Selrotine Special Precautions

Use of selective serotonin-reuptake inhibitors (SSRIs) such as Sertraline concurrently or in close succession with other drugs that affect serotonergic neurotransmission may result in serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reaction. Symptoms of serotonin may 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 GI symptoms (e.g. nausea, vomiting, diarrhea). Although the syndrome appears to be relatively uncommon and usually mild in severity, serious and potentially life-threatening complications, including seizures, disseminated intravascular coagulation, respiratory failure, and severe hyperthermia as well as death occasionally have been reported. In its most severe form, serotonin syndrome resembles NMS, which is characterized by hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation in vital signs, and mental status changes.
If signs and symptoms of serotonin syndrome or NMS develop during therapy, treatment with Sertraline and any concurrently administered serotonergic or antidopaminergic agents, including antipsychotic agents, should be discontinued immediately. Supportive and symptomatic treatment should be initiated.
The effectiveness of long-term use of SSRIs for OCD, panic disorder, social anxiety disorder, PMDD, and PTSD has not been systematically evaluated. However, the long-term use of SSRIs for depression has been evaluated and demonstrated to maintain antidepressant response for up to 1 year. Periodically reevaluate the SSRIs used for extended periods to determine long-term usefulness of the drug for the individual patient.
In patients receiving a SSRI in combination with a MAOI, serious, sometimes fatal reactions have occurred, including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include confusion, irritability, extreme agitation progressing to delirium, and coma. These reactions also have occurred in patients who have recently discontinued a SSRI and have been started on a MAOI. Therefore, it is recommended that SSRIs not be used in combination with a MAOI or within 14 days of discontinuing treatment with a MAOI. Allow at least 2 weeks after stopping the SSRIs before starting a MAOI.
Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and suicidality. Nevertheless, closely observe patients being treated with antidepressant for clinical worsening and suicidality, especially at the beginning of the course of drug therapy or at the time of dose changes, either increases or decreases.
Alter platelet function and/or abnormal results from laboratory studies in patients taking Sertraline have occurred. There have been reports of abnormal bleeding or purpura in several patients. Caution patients regarding the risk of bleeding associated with the concomitant use of SSRIs with NSAIDs, aspirin, or other drugs that affect coagulation.
Significant weight loss, especially in underweight depressed patients, has occurred. Approximately 3% to 7% of patients treated with a SSRI initially experienced anorexia. However, after prolonged treatments, patients tend to gain weight. Monitor weight change during therapy.
Activation of mania/hypomania occurred infrequently in approximately 0.1% to 2.6% of patients taking SSRIs. Use cautiously in patients with a history of mania.
Sertraline has not been evaluated in patients with a seizure disorder. Use with care in patients with history of seizure; discontinue therapy if seizures occur.
Several cases of Sertraline-induced hyponatremia (some with serum sodium less than 110 mmol/L) have occurred. The hyponatremia appeared to be reversible when the drug was discontinued. Although these cases were complex with varying possible etiologies, some were possibly because of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). The majority have been in elderly patients and in patients taking diuretics or who were otherwise volume-depleted.
Asymptomatic elevations in serum transaminase (AST or ALT) have occurred infrequently in association with Sertraline administration. These hepatic enzyme elevations usually occurred within the first 1 to 9 weeks of drug treatment and promptly diminished upon drug discontinuation. Sertraline therapy was associated with small mean increases in total cholesterol (approximately 3%) and triglycerides (approximately 5%) and a small mean decrease in serum uric acid (approximately 7%) of no apparent clinical importance.
Although SSRIs have not been shown to increase the impairment of mental and motor skills caused by alcohol, advise patients to avoid alcohol during therapy.