Even subjects randomized to placebo as the first treatment did not reach their baseline pruritus scores at the end of the 6‐week placebo treatment, suggesting that if there is a carry‐over effect, it is very long lasting.

Patients not responding to a 50 mg/day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to 150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing during the luteal phase of the menstrual cycle. Patients should be monitored for these symptoms when discontinuing treatment. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com.

In addition, subjects randomized to sertraline or its matching placebo were not naïve to sertraline; they had previously been treated with sertraline in the open‐label dose escalating phase of the study. The side effects of all subjects are reported in Table At each visit, subjects completed the 30‐item Inventory of Depressive Symptomatology–Self‐report (IDS‐SRAt the end of the double‐blind treatment, subjects were asked (1) which treatment (first or second) they thought was the sertraline, (2) why they thought so, and (3) which treatment they preferred. The physician may consider tapering ZOLOFT in the third trimester.Symptoms associated with discontinuation of ZOLOFT and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). The physician may consider tapering ZOLOFT in the third trimester.Symptoms associated with discontinuation of ZOLOFT and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Subsequently, the physician may continue decreasing the dose but at a more gradual rate.ZOLOFT Oral Concentrate contains 20 mg/mL of sertraline (as the hydrochloride) as the active ingredient and 12% alcohol. However, as women commonly report that symptoms worsen with age until relieved by the onset of menopause, it is reasonable to consider continuation of a responding patient.

It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Because sertraline is metabolized in the liver, one might have expected a higher frequency of side effects in a population with liver dysfunction. Therapy with ZOLOFT may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with ZOLOFT is unclear. Pruritus scores actually worsened slightly in the placebo group. After one week, the dose should be increased to 50 mg once daily.While a relationship between dose and effect has not been established for major depressive disorder, OCD, panic disorder, PTSD or social anxiety disorder, patients were dosed in a range of 50–200 mg/day in the clinical trials demonstrating the effectiveness of ZOLOFT for the treatment of these indications. Overall, the most common areas affected by cholestatic pruritus were the back, lower legs, upper arms, and thighs. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. Systematic evaluation of ZOLOFT has demonstrated that its efficacy in PTSD is maintained for periods of up to 28 weeks following 24 weeks of treatment at a dose of 50–200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. As an SSRI, Zoloft is thought to work by inhibiting the passage of serotonin between two nerve cells, allowing for the serotonin to stay in the synapse (gap) between the cells, thereby increasing its availability to bind with the proteins in the receiving cell.

Given the 24 hour elimination half-life of ZOLOFT, dose changes should not occur at intervals of less than 1 week.ZOLOFT treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.While a relationship between dose and effect has not been established for PMDD, patients were dosed in the range of 50–150 mg/day with dose increases at the onset of each new menstrual cycle (see Clinical Trials under CLINICAL PHARMACOLOGY). The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Do not mix in advance.