Venlafaxine ER 150mg Tablets

Manufacturer TRIGEN Active Ingredient Venlafaxine Extended-Release 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 is used to treat anxiety.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
Sep 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Venlafaxine ER is an antidepressant medication that works by affecting certain natural chemicals in the brain (serotonin and norepinephrine) that help regulate mood. It's used to treat depression, anxiety disorders, and panic disorder. The 'ER' means extended-release, so it's taken once a day.
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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.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.

Important Administration Instructions

Swallow your medication whole; do not chew, break, or crush it.
Take your medication with a full glass of water.

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 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, and consider participating in a drug take-back program in your area.

What to Do If You Miss a Dose

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

  • Take exactly as prescribed, usually once daily with food, at approximately the same time each day.
  • Swallow the extended-release capsule whole; do not crush, chew, or divide.
  • Avoid alcohol, as it can increase side effects and impair judgment.
  • Do not stop taking this medication suddenly, as it can cause withdrawal symptoms. Your doctor will guide you on how to slowly reduce the dose if needed.
  • Be aware of potential side effects like nausea, dizziness, sweating, and dry mouth, especially when starting or changing doses.
  • Monitor blood pressure regularly as instructed by your doctor.
  • Report any unusual changes in mood, behavior, or thoughts, especially suicidal thoughts, to your doctor immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: 75 mg once daily (extended-release)
Dose Range: 37.5 - 375 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial 75 mg once daily; may increase by 75 mg/day increments at intervals of no less than 4 days, up to 225 mg/day. For severe depression, doses up to 375 mg/day may be used.
Generalized Anxiety Disorder (GAD): Initial 75 mg once daily; may increase by 75 mg/day increments at intervals of no less than 4 days, up to 225 mg/day.
Social Anxiety Disorder (SAD): 75 mg once daily.
Panic Disorder (PD): Initial 37.5 mg once daily for 7 days, then 75 mg once daily; may increase by 75 mg/day increments at intervals of no less than 7 days, up to 225 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (safety and efficacy not established; Black Box Warning for suicidality)
Adolescent: Not established (safety and efficacy not established; Black Box Warning for suicidality)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl 61-90 mL/min)
Moderate: Reduce total daily dose by 25-50% (CrCl 31-60 mL/min)
Severe: Reduce total daily dose by 50% or more (CrCl <30 mL/min)
Dialysis: Reduce total daily dose by 50%; administer after dialysis session.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: Reduce total daily dose by 50%
Severe: Reduce total daily dose by 50% or more; individualize dosing.

Pharmacology

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Mechanism of Action

Venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent reuptake inhibitors of serotonin and norepinephrine and weak inhibitors of dopamine reuptake. This leads to increased concentrations of these neurotransmitters in the synaptic cleft, enhancing their activity in the central nervous system.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 45% (due to first-pass metabolism)
Tmax: Venlafaxine: 5.5 hours; ODV: 9 hours (for extended-release formulation)
FoodEffect: Food delays Tmax by 2-3 hours but does not significantly affect AUC or Cmax.

Distribution:

Vd: Approximately 7.5 L/kg
ProteinBinding: Venlafaxine: Approximately 27%; ODV: Approximately 30%
CnssPenetration: Yes

Elimination:

HalfLife: Venlafaxine: Approximately 5 hours; ODV: Approximately 11 hours
Clearance: Venlafaxine: 1.3 L/h/kg; ODV: 0.4 L/h/kg
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: Approximately 5% (venlafaxine); Approximately 0.2% (ODV)
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Pharmacodynamics

OnsetOfAction: Initial antidepressant effects may be seen within 1-2 weeks; full therapeutic effects typically take 4-6 weeks.
PeakEffect: Not directly quantifiable for clinical effect; steady-state plasma concentrations are achieved within 3 days for venlafaxine and 4-5 days for ODV.
DurationOfAction: Once daily dosing provides sustained therapeutic levels due to extended-release formulation and active metabolite.

