Pristiq 25mg Tablets

Manufacturer PFIZER U.S. 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?

Pristiq (desvenlafaxine) is a medication used to treat depression. It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain, which can improve mood and feelings of well-being.
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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

Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, ask your pharmacist. You may also want to check if there are any 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's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take the tablet whole; do not crush, chew, or divide it.
  • Can be taken with or without food.
  • Take at approximately the same time each day.
  • Avoid alcohol, as it may worsen side effects.
  • Be cautious when driving or operating machinery until you know how the medication affects you, as it may cause dizziness or drowsiness.
  • Do not stop taking this medication suddenly without consulting your doctor, as withdrawal symptoms can occur.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 50 mg once daily. Titrate as needed. The 25mg tablet is primarily for titration or specific patient needs, not a standard therapeutic dose.
Dose Range: 50 - 400 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): 50 mg once daily. Doses above 50 mg/day have not been shown to provide additional benefit and may increase adverse reactions.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy not established in pediatric patients. Use in pediatric patients is 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 (CrCl 30-49 mL/min)
Severe: Reduce dose to 50 mg every other day (CrCl <30 mL/min)
Dialysis: Reduce dose to 50 mg every other day. Administer after dialysis session.

Hepatic Impairment:

Mild: No dosage adjustment needed
Moderate: Reduce dose to 50 mg once daily
Severe: Reduce dose to 50 mg once daily

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: Approximately 80%
Tmax: Approximately 7.5 hours (for extended-release formulation)
FoodEffect: Food does not significantly affect the absorption or pharmacokinetics of desvenlafaxine.

Distribution:

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

Elimination:

HalfLife: Approximately 10-12 hours
Clearance: Approximately 15.5 L/hr
ExcretionRoute: Renal (primarily as unchanged drug and its glucuronide conjugate)
Unchanged: Approximately 45% (unchanged drug in urine)
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Pharmacodynamics

OnsetOfAction: Clinical effects may begin within 1-2 weeks, but full therapeutic effect may take 4-6 weeks.
PeakEffect: Typically 4-6 weeks for full antidepressant effect.
DurationOfAction: Due to its half-life and extended-release formulation, it is dosed once daily.

Safety & Warnings

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BLACK BOX WARNING

Antidepressants increased the risk compared to placebo of suicidal thinking 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 Pristiq 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 years 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. Pristiq is not approved for use in pediatric patients.
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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 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
Signs of lung or breathing problems, such as:
+ Shortness of breath or difficulty breathing
+ 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
+ Trouble getting or maintaining an erection
A potentially life-threatening condition called serotonin syndrome, which may occur, especially if you are taking certain other medications. Seek immediate medical attention 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

Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Dizziness
Drowsiness
Fatigue
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 suicidal thoughts, especially at the beginning of treatment or after a dose change.
  • Unusual changes in behavior or mood (e.g., agitation, restlessness, panic attacks, irritability, aggression, impulsivity, severe insomnia, hypomania, mania).
  • Signs of serotonin syndrome: fast heartbeat, sweating, fever, muscle stiffness or spasms, confusion, agitation, hallucinations, severe nausea, vomiting, or diarrhea.
  • Increased blood pressure or heart rate.
  • Unusual bleeding or bruising.
  • Symptoms of low sodium (hyponatremia): headache, confusion, weakness, unsteadiness, seizures.
  • Eye pain, changes in vision, or swelling or redness in or around the eye (signs of angle-closure glaucoma).
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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, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
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, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, taken within the last 14 days. This is crucial because combining these medications can 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 to confirm.

This list is not exhaustive, and it is crucial to disclose all your medications, including:

Prescription and over-the-counter (OTC) drugs.
Natural products.
* Vitamins.

Share your complete medical history and list of medications with your doctor and pharmacist to verify the safety of taking this medication with your existing treatments. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.

When to Expect Results and Potential Effects

You may need to take this medication for several months before you experience its full effects. Additionally, be cautious when performing tasks that require your attention, such as driving, until you understand how this medication affects you.

Preventing Dizziness and Falls

To minimize the risk of feeling dizzy or lightheaded, rise slowly from a sitting or lying down position. Be careful when climbing stairs, as this can increase your risk of falling.

Stopping the Medication

Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of side effects. In some cases, these side effects can be severe and long-lasting. If you need to discontinue the medication, your doctor will provide guidance on how to do so safely.

Monitoring Your Health

Regular blood pressure checks are essential 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.

Bleeding Risks

This medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.

Eye Problems

Some individuals may be more susceptible 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

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

High Cholesterol

High cholesterol has been reported in individuals taking this medication. If you have concerns, consult your doctor.

Lab Tests and Medication Interactions

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

Tablet Appearance in Stool

You may notice what appears to be the tablet in your stool. This is a normal occurrence and not a cause for concern. If you have questions, consult your doctor.

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.

