Sertraline should be administered once daily, either in the morning or evening.
Initial Treatment: Depression and OCD: Sertraline treatment should be administered at a dose of 50 mg/day.
Panic Disorder, PTSD and Social Phobia: Therapy should be initiated at 25 mg/day. After one week, the dose should be increased to 50 mg once daily. This dosage regimen has been shown to reduce the frequency of early-treatment-emergent side effects characteristic of panic disorder.
Premenstrual Dysphoric Disorder: Sertraline treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of menstrual cycle, depending on physician assessment.
Titration: Depression, OCD, Panic Disorder, PTSD and Social Phobia: Patients not responding to a 50 mg dose may benefit from dose increases. Dose changes should be made at intervals of at least one week, up to a maximum of 200 mg/day. Changes in dose should not be made more frequently than once per week given the 24-hour elimination half-life of sertraline.
The onset of therapeutic effect may be seen within 7 days. However, longer periods are usually necessary to demonstrate therapeutic response, especially in OCD.
Premenstrual Dysphoric Disorder: Patients not responding to a 50 mg 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. If a 100 mg/day dose has been established with luteal phase dosing, a 50 mg/day titration step for three days should be utilized at the beginning of each luteal phase dosing period.
Maintenance: Dosage during long-term therapy should be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response.
Use in Children: The safety and efficacy of sertraline have been established in pediatric OCD patients aged 6 to 17 years. The administration of sertraline to pediatric OCD patients (aged 13 to 17 years) should commence at 50 mg/day. Therapy for pediatric OCD patients (aged 6 to 12 years) should commence at 25 mg/day, increasing to 50 mg/day after one week. Subsequent doses may be increased in case of lack of response in 50 mg/day increments, up to 200 mg/day, as needed. In a clinical trial in patients aged 6 to 17 years with depression or OCD, sertraline appeared to have a similar pharmacokinetic profile to that found in adults. However, the generally lower body weights of children compared to those of adults should be taken into consideration when increasing the dose from 50 mg.
Titration in Children and Adolescents: Sertraline has an elimination half-life of approximately one day; dose changes should not occur at intervals of less than one week.
Use in the Elderly: The same dose range as in younger patients may be used in the elderly. Over 700 elderly patients (>65 years) have participated in clinical studies that demonstrated the efficacy of sertraline in this patient population. The pattern and incidence of adverse reactions in the elderly were similar to that in younger patients.
Use in Hepatic Insufficiency: The use of sertraline in patients with hepatic disease should be approached with caution. A lower or less frequent dose should be used in patients with hepatic impairment (see Precautions).
Use in Renal Insufficiency: Sertraline is extensively metabolized. Excretion of unchanged drug in urine is a minor route of elimination. As expected from the low renal excretion of sertraline, sertraline dosing does not have to be adjusted based on the degree of renal impairment (see Precautions).
Zoloft: Sertraline tablets can be administered with or without food.
Zoloft ODT: Sertraline orally disintegrating tablets should be placed in the mouth, on the tongue, where it will rapidly disintegrate, and then should be swallowed. The orally disintegrating tablets can be taken with or without water and should be taken immediately upon removal from the package. For patients requiring multiple orally disintegrating tablets in one dose, each orally disintegrating tablet should be placed individually in the mouth and swallowed upon disintegration before taking the subsequent tablet.
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