Devert-50/Devert-100 Special Precautions

Suicidal Thoughts and Behaviors: 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 strong 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 early phases of treatment. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Patients, their families and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual behavioral changes, worsening of depression and suicidal ideation, especially when starting therapy or during any change in the dose or dosing schedule. The risk of suicide attempt should be considered, especially in depressed patients, and the least amount of medication, consistent with a good patient management, should be provided to reduce the risk of overdose.
Mania/Hypomania: In clinical studies, mania was reported in 0.02% of patients treated with desvenlafaxine. Activation of mania/ hypomania has also been reported in a small proportion of patients with major affective disorder who were treated with other marketed antidepressants. As with all antidepressants, Desvenlafaxine should be used with caution in patients with a personal history or family history of mania or hypomania.
Serotonin Syndrome or reactions similar to Neuroleptic Malignant Syndrome (NMS): As with other serotonergic agents, the development of a potentially life-threatening serotonin syndrome can occur with treatment with desvenlafaxine, particularly with concomitant use of other serotonergic drugs (including SSRIs, SNRIs and triptans) with drugs which impair the metabolism of serotonin (e.g. MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists.
Symptoms of serotonin syndrome may include mental status changes (for e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, instable blood pressure and hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting and diarrhea). Serotonin syndrome in its most severe form can resemble NMS, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes. If concomitant treatment with desvenlafaxine and other agents that may affect the serotonergic and/or dopaminergic neurotransmitter system is clinically justified, a careful observation of the patient is recommended, particularly during treatment initiation and dose increases. Concomitant use of desvenlafaxine with serotonin precursors (such as tryptophan supplements) is not recommended.
Angle Closure Glaucoma: Mydriasis has been reported in association with desvenlafaxine; therefore, patients with raised intraocular pressure or those at risk of narrow/closed angle glaucoma should be monitored.
Effects on Blood Pressure: Regular monitoring of blood pressure for patients taking Desvenlafaxine is advised since increases in blood pressure were observed in studies. For patients with pre-existing hypertension, blood pressure should be controlled before installing treatment of Desvenlafaxine. For patients who experience a sustained increase in blood pressure while receiving desvenlafaxine, dose reduction or discontinuation should be considered. Caution should be taken in patients with medical conditions that might be compromised by increases in blood pressure.
Seizures: Cases of seizures have been reported in pre-marketing clinical studies with Desvenlafaxine. Desvenlafaxine has not been systematically evaluated in patients with seizure disorder. Patients with a history of seizures were excluded from clinical studies. Desvenlafaxine should be prescribed with caution in these patients.
Effects of Discontinuation of Treatment with Desvenlafaxine succinate monohydrate Tablets: During marketing of SNRIs and SSRIs, there have been spontaneous reports of adverse events that occurred from the discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g. paresthesias such as feelings of electric shock), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or discontinuation of treatment, resumption of the previously prescribed dose should be considered. Patients should be monitored for symptoms on discontinuing treatment with Desvenlafaxine.
Abnormal bleeding: SSRIs and SNRIs, including Desvenlafaxine, can increase the risk of bleeding events. Concomitant use of acetylsalicylic acid, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anti-coagulants may contribute to this risk. Bleeding-related to SSRIs and SNRIs ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. Patients should be cautioned about the risk of bleeding associated with concomitant use of Desvenlafaxine and NSAIDs, acetylsalicylic acid or other substances that affect coagulation or bleeding.
Hyponatremia: Cases of hyponatremia and/or Syndrome of Inappropriate Secretion of Antidiuretic Hormone (SIADH) have been reported with SNRIs (including desvenlafaxine succinate) and SSRIs, including elderly patients and patients taking diuretics (volume depleted). Discontinuation of Desvenlafaxine should be considered in patients with symptomatic hyponatremia (e.g. headache, difficulty of concentrating, memory impairment, confusion, weakness, and unsteadiness - which leads to falls) and appropriate medical intervention should be done. Signs and symptoms associated with more severe/acute cases include hallucination, syncope, seizure, coma, respiratory arrest, and death.
Interstitial Lung Disease and Eosinophilic Pneumonia: Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine therapy (parent drug of Desvenlafaxine) have been reported rarely. The possibility of these adverse effects should be considered in patients treated with Desvenlafaxine who develop progressive dyspnea, cough or chest discomfort. Those patients should undergo a prompt medical evaluation and should consider discontinuation of Desvenlafaxine.
Screening Patients for Bipolar Disorder: Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history because Desvenlafaxine is not approved for use in treating bipolar depression.
Serum Lipids: Dose-related elevations in fasting serum total cholesterol, LDL (low Density Lipoprotein) cholesterol, and triglycerides were observed. Measurement of serum lipids should be considered during treatment with desvenlafaxine.
Abuse and Dependence: Although desvenlafaxine has not been studied for its potential for abuse, no indication of drug-seeking behavior was reported.
Effects on ability to drive and use machines: Results of a clinical study that evaluated the effects of desvenlafaxine on behavioral performance of healthy subjects revealed no clinically significant impairment of psychomotor, cognitive, or complex behavior performance. However, like any CNS-active drug may impair judgment, thinking or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that therapy with desvenlafaxine does not have adverse effect on their ability to perform these activities.