Pristiq 100mg 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
Not available
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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. 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. It's essential to complete the full course of treatment as prescribed.

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 and secure location, out of 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. 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's 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 the missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily with or without food.
  • Swallow tablets whole; do not crush, chew, or dissolve.
  • Do not stop taking this medication suddenly without talking to your doctor, as it can cause withdrawal symptoms.
  • Avoid alcohol while taking this medication, as it can increase side effects like dizziness and drowsiness.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort, triptans, or other antidepressants.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial: 50 mg orally once daily. May increase to 100 mg/day if needed, but doses above 50 mg/day have not shown additional benefit and may increase adverse effects. Max: 400 mg/day (not recommended due to lack of additional benefit).
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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; Black Box Warning for suicidality risk in pediatric patients)
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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 twice weekly, administered after dialysis session (ESRD)

Hepatic Impairment:

Mild: No dosage adjustment needed
Moderate: Reduce dose to 50 mg once daily (Child-Pugh B)
Severe: Reduce dose to 50 mg once daily (Child-Pugh 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 believed to be responsible for its antidepressant effects.
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Pharmacokinetics

Absorption:

Bioavailability: 80%
Tmax: 7.5 hours (median)
FoodEffect: Minimal effect on Cmax or AUC

Distribution:

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

Elimination:

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

OnsetOfAction: 1-2 weeks (initial antidepressant effects), 4-6 weeks (full therapeutic effect)
PeakEffect: 4-6 weeks
DurationOfAction: 24 hours (due to once-daily dosing and half-life)

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 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 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 immediate 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of low sodium levels: headache, trouble 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 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, or a severe headache.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or 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:

  • New or worsening depression, anxiety, or panic attacks
  • Thoughts of self-harm or suicide
  • Unusual changes in behavior (e.g., agitation, irritability, aggression, impulsivity, restlessness)
  • Symptoms of serotonin syndrome: agitation, hallucinations, confusion, fast heart rate, sweating, fever, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea
  • Severe allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • Eye pain, changes in vision, or swelling around the eye (may indicate angle-closure glaucoma)
  • Seizures
  • Unusual bleeding or bruising
  • Significant increase in blood pressure or heart rate
  • Symptoms of hyponatremia (low sodium): headache, confusion, weakness, unsteadiness, severe drowsiness, seizures
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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 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 they may cause 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. They will help determine if it is safe to take this medication with your other treatments and health conditions. 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 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 Precautions

It may take several months to experience the full effects of this medication. In the meantime, be cautious when engaging in activities that require your full attention, such as driving, until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be careful when navigating stairs.

Stopping the Medication and Potential Side Effects

Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of severe and long-lasting side effects. If you need to discontinue the medication, your doctor will provide guidance on how to do so safely. Be sure to discuss any new or worsening symptoms with your doctor.

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.

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. 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 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

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

What to Expect

You may notice what appears to be a tablet in your stool. This is a normal occurrence and not a cause for concern. If you have questions, discuss them with 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 in 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
  • Hypertension
  • Hypotension
  • Serotonin syndrome
  • ECG changes (e.g., QTc prolongation)
  • Coma

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. Ensure adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Activated charcoal may be considered if ingested recently. There is no specific antidote.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOI or starting MAOI within 7 days of stopping desvenlafaxine)
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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 prolong the QT interval - theoretical risk of QT prolongation
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Moderate Interactions

  • CNS depressants (e.g., alcohol, benzodiazepines, opioids) - additive CNS depression
  • Drugs that increase blood pressure or heart rate (e.g., sympathomimetics) - additive effects
  • CYP2D6 substrates (e.g., metoprolol, atomoxetine) - desvenlafaxine is a weak inhibitor of CYP2D6, potentially increasing exposure of these drugs
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

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 for renal impairment.

Timing: Prior to initiation

Hepatic Function (Child-Pugh score)

Rationale: Dosage adjustment is required for hepatic impairment.

Timing: Prior to initiation

Suicidal Ideation/Behavior

Rationale: Increased risk of suicidality in children, adolescents, and young adults, especially at treatment initiation or dose changes.

Timing: Prior to initiation

History of Mania/Hypomania

Rationale: Risk of activating mania/hypomania in patients with bipolar disorder.

