Venlafaxine ER 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. The antidepressant and anxiolytic effects are believed to be related to the potentiation of neurotransmitter activity in the CNS.

Urgent Side Effects: Seek Medical Attention Immediately

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 help right away:

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 enlarge
+ 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
Sexual 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 help:

Difficulty sleeping
Feeling nervous, anxious, or excitable
Weight loss
Dizziness, drowsiness, tiredness, or weakness
Shakiness
Headache
Excessive sweating
Constipation, diarrhea, stomach upset, vomiting, or decreased appetite
Gas
Dry mouth
Vivid 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.

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 may be relevant to your treatment.
If you have narrow-angle glaucoma, a condition that affects the eyes.
If you are currently 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. This is crucial, as combining these medications can lead to very high blood pressure.

Please note that this is not an exhaustive list of all potential interactions. It is vital to inform your doctor and pharmacist about all your medications, including:

Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins

Sharing this information will help your doctor and pharmacist assess potential interactions and ensure it is safe for you to take this medication with your other drugs and health conditions. 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. This will help ensure your safety and prevent potential interactions with other treatments.

Until you know how this medication affects you, avoid driving and other activities that require alertness. 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 for a gradual discontinuation.

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.

To minimize potential risks, avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, cannabis, or any prescription or over-the-counter drugs that may cause drowsiness or slow your reactions.

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 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 (hyponatremia) 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 the results of 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 a normal and harmless occurrence. If you are 65 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, so discuss this with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby. Taking this medication in mid to late pregnancy may lead to health problems for both the mother (such as postpartum bleeding) and the newborn. If you are breastfeeding, your doctor will help you weigh the risks and benefits to your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of discontinuing MAOI or venlafaxine due to risk of serotonin syndrome)

• Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome
• Linezolid (MAOI activity)
• Methylene blue (MAOI activity)
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, tricyclic antidepressants) - theoretical risk of QT prolongation
• Warfarin (increased INR and bleeding risk)
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - increased venlafaxine exposure, decreased ODV exposure

• Alcohol (may increase CNS effects and impair motor skills)
• Cimetidine (inhibits first-pass metabolism of venlafaxine, minor effect on AUC)
• Haloperidol (increased haloperidol AUC)
• Imipramine (increased desipramine AUC)
• Metoprolol (increased metoprolol AUC)
• Indinavir (decreased indinavir AUC)

• Not available

• Worsening depression or anxiety
• Emergence of suicidal thoughts or behaviors
• Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
• Symptoms of serotonin syndrome (e.g., agitation, confusion, rapid heart rate, sweating, muscle rigidity, tremors, fever, nausea, vomiting, diarrhea)
• Symptoms of withdrawal (e.g., dizziness, headache, nausea, insomnia, irritability, anxiety, paresthesias, electric shock sensations, tremor, sweating, fatigue) upon discontinuation or dose reduction
• New or worsening hypertension
• Pupil dilation (mydriasis) and associated visual disturbances or eye pain (risk of angle-closure glaucoma)
• Abnormal bleeding or bruising

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.

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.

Not approved for use 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. Close monitoring for clinical worsening, suicidality, and unusual changes in behavior is essential if use is considered off-label.

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. Dosage adjustments may be necessary based on renal or hepatic impairment, which are more common in the elderly. Monitor for orthostatic hypotension.

• Venlafaxine ER capsules should be swallowed whole with food; do not crush, chew, or open, as this will disrupt the extended-release mechanism and lead to rapid drug release.
• Patients may notice 'ghost tablets' (empty capsule shells) in their stool, which is normal and indicates the medication has been absorbed.
• Dose-related increases in blood pressure are a known side effect; monitor BP regularly, especially during dose titration.
• Discontinuation syndrome (withdrawal symptoms) is common and can be severe, especially with abrupt cessation. Tapering the dose slowly over several weeks is crucial.
• Venlafaxine is a potent SNRI; caution is advised when switching from other serotonergic agents or when co-administering with other drugs that affect serotonin or norepinephrine.
• Consider the risk of angle-closure glaucoma; patients with a history of narrow-angle glaucoma should be monitored.

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

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult 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 reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.