Aurasert

Aurasert Warnings

sertraline

Manufacturer:

Aurobindo Pharma

Distributor:

Unimed
Full Prescribing Info
Warnings
Suicidality in children and adolescents: Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of an antidepressant in a child or adolescent for any clinical use must balance the risk of increased suicidality with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality or unusual changes in behavior. Families and caregivers should be advised to closely observe the patient and to communicate with the prescriber. A statement regarding whether the particular drug is approved for any pediatric indication(s) and, if so, which one(s).
Aurasert should not be used in combination with a MAOI, or within 14 days of discontinuing treatment with a MAOI.
As with other antidepressants, activation of mania/hypomania has been reported in a small proportion of patients.
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