Venlafaxine ER 150mg Capsules

Venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent reuptake inhibitors of serotonin and norepinephrine and weak inhibitors of dopamine reuptake. This dual reuptake inhibition is thought to potentiate neurotransmitter activity in the central nervous system, leading to 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 immediately or seek emergency medical attention:

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 vision
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
+ 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

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 for advice:

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
Strange or vivid dreams
Yawning

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have concerns or questions, 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 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 may 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 may cause very high blood pressure.
It is crucial to note that this is not an exhaustive list of all potential interactions. Therefore, you must 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 your safety while taking this medication.
* Do not start, stop, or change the dose of any medication without first consulting your doctor to verify that it is safe to do so in conjunction with this drug.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require alertness.

Stopping the Medication
Do not stop taking this medication abruptly without consulting your doctor, as this may 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. Report any new or worsening symptoms to your doctor.

Blood Pressure Monitoring
This medication may cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks.

Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or prescription or over-the-counter medications that may cause drowsiness, consult your doctor.

Bleeding Risk
This medication may increase the risk of bleeding, which can be life-threatening. Discuss this risk with your doctor.

Mental Health Considerations
If you have bipolar disorder, be aware that this medication may trigger manic episodes. Contact your doctor if you experience symptoms of a manic episode.

Eye Problems
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, contact your doctor immediately.

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

High Cholesterol
This medication may cause high cholesterol. If you have concerns, consult your doctor.

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

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

Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Effects on Growth in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks. Discuss this with your doctor.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. Taking this medication in mid to late pregnancy may increase the risk of health problems for the mother (such as postpartum bleeding) or the newborn. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy or breastfeeding.

• Monoamine Oxidase Inhibitors (MAOIs) - risk of serious, sometimes fatal, serotonin syndrome. Do not use within 14 days of discontinuing an MAOI, or within 7 days of discontinuing venlafaxine before starting an MAOI.

• Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, tramadol, tryptophan, buspirone, St. John's Wort, linezolid, methylene blue) - increased risk of serotonin syndrome.
• Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics) - potential for QT prolongation.
• Warfarin - increased risk of bleeding.
• Drugs affecting CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) - may increase venlafaxine levels and decrease ODV levels, potentially altering efficacy/side effects.
• Drugs affecting CYP3A4 (e.g., ketoconazole, clarithromycin, ritonavir) - may increase venlafaxine and ODV levels.

• Cimetidine - may inhibit first-pass metabolism of venlafaxine, increasing AUC.
• Haloperidol, Imipramine, Metoprolol, Risperidone - venlafaxine may increase plasma levels of these drugs.
• Ethanol - no significant pharmacokinetic interaction, but concurrent use may worsen CNS effects.

• Not available (Most clinically significant interactions are categorized as moderate or major)

• Worsening depression
• Emergence of suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity, akathisia, hypomania, mania)
• Serotonin syndrome (e.g., agitation, confusion, sweating, tremor, muscle rigidity, fever)
• Hypertension
• Tachycardia
• Nausea, vomiting, diarrhea
• Dizziness, somnolence
• Insomnia
• Sexual dysfunction
• Abnormal bleeding/bruising
• Hyponatremia (especially in elderly or those on diuretics)
• Angle-closure glaucoma symptoms (eye pain, vision changes, swelling/redness in/around eye)

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.

Venlafaxine and its active metabolite are excreted into breast milk. Monitor breastfed infants for adverse effects.

Safety and efficacy have not been established for MDD in pediatric patients. Antidepressants, including venlafaxine, increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults (see Black Box Warning). Use in this population is generally not recommended unless benefits clearly outweigh risks and with close monitoring.

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. Lower starting doses and slower titration may be considered.

• Venlafaxine ER should be taken with food to minimize gastrointestinal upset.
• Patients should be advised not to chew or crush the extended-release capsules, as this can lead to rapid release of the drug and increased side effects.
• Due to its dual mechanism of action (SNRI), venlafaxine can be effective for patients who have not responded to SSRIs alone.
• 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 if venlafaxine is stopped abruptly, especially at higher doses. Tapering should be gradual over several weeks.
• Be vigilant for symptoms of serotonin syndrome, particularly when co-administered with other serotonergic agents.

• 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)
• MAOIs (e.g., Phenelzine, Tranylcypromine - generally reserved for refractory cases)
• Psychotherapy (e.g., Cognitive Behavioral Therapy, Interpersonal Therapy)

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 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.