ZOLOFT (sertraline hydrochloride) is not indicated for use in children under 18 years of age (see INDICATIONS: Pediatrics (<18 years of age); WARNINGS: POTENTIAL ASSOCIATION WITH BEHAVIORAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM).
ZOLOFT should be administered with food once daily preferably with the evening meal, or, if administration in the morning is desired, with breakfast.
Depression and Obsessive-Compulsive Disorder:
As no clear dose-response relationship has been demonstrated over a range of 50-200 mg/day, a dose of 50 mg/day is recommended as the initial dose.
ZOLOFT treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily depending on tolerability and clinical response. No clear dose-response relationship has been demonstrated over a range of 50-200 mg/day.
In depression, OCD and panic disorder, a gradual increase in dosage may be considered if no clinical improvement is observed. Based on pharmacokinetic parameters, steady-state sertraline plasma levels are achieved after approximately 1 week of once daily dosing; accordingly, dose changes, if necessary, should be made at intervals of at least one week. Doses should not exceed a maximum of 200 mg/day.
The full therapeutic response may be delayed until 4 weeks of treatment or longer. Increasing the dosage rapidly does not normally shorten this latent period and may increase the incidence of side effects.
During long-term therapy for any indication, the dosage should be maintained at the lowest effective dose and patients should be periodically reassessed to determine the need for continued treatment.
As with many other medications, ZOLOFT should be used with caution in patients with hepatic impairment (see PRECAUTIONS). The effects of ZOLOFT in patients with moderate and severe hepatic impairment have not been studied.
(See INDICATIONS: Pediatrics (<18 years of age); WARNINGS: POTENTIAL ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM; ADVERSE REACTIONS).
TREATMENT OF PREGNANT WOMEN DURING THE THIRD TRIMESTER:
Post-marketing reports indicate that some neonates exposed to ZOLOFT, SSRIs, or other newer antidepressants late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating a pregnant woman with ZOLOFT during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering ZOLOFT in the third trimester.
SWITCHING PATIENTS TO OR FROM A MONOAMINE OXIDASE INHIBITOR:
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with ZOLOFT. In addition, at least 14 days should be allowed after stopping ZOLOFT before starting an MAOI (see CONTRAINDICATIONS).
DISCONTINUATION OF ZOLOFT TREATMENT:
Symptoms associated with the discontinuation or dosage reduction of ZOLOFT have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction (see PRECAUTIONS and ADVERSE REACTIONS).
A gradual reduction in the dose over several weeks rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient’s clinical response. (see PRECAUTIONS and ADVERSE REACTIONS).