EFEXOR XR® Maintenance therapy reduced the risk of recurrence in moderate-to-severe MDD1,2
Patients were initially randomized to double-blind treatment with EFEXOR XR® or fluoxetine for 10 weeks of acute treatment. Responders then received 6 months of double-blind continuation treatment. Those who remained responders were then enrolled into 2 consecutive 12-month maintenance periods, during which EFEXOR XR® responders were randomly assigned to receive double-blind treatment with EFEXOR XR® or placebo. Recurrence was defined as a 17-item Hamilton Rating Scale for Depression (HAM-D17) total score ≥12 and ≤50% reduction from baseline (acute phase) at 2 consecutive visits or at the last valid visit prior to discontinuation. Data are for the second year of maintenance treatment and derived from primary definition of the probability of recurrence after 12 months.2
Among patients who initially responded to treatment with EFEXOR XR®… The estimated- probability of recurrence was significantly lower with EFEXOR XR® vs. placebo at 2 years.1,2
EFEXOR XR®: TREAT YOUR MDD PATIENTS WITH NO FEAR OF RECURRENCE1,2
XR: extended release, MDD: Major Depressive Disorder
EFEXOR XR® rapid and powerful improvements of depressive symptoms in patients with MDD.3
- EFEXOR XR ® achieved significantly higher response rates vs. placebo at Week 6 and Week 8, as measured by the 21-item Hamilton Rating Scale for Depression (HAM-D21)and the CGI Improvement (CGI-I) scale.3 †
Background: This was a randomized, double-blind, placebo-controlled evaluation of the efficacy and safety of once-daily venlafaxine extended release (XR) in outpatients with DSM-IV major depression. Method: Patients were randomly assigned to venlafaxine XR (75–225 mg) once daily or placebo for up to 8 weeks. The primary efficacy variables were the 21-item Hamilton Rating Scale for Depression (HAM-D) total score and HAM-D depressed mood item, the Montgomery-Asberg Depression Rating Scale (MADRS) total scores, and the Clinical Global Impressions (CGI) Severity scale. Data were analyzed on a modified intent-to-treat basis using the last-observation carried-forward method.
MDD: Major Depressive Disorder; CGI-I: Clinical Global Impressions-Improvement
- Keller MB, Trivedi MH, Thase ME, et al. The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) Study: Outcomes from the Acute and Continuation Phases. Biol Psychiatry. 2007; 62:1371–1379.
- Keller MB, Trivedi MH, Thase ME, et al. The Prevention of Recurrent Episodes of Depression With Venlafaxine for Two Years (PREVENT) Study: Outcomes From the 2-Year and Combined Maintenance Phases. J Clin Psychiatry. 2007 Aug;68(8):1246-1256.
- Thase ME. Efficacy and tolerability of once-daily venlafaxine extended release (XR) in outpatients with major depression. The Venlafaxine XR 209 Study Group. J Clin Psychiatry. 1997 Sep;58(9):393-8.
Dosing & Administration
EFEXOR XR®: provides flexible, once-daily dosing1
Available strengths in Saudi Arabia are 75mg & 150mg
*If clinically warranted due to symptoms severity, dose increases can be made at more frequent intervals, but not less than 4 days.
MDD: Major Depressive Disorder XR: extended release
Choose EFEXOR XR® for your adult patients with MDD, anxiety,* or both.
*EFEXOR XR® is indicated for Major Depressive Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, and Panic Disorder.
†After 2 years of maintenance therapy amongst EFEXOR XR® responders.
a) Efexor XR 75mg [SmPC]. New Bridge, Ireland: Pfizer Ireland Pharmaceuticals; March 2021.
b) Efexor XR150 mg [SmPC]. New Bridge, Ireland: Pfizer Ireland Pharmaceuticals; August 2021.
- Thase ME. Efficacy and tolerability of once-daily venlafaxine extended release (XR) in outpatients with major depression. The Venlafaxine XR 209 Study Group. J Clin Psychiatry. 1997;58 (9):393-398.
- Entsuah AR, Huang H, Thase ME. Response and remission rates in different subpopulations with major depressive disorder administered venlafaxine, selective serotonin reuptake inhibitors, or placebo. J Clin Psychiatry. 2001;62(11):869-877.
- Keller MB, Trivedi MH, Thase ME, et al. The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) Study: Outcomes from the 2-year and combined maintenance phases. J Clin Psychiatry. 2007;68(8):1246-1256.
- Boyer P, Mahé V, Hackett D. Social adjustment in generalised anxiety disorder: a long-term placebo-controlled study of venlafaxine extended release. Eur Psychiatry. 2004;19(5):272-279.
- Data on File. Viatris Inc. 2015.
- American Chemical Society. Heroes of Chemistry Recipients.
https://www.acs.org/content/acs/en/funding/awards/heroes-of-chemistry/past-recipients/archive.html. Accessed February 8, 2022.
