Adderall 12.5mg Tablets

Manufacturer TEVA Active Ingredient Dextroamphetamine and Amphetamine Tablets(deks troe am FET a meen & am FET a meen) Pronunciation ADD-uh-ral (DEX-troe am-FET-uh-meen & am-FET-uh-meen)
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It is used to treat narcolepsy.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
CNS Stimulant
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Pharmacologic Class
Sympathomimetic Amine
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Pregnancy Category
Category C
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FDA Approved
Feb 1996
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Adderall is a medication that contains a combination of two stimulant drugs, dextroamphetamine and amphetamine. It works by increasing the levels of certain natural substances in the brain, like dopamine and norepinephrine, which can help improve focus, attention, and control impulsive behavior in people with ADHD, and reduce excessive daytime sleepiness in people with narcolepsy.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. However, take your last dose of the day at least 4 hours before bedtime to minimize any potential disruptions to your sleep.

Before using any over-the-counter (OTC) products, consult with your doctor, especially if they may increase your blood pressure. These products include cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, and certain natural products or aids.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. Dispose of any unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. If you have questions about the best way to dispose of your medication, consult with your pharmacist, who may be aware of drug take-back programs in your area.

What to Do If You Miss a Dose

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

  • Take exactly as prescribed; do not take more or less than directed.
  • Do not crush, chew, or break tablets; swallow whole.
  • Avoid taking doses late in the day to prevent sleep problems.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Avoid alcohol consumption while taking this medication.
  • Maintain a healthy diet and regular sleep schedule.
  • Store securely to prevent misuse or diversion.

Dosing & Administration

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Adult Dosing

Standard Dose: ADHD: Initial 5 mg orally 1-2 times daily. Narcolepsy: Initial 10 mg orally daily in divided doses.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

ADHD: Titrate in 5 mg increments weekly to a maximum of 40 mg/day in divided doses (usually 2-3 times daily).
Narcolepsy: Titrate in 10 mg increments weekly to a maximum of 60 mg/day in divided doses (usually 2-3 times daily).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (3-5 years): Initial 2.5 mg orally daily, titrate in 2.5 mg increments weekly to a maximum of 10 mg/day. ADHD (6-12 years): Initial 5 mg orally 1-2 times daily, titrate in 5 mg increments weekly to a maximum of 30 mg/day.
Adolescent: ADHD (13-17 years): Initial 5 mg orally 1-2 times daily, titrate in 5 mg increments weekly to a maximum of 40 mg/day in divided doses.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor for adverse effects.
Moderate: Consider dose reduction (e.g., 50% of usual dose) for CrCl 15-30 mL/min.
Severe: Consider dose reduction (e.g., 50% of usual dose) for CrCl < 15 mL/min. Use with caution.
Dialysis: Not well studied; amphetamines are not significantly removed by hemodialysis. Use with extreme caution, consider further dose reduction.

Hepatic Impairment:

Mild: No specific adjustment recommended, monitor for adverse effects.
Moderate: Use with caution; monitor for increased adverse effects due to potential for reduced metabolism.
Severe: Use with caution; monitor for increased adverse effects due to potential for significantly reduced metabolism. Consider lower starting doses and slower titration.

Pharmacology

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Mechanism of Action

Amphetamine is a non-catecholamine sympathomimetic amine that causes the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain. It also appears to block the reuptake of these monoamines into the presynaptic neuron, thereby increasing their concentrations in the synaptic cleft. The therapeutic effects in ADHD and narcolepsy are thought to be mediated through these actions in the central nervous system.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 75% for d-amphetamine, 50% for l-amphetamine (variable due to first-pass metabolism and pH-dependent absorption).
Tmax: Approximately 2-3 hours for immediate-release tablets.
FoodEffect: Food does not significantly alter the extent of absorption, but may delay Tmax.

Distribution:

Vd: Approximately 3-5 L/kg (variable, pH-dependent).
ProteinBinding: Approximately 15-20% (low).
CnssPenetration: Yes

Elimination:

HalfLife: d-amphetamine: 10-13 hours; l-amphetamine: 11-14 hours (highly dependent on urinary pH; shorter in acidic urine, longer in alkaline urine).
Clearance: Approximately 0.3-0.5 L/hr/kg (highly pH-dependent).
ExcretionRoute: Renal (primarily unchanged drug and metabolites).
Unchanged: Approximately 30-40% (acidic urine), 1% (alkaline urine).
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes.
PeakEffect: Approximately 2-3 hours.
DurationOfAction: Approximately 4-6 hours per dose.

