Venlafaxine ER 225mg Tablets

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, which is thought to mediate its antidepressant and anxiolytic 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 immediate medical attention:

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
+ Difficulty focusing
+ Memory problems
+ Confusion
+ Weakness
+ Seizures
+ 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 loss of consciousness
+ Changes in vision
Seizures
Chest pain or pressure
Shortness of breath
Cough
Bone pain
Sex 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. Symptoms include:
+ 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 experience 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:

Trouble sleeping
Feeling nervous or excitable
Anxiety
Weight loss
Dizziness, drowsiness, tiredness, or weakness
Shakiness
Headache
Excessive sweating
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
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, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any 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 or methylene blue, as these can cause serious interactions.
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Taking these medications with this drug can lead to very high blood pressure.

It is crucial to note that this is not an exhaustive list of all potential interactions or health problems that may affect the safety of this medication. Therefore, it is vital 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. 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 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 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 to 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.

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 aware that this medication may trigger manic episodes. Immediately contact your doctor if you experience 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 this risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor promptly.

Low blood sodium levels, which can be fatal in severe cases, may occur with this medication. 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 the tablet shell 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 adolescents. Regular growth checks may be necessary, and your doctor will discuss this with you.

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. Your doctor will help you weigh the risks and benefits.

• Monoamine Oxidase Inhibitors (MAOIs) (risk of serious, sometimes fatal, serotonin syndrome; allow at least 14 days between discontinuing MAOI and starting venlafaxine, and at least 7 days between discontinuing venlafaxine and starting MAOI)
• Linezolid (reversible non-selective MAOI)
• Methylene Blue (reversible non-selective MAOI)

• Other serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's Wort, amphetamines) - increased risk of serotonin syndrome.
• Drugs that impair metabolism of venlafaxine (e.g., strong CYP2D6 inhibitors like quinidine, fluoxetine, paroxetine) - may increase venlafaxine levels and decrease ODV levels.
• Warfarin - increased risk of bleeding.
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics) - theoretical risk of QT prolongation, though venlafaxine itself has minimal effect.

• Alcohol - may enhance CNS effects and impair psychomotor performance.
• Cimetidine - may inhibit first-pass metabolism of venlafaxine, increasing AUC.
• Haloperidol - increased haloperidol AUC and Cmax.
• Indinavir - decreased indinavir AUC and Cmax.
• Ketoconazole - increased venlafaxine and ODV AUC in poor CYP2D6 metabolizers.

• Not typically categorized as minor for venlafaxine, most interactions are moderate to major due to serotonin syndrome risk or pharmacokinetic changes.

• Worsening depression
• Suicidal thoughts or behavior (especially in young adults)
• Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
• Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle rigidity, twitching, incoordination, nausea, vomiting, diarrhea)
• Symptoms of withdrawal syndrome (e.g., dizziness, headache, nausea, insomnia, irritability, anxiety, electric shock-like sensations) upon abrupt discontinuation
• New or worsening hypertension
• New or worsening anxiety

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.

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.

Not approved for use in pediatric patients for MDD due to increased risk of suicidal thoughts and behaviors. Safety and efficacy have not been established. Use in children and adolescents should be carefully weighed against the risks, and patients should be closely monitored.

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. Elderly patients may be at increased risk for hyponatremia and falls. Dose adjustments may be necessary due to age-related decreases in renal and hepatic function.

• Venlafaxine ER capsules contain spheroids that release the drug slowly. Patients may notice these 'ghost tablets' in their stool, which is normal and does not mean the medication was not absorbed.
• Abrupt discontinuation or significant dose reduction can lead to severe withdrawal symptoms (e.g., dizziness, nausea, headache, 'brain zaps', anxiety, insomnia). Taper slowly over several weeks, especially after prolonged use.
• Monitor blood pressure regularly, as venlafaxine can cause dose-dependent hypertension, particularly at higher doses.
• Consider venlafaxine for patients who have not responded to SSRIs, as its dual mechanism (serotonin and norepinephrine reuptake inhibition) may be more effective for some individuals.
• Take with food to minimize gastrointestinal upset.

• 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)
• Monoamine Oxidase Inhibitors (MAOIs) (e.g., Phenelzine, Tranylcypromine, Selegiline - generally reserved for refractory cases)

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, a patient fact sheet that provides crucial information. 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.