Effexor 75mg 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, which can improve mood and reduce anxiety.
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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 closely. 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 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 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 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 one.
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Lifestyle & Tips

  • Take exactly as prescribed, do not stop suddenly without consulting your doctor, as this can cause withdrawal symptoms.
  • Avoid alcohol, as it can increase side effects like drowsiness and dizziness.
  • Be cautious when driving or operating machinery until you know how this medication affects you.
  • Report any unusual changes in mood or behavior, especially suicidal thoughts, to your doctor immediately.
  • Monitor your blood pressure regularly as advised by your doctor.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking to avoid dangerous interactions.

Dosing & Administration

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Adult Dosing

Standard Dose: 75 mg/day, divided into 2 or 3 doses (immediate release)
Dose Range: 75 - 225 mg

Condition-Specific Dosing:

depression: Initial: 25-37.5 mg BID or TID. Titrate to 75 mg/day, then up to 225 mg/day. Max 375 mg/day for severe depression in hospitalized patients.
generalized_anxiety_disorder: Initial: 37.5 mg/day (XR). Titrate to 75-225 mg/day.
social_anxiety_disorder: Initial: 75 mg/day (XR).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established for major depressive disorder in pediatric patients. Black Box Warning for suicidality.)
Adolescent: Not established (Safety and efficacy not established for major depressive disorder in pediatric patients. Black Box Warning for suicidality.)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl 60-90 mL/min)
Moderate: Reduce total daily dose by 25-50% (CrCl 30-59 mL/min)
Severe: Reduce total daily dose by 50% or more (CrCl <30 mL/min)
Dialysis: Reduce total daily dose by 50% and withhold dose until end of dialysis session (for hemodialysis patients)

Hepatic Impairment:

Mild: Reduce total daily dose by 50% (Child-Pugh A)
Moderate: Reduce total daily dose by 50% (Child-Pugh B)
Severe: Reduce total daily dose by 50% or more (Child-Pugh C)

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 a weak inhibitor 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: 45%
Tmax: Venlafaxine: 2 hours; ODV: 3 hours
FoodEffect: Food delays Tmax but does not significantly affect AUC or Cmax.

Distribution:

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

Elimination:

HalfLife: Venlafaxine: ~5 hours; ODV: ~11 hours
Clearance: Venlafaxine: ~1.3 L/h/kg; ODV: ~0.4 L/h/kg
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: Venlafaxine: ~5%; ODV: ~29%
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Pharmacodynamics

OnsetOfAction: 1-2 weeks for initial antidepressant effects; 4-6 weeks for full therapeutic effect.
PeakEffect: 4-6 weeks
DurationOfAction: Not directly applicable, continuous dosing required for sustained effect.

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.
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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
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that looks like coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that get bigger
+ Uncontrollable bleeding
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Seizures
Chest pain or pressure
Shortness of breath
Cough
Bone pain
Sex problems, such as:
+ Decreased interest in sex
+ Trouble having an orgasm
+ Ejaculation problems
+ Trouble getting or keeping an erection
Serotonin syndrome, a potentially life-threatening condition that may occur, especially if you take 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, upset stomach, or vomiting
+ Severe headache

Other Possible Side Effects

Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Trouble sleeping
Feeling nervous and excitable
Anxiety
Weight loss
Feeling dizzy, sleepy, tired, or weak
Shakiness
Headache
Excessive sweating
Constipation
Diarrhea
Upset stomach
Vomiting
Decreased appetite
Gas
Dry mouth
Strange or odd dreams
Yawning

Reporting 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:

  • Severe dizziness or fainting
  • Fast or irregular heartbeat
  • Severe headache
  • Blurred vision or eye pain (especially if you have glaucoma)
  • Muscle stiffness, twitching, or tremors
  • High fever, sweating, confusion (signs of serotonin syndrome)
  • Unusual bleeding or bruising
  • Seizures
  • New or worsening anxiety, panic attacks, trouble sleeping, irritability, agitation, aggression, restlessness, or other unusual changes in behavior.
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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 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: Taking these medications with this drug may 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 with other treatments.

Until you know how this medication affects you, avoid driving and engaging in activities that require your full attention. This is crucial to prevent accidents and ensure your safety.

Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of experiencing side effects, 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 necessary 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 or slow your reactions.

This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor, and seek medical attention immediately if you experience any bleeding.

If you have bipolar disorder, be aware that this medication may trigger manic episodes. Contact your doctor if you experience any symptoms of a manic episode, such as excessive excitement, irritability, or impulsive behavior.

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, this can be fatal. Discuss this risk with your doctor, and seek medical attention if you experience any symptoms of hyponatremia, such as headache, confusion, or seizures.

High cholesterol has been reported in some individuals taking this medication. If you have concerns or questions, discuss them with 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 to ensure accurate test results.

