Effexor 50mg Tablets

Manufacturer WYETH 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-Norepinephrine Reuptake Inhibitor (SNRI)
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Pregnancy Category
Not available
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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, anxiety, and panic 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 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 your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with food and at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available 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 a missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, do not stop suddenly without consulting your doctor, as this can cause withdrawal symptoms.
  • Avoid alcohol, as it can worsen side effects like drowsiness and dizziness.
  • Be cautious when driving or operating machinery until you know how this medication affects you.
  • Report any unusual changes in mood or behavior, especially suicidal thoughts, to your doctor immediately.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort or other antidepressants.
  • If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double the dose.

Dosing & Administration

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Adult Dosing

Standard Dose: 75 mg/day, administered in two or three divided doses (immediate-release) or once daily (extended-release)
Dose Range: 37.5 - 375 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial: 75 mg/day (IR, divided doses) or 75 mg/day (XR, once daily). May increase by 75 mg/day increments at intervals of â‰Ĩ4 days, up to 225 mg/day. For severe depression, some patients may benefit from doses up to 375 mg/day (IR, divided doses).
Generalized Anxiety Disorder (GAD): Initial: 75 mg/day (XR, once daily). May increase by 75 mg/day increments at intervals of â‰Ĩ7 days, up to 225 mg/day.
Social Anxiety Disorder (SAD): Initial: 75 mg/day (XR, once daily).
Panic Disorder (PD): Initial: 37.5 mg/day (XR, once daily) for 7 days, then increase to 75 mg/day. May increase by 75 mg/day increments at intervals of â‰Ĩ7 days, up to 225 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for routine use; limited data for specific conditions, generally not recommended due to suicidality risk.
Adolescent: Not established for routine use; limited data for specific conditions, generally not recommended due to suicidality risk. If used, close monitoring is essential.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: Reduce total daily dose by 50%
Moderate: Reduce total daily dose by 50%
Severe: Reduce total daily dose by 50% or more, individualize based on patient response.

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 a weak inhibitor of dopamine reuptake. The antidepressant and anxiolytic effects are believed to be related to the potentiation of neurotransmitter activity in the CNS.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 45% (due to presystemic metabolism)
Tmax: Venlafaxine: 2 hours (IR), 5.5 hours (XR); ODV: 3 hours (IR), 9 hours (XR)
FoodEffect: Food has no significant effect on the absorption or bioavailability of venlafaxine or ODV.

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 (approximately 87% of a dose is excreted in urine within 48 hours, primarily as ODV and its conjugates, and to a lesser extent as unchanged venlafaxine)
Unchanged: Approximately 5% (venlafaxine), 29% (ODV) in urine
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Pharmacodynamics

OnsetOfAction: Initial antidepressant effects may be seen within 1-2 weeks; full therapeutic effects may take 4-6 weeks.
PeakEffect: Peak plasma concentrations reached within hours, but clinical peak effect is delayed.
DurationOfAction: Due to half-lives, once-daily (XR) or twice/thrice daily (IR) dosing maintains therapeutic levels.

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. This risk must be balanced with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond 24 years of age; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 years and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. 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 immediate medical attention:

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 or 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 vision
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
A potentially life-threatening condition called serotonin syndrome, which may be more likely if you take certain other medications. Symptoms include:
+ 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 medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or if they persist or bother you, contact your doctor:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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:

  • Signs of Serotonin Syndrome: agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness/spasms, twitching, loss of coordination, nausea, vomiting, diarrhea.
  • Worsening depression, suicidal thoughts or attempts, new or worsening anxiety, panic attacks, agitation, restlessness, irritability, aggression, unusual changes in behavior.
  • Severe allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing).
  • Eye pain, vision changes, swelling or redness in or around the eye (signs of angle-closure glaucoma).
  • Unusual bleeding or bruising.
  • Seizures.
  • Symptoms of hyponatremia (low sodium): headache, confusion, weakness, unsteadiness.
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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.
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 interactions may occur.
* If you are taking or have recently taken certain medications, including:
+ Linezolid or methylene blue, as these can interact with this medication.
+ Drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Combining these medications can lead to very high blood pressure.

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 you have. Your doctor and pharmacist need this information to assess potential interactions and ensure it is safe for you to take this medication. Never 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 they are aware of any potential interactions or complications.

Until you know how this medication affects you, avoid driving and other activities that require your full attention. This is crucial to prevent accidents and ensure your safety.

Do not stop taking this medication abruptly 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 this medication, your doctor will guide you on how to gradually stop taking it. Be sure to discuss any new or worsening symptoms with your doctor.

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

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 slow your reactions.

This medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor, and seek medical attention immediately if you experience any bleeding.

If you have bipolar disorder, be aware that this medication may trigger manic episodes. Contact your doctor if you experience any symptoms of a manic episode, such as excessive energy, agitation, or impulsivity.

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, it can be fatal. Discuss this risk with your doctor, and monitor your sodium levels as advised.

High cholesterol has been reported in some individuals taking this medication. If you have concerns or questions, discuss them with 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 to ensure accurate test results.

