Effexor XR 75mg Capsules

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 an increase in the synaptic concentrations of these neurotransmitters in the central nervous system, thereby enhancing their neurotransmission. The antidepressant and anxiolytic effects are believed to be related to this potentiation of serotonergic and noradrenergic activity.

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 uncontrollable 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 (if you have concerns, discuss them with your doctor)

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, nausea, or vomiting
Severe headache

Other Possible Side Effects

As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, 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, 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. Describe the allergic reactions you 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 pressure in your 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.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is vital to:

Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor to verify that it is safe to take this medication with your existing conditions and treatments.
Never start, stop, or change the dose of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

To minimize the risk of severe side effects, do not abruptly stop taking this medication without consulting your doctor. If you need to discontinue use, your doctor will instruct you on how to gradually stop taking it. Be sure to discuss any new or worsening symptoms with your doctor.

Monitor your blood pressure regularly, as this medication can cause high blood pressure. Your doctor will advise you on the frequency of blood pressure checks.

Avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, cannabis, or prescription or over-the-counter drugs that may cause drowsiness.

Be aware that 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 cautious of manic episodes while taking this medication. Immediately contact your doctor if you experience symptoms of a manic episode.

Some individuals may be at a higher risk of 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, contact your doctor promptly.

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

High cholesterol has been associated with this medication. If you have 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 remnants of the medication in your stool, but this is normal and not a cause for concern. 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 teenagers. They may require regular growth checks, so discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the benefits and risks of taking this medication. Taking this medication in mid to late pregnancy may lead to health problems in the mother, such as postpartum bleeding, or the newborn. Breastfeeding mothers should discuss potential risks to their baby with their doctor.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of discontinuing MAOI, or within 7 days of discontinuing venlafaxine before starting MAOI) - risk of serotonin syndrome.

• Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's Wort, other SNRIs/SSRIs) - increased risk of serotonin syndrome.
• Linezolid, Methylene Blue (IV) - risk of serotonin syndrome.
• Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics) - potential for QT prolongation.
• Warfarin - increased risk of bleeding.
• Drugs affecting CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) - may increase venlafaxine levels and/or ODV levels, potentially increasing adverse effects.

• Alcohol - may impair psychomotor skills.
• Cimetidine - may inhibit first-pass metabolism of venlafaxine, increasing venlafaxine AUC.
• Haloperidol, Risperidone - venlafaxine may increase plasma levels of these antipsychotics.
• Indinavir - venlafaxine may decrease indinavir AUC.
• Metoprolol - venlafaxine may increase metoprolol AUC and Cmax.

• Not specifically categorized as minor, but general caution with CNS depressants.

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity)
• Panic attacks
• Insomnia
• New or worsening anxiety
• Restlessness
• Akathisia (psychomotor restlessness)
• Hypomania
• Mania
• Serotonin syndrome symptoms (e.g., fever, sweating, confusion, muscle rigidity, tremors, rapid heart rate)
• Abnormal bleeding or bruising
• New or worsening eye pain, blurred vision, or halos around lights (signs of acute narrow-angle glaucoma)
• Seizures
• Sexual dysfunction
• Nausea, vomiting, diarrhea, constipation
• Dizziness, headache
• Dry mouth
• Sweating
• Tremor

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SNRIs/SSRIs 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 human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Effexor XR, and any potential adverse effects on the breastfed infant from Effexor XR or from the underlying maternal condition. Monitor breastfed infants for sedation, poor feeding, and poor weight gain.

Safety and efficacy have not been established in pediatric patients. Antidepressants, including venlafaxine, increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults (aged 18-24) compared to placebo. Use is generally not recommended.

No overall differences in effectiveness were observed between geriatric and younger patients. However, elderly patients may be more sensitive to the effects of venlafaxine, particularly hyponatremia and orthostatic hypotension. Dosage adjustments may be necessary, especially in those with renal or hepatic impairment. Start with lower doses and titrate slowly.

• Effexor XR capsules contain spheroids that release venlafaxine slowly. Patients may notice these 'ghost' capsules in their stool, which is normal and does not mean the medication was not absorbed.
• Venlafaxine has a dose-dependent effect on norepinephrine reuptake; lower doses primarily affect serotonin, while higher doses also significantly affect norepinephrine.
• Discontinuation syndrome (withdrawal) is common and can be severe with venlafaxine due to its relatively short half-life compared to some other antidepressants. Tapering should be gradual, typically over several weeks, and individualized.
• Monitor blood pressure regularly, especially during dose escalation, as venlafaxine can cause sustained hypertension.
• Caution is advised in patients with a history of seizures, narrow-angle glaucoma, or cardiovascular disease.
• Sexual dysfunction (e.g., decreased libido, anorgasmia, ejaculatory delay) is a common side effect and should be discussed with patients.

• Other SNRIs (e.g., duloxetine, desvenlafaxine, levomilnacipran)
• SSRIs (e.g., fluoxetine, sertraline, paroxetine, citalopram, escitalopram)
• Atypical antidepressants (e.g., bupropion, mirtazapine, trazodone)
• Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, nortriptyline)
• MAOIs (e.g., phenelzine, tranylcypromine, selegiline)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
• Electroconvulsive Therapy (ECT) for severe depression

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 for guidance. 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 details about the overdose, including the medication taken, the amount, and the time it occurred.