Sertraline Dosage

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Usual Adult Dose for Depression

Initial dose: 50 mg orally once a day.
Increase dose by 50 mg increments no more often than weekly.
Maintenance Dose: Can increase once a week, to a maximum of 200 mg once a day.

Usual Adult Dose for Obsessive Compulsive Disorder

Initial dose: 50 mg orally once a day.
Increase dose by 50 mg increments no more often than weekly.
Maintenance Dose: Can increase once a week, to a maximum of 200 mg once a day.

Usual Adult Dose for Panic Disorder

Initial dose: 25 mg orally once a day, after one week, the dose may be increased to 50 mg once a day. Increase dose by 50 mg increments no more often than weekly.
Maintenance dose: Can increase once a week, to a maximum of 200 mg once a day.

Usual Adult Dose for Post Traumatic Stress Disorder

Initial dose: 25 mg orally once a day, after one week, the dose may be increased to 50 mg once a day. Increase dose by 50 mg increments no more often than weekly.
Maintenance dose: Can increase once a week, to a maximum of 200 mg once a day.

Usual Adult Dose for Social Anxiety Disorder

Initial dose: 25 mg orally once a day, after one week, the dose may be increased to 50 mg once a day. Increase dose by 50 mg increments no more often than weekly.
Maintenance dose: Can increase once a week, to a maximum of 200 mg once a day.

Usual Adult Dose for Premenstrual Dysphoric Disorder

Initial dose: 50 mg orally once a day, either throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle (depending on the clinical judgement of the physician).

Patients not responding to a 50 mg per day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to 150 mg per day when dosing daily throughout the menstrual cycle, or 100 mg per day when dosing during the luteal phase of the menstrual cycle. If a 100 mg per day dose is established with luteal phase dosing, a 50 mg per day titration step for three days should be utilized at the beginning of each luteal phase dosing period.

The effectiveness of sertraline for longer than three months has not been systematically evaluated in controlled trials.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Use with caution in patients with hepatic impairment. Lower or less frequent dosages are recommended.

Precautions

Children, adolescents, and young adults (18 to 24 years of age) with major depressive disorder and other psychiatric disorders may be at an increased risk of suicidal thinking and suicidality with antidepressant use, particularly during the first few months of treatment. Medical evidence has not shown this increased risk to exist in adults older than 24 years of age, but adults 65 years of age and older taking antidepressants appear to have a decreased risk of suicidality. The results of a meta-analysis indicate an overall favorable risk-to-benefit profile for the use of antidepressants (i.e., selective serotonin and/or norepinephrine reuptake inhibitors) in the treatment of pediatric patients (less than 19- years- old) with major depressive disorders (MDD), obsessive-compulsive disorder (OCD), or non- OCD anxiety disorders. Although this study also reports an overall increased risk of suicidal ideation/suicide attempt associated with the use of antidepressants in pediatric patients, the risk may be less than originally estimated. Additional prospective studies are warranted in order to confirm these findings.

Suicide related events have been reported in 2.7% of sertraline treated children and adolescents in controlled clinical trials versus 1.1% reported in placebo- treated patients. In addition, the FDA reports antidepressants may increase suicidal thoughts and actions in approximately 1 out of 50 pediatric patients (18 years or younger).

Worsening of depression and/or increased suicidal thinking or behavior may always be a possibility in patients treated with antidepressant medications, particularly those being treated for depression. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. It is unknown if these symptoms are a precursor to either worsening of depression or the emergence of suicidal impulses; however, there is concern that patients who experience one or more of these symptoms may be at increased risk for worsening depression or suicidality. Although the FDA has not concluded that antidepressant drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy.

Health care providers should carefully monitor patients receiving antidepressants for possible and/or persistent worsening of depression or emergent suicidality, especially at the beginning of therapy or when the dose either increases or decreases. If symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms, the health care provider will need to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated. Prescriptions should be written for small quantities of drug to reduce the risk of an attempt to overdose. Health care providers should instruct patients, their families and their caregivers to be alert for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality and worsening depression, and to report such symptoms immediately to their health care provider.

Because antidepressants are believed to have the potential for inducing manic episodes in patients with bipolar disorder, there is a concern about using antidepressants alone in this population. Therefore, patients should be adequately screened to determine if they are at risk for bipolar disorder before initiating antidepressant treatment so that they can be appropriately monitored during treatment. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Sertraline has the potential for clinically significant inhibition of the metabolizing isozyme CYP450 2D6. Sertraline should be used with caution when used concomitantly with other drugs that are metabolized by CYP450 2D6, particularly drugs with a narrow therapeutic index. Dosing adjustments may be required when sertraline is used concurrently or has been recently discontinued. In contrast, sertraline does not appear to have a clinically significant affect on CYP450 3A4.

Dialysis

No adjustment recommended

Other Comments

Sertraline should be administered once daily, either in the morning or evening.

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