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VENLOR XR Capsules are indicated for the treatment of MDD as defined in the DSM-5, including depression accompanied by anxiety. Following an initial response, VENLOR XR Capsules are indicated for the prevention of relapses of the initial episode of depression or recurrence of new episodes.
(A major depressive episode (DSM-5) implies a prominent and relatively persistent [nearly every day for at least 2 weeks] depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same 2-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, fatigue, feelings of guilt or worthlessness, diminished ability to think or concentrate, and recurrent suicide attempts or suicidal ideation.)
VENLOR XR Capsules are indicated for the treatment of GAD as defined in the DSM-5. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
(Generalized anxiety disorder [DSM-5] is characterized by excessive anxiety and worry [apprehensive expectation] that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least three of the following six symptoms: restlessness or feeling keyed-up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.)
VENLOR XR Capsules are indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in the DSM-5.
(Social anxiety disorder [DSM-5] is characterized by a marked and persistent fear of one or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The fear, anxiety, or avoidance is persistent, typically lasting for 6 months or more. The avoidance, anxious anticipation or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.)
VENLOR XR Capsules are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in the DSM-5.
(Panic disorder [DSM-5] is characterized by recurrent, unexpected panic attacks, i.e., a discrete period of intense fear or discomfort, in which four [or more] of the following symptoms develop abruptly and reach a peak within minutes: 1) palpitations, pounding heart or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded or faint; 9) Derealisation (feelings of unreality) or depersonalization [being detached from oneself]; 10) fear of losing control; 11) fear of dying; 12) paraesthesias (numbness or tingling sensations); and, 13) chills or hot flushes. It is also associated with concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behaviour related to the attacks.)
For most patients, the recommended starting dose of VENLOR XR Capsules is 75 mg/day, administered in a single dose. For some patients, it may be desirable to start at 37.5 mg/day for 4 to 7 days, to allow new patients to adjust to the medication before increasing to 75 mg/day. Patients not responding to the initial 75 mg/day dose may benefit from dose increases to a maximum of approximately 225 mg/day. Dose increases should be in increments of up to 75 mg/day, as needed, and should be made at intervals of not less than 4 days, since steady-state plasma levels of venlafaxine and its major metabolites are achieved in most patients by day 4.
In more severely depressed or hospitalized patients, and under the close supervision of a physician, the daily dose may then be increased to the maximum recommended dose of VENLOR XR Capsules 225 mg, given once daily. The experience with venlafaxine extended-release doses higher than 225 mg/day is very limited and therefore, higher doses should be administered under specialist supervision. The dose should then be gradually reduced, to the minimum effective dose consistent with patient response and tolerance. A limited amount of venlafaxine should be provided to reduce the risk from overdose.
There is no body of evidence available from controlled trials to indicate how long patients with MDD should be treated with venlafaxine. It is generally agreed that acute episodes of MDD require several months or longer of sustained pharmacological therapy beyond the response to the acute episode. Venlafaxine has been shown to be efficacious during long-term (up to 12 months) treatment. It is not known whether or not the dose of venlafaxine extended release needed for maintenance treatment should be identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment with VENLOR XR Capsules.
For most patients, the recommended starting dose of VENLOR XR Capsules is 75 mg/day, administered in a single dose. For some patients, it may be desirable to start at 37.5 mg/day for 4 to 7 days, to allow new patients to adjust to the medication before increasing to 75 mg/day. Patients not responding to the initial 75 mg/day dose may benefit from dose increases to a maximum of approximately 225 mg/day. Dose increases should be in increments of up to 75 mg/day, as needed, and should be made at intervals of not less than 4 days.
There is no body of evidence available from controlled trials to indicate how long patients with GAD should be treated with venlafaxine. The physician who elects to use VENLOR XR Capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
The recommended dose of VENLOR XR Capsules is 75 mg/day, administered in a single dose. There was no evidence that higher doses confer any additional benefit.
There is no body of evidence available from controlled trials to indicate how long patients with social anxiety disorder should be treated with venlafaxine. The need for continuing medication in patients with social anxiety disorder who improve with VENLOR XR Capsules treatment should be periodically reassessed.
