Venlafaxine 25mg 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-Norepinephrine Reuptake Inhibitor (SNRI)
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Pregnancy Category
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, anxiety, panic attacks, and social anxiety. It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain, which can improve mood and reduce anxiety.
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How to Use This Medicine

Taking Your Medication Correctly

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

Take your medication exactly as directed by your doctor.
Read and follow all instructions provided with your medication.
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 location, away from bathrooms.
Keep all medications in a secure place, out of 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 local drug take-back programs.

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

  • Take exactly as prescribed, do not stop abruptly due to withdrawal symptoms.
  • Avoid alcohol, as it can worsen side effects.
  • Be cautious when driving or operating machinery until you know how the medication affects you, as it can cause dizziness or drowsiness.
  • Report any unusual changes in mood or behavior, especially suicidal thoughts, to your doctor immediately.
  • Monitor blood pressure regularly as advised by your doctor.
  • Maintain good hydration to help manage potential side effects like dry mouth or constipation.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 25 mg orally two or three times daily (IR formulation). Titrate gradually.
Dose Range: 75 - 375 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial: 25 mg IR two or three times daily. May increase by 75 mg/day increments at intervals of no less than 4 days, up to 375 mg/day in divided doses. Max 375 mg/day for severe depression, otherwise 225 mg/day.
Generalized Anxiety Disorder (GAD): Initial: 37.5 mg XR once daily. May increase by 37.5 mg/day increments at intervals of no less than 7 days, up to 225 mg/day.
Social Anxiety Disorder (SAD): Initial: 75 mg XR once daily. No additional benefit shown for doses >75 mg/day.
Panic Disorder (PD): Initial: 37.5 mg XR once daily for 7 days, then 75 mg XR 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 for MDD in pediatric patients <18 years. Use generally not recommended due to increased risk of suicidal thoughts and behaviors.)
Adolescent: Not established (Safety and efficacy not established for MDD in pediatric patients <18 years. Use generally not recommended due to increased risk of suicidal thoughts and behaviors.)
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed for mild impairment (GFR 60-89 mL/min).
Moderate: Reduce total daily dose by 25% for moderate impairment (GFR 30-59 mL/min).
Severe: Reduce total daily dose by 50% for severe impairment (GFR <30 mL/min).
Dialysis: Reduce total daily dose by 50% and administer after dialysis session.

Hepatic Impairment:

Mild: Reduce total daily dose by 50% for mild to moderate impairment (Child-Pugh A or B).
Moderate: Reduce total daily dose by 50% for mild to moderate impairment (Child-Pugh A or B).
Severe: Reduce total daily dose by 50% or more for severe impairment (Child-Pugh C).

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 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: 2-4 hours (IR); ODV: 3-6 hours (IR)
FoodEffect: Food has no significant effect on the absorption or Cmax of venlafaxine or ODV.

Distribution:

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

Elimination:

HalfLife: Venlafaxine: 5 Âą 2 hours; ODV: 11 Âą 2 hours
Clearance: Venlafaxine: 1.3 Âą 0.6 L/h/kg; ODV: 0.4 Âą 0.2 L/h/kg
ExcretionRoute: Renal (approximately 87% of a dose is recovered in the urine within 48 hours, primarily as ODV and its conjugates, and to a lesser extent as unchanged venlafaxine)
Unchanged: Approximately 5% (venlafaxine); 29% (ODV)
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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: Typically 4-6 weeks for full therapeutic effect.
DurationOfAction: Due to half-life, effects persist for approximately 24 hours with once-daily dosing (XR) or with multiple daily doses (IR).

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 aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that get bigger
+ Uncontrollable bleeding
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
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
+ Difficulty getting or maintaining an erection
Serotonin syndrome, a potentially life-threatening condition that may occur, especially when taking 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 people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Trouble sleeping
Feeling nervous or excitable
Anxiety
Weight loss
Dizziness, drowsiness, tiredness, or weakness
Shakiness
Headache
Excessive sweating
Constipation
Diarrhea
Stomach upset
Vomiting
Decreased appetite
Gas
Dry mouth
Strange or unusual dreams
Yawning

Reporting 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 suicidal thoughts or behaviors
  • Agitation, restlessness, panic attacks, insomnia
  • Unusual changes in behavior (e.g., aggression, impulsivity, irritability)
  • Signs of serotonin syndrome (e.g., confusion, hallucinations, rapid heart rate, fever, muscle stiffness, twitching, severe nausea/vomiting/diarrhea)
  • Significant increase in blood pressure
  • Seizures
  • Eye pain, vision changes, swelling or redness around the eye (signs of angle-closure glaucoma)
  • Unexplained bleeding or bruising
  • Symptoms of hyponatremia (e.g., 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 reaction you experienced, including the symptoms that occurred.
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 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 drugs can interact with this medication.
+ Certain drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications with this drug can lead to very high blood pressure.
Other health problems or medications that may interact with this drug, as this is not an exhaustive list.

To ensure your safety, it is crucial to inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
* Your complete medical history, including any health problems.

Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so with this medication.
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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 proper care and avoid potential interactions.

