Dextroamphetamine 5mg Tablets

Manufacturer MALLINCKRODT PHARM Active Ingredient Dextroamphetamine Tablets(deks troe am FET a meen) Pronunciation deks-troe-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
Central Nervous System (CNS) Stimulant
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Pharmacologic Class
Sympathomimetic Amine
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Pregnancy Category
Category C
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FDA Approved
Jun 1976
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Dextroamphetamine is a stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy. It works by affecting certain natural chemicals in the brain that help with focus and wakefulness.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. However, to minimize the risk of sleep disturbances, it's best to avoid taking it late in the day. Additionally, do not consume this medication with fruit juice. To establish a routine, take your medication at the same time every day.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom. Keep your medication in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of 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. If you're unsure about the best way to dispose of your medication, consult your pharmacist or look into local drug take-back programs.

Missing 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 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 while taking this medication.
  • Be aware of the potential for abuse and dependence; store securely and do not share with others.
  • Report any new or worsening heart problems, mental health changes, or circulation issues to your doctor immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: ADHD: Initial 5 mg once or twice daily; Narcolepsy: Initial 10 mg daily
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

ADHD: Initial 5 mg once or twice daily; may increase by 5 mg weekly to a maximum of 40 mg/day in divided doses. Some patients may require up to 60 mg/day.
Narcolepsy: Initial 10 mg daily in divided doses; may increase by 10 mg weekly to a maximum of 60 mg/day in divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (6-12 years): Initial 2.5-5 mg once or twice daily; may increase by 2.5-5 mg weekly to a maximum of 40 mg/day in divided doses. Narcolepsy (6-12 years): Initial 5 mg daily; may increase by 5 mg weekly to a maximum of 60 mg/day in divided doses.
Adolescent: ADHD (13-17 years): Initial 5 mg once or twice daily; may increase by 5 mg weekly to a maximum of 40 mg/day in divided doses. Narcolepsy (13-17 years): Initial 10 mg daily in divided doses; may increase by 10 mg weekly to a maximum of 60 mg/day in divided doses.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but monitor for adverse effects.
Moderate: No specific dose adjustment recommended, but monitor for adverse effects. Consider lower initial doses.
Severe: Use with caution; consider lower initial doses and slower titration. Monitor for adverse effects. Dextroamphetamine is primarily eliminated renally.
Dialysis: Not well studied. Dextroamphetamine is not significantly removed by hemodialysis. Use with extreme caution and monitor closely.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended, but monitor for adverse effects as metabolism may be impaired.

Pharmacology

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Mechanism of Action

Dextroamphetamine is a sympathomimetic amine that stimulates the central nervous system. Its primary mechanism of action is thought to be the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain. It also inhibits the reuptake of these monoamines, leading to increased concentrations in the synaptic cleft. The exact mechanism by which it produces its therapeutic effects in ADHD and narcolepsy is not fully understood but is believed to involve activation of brainstem arousal system and cortex.
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Pharmacokinetics

Absorption:

Bioavailability: High (well absorbed orally)
Tmax: Oral tablet: 2-4 hours (range 1.5-6 hours)
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption. Acidifying agents (e.g., fruit juice) decrease absorption, while alkalinizing agents (e.g., antacids) increase absorption.

Distribution:

Vd: Approximately 3.5-4.5 L/kg
ProteinBinding: Approximately 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Adults: 10-12 hours (range 7-30 hours, highly variable due to urinary pH); Children: 9-11 hours
Clearance: Highly dependent on urinary pH. Acidic urine increases clearance, alkaline urine decreases clearance.
ExcretionRoute: Renal (primarily unchanged drug and metabolites)
Unchanged: Approximately 30-50% (highly dependent on urinary pH; up to 70% in acidic urine, less than 10% in alkaline urine)
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Pharmacodynamics

OnsetOfAction: Oral tablet: 30-60 minutes
PeakEffect: Oral tablet: 2-4 hours
DurationOfAction: Oral tablet: 4-6 hours

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 AND SHOULD BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF PATIENTS OBTAINING AMPHETAMINES FOR NONTHERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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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
Restlessness
Shakiness
Trouble controlling body movements
Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in eyesight or eye pain, swelling, or redness
Erectile dysfunction
Decreased sex interest
Seizures
Stomach pain
Muscle pain or weakness, dark urine, or difficulty passing urine
Frequent or prolonged erections
Changes in skin color, such as pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes

Important Heart-Related Warnings

If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, such as:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

Serotonin Syndrome: A Potentially Life-Threatening Condition

Taking this medication with certain other drugs can increase the risk of serotonin syndrome, a severe and potentially deadly condition. Call your doctor right away 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, nausea, or vomiting
Severe headache

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:

Dizziness or headache
Dry mouth
Trouble sleeping
Constipation, diarrhea, upset stomach, or decreased appetite
Weight loss
Bad taste in mouth
Feeling nervous and excitable
Hair loss

If you experience any of these side effects or any other symptoms that concern you, 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
  • Fainting spells
  • Fast or pounding heartbeat
  • New or worsening aggression or hostility
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New or worsening tics (uncontrolled movements or sounds)
  • Numbness, tingling, or coldness in fingers or toes
  • Unexplained wounds on fingers or toes
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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. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ Previous instances of drug abuse or stroke
Current or recent use of specific medications, such as:
+ Acetazolamide or sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
* If you are breastfeeding, as you should not breastfeed 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. They will help determine the safety of taking this medication with your other treatments and health issues. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication may cause dependence, and sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.