It is recommended that initial single doses of 37.5 mg/day of VENLOR XR Capsules be used for 7 days, followed by doses of 75 mg/day. Patients not responding to 75 mg/day may benefit from dose increases to a maximum of approximately 225 mg/day. Dose increases should be in increments of up to 75 mg/day, as needed, and should be made at intervals of not less than 7 days.
There is no body of evidence available from controlled trials to indicate how long patients with panic disorder should be treated with venlafaxine. The need for continuing medication in patients with panic disorder who improve with VENLOR XR Capsules treatment should be periodically reassessed.
Depressed patients who are currently being treated at a therapeutic dose with venlafaxine immediate-release may be switched to VENLOR XR Capsules at the nearest equivalent dose (mg/day), e.g. 37.5 mg venlafaxine twice daily to 75 mg VENLOR XR Capsules once daily. However, individual dosage adjustments may be necessary.
Symptoms associated with discontinuation of venlafaxine, other serotonin and nor-epinephrine reuptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs) have been reported. Reported symptoms include agitation, anorexia, anxiety, confusion, impaired coordination and balance, diarrhoea, dizziness, dry mouth, dysphoric mood, fasciculation, fatigue, flu-like symptoms, headaches, hypomania, insomnia, nausea, nervousness, nightmares, sensory disturbances (including shock-like electrical sensations), somnolence, sweating, tremor, vertigo and vomiting. Patients should be monitored for these symptoms when discontinuing treatment with VENLOR XR Capsules. 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. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. Individualization of tapering may be necessary.
At least 14 days should elapse between the discontinuation of MAO inhibitors and initiation of therapy with VENLOR XR Capsules. In addition, at least 7 days should be allowed after stopping VENLOR XR Capsules before starting MAO inhibitors.
Neonates exposed to venlafaxine and other SNRIs or SSRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support and tube feeding. When treating pregnant women with VENLOR XR Capsules during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering VENLOR XR Capsules in the third trimester.
It is recommended that the total daily dose of VENLOR XR Capsules be reduced by 50% in patients with mild-to-moderate hepatic impairment. Since there was much individual variability in clearance between subjects with cirrhosis, it may be necessary to reduce the dose even more than 50% and individualization of dosing may be desirable in some patients. Insufficient data are available to support the use of venlafaxine extended-release in patients with severe hepatic impairment.
Given the decrease in the clearance for venlafaxine and the increase in the elimination half-life for both venlafaxine and ODV that is observed in patients with renal impairment (GFR = 10 to 70 mL/min), it is recommended that the total daily dose of VENLOR XR Capsules be reduced by 25–50%. In patients undergoing haemodialysis, it is recommended that the total daily dose of VENLOR XR Capsules be reduced by 50%. Because there was much individual variability in the clearances between patients with renal impairment, individualization of dosage may be desirable in some patients.
No adjustment in the usual dosage is recommended for elderly patients. However, as with any therapy, caution should be exercised in treating the elderly (e.g. due to the possibility of renal impairment; see also dosage recommendations for renal impairment). The lowest effective dose of VENLOR XR Capsules should always be used and patients should be carefully monitored when an increase in the dose is required.
Electrocardiogram changes (e.g. prolongation of the QT interval, bundle-branch block, and QRS prolongation), sinus and ventricular tachycardia, bradycardia and seizures, hypotension, vertigo, serotonin syndrome and changes in the level of consciousness have been reported in association with an overdose of venlafaxine, usually when in combination with alcohol and/or other CNS drugs.
Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants. Epidemiological studies have shown that venlafaxinetreated patients have a higher pre-existing burden of suicide risk factors than SSRI-treated patients. The extent to which the finding of an increased risk of fatal outcomes can be attributed to the toxicity of venlafaxine in overdosage as opposed to some characteristic(s) of venlafaxine-treated patients is not clear. Prescriptions for venlafaxine should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
Treatment should consist of those general measures employed in the management of overdosage with any antidepressant
Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients.
Activated charcoal should be administered. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidotes for venlafaxine are known.
In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose.
Store at room temperature, in a cool dry place.
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