Effexor 37.5mg 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's important to take it regularly as prescribed and not to stop suddenly, as this can cause withdrawal symptoms.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions precisely. Take your medication with food and at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the 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. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

What to Do If You Miss a Dose

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

  • Take with food to minimize stomach upset.
  • Avoid alcohol, as it can increase side effects like drowsiness and dizziness.
  • Do not stop taking this medication suddenly without consulting your doctor, as withdrawal symptoms can occur.
  • Be aware of potential for increased blood pressure; regular monitoring may be necessary.
  • Report any unusual changes in mood or behavior, especially at the beginning of treatment or after dose changes.
  • Use caution when driving or operating machinery until you know how the medication affects you, as it may cause dizziness or drowsiness.

Dosing & Administration

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Adult Dosing

Standard Dose: 37.5 mg orally twice daily or 25 mg orally three times daily, initially. May increase by 75 mg/day increments at intervals of no less than 4 days, up to 225 mg/day. Max dose for severe depression is 375 mg/day in divided doses.
Dose Range: 37.5 - 375 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial: 37.5 mg orally twice daily or 25 mg orally three times daily. Titrate up to 75-225 mg/day. Max: 375 mg/day for hospitalized patients with severe depression.
Generalized Anxiety Disorder (GAD): Initial: 37.5 mg orally once daily (extended-release). For immediate-release, typically not preferred for GAD due to multiple daily dosing, but if used, similar titration as MDD.
Social Anxiety Disorder (SAD): Initial: 75 mg orally once daily (extended-release). For immediate-release, similar titration as MDD.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for routine use in depression due to Black Box Warning; limited data for other conditions.
Adolescent: Not established for routine use in depression due to Black Box Warning; limited data for other conditions. If used, typically lower starting doses and careful titration.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed (CrCl 60-90 mL/min).
Moderate: Reduce total daily dose by 25% (CrCl 30-59 mL/min).
Severe: Reduce total daily dose by 50% (CrCl <30 mL/min).
Dialysis: Reduce total daily dose by 50%. Administer after dialysis session.

Hepatic Impairment:

Mild: No dosage adjustment needed.
Moderate: Reduce total daily dose by 50%.
Severe: Reduce total daily dose by 50% or more, individualize based on patient response.

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. This leads to increased concentrations of these neurotransmitters in the synaptic cleft, enhancing their activity in the central nervous system.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 45% (due to first-pass metabolism)
Tmax: Venlafaxine: 2-4 hours (IR); ODV: 3-6 hours (IR)
FoodEffect: Food has no significant effect on the absorption or bioavailability of venlafaxine or ODV.

Distribution:

Vd: Approximately 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: Approximately 1.3 L/h/kg; ODV: Approximately 0.4 L/h/kg
ExcretionRoute: Renal (approximately 87% of a dose is excreted in urine within 48 hours, primarily as metabolites)
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: Typically 4-6 weeks for full therapeutic effect.
DurationOfAction: Due to half-lives, effects are sustained with regular daily dosing.

Safety & Warnings

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BLACK BOX WARNING

Antidepressants increased the risk compared to placebo of suicidal thoughts 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 Effexor 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. Effexor 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, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of bleeding, such as:
+ 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 increase in size
+ Uncontrollable bleeding
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting or changes in eyesight
Seizures
Chest pain or pressure
Shortness of breath
Cough
Bone pain
Sex problems, such as:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or maintaining an erection
Serotonin syndrome, a potentially life-threatening condition that may occur, especially when taking certain other medications. Symptoms include:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, stomach upset, 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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:

Trouble sleeping
Feeling nervous, excitable, or anxious
Weight loss
Dizziness, drowsiness, tiredness, or weakness
Shakiness
Headache
Excessive sweating
Constipation, diarrhea, stomach upset, vomiting, or decreased appetite
Gas
Dry mouth
Strange or unusual dreams
* Yawning

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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:

  • New or worsening depression or anxiety
  • Thoughts about suicide or harming yourself
  • Panic attacks
  • Agitation, restlessness, irritability, or aggressiveness
  • Unusual changes in behavior or mood
  • Severe headache, confusion, rapid heart rate, sweating, muscle stiffness, tremors, or twitching (signs of serotonin syndrome)
  • Sudden eye pain or vision changes (especially blurred vision, halos around lights, or eye swelling/redness)
  • Seizures
  • Unusual bleeding or bruising
  • Significant increase in blood pressure
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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 medications 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 reaction you experienced, including the symptoms that occurred.
If you have high blood pressure, as this medication may affect your condition.
If you have narrow-angle glaucoma, a condition that affects the pressure in your eyes.
If you are taking a weight loss drug, as this may interact with the medication.
If you are taking certain medications, such as:
+ Linezolid
+ Methylene blue
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications can lead to very high blood pressure.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
Health problems

Your doctor and pharmacist will help you determine if it is safe to take this medication with your existing medications and health conditions. Do not 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.