Safety & Warnings

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BLACK BOX WARNING

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE USUAL PRECAUTIONS OF CONTROLLING AVAILABILITY OF THE DRUG SHOULD BE OBSERVED. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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Side Effects

Serious 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 immediately or seek emergency medical attention:

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 high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or pelvic pain
Other serious side effects, including:
+ Erectile dysfunction
+ Changes in sex interest
+ Seizures
+ Trouble controlling body movements
+ Uncontrollable sounds, such as humming, throat clearing, yelling, or making loud noises
+ Restlessness
+ Changes in eyesight
+ Prolonged or frequent erections
+ Changes in skin color, such as pale, blue, gray, purple, or red discoloration
+ Numbness, pain, tingling, or cold feeling in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or trouble passing urine

Important Heart-Related Warnings

If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek immediate medical attention if you experience any signs of heart problems, including:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out

Other Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to report any concerns to your doctor. Common side effects include:

Feeling nervous and excitable
Headache
Trouble sleeping
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in your mouth
Weight loss

If you experience any of these side effects or any other concerns, contact your doctor for advice. 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:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention).
  • New or worsening aggression, hostility, or irritability.
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions).
  • New manic symptoms (e.g., extreme energy, racing thoughts).
  • Unexplained numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon).
  • Unexplained weight loss or slowed growth in children.
  • Blurred vision or other vision changes.
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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 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 and its symptoms.
A family history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ A history of drug abuse
+ A history of stroke
Kidney disease, as this may affect how your body processes the medication
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Antidepressants or Parkinson's disease medications (such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may increase the risk of very high blood pressure
+ Linezolid or methylene blue
If you are breast-feeding, as you should not breast-feed while taking this medication

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. 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.

When you first start taking this medication, be cautious when driving or performing tasks that require alertness and clear vision, as it may affect your ability to do so. Wait until you understand how this medication affects you before engaging in such activities.

Long-term or high-dose use of this medication can lead to tolerance, where the medication becomes less effective, and you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it previously did, contact your doctor. Do not take more than the prescribed dose, as this can lead to adverse effects.

Prolonged or regular use of this medication may cause dependence, and stopping it abruptly can result in withdrawal symptoms. If you need to reduce the dose or stop taking this medication, consult your doctor, who will provide guidance on how to do so safely.

Before starting this medication, you may need to undergo heart tests to ensure your safety. If you have any questions or concerns, discuss them with your doctor.

This medication may cause an increase in blood pressure. Monitor your blood pressure and heart rate as instructed by your doctor. Additionally, follow your doctor's recommendations for regular blood work to ensure your safety while taking this medication.

It is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests.

Do not take antacids while using this medication, as they may interact with it.

In some cases, this medication can cause changes in behavior and mood, such as altered thinking, anger, or hallucinations. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.

This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor to determine if you are more susceptible to seizures while taking this medication.

A rare but potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience symptoms such as agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.

In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary, and your doctor will discuss the potential risks and benefits with you. Different brands of this medication may be approved for use in different age groups, so consult your doctor before giving this medication to a child.

Before consuming alcohol while taking this medication, discuss the potential risks with your doctor.

If you are pregnant or plan to become pregnant, inform your doctor, as they will need to weigh the benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia
  • Rapid breathing
  • Confusion
  • Assaultiveness
  • Hallucinations
  • Panic states
  • High fever
  • Rhabdomyolysis
  • Arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma
  • Death

What to Do:

Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use due to risk of hypertensive crisis and serotonin syndrome)
  • Linezolid (MAOI activity)
  • Methylene Blue (MAOI activity)
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Major Interactions

  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
  • Antihypertensives - amphetamines may reduce the hypotensive effect.
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease amphetamine half-life and increase excretion.
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine half-life and decrease excretion.
  • Tricyclic Antidepressants (TCAs) - increased cardiovascular effects of amphetamines.
  • Proton Pump Inhibitors (PPIs) / H2 Blockers - may increase amphetamine absorption/exposure.
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Moderate Interactions

  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects.
  • Lithium - may inhibit stimulant effects.
  • Opioids - potential for additive CNS depression or respiratory depression (caution with co-administration).
  • Alcohol - may increase plasma levels of amphetamine and potentiate adverse effects.
  • Caffeine and other stimulants - additive stimulant effects, increased risk of cardiovascular adverse events.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Cardiovascular assessment (BP, HR, ECG if clinically indicated)

Rationale: To identify pre-existing cardiac conditions that may contraindicate use or require close monitoring due to risk of sudden cardiac death or serious cardiovascular events.

