Desvenlafaxine ER Succinate 50mg T

Desvenlafaxine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It enhances the neurotransmission of serotonin and norepinephrine in the central nervous system by blocking their reuptake pumps, leading to increased concentrations of these neurotransmitters in the synaptic cleft. This action is believed to be responsible for 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: 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.
Signs of lung or breathing problems: shortness of breath or other breathing difficulties, cough, or fever.
Chest pain or pressure.
Seizures.
Hallucinations (seeing or hearing things that are not there).
Sex problems, including decreased interest in sex, difficulty having an orgasm, ejaculation problems, or trouble getting or maintaining an erection. 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 medical help immediately 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, stomach upset, or vomiting, or a severe headache.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Dizziness, drowsiness, fatigue, or weakness.
Upset stomach or vomiting.
Constipation.
Dry mouth.
Difficulty sleeping.
Decreased appetite.
Sweating.
Shakiness.

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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.
A diagnosis of narrow-angle glaucoma.
High blood pressure.
Current or recent use of certain medications, including:
+ Linezolid or methylene blue.
+ Drugs for depression or Parkinson's disease taken within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure.
Use of another medication that contains the same active ingredient as this drug.
Use of a similar medication, if you are unsure, consult your doctor or pharmacist.

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This will help determine if it is safe to take this medication with your other treatments. Never start, stop, or adjust the dose of any medication without first consulting your doctor.

Important Information About Your Medication

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 any potential interactions with other treatments.

Effectiveness and Potential Side Effects

You may need to take this medication for several months to experience its full effects. During this time, be cautious when driving or performing tasks that require your full attention, as this medication may affect your alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be careful when climbing stairs.

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 discontinue the medication, your doctor will provide guidance on how to taper off safely. Be sure to discuss any new or worsening symptoms with your doctor.

Monitoring Your Health

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.

Interactions with Other Substances

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

Potential Risks and Complications

This medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor. Certain individuals may be more prone to 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 around the eye, seek medical attention immediately.

Low Blood Sodium Levels and High Cholesterol

This medication may cause low blood sodium levels, which can be fatal in severe cases. Discuss this risk with your doctor. High cholesterol has also been reported in individuals taking this medication. If you have concerns, consult your doctor.

Lab Tests and Medication Interactions

Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.

Stool Appearance and Age-Related Considerations

You may notice the tablet's appearance in your stool, but this is normal and not a cause for concern. If you have questions, consult your doctor. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. Taking this medication during the third trimester of pregnancy may increase your risk of bleeding after delivery and potentially cause health problems in the newborn. If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, selegiline, linezolid, methylene blue) - risk of serotonin syndrome. Allow at least 14 days between discontinuing an MAOI and starting desvenlafaxine, and 7 days between discontinuing desvenlafaxine and starting an MAOI.

• Other serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
• Anticoagulants/Antiplatelets (e.g., warfarin, aspirin, NSAIDs) - increased risk of bleeding.
• Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics) - theoretical risk, monitor ECG.
• Alcohol - may potentiate CNS effects and increase risk of liver toxicity.

• Drugs metabolized by CYP2D6 (e.g., metoprolol, atomoxetine, desipramine) - desvenlafaxine is a weak inhibitor of CYP2D6, potentially increasing concentrations of these drugs.
• P-glycoprotein (P-gp) inhibitors (e.g., quinidine, verapamil, ketoconazole) - may increase desvenlafaxine exposure (though desvenlafaxine is not a P-gp substrate to a significant extent).

• Not available (most minor interactions are not clinically significant enough to list broadly without specific context)

• Worsening depression or anxiety
• Emergence or worsening of suicidal thoughts or behavior
• Agitation, irritability, hostility, aggressiveness
• Panic attacks, insomnia, akathisia
• Mania or hypomania
• Serotonin syndrome symptoms (e.g., agitation, hallucinations, rapid heart beat, fever, sweating, shivering, muscle rigidity, twitching, incoordination, nausea, vomiting, diarrhea)
• Abnormal bleeding or bruising
• Hyponatremia symptoms (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures, falls)
• Symptoms of discontinuation syndrome (e.g., dizziness, nausea, headache, irritability, insomnia, vivid dreams, paresthesias, anxiety)

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Exposure during the third trimester may lead to complications in the neonate requiring prolonged hospitalization, respiratory support, and tube feeding. These complications can include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These effects are consistent with a direct toxic effect of the SNRI or a drug discontinuation syndrome. There is also a potential for persistent pulmonary hypertension of the newborn (PPHN) with SSRI/SNRI exposure in late pregnancy.

Desvenlafaxine is excreted into breast milk. The amount is relatively low, and adverse effects in breastfed infants are generally mild or absent. However, monitor infants for sedation, poor feeding, and poor weight gain. Use with caution, especially in preterm or neonates.

Safety and efficacy have not been established in pediatric patients for MDD. Antidepressants, including desvenlafaxine, increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults (see Black Box Warning). Not recommended for routine use in this population.

No overall differences in safety or efficacy 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. Use with caution, monitor for adverse effects, and consider lower starting doses or slower titration.

• Desvenlafaxine is the major active metabolite of venlafaxine, offering similar efficacy with potentially simpler pharmacokinetics (less CYP interaction).
• Always swallow the extended-release tablet whole; crushing or chewing can lead to rapid release and increased side effects.
• Monitor blood pressure regularly, especially during dose titration, as SNRIs can cause sustained hypertension.
• Educate patients about the importance of not abruptly discontinuing the medication to avoid discontinuation syndrome.
• Be vigilant for symptoms of serotonin syndrome, especially when co-administered with other serotonergic agents.
• Consider the risk of hyponatremia, particularly in elderly patients, those on diuretics, or those who are volume-depleted.

• Other SNRIs (e.g., venlafaxine, duloxetine, levomilnacipran)
• SSRIs (e.g., fluoxetine, sertraline, escitalopram, citalopram, paroxetine)
• Atypical antidepressants (e.g., bupropion, mirtazapine, trazodone)
• Tricyclic antidepressants (TCAs)
• Monoamine Oxidase Inhibitors (MAOIs)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully when you first receive your medication and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.