Until you know how this medication affects you, avoid driving and other activities that require you to be alert. If you need to stop taking this medication, do not do so abruptly without consulting your doctor, as this may increase your risk of side effects, which can be severe and long-lasting. Instead, follow your doctor's instructions to gradually taper off the medication. If you experience any new or worsening symptoms, discuss them with your doctor.

Regular blood pressure checks are crucial while taking this medication, as it may cause high blood pressure. Your doctor will advise you on the frequency of these checks.

It is recommended to 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 the 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. If you experience symptoms such as increased energy, agitation, or impulsivity, contact your doctor immediately.

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 this risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, seek medical attention promptly.

Low blood sodium levels (hyponatremia) can occur with this medication, and in severe cases, it can be fatal. Discuss this risk with your doctor. High cholesterol has also been reported in some individuals taking this medication. If you have concerns, consult your doctor.

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

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary, and your doctor will discuss this with you.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. 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. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy and breastfeeding.
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Overdose Information

Overdose Symptoms:

  • Somnolence
  • Mild tachycardia
  • Mydriasis
  • Nausea
  • Vomiting
  • Dizziness
  • ECG changes (e.g., QTc prolongation, bundle branch block, QRS prolongation)
  • Bradycardia
  • Hypotension
  • Seizures
  • Vertigo
  • Coma
  • Death

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is generally supportive and symptomatic. Activated charcoal may be considered if ingested recently. Ensure adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of serious, sometimes fatal, serotonin syndrome. Do not use within 14 days of stopping an MAOI, or start an MAOI within 7 days of stopping venlafaxine.
  • Linezolid (an antibiotic with MAOI activity)
  • Methylene blue (intravenous, with MAOI activity)
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Major Interactions

  • Other serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, fentanyl, lithium, tramadol, St. John's Wort, tryptophan) - increased risk of serotonin syndrome.
  • Drugs that impair metabolism of venlafaxine (e.g., strong CYP2D6 inhibitors like quinidine, fluoxetine, paroxetine) - may increase venlafaxine levels.
  • Drugs that impair metabolism of ODV (e.g., strong CYP3A4 inhibitors like ketoconazole, clarithromycin) - may increase ODV levels.
  • Warfarin - increased risk of bleeding.
  • CNS depressants (e.g., alcohol, benzodiazepines, opioids) - additive CNS depression.
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Moderate Interactions

  • Antihypertensives - venlafaxine can increase blood pressure, potentially antagonizing antihypertensive effects.
  • Drugs that increase heart rate (e.g., stimulants, decongestants) - additive effects.
  • Drugs that affect platelet function (e.g., NSAIDs, aspirin) - increased risk of bleeding.
  • Cimetidine - may inhibit first-pass metabolism of venlafaxine, increasing venlafaxine levels (less significant for ODV).
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Minor Interactions

  • Not specifically categorized as minor, but general caution with any drug affecting CNS or cardiovascular system.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: Venlafaxine can cause dose-dependent increases in blood pressure.

Timing: Prior to initiation of therapy.

Heart Rate

Rationale: Venlafaxine can cause increases in heart rate.

Timing: Prior to initiation of therapy.

Weight

Rationale: Monitor for significant weight changes (gain or loss).

Timing: Prior to initiation of therapy.

Suicidal ideation/behavior

Rationale: Increased risk in children, adolescents, and young adults, especially at treatment initiation or dose changes.

Timing: Prior to initiation of therapy and frequently during early treatment.

Personal/Family history of bipolar disorder or mania

Rationale: Risk of activating mania/hypomania.

Timing: Prior to initiation of therapy.

History of seizures

Rationale: Venlafaxine can lower seizure threshold.

Timing: Prior to initiation of therapy.

