The balance of risks and benefits should be considered before prescribing venlafaxine to patients at high risk of serious cardiac arrhythmia or QTc prolongation (see section 5.1).Convulsions may occur with venlafaxine therapy. The no-effect dose for these findings was 1.3 times the human dose. Mean ± SD plasma half-lives of venlafaxine and ODV are 5±2 hours and 11±2 hours, respectively. Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non-selective MAOI. Continue typing to refine. Caution is advised, and a dose reduction by more than 50% should be considered. It is recommended that venlafaxine should be discontinued for at least 7 days before starting treatment with a reversible MAOI (see section 4.4). Treatment should be reassessed regularly, on a case-by-case basis.It is recommended that a dose of 37.5 mg/day of prolonged-release venlafaxine be used for 7 days. Venlafaxine was not mutagenic in a wide range of Animal studies regarding reproductive toxicity have found in rats a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation. Absolute bioavailability is 40% to 45% due to presystemic metabolism. Epidemiological studies have shown that venlafaxine-treated patients have a higher burden of suicide risk factors than SSRI patients. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. The antibiotic linezolid is a weak reversible and non-selective MAOI and should not be given to patients treated with venlafaxine (see section 4.4).Severe adverse reactions have been reported in patients who have recently been discontinued from an MAOI and started on venlafaxine, or have recently had venlafaxine therapy discontinued prior to initiation of an MAOI. Caution should be exercised in patients whose underlying conditions might be compromised by increases in heart rate.Venlafaxine has not been evaluated in patients with a recent history of myocardial infarction or unstable heart disease. Dosage increases can be made at intervals of 2 weeks or more. Venlafaxine is not indicated for weight loss alone or in combination with other products.Mania/hypomania may occur in a small proportion of patients with mood disorders who have received antidepressants, including venlafaxine.
This exposure was approximately 1 to 2 times that of a human venlafaxine dose of 375 mg/day. 4.5 Interaction with other medicinal products and other forms of interaction6.6 Special precautions for disposal and other handling9.
Such complications can arise immediately upon delivery.Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Venlafaxine has been shown not to increase the impairment of mental and motor skills caused by ethanol.
In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition may occur with venlafaxine treatment, particularly with concomitant use of other agents that may affect the serotonergic neurotransmitter system (including triptans, SSRIs, SNRIs, amphetamines, lithium, sibutramine, St.John's Wort [Serotonin syndrome symptoms 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 gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).
This is most likely to occur within the first few weeks of treatment.
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