Abbreviated Prescribing Information
[Efexor XR] ® abbreviated prescribing information
Presentation: 75 mg & 150 mg, prolonged release hard capsules, Venlafaxine HCl.
Indication(s): 1. Treatment of major depressive episodes. 2. For prevention of recurrence of major depressive episodes. 3. Treatment of generalized anxiety disorder. 4. Treatment of social anxiety disorder. 5. Treatment of panic disorder, with or without agoraphobia
Dosage and Administration: Major depressive episodes: The recommended starting dose for prolonged-release venlafaxine is 75 mg given once daily. Patients not responding to the initial 75 mg/day dose may benefit from dose increases up to a maximum dose of 375 mg/day. Dosage increases can be made at intervals of 2 weeks or more. If clinically warranted due to symptom severity, dose increases can be made at more frequent intervals, but not less than 4 days. Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation. The lowest effective dose should be maintained. Patients should be treated for a sufficient period of time, usually several months or longer. Treatment should be reassessed regularly on a case-by-case basis. Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE). In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during the current episode. Antidepressant medicinal products should continue for at least six months following remission. Generalised anxiety disorder: The recommended starting dose for prolonged-release venlafaxine is 75 mg given once daily. Patients not responding to the initial 75 mg/day dose may benefit from dose increases up to a maximum dose of 225 mg/day. Dosage increases can be made at intervals of 2 weeks or more. Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation. The lowest effective dose should be maintained. Patients should be treated for a sufficient period of time, usually several months or longer. Treatment should be reassessed regularly, on a case-by-case basis. Social anxiety disorder: The recommended dose for prolonged-release venlafaxine is 75 mg given once daily. There is no evidence that higher doses confer any additional benefit. However, in individual patients not responding to the initial 75 mg/day, increases up to a maximum dose of 225 mg/day may be considered. Dosage increases can be made at intervals of 2 weeks or more. Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation. The lowest effective dose should be maintained. Patients should be treated for a sufficient period of time, usually several months or longer. Treatment should be reassessed regularly, on a case-by-case basis. Panic disorder: It is recommended that a dose of 37.5 mg/day of prolonged-release venlafaxine be used for 7 days. Dosage should then be increased to 75 mg/day. Patients not responding to the 75 mg/day dose may benefit from dose increases up to a maximum dose of 225 mg/day. Dosage increases can be made at intervals of 2 weeks or more. Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation. The lowest effective dose should be maintained. Patients should be treated for a sufficient period of time, usually several months or longer. Treatment should be reassessed regularly, on a case-by-case basis. Elderly patients: No specific dose adjustments of venlafaxine are considered necessary based on patient age alone. However, caution should be exercised in treating the elderly (e.g., due to the possibility of renal impairment, the potential for changes in neurotransmitter sensitivity and affinity occurring with aging). The lowest effective dose should always be used, and patients should be carefully monitored when an increase in the dose is required. Paediatric population: Venlafaxine is not recommended for use in children and adolescents. Controlled clinical studies in children and adolescents with major depressive disorder failed to demonstrate efficacy and do not support the use of venlafaxine in these patients. The efficacy and safety of venlafaxine for other indications in children and adolescents under the age of 18 have not been established. Patients with hepatic impairment: In patients with mild and moderate hepatic impairment, in general a 50% dose reduction should be considered. However, due to inter-individual variability in clearance, individualisation of dosage may be desirable. There are limited data in patients with severe hepatic impairment. Caution is advised, and a dose reduction by more than 50% should be considered. The potential benefit should be weighed against the risk in the treatment of patients with severe hepatic impairment. Patients with renal impairment: Although no change in dosage is necessary for patients with glomerular filtration rate (GFR) between 30-70 ml/minute, caution is advised. For patients that require haemodialysis and in patients with severe renal impairment (GFR < 30 ml/min), the dose should be reduced by 50%. 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. However, the time period required for tapering and the amount of dose reduction may depend on the dose, duration of therapy and the individual patient. In some patients, discontinuation may need to occur very gradually over periods of months or longer. 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 37.5 mg twice daily may be switched to venlafaxine prolonged-release capsules 75 mg once daily. 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. Pregnancy: There are no adequate data from the use of venlafaxine in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Venlafaxine must only be administered to pregnant women if the expected benefits outweigh any possible risk. As with other serotonin reuptake inhibitors (SSRIs/SNRIs), discontinuation symptoms may occur in the new borns if venlafaxine is used until or shortly before birth. Some new borns exposed to venlafaxine late in the third trimester have developed complications requiring tube-feeding, respiratory support or prolonged hospitalisation. Such complications can arise immediately upon delivery. Observational data indicate an increased risk (less than 2-fold) of
postpartum haemorrhage following SSRIs/ SNRIs exposure within the
month prior to birth.