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. This medication may pose risks to the fetus or newborn, particularly if taken during mid to late pregnancy. Your doctor will discuss the benefits and risks of taking this medication during pregnancy and breastfeeding.
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Overdose Information

Overdose Symptoms:

  • Somnolence
  • Mild to moderate increase in heart rate
  • Hypotension or hypertension
  • ECG changes (e.g., QTc prolongation, bundle branch block, QRS prolongation)
  • Seizures
  • Vertigo
  • Serotonin syndrome
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. Activated charcoal may be considered if ingested recently. There is no specific antidote.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome
  • Linezolid (reversible MAOI)
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Major Interactions

  • Other serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, fentanyl, tramadol, tryptophan, buspirone, St. John's Wort) - risk of serotonin syndrome
  • Warfarin - increased bleeding risk
  • Drugs that prolong QT interval (caution)
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - increased venlafaxine levels
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Moderate Interactions

  • Alcohol - increased CNS depression
  • Cimetidine - minor increase in venlafaxine AUC
  • Haloperidol - increased haloperidol AUC
  • Lithium - potential for increased neurotoxicity
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: Venlafaxine can cause dose-related sustained increases in BP.

Timing: Prior to initiation

Heart Rate

Rationale: Can cause increases in heart rate.

Timing: Prior to initiation

Weight

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

Timing: Prior to initiation

Mental Status/Suicidal Ideation

Rationale: Assess baseline mood, anxiety, and suicidal thoughts, especially in young adults.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

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

Target: Within normal limits or patient's baseline.

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

Heart Rate

Frequency: Periodically

Target: Within normal limits.

Action Threshold: Significant or symptomatic tachycardia.

Weight

Frequency: Periodically

Target: Stable or within acceptable range.

Action Threshold: Significant or rapid weight gain/loss.

Mental Status/Suicidal Ideation

Frequency: Weekly during initial treatment (first 4 weeks), then every 2-4 weeks, and with dose changes.

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

Action Threshold: Worsening depression, emergence of suicidal thoughts/behaviors, or unusual changes in behavior.

Serum Sodium

Frequency: Periodically, especially in elderly or those on diuretics.

Target: 135-145 mEq/L

Action Threshold: Hyponatremia (<135 mEq/L), especially if symptomatic.

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Symptom Monitoring

  • Worsening depression or anxiety
  • Emergence of suicidal thoughts or behaviors
  • Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity, akathisia, hypomania, mania)
  • Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart beat, fever, sweating, shivering, muscle stiffness/twitching, loss of coordination, nausea, vomiting, diarrhea)
  • Symptoms of withdrawal (e.g., dizziness, headache, nausea, vomiting, fatigue, irritability, insomnia, vivid dreams, paresthesias, electric shock sensations)
  • New or worsening hypertension
  • Visual disturbances (e.g., mydriasis, narrow-angle glaucoma)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Exposure during late pregnancy may lead to complications in the newborn 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: Not available
Third Trimester: Increased risk of persistent pulmonary hypertension of the newborn (PPHN) and withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia, constant crying) in the neonate.
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Lactation

Venlafaxine and its active metabolite (ODV) are excreted into breast milk. While some data suggest low infant exposure and generally mild or no adverse effects, caution is advised. Monitor breastfed infants for sedation, poor feeding, and poor weight gain.

Infant Risk: Low to moderate risk. Consider alternative if infant is premature or has underlying health issues.
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Pediatric Use

Not FDA approved for major depressive disorder in pediatric patients due to lack of established efficacy and increased risk of suicidality (Black Box Warning). Use in children and adolescents should be carefully considered and closely monitored by a specialist.

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Geriatric Use

Lower starting doses and slower titration may be necessary due to reduced renal and hepatic clearance. Elderly patients may be at increased risk for hyponatremia and falls. Monitor blood pressure and sodium levels closely.

Clinical Information

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Clinical Pearls

  • Venlafaxine immediate-release (IR) tablets are typically dosed 2-3 times daily, while extended-release (XR) capsules are once daily. Ensure correct formulation is prescribed and dispensed.
  • Withdrawal symptoms (discontinuation syndrome) can be severe, especially with abrupt cessation or rapid dose reduction. Taper slowly over several weeks to months.
  • Monitor blood pressure regularly, as venlafaxine can cause dose-dependent hypertension, particularly at higher doses.
  • Be vigilant for signs of serotonin syndrome, especially when co-administered with other serotonergic agents.
  • Patients should be advised to report any visual changes, as venlafaxine can cause mydriasis and potentially precipitate angle-closure glaucoma in susceptible individuals.
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Alternative Therapies

  • Other SNRIs (e.g., Duloxetine, Desvenlafaxine, Levomilnacipran)
  • SSRIs (e.g., Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram)
  • Tricyclic Antidepressants (TCAs)
  • Atypical Antidepressants (e.g., Bupropion, Mirtazapine)
  • MAOIs (e.g., Phenelzine, Tranylcypromine, Selegiline - generally reserved for refractory cases)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 for generic 30 tablets per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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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 and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is important to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediate action is necessary. Call your local poison control center or seek emergency medical attention right away. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it was taken.