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.

Avoid consuming alcohol while taking this medication, and consult your doctor before using marijuana, cannabis, or prescription or over-the-counter medications that may 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 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, which can be fatal in severe cases, may occur with this medication. Discuss this risk with your doctor.

High cholesterol has been reported in some individuals taking this medication. If you have concerns, consult your doctor.

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

If you are 65 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. Discuss this with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby. Taking this medication in mid to late pregnancy may lead to health problems in the mother, such as postpartum bleeding, or the newborn. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. Activated charcoal may be considered. There is no specific antidote.

Drug Interactions

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Contraindicated Interactions

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

  • Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
  • Linezolid, Methylene Blue (IV) - increased risk of serotonin syndrome.
  • Anticoagulants (e.g., warfarin) - increased risk of bleeding.
  • Antiplatelet agents (e.g., aspirin, NSAIDs) - increased risk of bleeding.
  • Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics) - theoretical risk of QT prolongation.
  • Strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may increase venlafaxine levels and decrease ODV levels, potentially altering efficacy/side effects.
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Moderate Interactions

  • Ethanol - may impair psychomotor skills.
  • Cimetidine - may inhibit first-pass metabolism of venlafaxine, increasing AUC.
  • Drugs that affect blood pressure (e.g., alpha-blockers, beta-blockers) - venlafaxine can cause dose-dependent increases in blood pressure.
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Minor Interactions

  • Not specifically categorized as minor, but general caution with CNS depressants.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: Venlafaxine can cause sustained dose-related increases in blood pressure.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: May cause increases in heart rate.

Timing: Prior to initiation

Weight

Rationale: Monitor for significant weight changes.

Timing: Prior to initiation

Sodium (Na+)

Rationale: Risk of hyponatremia, especially in elderly or those on diuretics.

Timing: Prior to initiation (especially in at-risk patients)

Suicidality assessment

Rationale: Increased risk of suicidal thoughts and behaviors, especially in young adults.

Timing: Prior to initiation

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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 target range.

Action Threshold: If sustained hypertension develops, consider dose reduction or discontinuation.

Heart Rate (HR)

Frequency: Periodically.

Target: Maintain within normal limits.

Action Threshold: Significant or symptomatic tachycardia.

Weight

Frequency: Periodically.

Target: Maintain stable weight.

Action Threshold: Significant or concerning weight gain/loss.

Sodium (Na+)

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

Target: 135-145 mEq/L

Action Threshold: <135 mEq/L or symptomatic hyponatremia.

Mental Status/Clinical Worsening/Suicidality

Frequency: Frequent observation during initial therapy and dose changes.

Target: Improvement in mood/anxiety symptoms.

Action Threshold: Emergence or worsening of agitation, irritability, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania, or suicidal ideation/behavior.

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Symptom Monitoring

  • Nausea
  • Insomnia
  • Sweating
  • Sexual dysfunction
  • Dizziness
  • Headache
  • Dry mouth
  • Constipation
  • Anxiety
  • Agitation
  • Tremor
  • Serotonin syndrome symptoms (agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
  • Withdrawal symptoms (dizziness, headache, nausea, insomnia, irritability, anxiety, paresthesias, electric shock sensations, tremor, confusion, sweating, diarrhea, fatigue, flu-like symptoms) upon abrupt discontinuation.

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SNRIs/SSRIs late in the third trimester have developed complications 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 malformations.
Second Trimester: Not well-studied for specific risks.
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. The American Academy of Pediatrics considers venlafaxine to be a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor infants for adverse effects such as sedation, poor feeding, and weight gain.

Infant Risk: L3 (Moderate risk - use with caution, monitor infant for adverse effects).
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Pediatric Use

Safety and efficacy not established in pediatric patients for MDD. Increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults (see Black Box Warning). Use generally not recommended.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for hyponatremia and falls. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Venlafaxine IR (25mg tablets) is typically dosed two or three times daily, while the XR formulation is once daily. Ensure patients understand the correct formulation and dosing schedule.
  • Abrupt discontinuation can lead to significant withdrawal symptoms (discontinuation syndrome). Taper dose gradually over several weeks, especially after prolonged use.
  • Monitor blood pressure regularly, as venlafaxine can cause dose-dependent hypertension, particularly at higher doses.
  • Be vigilant for signs of serotonin syndrome, especially when co-administered with other serotonergic agents.
  • Patients should be advised about the potential for sexual dysfunction, a common side effect of SNRIs.
  • The active metabolite, O-desmethylvenlafaxine (ODV), contributes significantly to the drug's therapeutic effects and half-life.
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Alternative Therapies

  • SSRIs (e.g., fluoxetine, sertraline, escitalopram, citalopram, paroxetine)
  • Other SNRIs (e.g., duloxetine, levomilnacipran)
  • Atypical antidepressants (e.g., bupropion, mirtazapine)
  • Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, nortriptyline)
  • MAOIs (e.g., phenelzine, tranylcypromine) - generally reserved for refractory cases due to significant interaction risks.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
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, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or 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 quantity, and the time it occurred.