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 new born (PPHN). Although no studies have investigated an association of PPHN to SNRI treatment, this potential risk cannot be ruled out with venlafaxine taking into account the related mechanism of action (inhibition of the re-uptake of serotonin). The following symptoms may be observed in neonates if the mother has used an SSRI/SNRI late in pregnancy: irritability, tremor, hypotonia, persistent crying, and difficulty in sucking or in sleeping. These symptoms may be due to either serotonergic effects or exposure symptoms. In the majority of cases, these complications are observed immediately or within 24 hours after partus. Breastfeeding: Venlafaxine and its active metabolite, O-desmethylvenlafaxine, are excreted in breast milk. There have been post-marketing reports of breast-fed infants who experienced crying, irritability, and abnormal sleep patterns. Symptoms consistent with venlafaxine drug discontinuation have also been reported after stopping breast-feeding. A risk to the suckling child cannot be excluded. Therefore, a decision to continue/discontinue breast-feeding or to continue/discontinue therapy with Efexor XR should be made, taking into account the benefit of breast-feeding to the child and the benefit of Efexor XR therapy to the woman.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. 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.
Warning and Precautions: Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). 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 metaanalysis 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 XR 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.g. methylene blue), with serotonin precursors (such as tryptophan supplements) or with antipsychotics or other dopamine antagonists.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). 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.If concomitant treatment with venlafaxine 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 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.g., those with impaired cardiac function. 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.In post marketing experience, cases of QTc prolongation, Torsade de Pointes (TdP), ventricular tachycardia, and fatal cardiac arrhythmias have been reported with the use of venlafaxine, especially in overdose or in patients with other risk factors for QTc prolongation/TdP. The balance of risks and benefits should be considered before prescribing venlafaxine to patients at high risk of serious cardiac arrhythmia or QTc prolongation. 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. Hyponatraemia: Cases of hyponatraemia and/or the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion may occur with venlafaxine. This has most frequently been reported in volume-depleted or dehydrated patients. Elderly patients, patients taking diuretics, and patients who are otherwise volumedepleted may be at greater risk for this event. Abnormal bleeding: Medicinal products that inhibit serotonin uptake may lead to reduced platelet function. Bleeding events related to SSRI and SNRI use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to gastrointestinal and life-threatening haemorrhages. The risk of haemorrhage, may be increased in patients taking venlafaxine. As with other serotonin-reuptake inhibitors, venlafaxine should be used cautiously in patients predisposed to bleeding, including patients on anticoagulants and platelet inhibitors. Serum cholesterol:Clinically relevant increases in serum cholesterol were recorded in 5.3% of venlafaxine-treated patients and 0.0% of placebo-treated patients treated for at least 3 months in placebocontrolled clinical trials. Measurement of serum cholesterol levels should be considered during long-term treatment. Co-administration with weight loss agents: The safety and efficacy of venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established. Co-administration of venlafaxine and weight loss agents is not recommended. Venlafaxine is not indicated for weight loss alone or in combination with other products. Mania/hypomania: 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: Aggression may occur in some patients who have received antidepressants, including venlafaxine. This has been reported under initiation, dose changes and discontinuation of treatment. As with other antidepressants, venlafaxine should be used cautiously in patients with a history of aggression. Discontinuation of treatment: Discontinuation effects are well known to occur with antidepressants, and sometimes these effects can be protracted and severe. Suicide/suicidal thoughts and aggression have been observed in patients during changes in venlafaxine dosing regimen, including during discontinuation. Therefore, patients should be closely monitored when the dose is reduced or during discontinuation. Withdrawal symptoms, when treatment is discontinued, are common, particularly if discontinuation is abrupt. In clinical trials, adverse events seen on treatment discontinuation (tapering and post-tapering) occurred in approximately 31% of patients treated with venlafaxine and 17% of patients taking placebo. The risk of withdrawal symptoms may be dependent on several factors, including the duration and dose of therapy and the rate of dose reduction. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, headache, visual impairment and hypertension are the most commonly reported reactions. Generally, these symptoms are mild to moderate; however, in some patients they may be severe in intensity. They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose. Generally, these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (23 months or more). It is therefore advised that venlafaxine should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient’s needs.In some patients, discontinuation could take months or longer. Sexual dysfunction: Serotonin-norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SNRIs. Akathisia/psychomotor restlessness: The use of venlafaxine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental. Dry mouth: Dry mouth is reported in 10% of patients treated with venlafaxine. This may increase the risk of caries, and patients should be advised upon the importance of dental hygiene. Diabetes: In patients with diabetes, treatment with an SSRI or venlafaxine may alter glycaemic control. Insulin and/or oral antidiabetic dosage may need to be adjusted. Drug-Laboratory Test Interactions: Sodium content: Efexor XR 150 mg capsules contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium free’. False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking venlafaxine. This is due to lack of specificity of the screening tests. False positive test results may be expected for several days following discontinuation of venlafaxine therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish venlafaxine from PCP and amphetamine.
