Usual Adult Dose for Depression

Initial dose: 50 mg orally once a day
Maintenance Dose: 50 to 200 mg orally once a day

Comments:

• Dose adjustments may be made at intervals of at least one week.
• Obsessive Compulsive Disorder (OCD) and acute episodes of Major Depressive Disorder (MDD) require several months or longer of sustained pharmacologic therapy.

• Treatment of MDD
• Treatment of OCD

Usual Adult Dose for Obsessive Compulsive Disorder

Initial dose: 50 mg orally once a day
Maintenance Dose: 50 to 200 mg orally once a day

Comments:

• Dose adjustments may be made at intervals of at least one week.
• Obsessive Compulsive Disorder (OCD) and acute episodes of Major Depressive Disorder (MDD) require several months or longer of sustained pharmacologic therapy.

• Treatment of MDD
• Treatment of OCD

Usual Adult Dose for Panic Disorder

Initial dose: 25 mg orally once a day, increased after one week to 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day

Comments:

• Dose adjustments may be made at intervals of at least one week.
• These conditions generally required several months or longer of sustained pharmacological therapy beyond initial treatment.

• Treatment of panic disorder
• Treatment of posttraumatic stress disorder (PTSD)
• Treatment of social anxiety disorder (SAD)

Usual Adult Dose for Post Traumatic Stress Disorder

Initial dose: 25 mg orally once a day, increased after one week to 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day

Comments:

• Dose adjustments may be made at intervals of at least one week.
• These conditions generally required several months or longer of sustained pharmacological therapy beyond initial treatment.

• Treatment of panic disorder
• Treatment of posttraumatic stress disorder (PTSD)
• Treatment of social anxiety disorder (SAD)

Usual Adult Dose for Social Anxiety Disorder

Initial dose: 25 mg orally once a day, increased after one week to 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day

Comments:

• Dose adjustments may be made at intervals of at least one week.
• These conditions generally required several months or longer of sustained pharmacological therapy beyond initial treatment.

• Treatment of panic disorder
• Treatment of posttraumatic stress disorder (PTSD)
• Treatment of social anxiety disorder (SAD)

Usual Adult Dose for Premenstrual Dysphoric Disorder

Continuous regimen:

• Initial dose: 50 mg orally once a day during the menstrual cycle
• Maintenance dose: 50 to 150 mg orally once a day during the menstrual cycle

• Initial dose: 50 mg orally once a day starting 14 days prior to the anticipated start of menstruation through to the first full day of menses, and repeated with each new cycle
• Maintenance dose: 50 to 100 mg orally once a day

• The dose may be increased in increments of 50 mg per menstrual cycle, increased at the onset of each new cycle; dosage adjustments may also include changes between regimens.
• If a 100 mg once daily dose has been established with the cyclic regimen, a titration step of 50 mg per day for three days should be used at the beginning of each dosing period (luteal phase of the menstrual cycle).
• The effectiveness of sertraline for longer than three months has not been systematically evaluated in controlled trials.

Usual Pediatric Dose for Obsessive Compulsive Disorder

6 to 12 years:

• Initial dose: 25 mg orally once a day
• Maintenance dose: 25 to 200 mg orally once a day

• Initial dose: 50 mg orally once a day
• Maintenance dose: 50 to 200 mg orally once a day

• The dose may be increased at intervals of at least one week.
• The potential risks versus clinical need should be assessed prior to using this drug in children and adolescents.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh 5 to 6): Patients should be given 50% of the initial and maintenance doses.
Moderate to severe liver dysfunction (Child-Pugh 7 to 15): Not recommended.

Dose Adjustments

Dose adjustments should be made to maintain patients on the lowest effective dose.

Switching from:

• MAOI to this drug: At least 14 days should elapse
• This drug to MAOI therapy: At least 14 days should elapse

• A gradual dose reduction is recommended instead of abrupt cessation where possible.
• If intolerable symptoms occur, it is recommended to consider resuming the previously prescribed dose and to decrease the dose at a more gradual rate.

Precautions

US BOXED WARNINGS:
SUICIDAL THOUGHTS AND BEHAVIORS:

• Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
• Anyone considering the use of sertraline or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.
• Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 years and older.
• Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.
• Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.
• Families and caregivers should be advised of the need for close observation and communication with the prescriber.
• Sertraline is not approved for use in pediatric patients (aged 6 to 17 years) except for patients with obsessive compulsive disorder (OCD).

Dialysis

Data not available

Other Comments

Administration advice:

• Oral administration with grapefruit juice should be avoided.
• Doses may be given either in the morning or evening.
• Sertraline oral concentrate solution should be diluted and mixed immediately before administration.

• The required dose of oral concentrate solution should be measured and mixed with half a cup of water, ginger ale, lemon/lime soda, lemonade, or orange juice only.

• The single dose bioavailability of the oral tablets is approximately equal to an equivalent dose of solution.
• The need for ongoing treatment should be regularly reviewed.
• Patients should be maintained on the lowest effective dose.
• For the treatment of PTSD, OCD and panic disorder, it is not known whether the dose of sertraline needed for maintenance is identical to the dose needed to achieve an initial response.

• Hepatic: Liver function
• Metabolic: Hyponatremia
• Nervous system: Serotonin syndrome
• Psychiatric: Emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

• Tell your healthcare provider about all of the medicines that you take, including prescription and non-prescription medicines.
• This medicine may increase the risk of suicidal thoughts and behavior. Be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report any behavior of concern to your healthcare provider as soon as possible.
• This medicine may cause impaired judgment, thinking, or motor skills; do not drive a car or operate dangerous machinery until you know how this drug affects you.
• Concomitant ingestion of alcohol is not advised.
• You should be advised to speak to a healthcare provider if you are pregnant, intend to become pregnant, or are breastfeeding.

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