Serax Warnings, Precautions, Pregnancy, Nursing, Abuse - Oxazepam

Serax Warnings, Precautions, Pregnancy, Nursing, Abuse - Oxazepam

WARNINGS

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 Oxazepam, possibly requiring adjustment of dosage or elimination of such agents.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see ADVERSE REACTIONS: DRUG ABUSE AND DEPENDENCE subsection).

Use in Pregnancy

An increased risk of congenital malformations associated with the use of minor tranquilizers (chlor-diazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy has been suggested in several studies. 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.

PRECAUTIONS

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.

Information for Patients

To assure the safe and effective use of oxazepam, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.