Interactions: 1) Monoamine Oxidase Inhibitors (MAOI): Irreversible non-selective MAOIs. Reversible, selective MAO-A inhibitor (moclobemide). Reversible, non-selective MAOI (linezolid). 2) 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, amphetamines, 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.g. methylene blue), with serotonin precursors (such as tryptophan supplements) or with antipsychotics or other dopamine antagonists. If concomitant treatment with venlafaxine and an SSRI, an SNRI or a serotonin receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of venlafaxine with serotonin precursors (such as tryptophan supplements) is not recommended. 3) CNS-active substances. 4) Ethanol. 5) Drugs that Prolong the QT Interval: Relevant classes include (this list is not exhaustive and other individual medicinal products known to significantly increase QT interval should be avoided): a) class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide) b) some antipsychotics (e.g. thioridazine) c) some macrolides (e.g. erythromycin) d) some antihistamines e) some quinolone antibiotics (e.g. moxifloxacin). 6) Effect of other medicinal products on venlafaxine:Ketoconazole (CYP3A4 inhibitor). 7) Effect of venlafaxine on other medicinal products: a) Lithium. b)Diazepam. c) Imipramine. d) Haloperidol. e) Risperidone. f) Metoprolol. g) Indinavir. h) Drugs Metabolized by Cytochrome P450 Isoenzymes. i) Oral contraceptives
Overdosing: In post-marketing experience, overdose with venlafaxine was reported predominantly in combination with alcohol and/or other medicinal products. The most commonly reported events in overdose include tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, convulsion, and vomiting. Other reported events include electrocardiographic changes (e.g., prolongation of QT interval, bundle branch block, QRS prolongation), ventricular tachycardia, bradycardia, hypotension, vertigo, and deaths. 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 venlafaxine-treated patients have a higher burden of suicide risk factors than SSRI 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 characteristics of venlafaxine-treated patients, is not clear. Prescriptions for venlafaxine should be written for the smallest quantity of the medicinal product consistent with good patient management in order to reduce the risk of overdose. Recommended treatment: General supportive and symptomatic measures are recommended; cardiac rhythm and vital signs must be monitored. When there is a risk of aspiration, induction of emesis is not recommended. Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. Administration of activated charcoal may also limit absorption of the active substance. Forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidotes for venlafaxine are known.
Adverse Reaction: Adverse reactions reported as Very common adverse reactions (>1/10); Insomnia, Headache*a, Dizziness, Sedation, Nausea, Dry mouth, Constipation, Hyperhidrosis* (including night sweats)*.Common adverse reactions (>1/100 to <1/10); Decreased appetite, Confusional state*, Depersonalization*, Abnormal dreams, Nervousness, Libido decreased, Agitation, *Anorgasmia, Akathisia*, Tremor, Paraesthesia, Dysgeusia, Visual impairment, Accommodation disorder, including vision blurred, Mydriasis, Tinnitus*, Tachycardia, Palpitations*, Hypertension, Hot flush, Dyspnoea*,Yawning, Diarrhoea*,Vomiting, Rash, Pruritus*, Hypertonia, Urinary hesitation, Urinary retention, Pollakiuria*, Menorrhagia*, Metrorrhagia*, Erectile dysfunction, Ejaculation disorder, Fatigue, Asthenia, Chills*, Weight decreased, Weight increased, Blood cholesterol increased. [*ADR identified post-marketing; aIn pooled clinical trials, the incidence of headache with venlafaxine and placebo were similar]. Discontinuation of venlafaxine (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraethesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, vertigo, headache, flu syndrome, visual impairment and hypertension are the most commonly reported reactions. Generally, these events are mild to moderate and are selflimiting; however, in some patients, they may be severe and/or prolonged. It is therefore advised that when venlafaxine treatment is no longer required, gradual discontinuation by dose tapering should be carried out. However, in some patients severe aggression, and suicidal ideation occurred when the dose was reduced or during discontinuation.
Pharmaceutical Precautions Shelf life: Keep out of the sight and reach of children. Do not store above 25oC. Do not use Efexor* XR after the expiry date which is stated on the Blister after EXP:. The expiry date refers to the last day of that month. Shelf life: 3 years
Efexor XR 75mg [SmPC]. New Bridge, Ireland: Pfizer Ireland
Pharmaceuticals; March 2021.
Efexor XR150 mg [SmPC]. New Bridge, Ireland: Pfizer Ireland
Pharmaceuticals; August 2021.
Date of This Document: 14 January 2022.
Full prescribing information is available upon request