Venlafaxine ER 37.5mg 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 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 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
A potentially life-threatening condition called serotonin syndrome, which may be more likely if you take certain other medications. Seek medical help immediately if you experience:
+ 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

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

Difficulty 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, 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. 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. Combining these medications can lead to very high blood pressure.
Other health problems or medications (prescription, over-the-counter, natural products, or vitamins) you are taking, as this medication may interact with them.

Remember, this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. 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 monitoring of your blood pressure is crucial while taking this medication, as it may cause high blood pressure. Follow your doctor's recommendations for blood pressure 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 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 monitor your condition closely.

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

You may notice remnants of the medication in your stool, but this is a normal occurrence and not a cause for concern.

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, 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 increase the risk of health problems for both the mother (such as postpartum bleeding) and the newborn. If you are breastfeeding, your doctor will help you weigh the potential risks to your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOI, or starting MAOI within 7 days of stopping venlafaxine)

• Linezolid
• Methylene blue
• Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's Wort) - increased risk of serotonin syndrome
• Warfarin (increased bleeding risk)
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics)

• Cimetidine (may increase venlafaxine levels)
• Haloperidol (may increase haloperidol levels)
• Metoprolol (may increase metoprolol levels)
• Ethanol (alcohol) - may increase CNS depression and impair psychomotor skills
• Drugs affecting CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) - may increase venlafaxine levels and decrease ODV levels

• Not available

• Worsening depression
• Emergence of suicidal thoughts or behaviors
• Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity)
• Manic or hypomanic episodes
• Serotonin syndrome (e.g., agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, GI symptoms)
• Withdrawal symptoms upon discontinuation (e.g., dizziness, headache, nausea, vomiting, insomnia, nightmares, paresthesias, anxiety, agitation, tremor, sweating, flu-like symptoms)
• New or worsening visual problems (e.g., angle-closure glaucoma)
• Seizures

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 human 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. Black Box Warning regarding increased risk of suicidal thinking and behavior in children, adolescents, and young adults. Efficacy and safety have not been established in this population for MDD, GAD, SAD, or PD.

No overall differences in safety or effectiveness were observed between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustments may be necessary due to age-related decreases in renal and hepatic function. Increased risk of hyponatremia and falls.

• Venlafaxine ER capsules should be swallowed whole; they contain spheroids that release the drug slowly. Patients may notice these spheroids in their stool, which is normal and does not indicate a lack of absorption.
• Blood pressure should be monitored regularly, especially during dose escalation, as venlafaxine can cause dose-dependent increases in blood pressure.
• Discontinuation syndrome is common with venlafaxine due to its relatively short half-life. Doses should be tapered gradually over several weeks to months to minimize withdrawal symptoms.
• Serotonin syndrome is a rare but potentially life-threatening risk, especially when co-administered with other serotonergic agents. Educate patients on symptoms and advise immediate medical attention if they occur.
• Patients should be monitored for activation of mania/hypomania, especially those with a history of bipolar disorder.
• Venlafaxine can cause mydriasis and has been associated with 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)
• Atypical antidepressants (e.g., Bupropion, Mirtazapine)
• Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
• Other anxiolytics (e.g., Buspirone, benzodiazepines for short-term use)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective 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 vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, 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 detailed information, including the name of the medication taken, the amount, and the time it occurred.