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As with other CNS-acting drugs, patients should be cautioned against driving automobiles or operating dangerous machinery until it is known that they do not become drowsy or dizzy on oxazepam therapy.
Patients should be warned that the effects of alcohol or other CNS-depressant drugs may be additive to those of Serax (oxazepam) , possibly requiring adjustment of dosage or elimination of such agents.
Physical and Psychological Dependence
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. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage-tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving oxazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence.
Use in Pregnancy
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. The possibility that a woman of childbearing potential may be pregnant at the time of Institution Of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug.
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.
Serax (oxazepam) 15 mg tablets, but none of the other available dosage forms of this product, contain FD&C Yellow 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Safety and effectiveness in pediatric patients under 6 years of age have not been established. Absolute dosage for pediatric patients 6 to 12 years of age is not established.
Clinical studies of Serax (oxazepam) were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects. Age (< 80 years old) does not appear to have a clinically significant effect on oxazepam kinetics (see CLINICAL PHARMACOLOGY).
Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered. Greater sensitivity of some older individuals to the effects of Serax (oxazepam) (e.g., sedation, hypotension, paradoxical excitation) cannot be ruled out (see PRECAUTIONS, General; see ADVERSE REACTIONS). In general, dose selection for Serax (oxazepam) for elderly patients should be cautious, usually starting at the lower end of the dosing range (See DOSAGE AND ADMINISTRATION).This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/20/2009
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