Venlafaxine 50mg Tablets

Manufacturer ZYDUS PHARMACEUTICALS (USA) Active Ingredient Venlafaxine Tablets(ven la FAX een) Pronunciation 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 and Norepinephrine Reuptake Inhibitor (SNRI)
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Pregnancy Category
C
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FDA Approved
Dec 1993
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Venlafaxine is a medication used to treat depression and anxiety disorders. It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain, which can improve mood and reduce feelings of anxiety.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication with food to help your body absorb it properly.
Establish a routine by taking your medication at the same time every day.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

To ensure your medication remains effective and safe:

Store your medication 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.
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 or healthcare provider.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also have access to drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take the missed dose as soon as you remember.
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 a missed dose.
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Lifestyle & Tips

  • Avoid alcohol while taking venlafaxine, as it can worsen side effects like drowsiness and dizziness.
  • Do not stop taking venlafaxine suddenly without consulting your doctor, as this can lead to withdrawal symptoms.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
  • Monitor your blood pressure regularly, especially if you have a history of high blood pressure.
  • Report any unusual changes in mood or behavior to your doctor immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 37.5 mg twice daily (BID) or 25 mg three times daily (TID) for 4-7 days, then 75 mg/day in 2-3 divided doses. Maintenance: 75-225 mg/day in divided doses. Max: 375 mg/day for severe depression (inpatient).
Dose Range: 75 - 375 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial: 37.5 mg BID or 25 mg TID for 4-7 days, then 75 mg/day in 2-3 divided doses. May increase by 75 mg/day increments at intervals of no less than 4 days, up to 225 mg/day. For severe depression (inpatient), doses up to 375 mg/day may be used in divided doses.
Generalized Anxiety Disorder (GAD): Not typically indicated for IR formulation; XR is preferred. If used, similar dosing to MDD, but target dose usually 75-225 mg/day.
Social Anxiety Disorder (SAD): Not typically indicated for IR formulation; XR is preferred. If used, similar dosing to MDD, but target dose usually 75-225 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (safety and efficacy not established for MDD in pediatric patients <18 years)
Adolescent: Not established (safety and efficacy not established for MDD in pediatric patients <18 years). Use with caution due to increased risk of suicidal thoughts and behaviors.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl 60-90 mL/min)
Moderate: Reduce total daily dose by 25% (CrCl 30-59 mL/min)
Severe: Reduce total daily dose by 50% (CrCl <30 mL/min)
Dialysis: Reduce total daily dose by 50% and administer after dialysis session.

Hepatic Impairment:

Mild: Reduce total daily dose by 25-50%
Moderate: Reduce total daily dose by 50%
Severe: Reduce total daily dose by 50% or more, use with extreme caution.

Pharmacology

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Mechanism of Action

Venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake. This leads to an increase in the synaptic concentrations of these neurotransmitters in the central nervous system, which is thought to mediate its antidepressant and anxiolytic effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 45% (due to first-pass metabolism)
Tmax: Venlafaxine: 2-4 hours; ODV: 4-8 hours
FoodEffect: Food does not significantly affect the absorption or peak concentration of venlafaxine or ODV, but may delay Tmax slightly.

Distribution:

Vd: Approximately 5.7 L/kg
ProteinBinding: Approximately 27% (venlafaxine) and 30% (ODV)
CnssPenetration: Yes

Elimination:

HalfLife: Venlafaxine: Approximately 5 hours; ODV: Approximately 11 hours
Clearance: Venlafaxine: 1.3 Âą 0.6 L/h/kg; ODV: 0.4 Âą 0.2 L/h/kg
ExcretionRoute: Primarily renal (approximately 87% of a dose is excreted in urine within 48 hours, mainly as ODV and its conjugates, and to a lesser extent as unchanged venlafaxine).
Unchanged: Approximately 5% (venlafaxine) and 0.2% (ODV) of the dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Initial antidepressant effects may be seen within 1-2 weeks, but full therapeutic effects may take 4-6 weeks.
PeakEffect: Peak plasma concentrations reached within 2-4 hours (IR).
DurationOfAction: Due to relatively short half-life, requires BID or TID dosing for IR formulation to maintain therapeutic levels.