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 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 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. 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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels: headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or changes in balance
Signs of bleeding: vomiting or coughing up blood, vomit that looks like 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, or uncontrolled bleeding
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in eyesight
Seizures
Chest pain or pressure
Shortness of breath
Cough
Bone pain
Sex problems, such as decreased interest in sex, trouble having an orgasm, ejaculation problems, or difficulty getting or maintaining an erection

A rare but potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking certain other medications. Seek medical help immediately if you experience any of the following symptoms:
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

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:

Trouble sleeping
Feeling nervous, excitable, or anxious
Weight loss
Feeling dizzy, sleepy, tired, or weak
Shakiness
Headache
Excessive sweating
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Gas
Dry mouth
Strange or odd dreams
* Yawning

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, irritability, aggression, panic attacks, restlessness)
  • Symptoms of serotonin syndrome (e.g., fever, sweating, confusion, muscle stiffness, twitching, severe diarrhea, shivering, agitation, hallucinations)
  • Symptoms of hyponatremia (e.g., headache, confusion, weakness, unsteadiness, seizures)
  • Unusual bleeding or bruising
  • Eye pain, changes in vision, swelling or redness in or around the eye (signs of angle-closure glaucoma)
  • Signs of 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, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have high blood pressure, as this condition may be affected by the medication.
If you have narrow-angle glaucoma, a condition that affects the eyes.
If you are currently taking a weight loss medication, as this may interact with the drug.
* If you are taking or have recently taken certain medications, including:
+ Linezolid or methylene blue, as these may cause adverse interactions.
+ Certain drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications in combination with this drug may lead to very high blood pressure.

It is crucial to note that this is not an exhaustive list of all potential interactions. Therefore, it is vital to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter medications, natural products, and vitamins, as well as any health problems you have. This will enable your healthcare team to assess the safety of taking this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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 that you receive the best possible care.

Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. Avoid driving or performing tasks that require alertness until you have a better understanding of the medication's effects.

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

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

It is recommended that you 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 slow 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 taking this medication may trigger manic episodes. If you experience symptoms of a manic episode, such as excessive energy or irritability, contact your doctor immediately.

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 in or around the eye, seek medical attention promptly.

Low blood sodium levels (hyponatremia) can occur with this medication, and in severe cases, this can be fatal. Discuss this risk with your doctor.

High cholesterol has been reported in some individuals taking this medication. If you have concerns or questions, 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.

You may notice the tablet shell in your stool, but this is a normal occurrence and not a cause for concern.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary, so discuss this with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. 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. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy or breastfeeding.
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Overdose Information

Overdose Symptoms:

  • Somnolence
  • Mild tremor
  • Nausea
  • Vomiting
  • Dizziness
  • Tachycardia
  • Mydriasis
  • Seizures
  • ECG changes (e.g., QTc prolongation, bundle branch block, QRS prolongation)
  • Coma

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. Activated charcoal may be considered if ingested recently.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of discontinuing MAOI or venlafaxine due to risk of serotonin syndrome)
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Major Interactions

  • Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
  • Drugs that impair metabolism of venlafaxine (e.g., strong CYP2D6 inhibitors like quinidine, fluoxetine, paroxetine) - increased venlafaxine levels.
  • Anticoagulants (e.g., warfarin) and antiplatelets (e.g., aspirin, NSAIDs) - increased risk of bleeding.
  • CNS depressants (e.g., alcohol, benzodiazepines) - additive CNS depression.
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Moderate Interactions

  • Drugs that affect blood pressure (e.g., alpha-blockers, beta-blockers) - potential for additive effects on blood pressure.
  • Cimetidine - may inhibit first-pass metabolism of venlafaxine, increasing AUC.
  • Haloperidol - increased haloperidol AUC and Cmax.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

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

Timing: Prior to initiation

Heart Rate (HR)

Rationale: Can cause sustained increases in heart rate.

Timing: Prior to initiation

Weight

Rationale: Monitor for significant weight changes (loss or gain).

Timing: Prior to initiation

Suicidal Ideation/Behavior

Rationale: Risk of suicidality, especially in young adults and during initial treatment/dose changes.