Timing: Prior to initiation

Glaucoma (narrow-angle)

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

Timing: Prior to initiation (if patient has pre-existing narrow-angle glaucoma)

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Routine Monitoring

Blood Pressure and Heart Rate

Frequency: Regularly, especially during initial treatment and dose escalation

Target: Within patient's normal range or acceptable limits

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

Suicidal Ideation/Behavior

Frequency: Frequently during the first few weeks of treatment and with dose changes

Target: Absence of new or worsening suicidal thoughts/behaviors

Action Threshold: Any new or worsening suicidal ideation or behavior requires immediate clinical assessment and intervention.

Weight

Frequency: Periodically

Target: Stable weight

Action Threshold: Significant, unexplained weight loss or gain may warrant investigation.

Symptoms of Depression and Adverse Effects

Frequency: Regularly (e.g., weekly for first month, then monthly or as clinically indicated)

Target: Improvement in depressive symptoms, tolerability of side effects

Action Threshold: Lack of efficacy after adequate trial, intolerable side effects, or emergence of severe adverse events (e.g., serotonin syndrome, severe hyponatremia).

Serum Sodium

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

Target: 135-145 mEq/L

Action Threshold: Hyponatremia (<135 mEq/L), especially if symptomatic, requires intervention.

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Symptom Monitoring

  • Worsening depression
  • New or worsening anxiety
  • Agitation
  • Panic attacks
  • Insomnia
  • Irritability
  • Hostility
  • Impulsivity
  • Akathisia (psychomotor restlessness)
  • Hypomania
  • Mania
  • Unusual changes in behavior
  • Dizziness
  • Nausea
  • Headache
  • Sweating
  • Dry mouth
  • Constipation
  • Sexual dysfunction
  • Blurred vision
  • Tremor
  • Serotonin syndrome symptoms (agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, sweating, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, GI symptoms)
  • Withdrawal symptoms upon discontinuation (dizziness, headache, nausea, diarrhea, insomnia, irritability, anxiety, paresthesia, fatigue, flu-like symptoms)

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 to SNRIs late in the third trimester has been associated with complications in neonates 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. Persistent Pulmonary Hypertension of the Newborn (PPHN) has been reported with SSRI/SNRI exposure during pregnancy.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations compared to other trimesters. However, individual risk-benefit assessment is crucial.
Second Trimester: Similar to first trimester, continued monitoring of maternal mental health is important.
Third Trimester: Increased risk of neonatal complications (e.g., withdrawal symptoms, respiratory distress, PPHN) if exposed late in the third trimester. Gradual tapering before delivery may be considered, but risk of relapse must be weighed.
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Lactation

Desvenlafaxine is excreted into human 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 breastfed infants for sedation, poor feeding, and poor weight gain.

Infant Risk: L3 (Moderately Safe) - Infant exposure is relatively low, but potential for adverse effects exists. Monitor infant for drowsiness, irritability, poor feeding, and changes in sleep patterns.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients for Major Depressive Disorder. Antidepressants, including desvenlafaxine, increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults (see Black Box Warning). Use in this population is generally not recommended unless benefits clearly outweigh risks and under close supervision.

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Geriatric Use

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. Dosage adjustments may be necessary based on renal function, which commonly declines with age. Start with lower doses and monitor closely.

Clinical Information

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Clinical Pearls

  • Desvenlafaxine is the active metabolite of venlafaxine, offering similar efficacy with potentially simpler pharmacokinetics (less CYP interaction).
  • Always counsel patients on the importance of not abruptly discontinuing desvenlafaxine due to the risk of significant withdrawal symptoms (SNRI discontinuation syndrome). Taper slowly over several weeks.
  • Monitor blood pressure regularly, especially during the initial weeks of treatment and with dose increases, as SNRIs can cause sustained hypertension.
  • Be vigilant for symptoms of serotonin syndrome, especially when co-administered with other serotonergic agents.
  • Advise patients that the tablet matrix may be visible in the stool; this is normal and does not mean the medication was not absorbed.
  • Consider the risk of activating mania/hypomania in patients with undiagnosed bipolar disorder; screen for bipolar disorder before initiating antidepressant therapy.
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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, Vortioxetine, Vilazodone)
  • Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
  • MAOIs (e.g., Phenelzine, Tranylcypromine, Selegiline) - generally reserved for refractory cases due to significant drug and food interactions
  • Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT, Interpersonal Therapy - IPT)
  • Electroconvulsive Therapy (ECT) for severe or refractory depression
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Cost & Coverage

Average Cost: Varies widely, typically $30-$150 per 30 tablets (generic 100mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (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, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.