Desvenlafaxine ER Succinate 100mg 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 inhibiting their reuptake at the presynaptic neuronal membrane. This leads to increased concentrations of these neurotransmitters in the synaptic cleft, thereby modulating mood and behavior.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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

Additionally, a severe and potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking certain other medications. Seek medical help immediately if you experience any of the following symptoms:
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 people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not resolve:

Dizziness, drowsiness, fatigue, or weakness
Nausea 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust the dosage 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. The full effects of this drug may not be apparent for several months.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

Do not abruptly stop taking this medication 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 this drug, your doctor will provide guidance on how to gradually stop taking it. If you experience any new or worsening symptoms, discuss them with your doctor.

This medication may cause high blood pressure, so it is crucial to have your blood pressure monitored as directed by your doctor. Avoid consuming alcohol while taking this drug. Before using marijuana, cannabis, or prescription or over-the-counter medications that may impair your actions, consult with your doctor.

There is a potential risk of bleeding associated with this medication, 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 drug. 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, contact your doctor immediately.

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 also been reported in patients taking this drug; if you have concerns, consult with 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 drug. If you notice what appears to be a tablet in your stool, this is a normal occurrence and not a cause for concern; however, if you have questions, discuss them with your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. Taking this drug during the third trimester of pregnancy may increase the risk of bleeding after delivery and potentially cause health problems in the newborn. Breastfeeding mothers should also discuss any potential risks to their baby with their doctor.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOIs, or starting MAOIs within 7 days of stopping desvenlafaxine due to risk of serotonin syndrome)
• Linezolid (an antibiotic with MAOI activity)
• Methylene Blue (an MAOI)

• Other serotonergic drugs (SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
• Anticoagulants/Antiplatelets (warfarin, aspirin, NSAIDs) - increased risk of bleeding.
• Drugs that prolong the QT interval - theoretical risk of QT prolongation (though desvenlafaxine itself has minimal effect).

• Ethanol (alcohol) - may increase CNS depression.
• Drugs metabolized by CYP2D6 (e.g., metoprolol, atomoxetine, desipramine) - desvenlafaxine is a weak inhibitor of CYP2D6, potentially increasing concentrations of these drugs.
• Drugs that affect blood pressure (e.g., antihypertensives) - desvenlafaxine can cause dose-dependent increases in blood pressure.

• Not available (most interactions are categorized as moderate or higher due to clinical significance)

• Worsening depression
• Suicidal thoughts or behaviors
• Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity)
• Mania or hypomania
• Anxiety
• Panic attacks
• Insomnia
• Restlessness
• Serotonin syndrome symptoms (e.g., confusion, rapid heart rate, sweating, muscle rigidity, tremors)
• Abnormal bleeding or bruising
• Symptoms of hyponatremia (e.g., headache, confusion, weakness, seizures)
• New or worsening hypertension

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.

Desvenlafaxine is excreted into human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for desvenlafaxine, and any potential adverse effects on the breastfed infant from desvenlafaxine or from the underlying maternal condition. Monitor infants for sedation, poor feeding, and poor weight gain.

Safety and efficacy have not been established in pediatric patients. Antidepressants increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults. Use is generally not recommended.

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. Use lowest effective dose and monitor closely.

• Desvenlafaxine is the major active metabolite of venlafaxine, offering a similar mechanism of action but with potentially simpler pharmacokinetics due to less reliance on CYP2D6 metabolism.
• The 100 mg dose of desvenlafaxine has not shown significantly greater efficacy than 50 mg in MDD trials but is associated with higher rates of adverse events, particularly nausea and hypertension. Therefore, 50 mg is often the target dose.
• Patients should be advised that they may see the 'ghost tablet' in their stool, which is the inert matrix of the extended-release tablet and does not mean the medication was not absorbed.
• Blood pressure should be monitored regularly, especially during the initial weeks of treatment and dose increases, as desvenlafaxine can cause dose-dependent increases in blood pressure.
• Discontinuation syndrome is common with SNRIs, including desvenlafaxine. Tapering the dose gradually over several weeks is crucial to minimize withdrawal symptoms (e.g., dizziness, nausea, headache, irritability, paresthesias, anxiety, insomnia).
• Caution is advised when switching from other antidepressants, especially MAOIs, due to the risk of serotonin syndrome. A washout period is required.

• Other SNRIs (e.g., Venlafaxine, Duloxetine, Levomilnacipran)
• SSRIs (e.g., Sertraline, Fluoxetine, Escitalopram, Paroxetine, Citalopram)
• Atypical Antidepressants (e.g., Bupropion, Mirtazapine, Trazodone)
• Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
• MAOIs (e.g., Phenelzine, Tranylcypromine, Selegiline)
• 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 is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When seeking help, be prepared to provide detailed information about the overdose, including the type and amount of medication taken, as well as the time it occurred.