Sertraline should be administered once daily in the morning or evening at the same time every day. Sertraline can be administered with or without food. If somnolence is noted, Sertraline should be given at bedtime.
Patients receiving Sertraline should be monitored for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustment.
Recommended dosage: Major Depressive Disorder (MDD): Adult: Initial treatment: 50 mg orally once daily or following doctor's instruction.
Maintenance treatment: Dose may be increased, if necessary, in increments of 50 mg daily at intervals of at least a week to a maximum of 200 mg daily or following doctor's instruction.
Note: For the management of depressive symptoms associated with dementia of the Alzheimer's type in geriatric patients, recommended an initial Sertraline dosage of 12.5-25 mg once daily. The dosage may then be gradually increased at intervals of 1-2 weeks up to a maximum dosage of 150-200 mg once daily.
Obsessive Compulsive Disorder (OCD): Adult: Initial treatment: 50 mg orally once daily or following doctor's instruction.
Maintenance treatment: Dose may be increased, if necessary, in increments of 50 mg daily at intervals of at least a week to a maximum of 200 mg daily or following doctor's instruction.
Children: Initial treatment: 6 to 12 years: 25 mg orally once daily or following doctor's instruction.
13 to 17 years: 50 mg orally once daily or following doctor's instruction.
Maintenance treatment: Dose may be increased, if necessary, in increments of 50 mg daily at intervals of at least a week to a maximum of 200 mg daily or following doctor's instruction.
Note: Increases in doses, the lower body weights of children should be considered in order to avoid excessive doses.
Panic Disorder: Adult: Initial treatment: 25 mg orally once daily, increased after one week to 50 mg daily or following doctor's instruction.
Maintenance treatment: Dose may be increased, if necessary, in increments of 50 mg daily at intervals of at least a week to a maximum of 200 mg daily or following doctor's instruction.
Social Anxiety Disorder (SAD): Adult: Initial treatment: 25 mg orally once daily, increased after one week to 50 mg daily or following doctor's instruction.
Maintenance treatment: Dose may be increased, if necessary, in increments of 50 mg daily at intervals of at least a week to a maximum of 200 mg daily or following doctor's instruction.
Post-traumatic Stress Disorder (PTSD): Adult: Initial treatment: 25 mg orally once daily, increased after one week to 50 mg daily or following doctor's instruction.
Maintenance treatment: Dose may be increased, if necessary, in increments of 50 mg daily at intervals of at least a week to a maximum of 200 mg daily or following doctor's instruction.
Premenstrual Dysphoric Disorder (PMDD): Adult: Initial treatment: 50 mg orally once daily, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.
Maintenance treatment: Dose may be increased, if necessary, by 50 mg each menstrual cycle up to maximum of 150 mg daily when dosing daily throughout the menstrual cycle or 100 mg daily when dosing during the luteal phase of menstrual cycle or following doctor's instruction.
Note: If a 100 mg daily dose has been established with luteal phase dosing, utilize a 50 mg daily titration step for 3 days at beginning of each luteal phase dosing period.
Discontinuation of Sertraline: Symptoms associated with discontinuation of Sertraline and other selective serotonin-reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) have been reported. Monitor patients for these symptoms e.g. dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the health care provider may continue decreasing the dose but at a more gradual rate.
Switching patients to or from MAOIs: At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with Sertraline. In addition, allow at least 14 days after stopping Sertraline before starting a MAOI.
Dosage in pediatric patients: Safety and efficacy of Sertraline in children with Obsessive Compulsive Disorder (OCD) younger than 6 years of age have not been established. Safety and efficacy of Sertraline in children younger than 17 years of age with Panic Disorder, Social Anxiety Disorder (SAD), Post-traumatic Stress Disorder (PTSD), and Premenstrual Dysphoric Disorder (PMDD) have not been established.
If the drug is considered to be used in child or adolescent for any clinical use must balance the potential risk of therapy with the clinical need.
Dosage in geriatric patients: The efficacy or adverse effects in the elderly was similar to that in younger patients. However, plasma clearance of Sertraline may be decreased in geriatric patients.
Dosage in hepatic impairment: Sertraline should be administered with caution and in a reduced dosage or less frequently in patients with hepatic impairment.
Dosage in renal impairment: No need for dosage adjustment in patients with renal impairment. Because Sertraline does not appear to be removed substantially by dialysis, supplemental doses of the drug are probably unnecessary after dialysis.
Dosage in pregnancy and lactation: There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed.
Neonates exposed to SSRIs or serotonin-norepinephrine reuptake inhibitors (SNRIs) late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included apnea, constant crying, cyanosis, feeding difficulty, hyperreflexia, hypertonia, hypoglycemia, hypotonia, irritability, jitteriness, respiratory distress, seizure, temperature instability, tremor, and vomiting. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is constant with serotonin syndrome. When treating a pregnant woman with SSRIs during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
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