Venlafaxine ER 37.5mg Tablets

Venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent serotonin and norepinephrine reuptake inhibitors (SNRIs). They weakly inhibit dopamine reuptake. The antidepressant and anxiolytic effects are believed to be associated with the potentiation of neurotransmitter activity in the CNS.

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 immediate medical attention:

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 certain other medications. Seek immediate medical attention if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Rapid 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

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Difficulty sleeping
Feeling anxious, nervous, or excitable
Anxiety
Weight loss
Dizziness, drowsiness, fatigue, or weakness
Shakiness
Headache
Excessive sweating
Constipation, diarrhea, stomach pain, 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 about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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. Be sure to describe the symptoms you experienced.
If you have high blood pressure, as this condition may be affected by the medication.
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 interact with the medication.
+ Certain drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications with this drug 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 drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure that it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

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 other activities that require you to be alert. Stopping this medication abruptly without consulting your doctor can increase your risk of side effects, which can be severe and long-lasting. If you need to stop taking this medication, your doctor will instruct you on how to gradually discontinue 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. Your doctor will advise you on the frequency of these checks.

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, especially if you have any concerns.

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

Low blood sodium levels can occur with this medication, and in severe cases, this can be fatal. Discuss this risk with your doctor and report any concerns.

High cholesterol has been associated with this medication. If you have questions or concerns, consult your doctor.

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

You may notice the tablet shell in your stool, but this is a normal and harmless occurrence. 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 pose health risks to 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 or breastfeeding.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of discontinuing MAOI or venlafaxine)

• Other serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, fentanyl, tramadol, tryptophan, buspirone, St. John's Wort, linezolid, methylene blue) - increased risk of serotonin syndrome
• Anticoagulants (e.g., warfarin) and antiplatelet agents (e.g., aspirin, NSAIDs) - increased risk of bleeding
• Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics) - theoretical risk of QT prolongation (venlafaxine's risk is low but additive effects possible)
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may increase venlafaxine levels and decrease ODV levels

• Alcohol - increased CNS depression and psychomotor impairment
• Cimetidine - may inhibit first-pass metabolism of venlafaxine, increasing venlafaxine AUC
• Drugs that affect blood pressure (e.g., antihypertensives) - venlafaxine can cause dose-dependent increases in blood pressure
• CNS depressants (e.g., benzodiazepines, opioids, sedatives) - additive CNS depression

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

• Worsening depression
• Suicidal ideation or behavior
• Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity)
• Mania or hypomania (e.g., elevated mood, grandiosity, decreased need for sleep, racing thoughts)
• Serotonin syndrome (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
• Hypertension
• Tachycardia
• Dizziness
• Nausea/vomiting
• Dry mouth
• Constipation
• Insomnia
• Sweating
• Sexual dysfunction
• Abnormal bleeding or bruising
• Visual disturbances (e.g., blurred vision, eye pain, pupil dilation)

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These complications can arise immediately upon delivery.

Venlafaxine and its active metabolite (ODV) are excreted into breast milk. The American Academy of Pediatrics considers venlafaxine to be a drug for which the effect on a nursing infant is unknown but may be of concern. Monitor infants for sedation, poor feeding, and poor weight gain. Weigh the benefits of breastfeeding against the potential risks to the infant.

Safety and efficacy have not been established in pediatric patients for MDD. A black box warning exists regarding increased risk of suicidality in children, adolescents, and young adults. Use in this population should be carefully considered and closely monitored.

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for hyponatremia and falls. Start with lower doses and titrate slowly, monitoring closely for adverse effects, especially blood pressure changes and hyponatremia.

• Venlafaxine ER should be taken with food to minimize gastrointestinal upset and improve tolerability.
• Swallow the capsule/tablet whole; do not crush, chew, or divide, as this will disrupt the extended-release mechanism and can lead to rapid drug release and increased side effects.
• Patients may notice a 'ghost tablet' in their stool, which is the empty shell of the extended-release tablet and is normal.
• Blood pressure should be monitored regularly, especially during dose escalation, as venlafaxine can cause dose-dependent increases in blood pressure.
• Discontinuation syndrome (withdrawal symptoms) is common and can be severe if venlafaxine is stopped abruptly. Symptoms include dizziness, nausea, headache, insomnia, irritability, and paresthesias ('electric shock' sensations). Taper the dose gradually over several weeks, or longer if needed, under medical supervision.
• Serotonin syndrome is a rare but potentially life-threatening condition. Educate patients on symptoms and advise immediate medical attention if suspected.
• Venlafaxine is a potent SNRI; at lower doses (<150 mg/day), it primarily acts as an SSRI, while at higher doses, norepinephrine reuptake inhibition becomes more prominent.

• Other SNRIs (e.g., Duloxetine, Levomilnacipran)
• SSRIs (e.g., Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram)
• Atypical antidepressants (e.g., Bupropion, Mirtazapine)
• Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
• Other anxiolytics (e.g., Buspirone for GAD, benzodiazepines for short-term use)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)

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 of this medication. 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 amount, and the time it occurred.