsive to oxazepam therapy. • This product has been found particularly useful in the management of anxiety, tension, agitation, and irritability in older patients. • Alcoholics with acute tremulousness, inebriation, or with anxiety associated with alcohol withdrawal are responsive to therapy. The effectiveness of oxazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient. Not indicated for psychosis. Advise both patients and caregivers about the risks of respiratory depression and sedation when oxazepam is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined. Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting, and sweating), have occurred following abrupt discontinuance of oxazepam. Although hypotension has occurred only rarely, oxazepam should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac complications. This is particularly true in the elderly patient. Although rare, leukopenia and hepatic dysfunction including jaundice have been reported during therapy. Periodic blood counts and liver-function tests are advisable. Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Serax (oxazepam), a benzodiazepine derivative, has not been studied adequately to determine whether it, too, may be associated with an increased risk of fetal abnormality. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. |
| Off-label Uses |
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• Use in patients under the age of 6. GoToSource • Psychosis. GoToSource • Use longer than 4 months. GoToSource • Insomnia. GoToSource • Akathisia associated with neuroleptic use. GoToSource • Familial paroxysmal dystonic choreoathetosis. GoToSource • Myoclonus, catatonia and mutism. GoToSource • Cocaine dependence. GoToSource |
| Adverse Events |
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Memory impairment. GoToSource Congenital malformations. GoToSource Lung cancer. GoToSource Dependency and withdrawal syndrome. GoToSource Increased risk of falls in elderly patients. GoToSource Seizures. GoToSource Eosinophilic myocarditis (inflammation of the heart muscle). GoToSource Sudden death. GoToSource Increased risk of dementia in elderly patients. GoToSource |
| Litigation |
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Lawsuits filed for dementia. |
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