Desvenlafaxine ER Succinate 25mg T

Manufacturer WEST-WARD Active Ingredient Desvenlafaxine(des ven la FAX een) Pronunciation des-ven-la-FAX-een
WARNING: Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug is not approved for use in children. Talk with the doctor. @ COMMON USES: It is used to treat depression.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antidepressant
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Pharmacologic Class
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
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Pregnancy Category
C
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FDA Approved
Feb 2008
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Desvenlafaxine is an antidepressant medication that works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain. It is used to treat major depressive disorder.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but be sure to swallow the tablet whole with a fluid. Do not chew, break, crush, or dissolve the tablet. Take your medication at the same time every day to establish a routine. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. If you have questions about disposing of your medication, consult with your pharmacist, who may be aware of drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take the medication exactly as prescribed, usually once daily, at approximately the same time each day.
  • Swallow the extended-release tablet whole; do not crush, chew, or divide it.
  • It can be taken with or without food.
  • Avoid alcohol consumption, as it may worsen side effects.
  • Be aware that antidepressant effects may take several weeks to become noticeable.
  • Do not stop taking the medication suddenly without consulting your doctor, as this can lead to withdrawal symptoms.
  • Report any new or worsening symptoms, especially changes in mood, behavior, or suicidal thoughts, to your doctor immediately.
  • Be cautious when driving or operating machinery until you know how the medication affects you, as it may cause dizziness or drowsiness.
  • Monitor blood pressure regularly as advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 50 mg once daily
Dose Range: 25 - 400 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial dose 50 mg once daily. Some patients may benefit from starting at 25 mg once daily for several days to allow for adjustment to the medication before increasing to 50 mg once daily. Doses above 50 mg/day have not been shown to provide additional benefit and may increase adverse reactions. Maximum recommended dose is 50 mg/day for most patients.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy not established for MDD in pediatric patients. Use in pediatric patients is generally not recommended due to increased risk of suicidal thoughts and behaviors.)
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed (CrCl 50-70 mL/min)
Moderate: Reduce dose to 50 mg every other day or 25 mg once daily (CrCl 30-50 mL/min)
Severe: Reduce dose to 25 mg every other day (CrCl <30 mL/min)
Dialysis: Reduce dose to 25 mg twice weekly, administered after dialysis sessions.

Hepatic Impairment:

Mild: No dosage adjustment needed
Moderate: Reduce dose to 50 mg once daily (Child-Pugh class B)
Severe: Not recommended (Child-Pugh class C)

Pharmacology

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Mechanism of Action

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 thought to be responsible for its antidepressant effects.
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Pharmacokinetics

Absorption:

Bioavailability: 80%
Tmax: 7.5-10 hours (extended-release)
FoodEffect: Minimal effect on Cmax or AUC. Can be taken with or without food.

Distribution:

Vd: 3.4 L/kg
ProteinBinding: 30%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 11 hours
Clearance: Not available (Systemic clearance approximately 10.8 L/h)
ExcretionRoute: Renal (primarily as conjugated metabolites and unchanged drug)
Unchanged: 45%
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Pharmacodynamics

OnsetOfAction: Within 1-2 weeks (for antidepressant effects, though full effect may take 4-6 weeks)
PeakEffect: 4-6 weeks for full therapeutic effect
DurationOfAction: 24 hours (due to extended-release formulation and half-life)

Safety & Warnings

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BLACK BOX WARNING

Antidepressants increased the risk compared to placebo of suicidal thoughts and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of desvenlafaxine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond 24 years of age; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
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Side 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 real).
Sex problems, including decreased interest in sex, difficulty having an orgasm, ejaculation problems, or trouble achieving 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
Severe headache

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor 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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening depression or anxiety
  • Thoughts of self-harm or suicide
  • New or increased agitation, restlessness, panic attacks, insomnia
  • New or increased irritability, aggressiveness, impulsivity
  • Unusual changes in behavior or mood
  • Symptoms of serotonin syndrome: agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness/twitching, loss of coordination, nausea, vomiting, diarrhea
  • Symptoms of hyponatremia: headache, confusion, weakness, unsteadiness, seizures
  • New or worsening eye pain, redness, or vision changes (especially blurred vision, halos around lights)
  • Unusual bleeding or bruising
  • Severe allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing)
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Before Using This Medicine

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. Be sure to describe the allergic reaction and its symptoms.
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 change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

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 potential interactions with other treatments.

When to Expect Results and Precautions

You may need to wait several months to experience the full effects of this medication. In the meantime, be cautious when driving or engaging in activities 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 guide you on how to taper off slowly.

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 or slow your reactions.

Potential Risks and Side Effects

This medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor. Some 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 in or around the eye, contact your doctor immediately.

Low blood sodium levels, which can be fatal in severe cases, may also occur with this medication. High cholesterol is another potential side effect. If you have concerns or questions, discuss them with 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.

Additional Information

You may notice the tablet appearing intact in your stool, but this is normal and not a cause for concern. If you have questions, consult your doctor.

