Effexor 25mg Tablets

Manufacturer WYETH Active Ingredient Venlafaxine Tablets(ven la FAX een) Pronunciation ven-la-FAX-een
WARNING: Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug is not approved for use in children. Talk with the doctor. @ COMMON USES: It is used to treat depression.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antidepressant
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Pharmacologic Class
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
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Pregnancy Category
Not available
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FDA Approved
Dec 1993
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Venlafaxine is a medication used to treat depression, anxiety, and panic disorder. It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain. It can help improve your mood, sleep, appetite, and energy level, and decrease anxiety and panic attacks.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor.
Read and follow all instructions provided with your medication.
Take your medication with food to help your body absorb it properly.
Establish a routine by taking your medication at the same time every day.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

To ensure your medication remains effective and safe:

Store your medication at room temperature in a dry location, avoiding bathrooms and areas prone to moisture.
Keep all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in local drug take-back programs.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take the missed dose as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily for the extended-release form, with food.
  • Do not crush, chew, or dissolve extended-release capsules/tablets. Swallow whole.
  • Avoid alcohol, as it can increase side effects like drowsiness and dizziness.
  • Be aware of potential for increased blood pressure; regular monitoring is important.
  • Do not stop taking venlafaxine suddenly without consulting your doctor, as this can lead to withdrawal symptoms (e.g., dizziness, nausea, headache, anxiety, electric shock sensations). Your doctor will guide you on how to slowly reduce the dose.
  • Report any new or worsening symptoms, especially changes in mood, behavior, or suicidal thoughts, to your doctor immediately.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.

Dosing & Administration

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Adult Dosing

Standard Dose: For Major Depressive Disorder (MDD), initial dose is typically 75 mg/day for extended-release (XR) formulation, given once daily. For immediate-release (IR) formulation, initial dose is 37.5 mg twice daily or 25 mg three times daily.
Dose Range: 37.5 - 375 mg

Condition-Specific Dosing:

MDD_IR: Initial: 25 mg three times daily or 37.5 mg twice daily. Titrate by 75 mg/day increments at intervals of no less than 4 days. Max: 375 mg/day in divided doses.
MDD_XR: Initial: 75 mg once daily. Some patients may start at 37.5 mg once daily for 4-7 days to allow for adjustment. Titrate by 75 mg/day increments at intervals of no less than 4 days. Max: 225 mg/day (for most patients), up to 375 mg/day for severe depression.
GAD_XR: Initial: 37.5 mg once daily for 4-7 days, then increase to 75 mg once daily. Max: 225 mg/day.
SAD_XR: Initial: 75 mg once daily. Max: 225 mg/day.
PanicDisorder_XR: Initial: 37.5 mg once daily for 7 days, then increase to 75 mg once daily. Max: 225 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established for MDD in pediatric patients <18 years old. Use in pediatric patients for other indications is off-label and generally not recommended due to suicidality risk.)
Adolescent: Not established (Safety and efficacy not established for MDD in pediatric patients <18 years old. Use in pediatric patients for other indications is off-label and generally not recommended due to suicidality risk.)
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Dose Adjustments

Renal Impairment:

Mild: CrCl 30-60 mL/min: Reduce total daily dose by 25%.
Moderate: CrCl 10-29 mL/min: Reduce total daily dose by 50%.
Severe: CrCl <10 mL/min: Not recommended or significant dose reduction (e.g., 75% reduction).
Dialysis: Reduce total daily dose by 50%. Administer after dialysis session.

Hepatic Impairment:

Mild: Child-Pugh A: Reduce total daily dose by 25%.
Moderate: Child-Pugh B: Reduce total daily dose by 50%.
Severe: Child-Pugh C: Reduce total daily dose by 50% or more. Use with caution.

Pharmacology

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Mechanism of Action

Venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake. The antidepressant and anxiolytic effects are believed to be associated with the potentiation of neurotransmitter activity in the central nervous system.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 45% (due to first-pass metabolism)
Tmax: Venlafaxine IR: 2-4 hours; Venlafaxine XR: 5.5 hours; ODV: 9 hours (XR)
FoodEffect: Food has no significant effect on the absorption or bioavailability of venlafaxine or ODV from the extended-release formulation. For IR, food may slightly delay Tmax but does not affect AUC.

