Pristiq 50mg Tablets

Manufacturer PFIZER 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
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 a medication used to treat depression and generalized anxiety disorder. It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain, which can improve mood and reduce anxiety.
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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 any unused or expired medication properly. Do not flush medication down the toilet or pour it 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 is close to the time for your next dose, skip the missed dose and return to your regular 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 exactly as prescribed, usually once daily with or without food, at approximately the same time each day.
  • Do not crush, chew, or dissolve the extended-release tablet; swallow it whole.
  • Do not stop taking this medication suddenly without consulting your doctor, as withdrawal symptoms can occur (e.g., dizziness, nausea, headache, irritability).
  • Avoid alcohol while taking this medication, as it can worsen side effects.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it may cause dizziness or drowsiness.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort.
  • Monitor your blood pressure regularly as advised by your doctor.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 50 mg once daily
Dose Range: 50 - 100 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial: 50 mg once daily. Max: 100 mg once daily (no additional benefit shown above 50 mg/day for MDD, but 100 mg/day may be used in some cases).
Generalized Anxiety Disorder (GAD): Initial: 50 mg once daily. Max: 100 mg once daily.
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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. Antidepressants increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults.)
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed (CrCl 50-70 mL/min)
Moderate: 50 mg every other day (CrCl 30-49 mL/min)
Severe: 50 mg every other day (CrCl <30 mL/min)
Dialysis: 50 mg twice weekly, administered after dialysis session.

Hepatic Impairment:

Mild: No dosage adjustment needed
Moderate: 50 mg once daily
Severe: 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 into presynaptic neurons. This leads to increased concentrations of these neurotransmitters in the synaptic cleft, which is thought to contribute to its antidepressant and anxiolytic effects.
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Pharmacokinetics

Absorption:

Bioavailability: 80%
Tmax: 7.5 hours (median)
FoodEffect: Food does not significantly affect absorption or Cmax, but Tmax may be delayed by 2-3 hours.

Distribution:

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

Elimination:

HalfLife: 10-12 hours
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (45% as unchanged drug, 19% as glucuronide metabolite)
Unchanged: 45%
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Pharmacodynamics

OnsetOfAction: 1-2 weeks (for initial therapeutic effects, full effect may take 4-6 weeks)
PeakEffect: 4-6 weeks
DurationOfAction: 24 hours (due to once-daily dosing)

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 age 24; 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 or seek medical attention immediately:

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
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ 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 get bigger
+ Uncontrollable bleeding
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of lung or breathing problems, such as:
+ Shortness of breath or other breathing difficulties
+ Cough
+ Fever
Chest pain or pressure
Seizures
Hallucinations (seeing or hearing things that are not there)
Sex problems, including:
+ Decreased interest in sex
+ Trouble having an orgasm
+ Ejaculation problems
+ Difficulty getting or maintaining an erection
A severe and potentially life-threatening condition called serotonin syndrome may occur, especially if you take certain other medications. Seek medical help immediately if you experience:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast 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 side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Feeling dizzy, sleepy, tired, or weak
Upset stomach or vomiting
Constipation
Dry mouth
Trouble sleeping
Decreased appetite
Sweating
Shakiness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening depression or anxiety
  • New or worsening thoughts of self-harm or suicide
  • Unusual changes in behavior (e.g., agitation, restlessness, panic attacks, irritability, aggression, impulsivity, severe insomnia, hypomania, mania)
  • Symptoms of serotonin syndrome (e.g., confusion, hallucinations, rapid heart rate, sweating, muscle stiffness or twitching, fever, nausea, vomiting, diarrhea)
  • Symptoms of hyponatremia (low sodium) (e.g., headache, confusion, weakness, unsteadiness, seizures)
  • Unusual bleeding or bruising
  • New or worsening eye pain, vision changes, or swelling around the eye (especially if at risk for angle-closure glaucoma)
  • Allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty 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 known allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
A diagnosis of narrow-angle glaucoma.
High blood pressure.
Current or recent use of specific medications, including:
+ Linezolid or methylene blue.
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they may cause a sudden increase in blood pressure.
Concurrent use of another medication containing the same active ingredient or a similar drug.
Uncertainty about potential interactions with other medications, including prescription, over-the-counter, natural products, and vitamins.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, health problems, and supplements. This will help determine whether it is safe to take this medication with your existing treatments. Never start, stop, or adjust the dosage of any medication without 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, some of which 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 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 impair your actions.

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 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 Other Considerations

This medication may affect certain laboratory tests. Inform all your healthcare providers and lab personnel that you are taking this medication. You may notice the tablet appearing in your stool, but this is a normal occurrence and not a cause for concern. If you have questions, consult your doctor.

Special Precautions for Older Adults and Pregnant or Breastfeeding Women

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 in the third trimester of pregnancy may increase the risk of bleeding after delivery and potentially harm the newborn. If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
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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. Treatment is generally supportive and symptomatic. There is no specific antidote.