Timing: Prior to initiation of therapy

Psychiatric history and mental status exam

Rationale: To screen for bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated by stimulants.

Timing: Prior to initiation of therapy

Height and weight

Rationale: To establish baseline for growth monitoring, especially in pediatric patients.

Timing: Prior to initiation of therapy

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit (e.g., every 3-6 months or as clinically indicated)

Target: Within normal limits for age; avoid sustained elevations.

Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant investigation and potential dose adjustment or discontinuation.

Height and Weight

Frequency: Every 3-6 months in children/adolescents; annually in adults.

Target: Maintain appropriate growth trajectory/stable weight.

Action Threshold: Significant growth deceleration or weight loss may require dose adjustment, drug holiday, or alternative therapy.

Psychiatric status (mood, anxiety, psychotic symptoms, tics)

Frequency: At each visit

Target: Stable mood, absence of new or worsening psychiatric symptoms.

Action Threshold: Emergence of new psychotic symptoms, mania, severe anxiety, or tics warrants immediate evaluation and potential discontinuation.

Efficacy (ADHD symptoms, narcolepsy symptoms)

Frequency: At each visit

Target: Improvement in target symptoms with acceptable side effects.

Action Threshold: Lack of efficacy or intolerable side effects warrants dose adjustment or change in therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New onset or worsening psychosis
  • Mania
  • Aggression
  • Anxiety
  • Depression
  • Tics
  • Blurred vision
  • Numbness/tingling in extremities (Raynaud's phenomenon)
  • Unexplained weight loss
  • Growth deceleration

Special Patient Groups

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Pregnancy

Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Amphetamines can cause fetal harm, including premature birth and low birth weight. Neonates exposed to amphetamines during the third trimester are at risk for withdrawal symptoms.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for increased risk of congenital malformations not definitively established.
Second Trimester: Potential for growth restriction.
Third Trimester: Risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence).
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Lactation

Amphetamines are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, anorexia, reduced weight gain), breastfeeding is not recommended during treatment with Adderall.

Infant Risk: High (L4 - Potentially Hazardous)
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Pediatric Use

Approved for ADHD in children 3 years and older. Monitor growth (height and weight) regularly. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics). Long-term safety and efficacy in children under 3 years have not been established.

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Geriatric Use

Use with caution in elderly patients, generally starting at the lower end of the dosing range. Elderly patients may be more sensitive to the cardiovascular and CNS effects of amphetamines. Consider age-related decreases in renal function and potential for comorbidities and polypharmacy.

Clinical Information

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Clinical Pearls

  • Adderall IR is typically dosed 2-3 times daily due to its relatively short duration of action (4-6 hours per dose).
  • Dosing should be individualized based on patient response and tolerability.
  • Patients should be advised to avoid abrupt discontinuation, especially after prolonged high-dose therapy, to prevent withdrawal symptoms (e.g., extreme fatigue, depression).
  • Monitor for signs of abuse or diversion, given the Schedule II classification.
  • Educate patients and caregivers on the importance of proper storage to prevent accidental ingestion or misuse.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
  • Inform patients about potential cardiovascular risks and psychiatric adverse events.
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta, Focalin)
  • Lisdexamfetamine (Vyvanse)
  • Dexmethylphenidate (Focalin)
  • Atomoxetine (Strattera) - non-stimulant
  • Guanfacine ER (Intuniv) - non-stimulant
  • Clonidine ER (Kapvay) - non-stimulant
  • Bupropion (Wellbutrin) - off-label for ADHD
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Cost & Coverage

Average Cost: $100 - $300 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 for generic; Tier 2 or 3 for brand (varies by plan)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.