Distribution:

Vd: Venlafaxine: 7.5 L/kg; ODV: 5.7 L/kg
ProteinBinding: Venlafaxine: Approximately 27%; ODV: Approximately 30%
CnssPenetration: Yes

Elimination:

HalfLife: Venlafaxine: Approximately 5 hours; ODV: Approximately 11 hours
Clearance: Venlafaxine: 1.3 Β± 0.6 L/h/kg; ODV: 0.4 Β± 0.2 L/h/kg
ExcretionRoute: Renal (approximately 87% of a dose is excreted in the urine within 48 hours, primarily as ODV and its conjugates, and to a lesser extent as unchanged venlafaxine and NDV)
Unchanged: Approximately 5% (venlafaxine); approximately 29% (ODV)
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Pharmacodynamics

OnsetOfAction: Initial antidepressant effects may be seen within 1-2 weeks, but full therapeutic effects may take 4-6 weeks.
PeakEffect: Peak plasma concentrations are reached within hours, but clinical peak effect is delayed.
DurationOfAction: Due to half-lives, once-daily dosing for XR provides sustained therapeutic levels over 24 hours. IR requires multiple daily doses.

Safety & Warnings

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BLACK BOX WARNING

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Venlafaxine is not approved for use in pediatric patients.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels: headache, difficulty focusing, memory problems, confusion, weakness, seizures, or changes in balance
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrolled bleeding
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Seizures
Chest pain or pressure
Shortness of breath
Cough
Bone pain
Sexual problems, including decreased libido, difficulty achieving orgasm, ejaculation problems, or erectile dysfunction

A potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking other medications. Seek medical help immediately if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Abnormal or rapid heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Difficulty sleeping
Feeling nervous, anxious, or excitable
Anxiety
Weight loss
Dizziness, drowsiness, fatigue, or weakness
Shakiness
Headache
Excessive sweating
Constipation, diarrhea, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Vivid or unusual dreams
Yawning

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening depression or anxiety
  • Thoughts of self-harm or suicide
  • Unusual agitation, restlessness, or irritability
  • Panic attacks
  • Difficulty sleeping (insomnia)
  • Aggressive or violent behavior
  • Acting on dangerous impulses
  • An extreme increase in activity and talking (mania)
  • Severe headache, confusion, rapid heart rate, sweating, muscle stiffness, tremors, twitching, loss of coordination, nausea, vomiting, diarrhea (signs of serotonin syndrome)
  • New or worsening high blood pressure
  • Unusual bleeding or bruising
  • Eye pain, vision changes, swelling or redness around the eye (signs of angle-closure glaucoma)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
If you have high blood pressure, as this medication may affect your condition.
If you have narrow-angle glaucoma, a condition that affects the eyes.
If you are taking a weight loss drug, as this may interact with the medication.
* If you are taking or have recently taken certain medications, including:
+ Linezolid or methylene blue, as these can cause serious interactions.
+ Certain drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. This is crucial because combining these medications can lead to very high blood pressure.

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to assess the safety of taking this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.

Before engaging in activities that require your full attention, such as driving, wait until you understand how this medication affects you. This will help you avoid accidents and ensure your safety.

Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of experiencing side effects, some of which can be severe and long-lasting. If you need to discontinue this medication, your doctor will provide guidance on how to gradually stop taking it. Be sure to discuss any new or worsening symptoms with your doctor.

Regular blood pressure checks are crucial while taking this medication, as it may cause high blood pressure. Follow your doctor's instructions for monitoring your blood pressure.

It is recommended that you avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness.

This medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.

If you have bipolar disorder, be aware that this medication may trigger manic episodes. Contact your doctor immediately if you experience symptoms of a manic episode.

Some individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, seek medical attention promptly.

This medication may cause low blood sodium levels, which can be fatal in severe cases. Discuss this risk with your doctor.