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 venlafaxine 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 65 years of age 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. Venlafaxine 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 medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or 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 changes in eyesight
Seizures
Chest pain or pressure
Shortness of breath
Cough
Bone pain
Sexual problems, such as:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or maintaining an erection
Serotonin syndrome, a potentially life-threatening condition, which may be more likely if you take certain other medications. Symptoms include:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Abnormal or rapid heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, nausea, or vomiting
+ Severe headache

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Difficulty sleeping
Feeling nervous, anxious, or excitable
Weight loss
Dizziness, drowsiness, fatigue, or weakness
Shakiness
Headache
Excessive sweating
Constipation, diarrhea, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Strange or unusual dreams
* Yawning

Reporting Side Effects

This list is not exhaustive, and you may experience other 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:

  • Thoughts of self-harm or suicide
  • New or worsening anxiety, panic attacks, agitation, restlessness, irritability, aggression, or hostility
  • Extreme increase in activity and talking (mania)
  • Unusual changes in behavior
  • Symptoms of serotonin syndrome: fast heartbeat, sweating, muscle stiffness or spasms, fever, confusion, severe diarrhea, agitation, hallucinations
  • Severe allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • Eye pain, vision changes, or swelling around the eye (risk of angle-closure glaucoma)
  • Seizures
  • Unusual bleeding or bruising
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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 medications to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have high blood pressure, as this medication may affect your condition.
If you have narrow-angle glaucoma, a condition that affects the eyes.
If you are taking a weight loss drug, as this may interact with the medication.
If you are taking certain medications, such as:
+ Linezolid
+ Methylene blue
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications can lead to very high blood pressure.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
Health problems

Your doctor and pharmacist will help you determine if it is safe to take this medication with your existing medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

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 any potential interactions with other treatments.

Until you know how this medication affects you, avoid driving and other activities that require alertness. If you need to stop taking this medication, do not do so abruptly without consulting your doctor, as this may increase your risk of side effects, which can be severe and long-lasting. Instead, follow your doctor's instructions for a gradual tapering of the dose. If you experience any new or worsening symptoms, discuss them with your doctor.

Regular blood pressure monitoring is crucial while taking this medication, as it may cause high blood pressure. Follow your doctor's recommendations for blood pressure checks.

It is recommended to avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness or impair your reactions.

This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor. If you have bipolar disorder, be aware that this medication may trigger manic episodes. Contact your doctor immediately if you experience symptoms of a manic episode.

Some individuals may be at a higher risk of developing 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, seek medical attention promptly.

Low blood sodium levels (hyponatremia) can occur with this medication, and in severe cases, it can be fatal. Discuss this risk with your doctor. High cholesterol has also been reported in some individuals taking this medication. If you have concerns, consult your doctor.

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

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary, and your doctor will discuss this with you.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of taking this medication. Taking this medication during mid to late pregnancy may increase the risk of health problems for both the mother (such as postpartum bleeding) and the newborn. If you are breastfeeding, your doctor will help you weigh the potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Somnolence
  • Mild tachycardia
  • Mydriasis
  • Nausea
  • Vomiting
  • Dizziness
  • ECG changes (e.g., QT prolongation, bundle branch block, QRS prolongation)
  • Bradycardia
  • Hypotension
  • Seizures
  • Vertigo
  • Coma
  • 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. 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) (concurrent use or within 14 days of stopping MAOI, or starting MAOI within 7 days of stopping venlafaxine due to 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
  • Linezolid (MAOI activity)
  • Methylene blue (MAOI activity)
  • Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics) - theoretical risk of QT prolongation
  • Anticoagulants (e.g., warfarin) - increased risk of bleeding
  • NSAIDs, aspirin, other antiplatelet agents - increased risk of bleeding
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Moderate Interactions

  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may increase venlafaxine levels and decrease ODV levels, potentially altering efficacy/side effects
  • CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - may increase venlafaxine and ODV levels
  • CNS depressants (e.g., alcohol, benzodiazepines, opioids) - additive CNS depression
  • Diuretics (especially in elderly) - increased risk of hyponatremia
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Psychiatric evaluation (mood, anxiety, suicidal ideation)

Rationale: To establish baseline symptom severity and assess risk factors for suicide.

Timing: Prior to initiation of therapy

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Venlafaxine can cause dose-related increases in BP and HR.

Timing: Prior to initiation of therapy

Weight

Rationale: To monitor for significant weight changes.