Timing: Prior to initiation

Personal/Family History of Bipolar Disorder or Mania

Rationale: Risk of activating mania/hypomania.

Timing: Prior to initiation

Glaucoma Assessment

Rationale: Risk of mydriasis and angle-closure glaucoma.

Timing: Prior to initiation (if patient is at risk)

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter.

Target: Maintain within normal limits or patient's baseline.

Action Threshold: Sustained hypertension (e.g., >140/90 mmHg) may require dose reduction or discontinuation.

Heart Rate (HR)

Frequency: Periodically.

Target: Maintain within normal limits.

Action Threshold: Sustained tachycardia.

Weight

Frequency: Periodically.

Target: Maintain stable weight.

Action Threshold: Significant, unexplained weight loss or gain.

Mood/Symptom Assessment

Frequency: Regularly, especially during initial weeks and dose changes.

Target: Improvement in depressive/anxiety symptoms.

Action Threshold: Worsening symptoms, emergence of new symptoms, or activation of mania/hypomania.

Suicidal Ideation/Behavior

Frequency: Closely monitor, especially in first few months and during dose changes.

Target: Absence of suicidal thoughts or behaviors.

Action Threshold: Emergence or worsening of suicidal ideation/behavior.

Serum Sodium (Na+)

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

Target: 135-145 mEq/L

Action Threshold: Hyponatremia (<135 mEq/L), especially symptomatic hyponatremia.

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Symptom Monitoring

  • Serotonin syndrome (agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, GI symptoms)
  • Hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls, severe: hallucinations, syncope, seizures, coma, respiratory arrest)
  • Abnormal bleeding (ecchymoses, hematomas, epistaxis, petechiae, GI bleeding)
  • Activation of mania/hypomania (elevated mood, increased energy, decreased need for sleep, racing thoughts, grandiosity)
  • New or worsening anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania
  • Visual disturbances (eye pain, changes in vision, swelling or redness in or around the eye - signs of angle-closure glaucoma)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Category C.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations.
Second Trimester: Not available
Third Trimester: Exposure in late pregnancy may lead to complications in the neonate 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 also been reported with SSRI/SNRI exposure in late pregnancy.
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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 sedation, poor feeding, and poor weight gain.

Infant Risk: L3 (Moderate risk). Potential for adverse effects in breastfed infants, though many exposed infants show no adverse effects. Monitor for irritability, sleep disturbances, and feeding issues.
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Pediatric Use

Not approved for use in pediatric patients. Black Box Warning regarding increased risk of suicidal thoughts and behavior in children, adolescents, and young adults.

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Geriatric Use

Increased risk of hyponatremia, especially in patients taking diuretics or who are volume-depleted. Increased risk of falls due to orthostatic hypotension or other CNS effects. Use lower initial doses and monitor closely.

Clinical Information

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Clinical Pearls

  • Venlafaxine ER should be taken with food to minimize GI upset and improve tolerability.
  • Do not crush, chew, or dissolve the extended-release capsules; they are designed to release medication slowly over time.
  • Blood pressure monitoring is crucial, especially during dose escalation, as venlafaxine can cause sustained hypertension.
  • Tapering off venlafaxine is essential to avoid severe withdrawal symptoms (e.g., dizziness, nausea, headache, paresthesias, vivid dreams, irritability). The tapering schedule should be individualized and gradual.
  • Be vigilant for signs of serotonin syndrome, especially when co-prescribing with other serotonergic agents.
  • Consider the risk of angle-closure glaucoma, particularly in patients with a history of narrow-angle glaucoma or increased intraocular pressure.
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Alternative Therapies

  • Other SNRIs (e.g., Duloxetine, Desvenlafaxine, Levomilnacipran)
  • SSRIs (e.g., Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram)
  • Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
  • Atypical Antidepressants (e.g., Bupropion, Mirtazapine)
  • MAOIs (e.g., Phenelzine, Tranylcypromine, Selegiline - generally reserved for refractory cases)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy, Interpersonal Therapy)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 for 30 tablets of generic 150mg ER per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred Brand) on most formularies
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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 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.