High cholesterol has been reported in some individuals taking this medication. If you have concerns, consult your doctor.

This medication may affect the results of certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary. Discuss this with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of taking this medication during pregnancy or breastfeeding. Taking this medication in mid to late pregnancy may increase the risk of health problems for both the mother (such as postpartum bleeding) and the newborn.
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Overdose Information

Overdose Symptoms:

  • Somnolence
  • Mild tachycardia
  • Mydriasis
  • Nausea
  • Vomiting
  • Dizziness
  • ECG changes (e.g., QT prolongation, bundle branch block, QRS prolongation)
  • Seizures
  • Coma
  • Serotonin syndrome

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). There is no specific antidote. Treatment is supportive and symptomatic, including maintaining an adequate airway, oxygenation, and ventilation. Activated charcoal may be considered if ingested recently.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of discontinuing MAOI or venlafaxine due to risk of serotonin syndrome)
  • Linezolid (reversible non-selective MAOI)
  • Methylene blue (reversible non-selective MAOI)
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Major Interactions

  • Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome
  • Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics) - theoretical risk of QT prolongation
  • Anticoagulants/Antiplatelets (e.g., warfarin, aspirin, NSAIDs) - increased risk of bleeding
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may increase venlafaxine levels and ODV levels (less pronounced effect on ODV)
  • CNS depressants (e.g., alcohol, benzodiazepines, opioids) - additive CNS depression
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Moderate Interactions

  • Cimetidine (may inhibit first-pass metabolism of venlafaxine, particularly in poor CYP2D6 metabolizers)
  • Ketoconazole (CYP3A4 inhibitor, may increase venlafaxine and ODV levels)
  • Metoprolol (venlafaxine may increase metoprolol AUC and Cmax)
  • Haloperidol (venlafaxine may increase haloperidol AUC and Cmax)
  • Imipramine/Desipramine (venlafaxine may increase plasma levels of imipramine and desipramine)
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Minor Interactions

  • Not specifically categorized as minor, but general caution with drugs affecting blood pressure or heart rate.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Venlafaxine can cause dose-dependent increases in BP and HR. Pre-existing hypertension should be controlled before treatment.

Timing: Before initiating treatment

Weight

Rationale: Monitor for significant weight changes, though venlafaxine is generally associated with less weight gain than some other antidepressants.

Timing: Before initiating treatment

Serum Sodium

Rationale: Risk of hyponatremia/SIADH, especially in elderly, volume-depleted, or those on diuretics.

Timing: Before initiating treatment (especially in at-risk patients)

Ophthalmologic Exam (for narrow-angle glaucoma)

Rationale: Venlafaxine can cause mydriasis, potentially precipitating an acute narrow-angle glaucoma attack.

Timing: Before initiating treatment in patients at risk

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter.

Target: Maintain within normal limits or patient's target range.

Action Threshold: Sustained elevation requiring intervention (e.g., >140/90 mmHg or significant increase from baseline) may require dose reduction or discontinuation.

Mental Status (for suicidality, worsening depression, unusual behavior changes)

Frequency: Frequently during initial therapy (first few months) and after dose changes, then periodically.

Target: Improvement in mood/anxiety symptoms, absence of suicidal ideation/behavior.

Action Threshold: Emergence or worsening of suicidal thoughts/behavior, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania. Requires immediate clinical assessment and intervention.

Serum Sodium

Frequency: Periodically, especially in elderly, those on diuretics, or with symptoms of hyponatremia.

Target: 135-145 mEq/L

Action Threshold: <135 mEq/L or symptomatic hyponatremia (e.g., headache, confusion, weakness, seizures).

Weight

Frequency: Periodically

Target: Stable weight or healthy weight gain/loss as appropriate.

Action Threshold: Clinically significant or undesirable weight changes.

