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Venlafaxine has not been evaluated in patients with a recent history of myocardial infarction or unstable heart disease. Therefore, it should be used with caution in these patients.
Dose-related increases in blood pressure have been reported in some patients treated with venlafaxine. Cases of elevated blood pressure requiring immediate treatment have been reported in post-marketing experience. Measurement of blood pressure is recommended for patients receiving venlafaxine. Preexisting hypertension should be controlled before treatment with venlafaxine. Caution should be exercised in patients whose underlying conditions might be compromised by increases in blood pressure.
Increases in heart rate can occur, particularly with higher doses. Caution should be exercised in patients whose underlying conditions might be compromised by increases in heart rate.
Convulsions may occur with venlafaxine therapy. As with all antidepressants, venlafaxine should be introduced with caution in patients with a history of convulsions.
Mania/hypomania may occur in a small proportion of patients with mood disorders who have received antidepressants, including venlafaxine. As with other antidepressants, venlafaxine should be used cautiously in patients with a history or family history of bipolar disorder.
Aggression may occur in a small proportion of patients who have received antidepressants, including venlafaxine treatment, dose reduction or discontinuation.
As with other antidepressants, venlafaxine should be used cautiously in patients with a history of aggression.
Cases of hyponatremia and/or the syndrome of inappropriate antidiuretic hormone (SIADH) secretion may occur with venlafaxine, usually in volume-depleted or dehydrated patients. Elderly patients, patients taking diuretics and patients who are otherwise volume depleted, may be at a greater risk for this event.
Drugs that inhibit serotonin uptake may lead to abnormalities of platelet aggregation. The risk of skin and mucous membrane bleeding, including gastrointestinal hemorrhage, may be increased in patients taking venlafaxine. As with other serotonin re-uptake inhibitors, venlafaxine should be used cautiously in patients predisposed to bleeding, including patients on anticoagulants and platelet inhibitors.
The safety and efficacy of venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established. Co-administration of venlafaxine HCl and weight loss agents is not recommended. Venlafaxine HCl is not indicated for weight loss alone or in combination with other products.
Clinically relevant increases in serum cholesterol were recorded in 5.3% of venlafaxine-treated patients and 0% of placebo-treated patients treated for at least 3 months in placebo-controlled clinical trials. Measurement of serum cholesterol levels should be considered during long-term treatment.
Discontinuation effects are well-known to occur with antidepressants, and it is therefore recommended that the dosage of either formulation of venlafaxine be tapered gradually and the patient monitored. (See Dosage & Administration and Adverse Reactions.)
Abuse and Dependence: Clinical studies did not show evidence of drug-seeking behavior, development of tolerance or dose escalation over time.
In vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (PCP) or N-methyl-D-aspartic acid (NMDA) receptors. Venlafaxine was not found to have any significant CNS stimulant activity in rodents. In primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability. However, physicians should evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of Efexor XR eg, development of tolerance, dose escalation or drug-seeking behavior.
Effects on the Ability to Drive or Operate Machinery: Venlafaxine did not affect psychomotor, cognitive or complex behavior performance in healthy volunteers. However, any psychoactive drug may impair judgment, thinking and motor skills. Therefore, patients should be cautioned about their ability to drive or operate hazardous machinery.
Use in Pregnancy: The safety of venlafaxine in human pregnancy has not been established. Venlafaxine must be administered to pregnant women only if the expected benefits outweigh the possible risks. If venlafaxine is used until or shortly before birth, discontinuation effects in the newborn should be considered. Some neonates exposed to venlafaxine late in the 3rd trimester have developed complications requiring tube-feeding, respiratory support or prolonged hospitalization. Such complications can arise immediately upon delivery.
Use in Lactation: Venlafaxine and ODV are excreted in human milk; therefore, a decision should be made whether not to breastfeed or to discontinue venlafaxine.
Use in Children: Efficacy in patients <18 years has not been established.
In pediatric clinical trials, the adverse reaction, suicidal ideation, was observed. There were also increased reports of hostility and especially in major depressive disorder, self-harm.
As with adults, decreased appetite, weight loss, increased blood pressure and increased serum cholesterol have been observed in children and adolescents (6-17 years; see Adverse Reactions). Regular measurement of weight and blood pressure is recommended if venlafaxine is used in children and adolescents. Discontinuation of venlafaxine treatment should be considered for children and adolescents who experience a sustained increase in blood pressure. Measurement of serum cholesterol levels should be considered during long-term treatment of children and adolescents (see Dosage & Administration and Adverse Reactions). Safety in children <6 years has not been evaluated.
Use in the Elderly: No specific dosage adjustments of venlafaxine are recommended based on patient age.