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, inform your doctor. Taking this medication in 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
  • Hypotension
  • Rhabdomyolysis
  • Vertigo
  • Death

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (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.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of discontinuing MAOI, or within 7 days of discontinuing venlafaxine before starting MAOI) - risk of serotonin syndrome.
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Major Interactions

  • Other serotonergic drugs (e.g., SSRIs, triptans, fentanyl, lithium, tramadol, St. John's Wort, tryptophan) - increased risk of serotonin syndrome.
  • Linezolid, Methylene Blue (IV) - MAOI activity, 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 antiplatelet agents (e.g., aspirin, NSAIDs) - increased risk of bleeding.
  • Drugs that prolong QT interval - theoretical risk of additive QT prolongation.
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Moderate Interactions

  • CNS depressants (e.g., alcohol, benzodiazepines, opioids) - additive CNS depression.
  • Drugs that increase blood pressure (e.g., decongestants, stimulants) - potential for additive pressor effects.
  • Cimetidine - may inhibit first-pass metabolism of venlafaxine, increasing venlafaxine levels (more pronounced in poor CYP2D6 metabolizers).
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Minor Interactions

  • None specifically categorized as minor with significant clinical impact.

Monitoring

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Baseline Monitoring

Blood Pressure and Heart Rate

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

Timing: Prior to initiation

Weight

Rationale: Monitor for significant weight changes.

Timing: Prior to initiation

Mental Status/Suicidality

Rationale: Assess baseline mood, anxiety, and suicidal ideation, especially in young adults and adolescents.

Timing: Prior to initiation

Sodium levels

Rationale: Baseline for patients at risk of hyponatremia (e.g., elderly, those on diuretics).

Timing: Prior to initiation (if indicated)

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Routine Monitoring

Blood Pressure and Heart Rate

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

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

Action Threshold: Sustained clinically significant increases (e.g., >10-15 mmHg diastolic, >20 mmHg systolic) may require dose reduction or discontinuation.

Mental Status/Suicidality

Frequency: Weekly for the first 4 weeks, then every 2-4 weeks for the next 8 weeks, then periodically. Closely monitor during dose changes.

Target: Improvement in target symptoms, absence of suicidal ideation.

Action Threshold: Worsening depression, emergence of suicidal thoughts/behavior, or unusual changes in behavior require immediate re-evaluation.

Weight

Frequency: Periodically

Target: Maintain stable weight.

Action Threshold: Significant or rapid weight gain/loss.

Sodium levels

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

Target: 135-145 mEq/L

Action Threshold: Hyponatremia (<135 mEq/L) requires investigation and potential discontinuation.

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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)
  • Suicidal ideation or worsening depression/anxiety
  • Abnormal bleeding (e.g., bruising, petechiae, GI bleeding)
  • Hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls)
  • Withdrawal symptoms upon abrupt discontinuation (dizziness, headache, nausea, vomiting, irritability, insomnia, anxiety, paresthesias, electric shock sensations)
  • Manic/hypomanic episodes (in patients with bipolar disorder)
  • Angle-closure glaucoma (eye pain, vision changes, swelling or redness in or around the eye)

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: No specific increased risks identified beyond general antidepressant use.
Third Trimester: Increased risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia, constant crying) if exposed during the third trimester.
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Lactation

Venlafaxine and its active metabolite (ODV) are excreted into breast milk. While some infants may experience no adverse effects, there have been reports of sedation, poor feeding, and weight loss. Weigh the benefits of breastfeeding against the potential risks to the infant.

Infant Risk: L3 (Moderate risk). Monitor breastfed infants for sedation, irritability, poor feeding, and weight gain. Consider alternative agents or closer monitoring.
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Pediatric Use

Not approved for use in pediatric patients. Black Box Warning regarding increased risk of suicidality in children, adolescents, and young adults. Use only after careful consideration of risks vs. benefits and close monitoring.

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Geriatric Use

Increased risk of hyponatremia (SIADH) and falls, especially in those taking diuretics. Start with lower doses and titrate slowly. Monitor blood pressure, heart rate, and sodium levels more closely.

Clinical Information

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Clinical Pearls

  • Venlafaxine is an SNRI, affecting both serotonin and norepinephrine. Lower doses (e.g., <150 mg/day) primarily affect serotonin reuptake, while higher doses also significantly affect norepinephrine reuptake.
  • Abrupt discontinuation can lead to significant and uncomfortable withdrawal symptoms (e.g., dizziness, nausea, headache, paresthesias, 'brain zaps'). Tapering should be gradual, typically over several weeks.
  • Monitor blood pressure regularly, especially during dose escalation, as venlafaxine can cause dose-dependent hypertension.
  • Extended-release (XR) formulation is generally preferred for better tolerability and once-daily dosing.
  • Caution in patients with a history of seizures, angle-closure glaucoma, or bipolar disorder (risk of inducing mania/hypomania).
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Alternative Therapies

  • Other SNRIs (e.g., duloxetine, desvenlafaxine, levomilnacipran)
  • SSRIs (e.g., fluoxetine, sertraline, escitalopram, citalopram, paroxetine)
  • Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, imipramine, nortriptyline)
  • Atypical Antidepressants (e.g., bupropion, mirtazapine)
  • Other anxiolytics (e.g., buspirone, benzodiazepines for short-term use)
  • Cognitive Behavioral Therapy (CBT) and other psychotherapies
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (50mg IR)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic venlafaxine)
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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, do not share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides important 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 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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.