Timing: Prior to initiation of therapy

Sodium (Na+)

Rationale: To assess baseline electrolyte status, especially in elderly or those on diuretics, due to risk of hyponatremia.

Timing: Prior to initiation of therapy (consider in at-risk patients)

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Routine Monitoring

Psychiatric symptoms (mood, anxiety, suicidal ideation, agitation, mania)

Frequency: Weekly for first 4 weeks, then monthly or as clinically indicated, especially after dose changes.

Target: Improvement in target symptoms, absence of suicidal ideation/behavior, absence of emergent mania/hypomania.

Action Threshold: Worsening symptoms, emergence of suicidal ideation, agitation, or manic symptoms require immediate re-evaluation and potential dose adjustment or discontinuation.

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly, especially during dose titration and at higher doses (e.g., weekly for first few weeks, then monthly).

Target: Within patient's normal range or target BP.

Action Threshold: Sustained increase in BP (e.g., >10-15 mmHg diastolic or systolic) or HR requires dose reduction or consideration of antihypertensive therapy.

Weight

Frequency: Periodically (e.g., every 3-6 months).

Target: Stable weight or clinically acceptable changes.

Action Threshold: Significant or rapid weight gain/loss may require intervention.

Sodium (Na+)

Frequency: Periodically, especially in elderly, those on diuretics, or with symptoms of hyponatremia.

Target: 135-145 mEq/L

Action Threshold: Na+ <135 mEq/L, especially with symptoms (e.g., headache, confusion, weakness), requires immediate evaluation.

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Symptom Monitoring

  • Worsening depression
  • Emergence of suicidal thoughts or behavior
  • Unusual changes in behavior (e.g., agitation, irritability, hostility, aggression, impulsivity, akathisia, hypomania, mania)
  • Serotonin syndrome symptoms (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, dizziness, diaphoresis, tremor, rigidity, myoclonus, hyperreflexia, fever, nausea, vomiting, diarrhea)
  • Withdrawal symptoms upon discontinuation (e.g., dizziness, nausea, headache, irritability, insomnia, vivid dreams, paresthesias, tremor, anxiety, diarrhea, fatigue, flu-like symptoms)
  • Increased blood pressure or heart rate
  • Sexual dysfunction
  • Gastrointestinal upset (nausea, constipation)
  • Dry mouth
  • Sweating
  • Insomnia or somnolence
  • Dizziness

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, feeding difficulties, irritability, tremor, hypotonia, constant crying).
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Lactation

Venlafaxine and ODV are excreted into breast milk. Weigh the benefits of breastfeeding against the potential risks to the infant. Monitor breastfed infants for adverse effects (e.g., sedation, poor feeding, weight loss, irritability).

Infant Risk: L3 (Moderately Safe) - Monitor infant for sedation, irritability, poor feeding, and weight gain. Consider alternative if infant is premature or has underlying medical conditions.
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Pediatric Use

Not approved for use in pediatric patients for MDD due to increased risk of suicidal thoughts and behaviors. Safety and efficacy have not been established.

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Geriatric Use

Use with caution. Elderly patients may be more sensitive to the effects of venlafaxine, including hyponatremia, orthostatic hypotension, and falls. Start with lower doses and titrate slowly. Monitor blood pressure, heart rate, and sodium levels closely.

Clinical Information

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Clinical Pearls

  • Venlafaxine IR requires multiple daily doses (BID or TID) due to its shorter half-life, which can impact adherence. Effexor XR (extended-release) is dosed once daily and is generally preferred for convenience and potentially better tolerability.
  • Tapering is crucial when discontinuing venlafaxine, even after short-term use, to minimize withdrawal symptoms (e.g., dizziness, nausea, headache, paresthesias, anxiety, insomnia). The taper should be gradual, over several weeks to months, depending on dose and duration of therapy.
  • Monitor blood pressure regularly, especially at higher doses, as venlafaxine can cause sustained increases in blood pressure in some patients.
  • Be vigilant for symptoms of serotonin syndrome, especially when co-administered with other serotonergic agents.
  • Venlafaxine can cause dose-related increases in sweating and sexual dysfunction.
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Alternative Therapies

  • Other SNRIs (e.g., Duloxetine, Desvenlafaxine, 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, Imipramine)
  • MAOIs (e.g., Phenelzine, Tranylcypromine, Selegiline - generally reserved for refractory cases)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 50mg IR)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.