Aurasert Special Precautions

General: Sertraline should be used with caution in patients with hepatic impairment; in patients with cirrhosis of the liver, a lower dose or a lower frequency of dosing should be employed. Since sertraline is extensively metabolized in the liver, renal route is a minor route of elimination. Therefore, sertraline dosing does not have to be adjusted based on the degree of renal impairment. However, caution is advised in patients with severe renal impairment, until more data becomes available. Sertraline should be introduced with care in patients with seizure disorders. No clinical studies have been performed on the risks/benefits of combining sertraline therapy with electroconvulsive therapy. Careful supervision of depresses patients with suicidal tendencies is recommended especially during the early treatment phase.
Concomitant use of alcohol with Aurasert should be avoided.
Use in Children: The safety and efficacy of sertraline for the treatment of obsessive compulsive disorder has been demonstrated in a 12 week, multicenter, placebo-controlled study. The risks, if any that may be associated with sertraline's extended use in children adolescents with OCD have not been systematically assessed. Safety and effectiveness in pediatric patients below the age of 6 have not been established. Effectiveness of sertraline in pediatric patients with depression or panic disorder has not been established.