Destiq Special Precautions

Special Warnings: Clinical worsening of depressive symptoms, unusual changes in behavior, and suicidality: Desvenlafaxine succinate is an SNRI, a class of medicines that may be used to treat depression. All in those treated with desvenlafaxine should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual change in behaviour. They, 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 changes in behavior, worsening of depression, and suicidal ideation, especially when initiating therapy or during any change in dose or dosage regimen. The risk of suicide attempt must be considered, especially in depressed, and the smallest quantity of drug, consistent with good in those management, should be provided to reduce the risk of overdose.
Suicidality in Children and Adolescents: Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders.
Anyone considering the use of an antidepressant in a child or adolescent for any clinical use must balance the risk of increased suicidality with the clinical need.
In those who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior.
Families and caregivers should be advised to closely observe the patient and to communicate with the prescriber.
Discontinuation effects: During marketing of serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), there have been post-marketing reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, seizures, visual impairment, and hypertension. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms, and sometimes these effects can be protracted and severe. In addition, suicide/suicidal thoughts and aggression have been observed in those during changes in desvenlafaxine dosing regimen, including during discontinuation.
They should be monitored when discontinuing treatment with desvenlafaxine. 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 (see Dosage & Administration; AAdverse Reactions).
Sexual dysfunction: Serotonin-norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see Adverse Reactions). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SNRIs.
Mania/Hypomania: Activation of mania/hypomania has also been reported in a small proportion with major affective disorder who were treated with other marketed antidepressants. As with all antidepressants, desvenlafaxine should be used cautiously in those with a history or family history of mania or hypomania (see Adverse Reactions).
Serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions: As with other serotonergic agents, the development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions may occur with desvenlafaxine treatment, particularly with concomitant use of other serotonergic drugs (including SSRIs, SNRIs, amphetamines and triptans), with drugs that impair metabolism of serotonin (e.g., MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists (see Dosage & Administration; Contraindications). Serotonin syndrome symptoms may include mental status changes (agitation, hallucinations, and coma), autonomic instability (e.g., tachycardia, labile 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 fluctuation of vital signs, and mental status changes (see Interactions). If concomitant treatment with desvenlafaxine and other agents that may affect the serotonergic and/or dopaminergic neurotransmitter systems is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of desvenlafaxine with serotonin precursors (such as tryptophan supplements) is not recommended.
Narrow-angle glaucoma: Mydriasis has been reported in association with desvenlafaxine; therefore, in those with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored (see Adverse Reactions).
Other information - Residual inert matrix tablet: In those receiving desvenlafaxine succinate may notice an inert matrix tablet passing in the stool or via colostomy. In those should be informed that the active medication has already been absorbed by the time the patient sees the inert matrix tablet.
Precautions: Co-administration of drugs containing venlafaxine and/or desvenlafaxine: Desvenlafaxine is the major active metabolite of venlafaxine. Products containing desvenlafaxine succinate should not be used concomitantly with products containing venlafaxine hydrochloride or other products containing desvenlafaxine succinate.
Effects on blood pressure: Pre-existing hypertension should be controlled before treatment with desvenlafaxine. In those who are receiving desvenlafaxine should have regular monitoring of blood pressure. Cases of elevated blood pressure requiring immediate treatment have been reported with desvenlafaxine.
Sustained blood pressure increases could have adverse consequences. In those who experience a sustained increase in blood pressure while receiving desvenlafaxine, either dose reduction or discontinuation should be considered. Caution should be exercised in treating in those with underlying conditions that might be compromised by increases in blood pressure (see Adverse Reactions).
Cardiovascular/cerebrovascular disorders: Caution is advised in administering desvenlafaxine to those with cardiovascular, cerebrovascular, or lipid metabolism disorders. Desvenlafaxine has not been evaluated systematically in those with a recent history of myocardial infarction, unstable heart disease, uncontrolled hypertension, or cerebrovascular disease (see Adverse Reactions).
Serum lipids: Measurement of serum lipids should be considered during treatment with desvenlafaxine (see Adverse Reactions).
Seizures: Desvenlafaxine has not been systematically evaluated with a seizure disorder. Desvenlafaxine should be prescribed with caution in those who have a seizure disorder (see Adverse Reactions).
Abnormal bleeding: Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), including desvenlafaxine, may increase risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants may add to this risk. Bleeding events related to SSRIs and SNRIs have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. Those should be cautioned about the risk of bleeding associated with the concomitant use of desvenlafaxine and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding.
Hyponatremia: Cases of hyponatremia and/or the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion have been described with SNRIs (including desvenlafaxine succinate) and SSRIs, usually in volume-depleted or dehydrated, including elderly and in those who take diuretics (see Adverse Reactions).
Effects on ability to drive and use machines: Interference with cognitive and motor performance: 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 desvenlafaxine therapy does not adversely affect their ability to engage in such activities.