Narrow-angle glaucoma

Rationale: Risk of mydriasis and acute angle-closure glaucoma.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP)

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

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

Action Threshold: Significant or sustained elevation (e.g., >140/90 mmHg) may require dose reduction or discontinuation.

Heart Rate

Frequency: Periodically.

Target: Within normal limits.

Action Threshold: Persistent tachycardia.

Suicidal ideation/behavior

Frequency: Weekly for the first 4 weeks, then every other week for the next 4 weeks, then monthly for 4 months, and periodically thereafter.

Target: Absence of new or worsening suicidal thoughts/behaviors.

Action Threshold: Any emergence or worsening of suicidal ideation/behavior requires immediate clinical assessment and intervention.

Weight

Frequency: Periodically.

Target: Maintain stable weight.

Action Threshold: Significant, unexplained weight gain or loss.

Symptoms of Serotonin Syndrome

Frequency: Continuously, especially when co-administered with other serotonergic drugs.

Target: Absence of symptoms.

Action Threshold: Agitation, hallucinations, delirium, tachycardia, labile BP, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea.

Symptoms of Hyponatremia

Frequency: Periodically, especially in elderly or volume-depleted patients.

Target: Absence of symptoms.

Action Threshold: Headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls.

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Symptom Monitoring

  • Worsening depression
  • Emergence of suicidal thoughts or behavior
  • Unusual changes in behavior (e.g., agitation, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania)
  • Symptoms of serotonin syndrome (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
  • Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls)
  • Symptoms of withdrawal (e.g., dizziness, nausea, headache, irritability, insomnia, anxiety, paresthesia, tremor) if discontinuing or missing doses
  • Visual changes or eye pain (due to risk of angle-closure glaucoma)

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 the third trimester may lead to complications in the neonate requiring prolonged hospitalization, respiratory support, and tube feeding. These complications can arise immediately upon delivery.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations.
Second Trimester: Limited data.
Third Trimester: Risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia, constant crying).
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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) - Monitor infant for adverse effects. Some data suggest low risk, but individual variability exists.
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Pediatric Use

Not approved for use in pediatric patients for Major Depressive Disorder due to the Black Box Warning regarding increased risk of suicidal thoughts and behavior. Safety and efficacy have not been established in pediatric patients for other indications, though it is sometimes used off-label for anxiety disorders under specialist supervision.

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Geriatric Use

Use with caution in elderly patients. Increased risk of hyponatremia (SIADH), falls, and orthostatic hypotension. Start with lower doses and titrate slowly. Monitor for adverse effects, especially cardiovascular and CNS effects.

Clinical Information

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Clinical Pearls

  • Venlafaxine IR (Effexor) requires multiple daily dosing, which can impact adherence. Effexor XR (extended-release) is dosed once daily and is generally preferred for convenience and potentially fewer peak-related side effects.
  • Do not discontinue venlafaxine abruptly due to significant risk of withdrawal symptoms (e.g., dizziness, nausea, headache, irritability, insomnia, anxiety, paresthesia, tremor, 'brain zaps'). Taper dose gradually over several weeks, or longer if needed.
  • Monitor blood pressure regularly, especially during dose titration, as venlafaxine can cause dose-dependent increases in BP. Consider alternative agents if significant hypertension develops.
  • Be vigilant for signs of serotonin syndrome, particularly when co-administered with other serotonergic agents. Educate patients on these symptoms.
  • Patients should be advised to report any unusual bleeding or bruising, especially if taking NSAIDs, aspirin, or anticoagulants concurrently.
  • The 37.5mg tablet is often used as a starting dose or for dose titration, particularly for immediate-release formulations.
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Alternative Therapies

  • Selective Serotonin Reuptake Inhibitors (SSRIs) - e.g., fluoxetine, sertraline, escitalopram, paroxetine, citalopram (for depression, anxiety disorders).
  • Tricyclic Antidepressants (TCAs) - e.g., amitriptyline, nortriptyline (older class, more side effects).
  • Atypical Antidepressants - e.g., bupropion, mirtazapine, trazodone.
  • Other anxiolytics - e.g., benzodiazepines (for short-term anxiety relief, not long-term depression/anxiety management).
  • Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT) - often used in combination with pharmacotherapy.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$30 per 30 tablets (generic 37.5mg IR)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic venlafaxine is usually preferred and covered well by most insurance plans)
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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 your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you to discuss them with 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it occurred.