The efficacy and safety of venlafaxine for other indications in children and adolescents under the age of 18 have not been established. However, due to inter-individual variability in clearance, individualisation of dosage may be desirable.
There are limited data in patients with severe hepatic impairment. The potential benefit should be weighed against the risk in the treatment of patients with severe hepatic impairment. Because of inter-individual variability in clearance in these patients, individualisation of dosage may be desirable. Withdrawal symptoms seen on discontinuation of venlafaxine Abrupt discontinuation should be avoided. When stopping treatment with venlafaxine, the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions see sections 4.
If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate. Method of administration For oral use. It is recommended that venlafaxine prolonged-release capsules be taken with food, at approximately the same time each day. Capsules must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.
Patients treated with venlafaxine immediate-release tablets may be switched to venlafaxine prolonged-release capsules at the nearest equivalent daily dosage.
For example, venlafaxine immediate-release tablets Individual dosage adjustments may be necessary. Venlafaxine prolonged-release capsules contain spheroids, which release the active substance slowly into the digestive tract.
The insoluble portion of these spheroids is eliminated and may be seen in faeces. Concomitant treatment with irreversible monoamine oxidase inhibitors MAOIs is contraindicated due to the risk of serotonin syndrome with symptoms such as agitation, tremor and hyperthermia.
Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI. Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible MAOI see sections 4. This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Other psychiatric conditions for which venlafaxine is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients, and in particular those at high risk, should accompany drug therapy, especially in early treatment and following dose changes.
Patients and caregivers of patients should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour, and to seek medical advice immediately if these symptoms present. Paediatric population Efexor XL should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours suicide attempt and suicidal thoughts and hostility predominantly aggression, oppositional behaviour and anger were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Serotonin syndrome 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, lithium, sibutramine, St. John's Wort [Hypericum perforatum], fentanyl and its analogues, tramadol, dextromethorphan, tapentadol, pethidine, methadone and pentazocine , with medicinal agents that impair metabolism of serotonin such as MAOIs e.
Serotonin syndrome symptoms may include mental status changes e. 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.
The concomitant use of venlafaxine with serotonin precursors such as tryptophan supplements is not recommended. Narrow-angle glaucoma Mydriasis may occur in association with venlafaxine.
It is recommended that patients with raised intraocular pressure or patients at risk for acute narrow-angle glaucoma angle-closure glaucoma be closely monitored.
Blood pressure Dose-related increases in blood pressure have been commonly reported with venlafaxine. In some cases, severely elevated blood pressure requiring immediate treatment has been reported in postmarketing experience. All patients should be carefully screened for high blood pressure and pre-existing hypertension should be controlled before initation of treatment.
Blood pressure should be reviewed periodically, after initiation of treatment and after dose increases. Caution should be exercised in patients whose underlying conditions might be compromised by increases in blood pressure, e. Heart rate 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. Cardiac disease and risk of arrhythmia 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. 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. Convulsions Convulsions may occur with venlafaxine therapy. As with all antidepressants, venlafaxine should be introduced with caution in patients with a history of convulsions, and concerned patients should be closely monitored.
Treatment should be discontinued in any patient who develops seizures. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine.
Your mouth may get dry. Chewing sugarless gum, sucking hard candy and drinking plenty of water will help. Contact your doctor if the problem does not go away or is severe. What side effects may I notice from receiving this medicine? Side effects that you should report to your doctor or health care professional as soon as possible: Call your doctor for medical advice about side effects. Where should I keep my medicine?
Keep out of the reach of children. Concomitant Medication Advise patients taking Effexor XR not to use concomitantly other products containing venlafaxine or desvenlafaxine. Angle Closure Glaucoma Patients should be advised that taking Effexor XR can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy.
Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure e. Discontinuation [Symptoms] Advise patients not to stop taking Effexor XR without talking first with their healthcare professional.
Interference With Cognitive And Motor Performance Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that Effexor XR therapy does not adversely affect their ability to engage in such activities.
Allergic Reactions Advise patients to notify their physician if they develop allergic phenomena such as rash, hives, swelling, or difficulty breathing. Pregnancy Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy [see Use In Specific Populations]. Nursing Advise patients to notify their physician if they are breast-feeding an infant [see Use In Specific Populations].
Residual Spheroids Effexor XR contains spheroids, which release the drug slowly into the digestive tract. The insoluble portion of these spheroids is eliminated, and patients may notice spheroids passing in the stool or via colostomy. Patients should be informed that the active medication has already been absorbed by the time the patient sees the spheroids.
Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Carcinogenesis Tumors were not increased by venlafaxine treatment in mice or rats.
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