Pregnancy and Breastfeeding

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. Taking this medication during the third trimester of pregnancy may increase your risk of bleeding after delivery and may cause health problems in the newborn. Your doctor will discuss the benefits and risks of taking this medication during pregnancy and breastfeeding.
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Overdose Information

Overdose Symptoms:

  • Somnolence
  • Nausea
  • Vomiting
  • Dizziness
  • Tachycardia
  • Mydriasis
  • Convulsions
  • Hypertension
  • Serotonin syndrome
  • ECG changes (e.g., QTc prolongation, bundle branch block, QRS prolongation)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. Ensure adequate airway, oxygenation, and ventilation. Activated charcoal may be considered if ingested recently. Monitor cardiac rhythm and vital signs.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, selegiline, tranylcypromine, linezolid, methylene blue) - risk of serotonin syndrome.
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Major Interactions

  • Other serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, fentanyl, 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., certain antipsychotics, antiarrhythmics) - theoretical risk, monitor ECG.
  • Alcohol - may potentiate CNS effects and impair cognitive/motor skills.
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Moderate Interactions

  • 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) - monitor blood pressure.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Depression severity (e.g., PHQ-9, HAM-D)

Rationale: To establish baseline and assess treatment efficacy.

Timing: Prior to initiation

Suicidal ideation/behavior

Rationale: Antidepressants carry a black box warning for increased risk in young adults.

Timing: Prior to initiation

Blood pressure and heart rate

Rationale: SNRIs can cause dose-dependent increases in blood pressure and heart rate.

Timing: Prior to initiation

Electrolytes (especially sodium)

Rationale: Risk of hyponatremia, particularly in elderly or those on diuretics.

Timing: Prior to initiation

Renal and hepatic function tests

Rationale: To guide dosing adjustments in impaired patients.

Timing: Prior to initiation

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Routine Monitoring

Depression severity and clinical response

Frequency: Weekly for first few weeks, then monthly or as clinically indicated

Target: Reduction in symptoms, remission

Action Threshold: Lack of improvement after 4-6 weeks, worsening symptoms

Suicidal ideation/behavior

Frequency: Especially during initial treatment and dose changes, then regularly

Target: Absence of ideation/behavior

Action Threshold: Emergence or worsening of suicidal thoughts/behaviors

Blood pressure and heart rate

Frequency: Regularly, especially during dose titration

Target: Within normal limits or patient's baseline

Action Threshold: Sustained clinically significant increases

Side effects (e.g., nausea, dizziness, insomnia, sweating, sexual dysfunction)

Frequency: Regularly, especially during initial treatment

Target: Tolerable or absent

Action Threshold: Intolerable side effects, requiring dose adjustment or discontinuation

Weight

Frequency: Periodically

Target: Stable or within healthy range

Action Threshold: Significant weight gain or loss

Electrolytes (sodium)

Frequency: Periodically, especially in at-risk patients (elderly, diuretic use)

Target: 135-145 mEq/L

Action Threshold: Hyponatremia (<135 mEq/L)

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Symptom Monitoring

  • Worsening depression
  • Emergence of suicidal thoughts or behavior
  • Unusual changes in behavior or mood (e.g., agitation, irritability, panic attacks, insomnia, aggression, impulsivity, akathisia, hypomania, mania)
  • Signs of serotonin syndrome (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
  • Increased blood pressure or heart rate
  • Excessive sweating
  • Nausea, vomiting, diarrhea, constipation
  • Dizziness, headache
  • Insomnia or somnolence
  • Sexual dysfunction
  • Abnormal bleeding or bruising
  • Symptoms of hyponatremia (e.g., headache, confusion, weakness, seizures)

Special Patient Groups

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Pregnancy

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.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations.
Second Trimester: Limited data.
Third Trimester: Risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, cyanosis, apnea, seizures, feeding difficulties, tremor, irritability, constant crying).
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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.

Infant Risk: L3 (Moderate risk). Monitor infants for irritability, poor feeding, and somnolence. The relative infant dose is generally low.
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Pediatric Use

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 (see Black Box Warning). Not recommended for use in this population.

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Geriatric Use

Increased risk of hyponatremia, especially in patients taking diuretics. Increased risk of falls. Use with caution, and monitor for adverse effects. No specific dose adjustment based on age alone, but consider renal function.

Clinical Information

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Clinical Pearls

  • Pristiq 25mg is often a starting dose or used for titration, but the typical therapeutic dose for MDD is 50mg once daily. Doses above 50mg generally do not provide additional benefit and may increase side effects.
  • Take the tablet whole; it is an extended-release formulation and should not be crushed, chewed, or divided.
  • Monitor blood pressure regularly, especially during dose titration, as SNRIs can cause sustained increases.
  • Be aware of the risk of serotonin syndrome, especially when co-administered with other serotonergic agents or MAOIs.
  • Patients should be advised not to discontinue desvenlafaxine abruptly due to the risk of withdrawal symptoms (e.g., dizziness, nausea, headache, irritability, insomnia, anxiety). Tapering is recommended.
  • Counsel patients on the black box warning regarding suicidal thoughts and behaviors, particularly in young adults, and the importance of reporting any changes in mood or behavior.
  • Consider the risk of hyponatremia, especially in elderly patients or those on diuretics, and monitor sodium levels if clinically indicated.
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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, trazodone)
  • Tricyclic Antidepressants (TCAs)
  • MAOIs (less common due to side effect profile and interactions)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 for generic desvenlafaxine 25mg per 30 tablets
Generic Available: Yes
Insurance Coverage: Generic desvenlafaxine is typically covered as a Tier 1 or Tier 2 medication. Brand Pristiq is often Tier 3 or higher.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. 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. 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.