Exulten Special Precautions



United Pharma


Full Prescribing Info
Special Precautions
Suicidality and Antidepressant Drugs: 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 24 years old; there was a reduction in risk with antidepressants compared to placebo in adults 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 except for patients with obsessive-compulsive disorder (OCD).
Clinical Worsening and Suicide Risk: Patients with MDD, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.
Symptoms such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for MDD as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Families and caregivers of patients being treated with antidepressants for MDD or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and other symptoms described previously, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.
Prescriptions of sertraline should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
Screening for Bipolar Disorder: Bipolar disorder may present initially as a Major Depressive Episode (MDE). Treating an MDE with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Adequately screen patients with depressive symptoms if they are at risk for bipolar disorder before starting antidepressant treatment. Include a detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) during such screening. Sertraline is not approved for use in treating bipolar depression.
Serotonin Syndrome or neuroleptic malignant syndrome (NMS): SSRIs such as sertraline, and SNRIs can cause potentially life-threatening serotonin syndrome or NMS-like reactions, particularly when taken together with serotonergic drugs (including triptans and fentanyl), with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Characteristic symptoms of serotonin syndrome include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form can resemble NMS, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.
Activation of Mania/Hypomania: Mania or hypomania has been reported in patients taking sertraline.
Seizures: Use sertraline cautiously in patients with seizure disorder.
Potential Interaction with MAOIs: Cases of serious sometimes fatal reactions have been reported in patients receiving sertraline, an SSRI, in combination with a MAOI. Symptoms of a drug interaction between an SSRI and a MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability, and extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued an SSRI and have been started on a MAOI; some cases presented with features resembling NMS. Thus, sertraline should not be used in combination with a MAOI, or within 14 days of discontinuing treatment with a MAOI. Similarly, at least 14 days should be allowed after stopping sertraline before starting a MAOI.
Weight Loss: Sertraline may cause significant weight loss which may be undesirable for some patients.
Diabetes/Loss of Glycemic Control: Cases of new onset diabetes mellitus have been reported in patients receiving SSRIs including sertraline. Loss of glycemic control including both hyperglycemia and hypoglycemia has also been reported in patients with and without pre-existing diabetes. Thus, patients should be monitored for signs and symptoms of glucose fluctuations. Diabetic patients especially should have their glycemic control carefully monitored since their dosage of insulin and/or concomitant oral hypoglycemic drug may need to be adjusted.
Weak Uricosuric Effect: Sertraline hydrochloride may decrease serum uric acid. The clinical significance of this weak uricosuric effect is unknown.
Hyponatremia: Hyponatremia may occur as a result of treatment with SSRIs, including sertraline, and SNRIs. This hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk. Discontinuation of sertraline should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.
Abnormal Bleeding: SSRIs, including sertraline, and SNRIs may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies have shown an association between the use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to the use of SSRIs and SNRIs have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.
Patients should be cautioned about the risk of bleeding associated with the concomitant use of sertraline and NSAID, aspirin, or other drugs that affect coagulation.
Platelet Function: Sertraline may cause alteration of platelet function and/or abnormal laboratory results. Although abnormal bleeding or purpura has also been reported with sertraline use, the causative role of sertraline is unclear.
Use in Patients with Concomitant Illness: Use sertraline cautiously in patients with diseases or conditions that could affect metabolism or hemodynamic responses.
Discontinuation of Sertraline Treatment: Dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania have been associated with discontinuation of sertraline, particularly when abrupt, and other SSRIs and SNRIs.
Interference with Cognitive and Motor Performance: Sertraline does not cause sedation or interfere with psychomotor performance. However, as psychotropic drugs may impair the mental or physical ability required for the performance of potentially hazardous tasks such as driving a car or operating machinery, the patient should be cautioned accordingly.
Use in Children: Infants and Children: Sertraline should not be used in the treatment of children and adolescents under 18 years old, except for patients with OCD aged 6 to 17 years old. Suicide-related behaviors (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behavior and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioral development are lacking. Physicians must monitor pediatric patients on long term treatment for abnormalities in these body systems.
Use in the Elderly: No overall differences in efficacy or adverse effects are observed in geriatric patients relative to younger patients. The elderly should be dosed carefully, as they may be more at risk for hyponatremia.
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