Heart-Related Precautions
You may need to undergo heart tests before starting this medication. If you have questions or concerns, discuss them with your doctor. This medication may cause high blood pressure, so monitor your blood pressure and heart rate as directed by your doctor. Be aware of the signs of high blood pressure, such as severe headache, dizziness, fainting, or changes in vision, and contact your doctor immediately if you experience any of these symptoms.

Interactions with Other Medications
Certain over-the-counter (OTC) products, including cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids, may increase blood pressure. Consult your doctor before using these products.

Lab Tests and Seizure Risk
This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this medication. Additionally, this medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk of seizures with your doctor.

Mental Health and Mood Changes
This medication may cause changes in behavior, mood, or thinking, including hallucinations, anger, or depression. If you or a family member have a history of mental health problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Contact your doctor immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, or anxiety.

Growth Effects in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks, so discuss this with your doctor.

Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, consult your doctor to discuss 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:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes symptomatic and supportive measures, including gastric lavage, activated charcoal, and sedation for CNS overstimulation.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
  • Linezolid (reversible MAOI activity)
  • Methylene Blue (reversible MAOI activity)
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, tramadol, St. John's Wort) - risk of serotonin syndrome
  • Antihypertensive agents - may antagonize hypotensive effects
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease amphetamine levels
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - increase amphetamine levels
  • Proton pump inhibitors (e.g., omeprazole) - may increase amphetamine levels
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, ritonavir) - may increase amphetamine exposure
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Moderate Interactions

  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
  • Antihistamines (e.g., diphenhydramine) - may potentiate CNS stimulation
  • Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines
  • Atomoxetine - increased risk of cardiovascular effects
  • Caffeine and other CNS stimulants - increased risk of adverse cardiovascular and CNS effects
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).

Timing: Prior to initiation and periodically during treatment.

Height and Weight

Rationale: Risk of growth suppression in pediatric patients.

Timing: Prior to initiation (pediatric patients).

Psychiatric History (including family history of tics, Tourette's syndrome, bipolar disorder, psychosis)

Rationale: Risk of exacerbating pre-existing psychiatric conditions or inducing new ones.

Timing: Prior to initiation.

Electrocardiogram (ECG)

Rationale: Consider for patients with pre-existing cardiac conditions or family history of sudden cardiac death/arrhythmias.

Timing: Prior to initiation (if indicated).

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or every 3-6 months

Target: Within normal limits for age/baseline

Action Threshold: Sustained elevation (e.g., >95th percentile for age/sex or significant increase from baseline) warrants investigation and potential dose adjustment/discontinuation.

Height and Weight

Frequency: Every 3-6 months (pediatric patients)

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration (e.g., crossing two major percentile lines) warrants investigation and potential drug holiday or alternative therapy.

Psychiatric Status (mood, anxiety, psychosis, tics)

Frequency: At each visit

Target: Stable, absence of new or worsening symptoms

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

Abuse/Diversion Potential

Frequency: At each visit

Target: No signs of misuse or diversion

Action Threshold: Signs of abuse or diversion warrant intervention and potential discontinuation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • New or worsening tics
  • Numbness or tingling in fingers/toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers/toes

Special Patient Groups

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Pregnancy

Dextroamphetamine is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, and there are no adequate and well-controlled studies in pregnant women. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence).

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations, though data are conflicting and limited.
Second Trimester: Potential for growth restriction and premature birth.
Third Trimester: Risk of neonatal withdrawal symptoms, premature birth, and low birth weight.
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Lactation

Dextroamphetamine is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, weight loss, and potential long-term neurodevelopmental effects), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The American Academy of Pediatrics considers amphetamines to be a drug for which the effect on the nursing infant is unknown but may be of concern. Lactation Risk Category L4 (Possibly Hazardous).

Infant Risk: High risk of irritability, poor feeding, sleep disturbances, weight loss, and potential long-term neurodevelopmental effects. Monitor infant for adverse effects.
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Pediatric Use

Dextroamphetamine is approved for ADHD and narcolepsy in children 6 years and older. Long-term use in children has been associated with growth suppression (weight and height). Growth should be monitored regularly. Psychiatric adverse events (e.g., psychosis, mania, aggression) can occur. Cardiovascular monitoring is essential.

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Geriatric Use

Use with caution in elderly patients due to a greater likelihood of age-related decreases in renal function and potential for comorbidities (e.g., cardiovascular disease, hypertension). Start with lower doses and titrate slowly. Monitor for cardiovascular and psychiatric adverse effects.

Clinical Information

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Clinical Pearls

  • Dextroamphetamine has a high abuse potential; careful patient selection and monitoring are crucial.
  • Administer the last dose of the day at least 6 hours before bedtime to minimize insomnia.
  • Monitor blood pressure and heart rate at baseline and regularly during treatment, especially in patients with pre-existing cardiovascular conditions.
  • In pediatric patients, monitor height and weight regularly due to the risk of growth suppression. Consider drug holidays if growth deceleration is significant.
  • Educate patients and caregivers about the signs of psychiatric adverse events (e.g., hallucinations, paranoia, mania) and the importance of reporting them immediately.
  • Avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms (e.g., extreme fatigue, depression, sleep disturbances).
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta)
  • Atomoxetine (Strattera)
  • Guanfacine (Intuniv)
  • Clonidine (Kapvay)
  • Modafinil (Provigil) - for narcolepsy
  • Armodafinil (Nuvigil) - for narcolepsy
  • Non-pharmacological interventions (e.g., behavioral therapy, cognitive behavioral therapy, lifestyle modifications)
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Cost & Coverage

Average Cost: $30 - $100 per 30 tablets (5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic), Tier 3 or 4 (Brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.