Special Considerations

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

Overdose Symptoms:

  • Somnolence
  • Nausea
  • Vomiting
  • Dizziness
  • Tachycardia
  • Mydriasis
  • Convulsions
  • Serotonin syndrome

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. There is no specific antidote; treatment is symptomatic and supportive. Ensure adequate airway, oxygenation, and ventilation. Activated charcoal may be considered if administered soon after ingestion.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
  • Linezolid (MAOI activity)
  • Methylene blue (MAOI activity)
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Major Interactions

  • Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome
  • Anticoagulants (e.g., warfarin) and antiplatelet agents (e.g., aspirin, NSAIDs) - increased risk of bleeding
  • Drugs that increase blood pressure or heart rate (e.g., stimulants, decongestants, certain migraine medications) - potential for additive effects
  • Alcohol - may potentiate CNS effects and impair cognitive/motor skills
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Moderate Interactions

  • Drugs metabolized by CYP2D6 (e.g., atomoxetine, desipramine, metoprolol) - desvenlafaxine is a weak inhibitor of CYP2D6, potential for increased exposure of these drugs
  • Drugs that cause hyponatremia (e.g., diuretics) - increased risk of hyponatremia
  • CNS depressants (e.g., benzodiazepines, hypnotics, antipsychotics) - additive CNS depression
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Minor Interactions

  • Not specifically listed as minor, but general caution with any new medication.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: SNRIs can cause sustained increases in BP and HR.

Timing: Prior to initiation

Weight

Rationale: Changes in weight can occur with antidepressant treatment.

Timing: Prior to initiation

Mood and Suicidal Ideation

Rationale: Risk of worsening depression and suicidality, especially in young adults.

Timing: Prior to initiation and frequently during initial therapy

Personal and Family History of Bipolar Disorder or Mania

Rationale: Risk of activating mania/hypomania in susceptible individuals.

Timing: Prior to initiation

History of Angle-Closure Glaucoma

Rationale: Risk of mydriasis and acute angle-closure attack.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter

Target: Individualized, within normal limits

Action Threshold: Sustained clinically significant increases; consider dose reduction or alternative therapy.

Mood and Suicidal Ideation

Frequency: Weekly during initial weeks of therapy, then periodically

Target: Improvement in depressive symptoms, absence of suicidal thoughts/behaviors

Action Threshold: Worsening depression, emergence of suicidal thoughts/behaviors; immediate clinical assessment and intervention.

Weight

Frequency: Periodically

Target: Stable

Action Threshold: Significant or concerning weight changes.

Serum Sodium

Frequency: Periodically, especially in elderly, volume-depleted, or those on diuretics

Target: 135-145 mEq/L

Action Threshold: Hyponatremia (<135 mEq/L); investigate cause, consider discontinuation.

Symptoms of Serotonin Syndrome

Frequency: Ongoing, especially when co-administered with other serotonergic agents

Target: Absence of symptoms (e.g., agitation, hallucinations, tachycardia, fever, hyperreflexia, incoordination, nausea, vomiting, diarrhea)

Action Threshold: Emergence of symptoms; discontinue desvenlafaxine and provide supportive care.

Bleeding/Bruising

Frequency: Ongoing, especially with concomitant use of anticoagulants/antiplatelets

Target: Absence of abnormal bleeding

Action Threshold: Unexplained bruising, petechiae, or other signs of bleeding.

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Symptom Monitoring

  • Worsening depression
  • Suicidal thoughts or behavior
  • Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, aggression, mania/hypomania)
  • Symptoms of serotonin syndrome (e.g., agitation, confusion, rapid heart rate, fever, sweating, muscle rigidity, tremors, twitching, nausea, vomiting, diarrhea)
  • Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures)
  • New or worsening eye pain, redness, or vision changes (angle-closure glaucoma)
  • Abnormal bleeding or bruising
  • Dizziness or lightheadedness upon standing (orthostatic hypotension)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy 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.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations compared to other antidepressants. However, all medications should be used cautiously.
Second Trimester: No specific increased risks identified beyond general antidepressant use.
Third Trimester: Risk of neonatal withdrawal syndrome (e.g., respiratory distress, cyanosis, apnea, seizures, feeding difficulties, irritability, constant crying, tremor, hypotonia, hypertonia, hyperreflexia) and persistent pulmonary hypertension of the newborn (PPHN).
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Lactation

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.

Infant Risk: L3 (Moderately Safe) - Monitor for adverse effects.
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Pediatric Use

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). Use is generally not recommended.

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Geriatric Use

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 or slower titration may be considered, especially in those with renal impairment.

Clinical Information

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Clinical Pearls

  • Desvenlafaxine is the major active metabolite of venlafaxine. It may be an option for patients who do not tolerate venlafaxine due to CYP2D6 polymorphism issues, as desvenlafaxine bypasses this metabolic pathway.
  • Blood pressure monitoring is crucial, especially during the initial weeks of treatment and dose escalation, as sustained hypertension can occur.
  • Discontinuation syndrome is common with SNRIs; taper the dose gradually over several weeks to months to minimize withdrawal symptoms (e.g., dizziness, nausea, headache, irritability, sensory disturbances).
  • The 25 mg dose is primarily for initiation or for patients with renal/hepatic impairment; 50 mg is the standard therapeutic dose for MDD, and higher doses generally do not provide additional efficacy but increase side effects.
  • Patients should be advised that they may see a 'ghost tablet' in their stool, which is the inert shell of the extended-release tablet and does not mean the medication was not absorbed.
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Alternative Therapies

  • Other SNRIs (e.g., venlafaxine, duloxetine, levomilnacipran)
  • SSRIs (e.g., fluoxetine, sertraline, escitalopram, citalopram, paroxetine)
  • Atypical antidepressants (e.g., bupropion, mirtazapine, vortioxetine, vilazodone)
  • Tricyclic Antidepressants (TCAs)
  • MAOIs (less common due to side effects and interactions)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
  • Electroconvulsive Therapy (ECT) for severe, treatment-resistant depression
  • Transcranial Magnetic Stimulation (TMS)
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Cost & Coverage

Average Cost: Varies widely, typically $50-$300+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic, Tier 3 or higher for brand
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General Drug Facts

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 refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the quantity, and the time it occurred.