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Symptom Monitoring

  • Worsening depression
  • Suicidal thoughts or behavior
  • Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity)
  • Anxiety
  • Panic attacks
  • Insomnia
  • Akathisia (restlessness)
  • Hypomania or mania
  • Serotonin syndrome symptoms (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
  • Bleeding (e.g., bruising, petechiae, GI bleeding)
  • Symptoms of hyponatremia (e.g., headache, confusion, weakness, seizures)
  • New or worsening visual problems (e.g., eye pain, blurred vision, halos around lights)

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Exposure during late pregnancy may lead to complications in the neonate requiring prolonged hospitalization, respiratory support, and tube feeding. These complications can arise immediately upon delivery and are consistent with a direct toxic effect of SSRIs/SNRIs or, possibly, a drug discontinuation syndrome.

Trimester-Specific Risks:

First Trimester: Limited data, but some studies suggest a possible association with increased risk of certain birth defects (e.g., cardiac) with SSRI/SNRI exposure, though data for venlafaxine are less clear or inconsistent. Overall risk appears low.
Second Trimester: Risk of persistent pulmonary hypertension of the newborn (PPHN) has been reported with SSRI exposure during late pregnancy. While data for venlafaxine are less robust, it's a class effect concern.
Third Trimester: Risk of neonatal withdrawal/toxicity syndrome (e.g., respiratory distress, feeding difficulties, jitteriness, seizures, persistent crying) if exposed late in the third trimester. PPHN risk also applies.
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Lactation

Venlafaxine and its active metabolite (ODV) are excreted into breast milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for venlafaxine, and any potential adverse effects on the breastfed infant from venlafaxine or from the underlying maternal condition. Monitor infants for sedation, poor feeding, and poor weight gain.

Infant Risk: L3 (Moderately Safe) - Some data suggest low levels in milk and generally low risk of adverse effects in infants, but caution and monitoring are advised, especially in neonates or premature infants.
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Pediatric Use

Not approved for use in pediatric patients for MDD due to increased risk of suicidality. Safety and efficacy have not been established. Use in other pediatric indications is off-label and generally not recommended.

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Geriatric Use

Use with caution in elderly patients due to increased risk of hyponatremia/SIADH, falls, and potential for greater sensitivity to side effects (e.g., dizziness, orthostatic hypotension). Lower starting doses and slower titration may be appropriate. Monitor renal function.

Clinical Information

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Clinical Pearls

  • Venlafaxine is an SNRI, meaning it affects both serotonin and norepinephrine. At lower doses, it primarily acts as an SSRI; at higher doses, norepinephrine reuptake inhibition becomes more prominent.
  • Extended-release (XR) formulation is generally preferred due to once-daily dosing and potentially better tolerability compared to immediate-release (IR) due to more stable plasma levels.
  • Discontinuation syndrome is common and can be severe if venlafaxine is stopped abruptly. Tapering should be slow and gradual, typically over several weeks to months, depending on dose and duration of treatment.
  • Monitor blood pressure regularly, especially during dose escalation, as venlafaxine can cause sustained hypertension in a dose-dependent manner.
  • Be vigilant for symptoms of serotonin syndrome, especially when co-administered with other serotonergic agents.
  • The 25mg tablet is an immediate-release formulation, typically used for initial titration or in divided doses. Most patients are transitioned to higher doses or the XR formulation.
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Alternative Therapies

  • Other SNRIs (e.g., Duloxetine, Desvenlafaxine, Levomilnacipran)
  • SSRIs (e.g., Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram)
  • Atypical Antidepressants (e.g., Bupropion, Mirtazapine, Vortioxetine, Vilazodone)
  • Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
  • MAOIs (e.g., Phenelzine, Tranylcypromine, Selegiline)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
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Cost & Coverage

Average Cost: Varies widely by formulation (IR vs. XR), strength, and pharmacy. Generic venlafaxine 25mg IR can be very inexpensive (e.g., $10-$30 for 30 tablets). Brand Effexor XR is significantly more expensive (e.g., $200-$400+ for 30 tablets). per 30 tablets
Generic Available: Yes
Insurance Coverage: Generic venlafaxine is typically covered as Tier 1 or Tier 2. Brand Effexor XR may be Tier 3 or non-preferred, requiring prior authorization.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.