DESCRIPTION
Serax is the first of a chemically
new series of compounds, the 3-hydroxybenzodiazepinones. Serax is
a new therapeutic agent providing versatility and flexibility in control
of common emotional disturbances. this product exerts prompt action
in a wide variety of disorders such as anxiety, tension, agitation, and
irritability, and anxiety associated with depression. Serax capsules
contain 10 mg, 15 mg, or 30 mg oxazepam. The inactive ingredients
present are gelatin, lactose, titanium dioxide, and other ingredients.
Serax's molecular name is oxazepam. Its molecular formula is C15-H1-Cl-N2-O2.
CLINICAL PHARMACOLOGY
Pharmacokinetic testing in twelve volunteers demonstrated that when given as a single 30 mg dose, the capsule, tablet, and suspension were equivalent in extent of absorption. For the capsule and tablet, peak plasma levels averaged 450 ng/mL and were observed to occur about 3 hours after dosing. The mean half-life for oxazepam was approximately 8.2 hours (range 5.7 to 10.9 hours).
Studies in dogs for four weeks at 480 mg/kg daily showed no specific changes; at 960 mg/kg two out of eight died with evidence of circulatory collapse. Chronic toxicity studies of Serax in dogs at 120 mg/kg/day for 52 weeks produced no toxic manifestation.
Fatty metamorphosis of the liver has been noted in six-week toxicity studies in rats given this product at 0.5% of the diet.
An earlier published study reported that mice fed dietary dosages of 35 or 100 times the human daily dose of oxazepam for 9 months developed a dose-related increase in liver adenomas. In an independent analysis of some of the microscopic slides from this mouse study several of these tumors were classified as liver carcinomas. At this time, there is no evidence that clinical use of oxazepam is associated with tumors.
INDICATIONS
Serax (oxazepam) is 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 treament of Serax. This produce is particularly useful in the management of anxiety, tension, agitation, and irritability in older patients. Alcoholics experiencing withdrawal symptoms are also responsive to therapy.
ADVERSE REACTIONS
Mild drowsiness is commonly seen in the first few days of therapy. Mild paradoxical reactions, i.e., excitement, stimulation of affect, have been reported in psychiatric patients; these reactions may be secondary to relief of anxiety and usually appear in the first two weeks of therapy. Other side effects occurring during oxazepam therapy include rare instances of nausea, slurred speech, and tremor.