Drug Interactions

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Contraindicated Interactions

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

  • Other serotonergic drugs (e.g., SSRIs, other 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 (e.g., decongestants, certain stimulants) - additive pressor effects.
  • Drugs that prolong QT interval (e.g., certain antiarrhythmics, antipsychotics) - theoretical risk, monitor.
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Moderate Interactions

  • Ethanol (alcohol) - may potentiate CNS effects and impair psychomotor skills.
  • Drugs metabolized by CYP2D6 (e.g., metoprolol, atomoxetine, desipramine) - desvenlafaxine is a weak inhibitor of CYP2D6, potential for increased levels of co-administered drugs.
  • Drugs that cause hyponatremia (e.g., diuretics) - increased risk of hyponatremia.
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Minor Interactions

  • Not available (most minor interactions are managed by monitoring)

Monitoring

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Baseline Monitoring

Depression/Anxiety Symptom Assessment

Rationale: To establish baseline severity and guide treatment.

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

Renal Function (CrCl)

Rationale: Dosage adjustment is required in patients with renal impairment.

Timing: Prior to initiation

Hepatic Function (LFTs)

Rationale: Dosage adjustment is required in patients with moderate to severe hepatic impairment.

Timing: Prior to initiation

Personal/Family History of Bipolar Disorder or Mania

Rationale: To assess risk of mood switching.

Timing: Prior to initiation

History of Seizures

Rationale: SNRIs may lower seizure threshold.

Timing: Prior to initiation

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Routine Monitoring

Depression/Anxiety Symptom Assessment

Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated

Target: Reduction in symptom severity

Action Threshold: Lack of improvement, worsening symptoms, or emergence of new symptoms (e.g., suicidality)

Blood Pressure and Heart Rate

Frequency: Regularly, especially during dose titration and periodically thereafter

Target: Within normal limits or patient's baseline

Action Threshold: Sustained clinically significant elevation (e.g., >140/90 mmHg or significant increase from baseline)

Emergence of Suicidal Thoughts/Behaviors

Frequency: Especially during initial treatment and dose changes

Target: Absence of suicidal ideation/behavior

Action Threshold: Any new or worsening suicidal thoughts/behaviors

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

Frequency: Regularly, especially during initial treatment

Target: Tolerable side effect profile

Action Threshold: Intolerable side effects leading to non-adherence or significant distress

Weight

Frequency: Periodically

Target: Stable weight

Action Threshold: Significant weight gain or loss

Serum Sodium (Na+)

Frequency: Periodically, especially in elderly or those on diuretics

Target: 135-145 mEq/L

Action Threshold: Hyponatremia (<135 mEq/L)

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Symptom Monitoring

  • Worsening depression
  • Suicidal thoughts or behavior
  • Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
  • Serotonin syndrome symptoms (e.g., agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, GI symptoms)
  • Hyponatremia symptoms (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, hallucinations, syncope, seizures, coma)
  • Increased blood pressure or heart rate
  • Abnormal bleeding or bruising
  • New or worsening eye pain, vision changes (for patients at risk of angle-closure glaucoma)

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 late pregnancy may lead to complications in the neonate requiring prolonged hospitalization, respiratory support, and tube feeding. These complications can arise immediately upon delivery.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations.
Second Trimester: Limited data.
Third Trimester: Increased risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying). Monitor neonates for these symptoms.
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Lactation

Desvenlafaxine is excreted into breast 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 (Moderate risk - monitor infant for adverse effects)
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Antidepressants, including desvenlafaxine, increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults (aged 18-24) compared to placebo.

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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. Use with caution, generally starting at the lower end of the dosing range.

Clinical Information

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Clinical Pearls

  • Desvenlafaxine is the major active metabolite of venlafaxine, offering a similar mechanism of action but with potentially more predictable pharmacokinetics due to bypassing first-pass metabolism.
  • Extended-release formulation means it should be swallowed whole; crushing or chewing can lead to rapid release and increased side effects.
  • Patients may notice a 'ghost tablet' in their stool, which is the inert shell of the extended-release tablet and is normal.
  • Blood pressure monitoring is crucial, especially during dose titration, as SNRIs can cause sustained hypertension.
  • Gradual tapering is essential when discontinuing to minimize withdrawal symptoms (e.g., dizziness, nausea, headache, paresthesias, anxiety, insomnia).
  • Educate patients and caregivers about the black box warning regarding suicidality, especially in younger populations, and the importance of monitoring for behavioral changes.
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Alternative Therapies

  • Other SNRIs (e.g., Venlafaxine, Duloxetine, Levomilnacipran)
  • SSRIs (e.g., Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram)
  • 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)
  • Electroconvulsive Therapy (ECT) for severe, refractory depression
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Cost & Coverage

Average Cost: Varies, typically $30-$150 per 30 tablets (generic 50mg)
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 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, we encourage you to discuss them with 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.