Dextroamphetamine 15mg Tablets

Manufacturer WILSHIRE PHARMACEUTICALS Active Ingredient Dextroamphetamine Tablets(deks troe am FET a meen) Pronunciation deks troe am FET a 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; Indirect-acting Adrenergic Agonist
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Pregnancy Category
Category C
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FDA Approved
Jan 1952
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Dextroamphetamine is a 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. It can help improve attention, concentration, and reduce impulsivity in people with ADHD, and help people with narcolepsy stay awake during the day.
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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. To minimize the risk of sleep disturbances, avoid taking it late in the day. Additionally, do not take this medication with fruit juice. Consistency is key, so take your medication at the same time every day.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. It's essential to store your medication in a secure location, out of sight and reach of children and pets, and inaccessible to others. Consider using a locked box or area to prevent unauthorized access. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, and explore local drug take-back programs.

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 the missed one.
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Lifestyle & Tips

  • Take exactly as prescribed by your doctor; do not take more or less than directed.
  • Do not share this medication with others, as it has a high potential for abuse.
  • Avoid alcohol consumption while taking this medication.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Monitor your heart rate and blood pressure regularly as advised by your doctor.
  • Maintain a healthy diet and ensure adequate sleep, as stimulants can sometimes affect appetite and sleep patterns.
  • Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness or blurred vision.

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.
Narcolepsy: Initial 10 mg daily; 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; 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: Use with caution; consider lower initial doses and slower titration.
Moderate: Use with caution; consider lower initial doses and slower titration.
Severe: Use with caution; consider lower initial doses and slower titration. Dextroamphetamine is primarily renally excreted, so significant impairment may require substantial dose reduction.
Dialysis: Not well studied; likely not dialyzable due to protein binding and volume of distribution. Avoid or use with extreme caution and close monitoring.

Hepatic Impairment:

Mild: Use with caution; consider lower initial doses and slower titration.
Moderate: Use with caution; consider lower initial doses and slower titration.
Severe: Use with caution; consider lower initial doses and slower titration. Dextroamphetamine is metabolized by the liver (CYP2D6), so severe impairment may necessitate significant dose reduction.

Pharmacology

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Mechanism of Action

Dextroamphetamine is a central nervous system (CNS) stimulant. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The therapeutic effects in ADHD and narcolepsy are believed to be mediated through these actions in the brain.
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Pharmacokinetics

Absorption:

Bioavailability: High (well absorbed orally)
Tmax: 2-4 hours (immediate-release)
FoodEffect: Food can delay Tmax but generally does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 2-4 L/kg
ProteinBinding: Approximately 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: 10-12 hours (adults); pH-dependent (shorter in acidic urine, longer in alkaline urine)
Clearance: Variable, pH-dependent
ExcretionRoute: Renal
Unchanged: Approximately 30-40% (in normal urine pH); up to 70% in acidic urine.
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (immediate-release)
PeakEffect: 2-4 hours (immediate-release)
DurationOfAction: 4-6 hours (immediate-release)
Confidence: Medium

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 NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE USUAL PRECAUTIONS OF CONTROLLING THE AVAILABILITY OF A DRUG SO SUBJECT TO ABUSE SHOULD BE OBSERVED.
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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
Trouble 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 trouble passing urine
Prolonged or frequent 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 feeling 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 medical help immediately 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. If you experience any of the following symptoms, contact your doctor right away:

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 side effects or only have mild side effects, it's essential to be aware of the following possible 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 guidance. 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., hearing voices, believing things that are not true)
  • Manic symptoms (e.g., unusually high energy, racing thoughts, decreased need for sleep)
  • Unexplained numbness, coolness, or pain in fingers or toes, or skin color changes (Raynaud's phenomenon)
  • Severe headache
  • Blurred vision
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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:

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 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 (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ 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 problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. 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 engaging in activities that require alertness or clear vision until you understand how this medication affects you.

Tolerance and Dosage
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively. In this case, you may need higher doses to achieve the same effect. If you notice this medication is no longer working well, contact your doctor. Do not exceed the prescribed dose.

Dependence and Withdrawal
Long-term or regular use of this medication can lead to dependence. Stopping it abruptly may cause withdrawal symptoms. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions carefully. Report any adverse effects to your doctor.

Cardiovascular Precautions
You may need to undergo heart tests before starting this medication. If you have questions, discuss them with your doctor. This medication can 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
Before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products, consult your doctor.

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 it. Additionally, this medication may increase the risk of seizures in some individuals, including those with a history of seizures. Discuss your risk with your doctor.

Mental Health and Mood Changes
New or worsening behavior and mood changes, such as altered thinking, anger, or hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood 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, emotional instability, abnormal thinking, anxiety, or loss of interest in life.

Pediatric Growth and Development
This medication may affect growth in children and adolescents. They may require regular growth checks. 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
  • Cardiac arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea, vomiting, diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma

What to Do:

In case of suspected overdose, seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis)
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - increase renal excretion, decrease plasma levels
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease renal excretion, increase plasma levels and prolong half-life
  • Adrenergic blockers (e.g., guanethidine) - may antagonize the hypotensive effect of guanethidine
  • Antihypertensives - may reduce the hypotensive effect of these drugs
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Moderate Interactions

  • Tricyclic Antidepressants (TCAs) - may potentiate the effects of dextroamphetamine, increasing risk of cardiovascular effects
  • Antacids (e.g., magnesium hydroxide, aluminum hydroxide) - may increase absorption of dextroamphetamine
  • Phenothiazines (e.g., chlorpromazine) - may inhibit the stimulant effects of dextroamphetamine
  • Haloperidol - may inhibit the stimulant effects of dextroamphetamine
  • Lithium - may inhibit the stimulant effects of dextroamphetamine
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Minor Interactions

  • Caffeine - additive stimulant effects, increased risk of adverse effects

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To establish baseline cardiovascular status due to risk of increased BP and HR.

Timing: Prior to initiation of therapy.

Weight and Height (for pediatric patients)

Rationale: To establish baseline growth parameters due to potential for growth suppression.

Timing: Prior to initiation of therapy.

Psychiatric History and Status

Rationale: To screen for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) that may be exacerbated.

Timing: Prior to initiation of therapy.

Family History of Sudden Cardiac Death or Arrhythmias

Rationale: To assess for underlying cardiac risk factors.

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/individual baseline

Action Threshold: Sustained elevation above baseline or age-appropriate norms; consider dose reduction or discontinuation.

Weight and Height (for pediatric patients)

Frequency: Every 3-6 months

Target: Consistent growth along established percentile curves

Action Threshold: Significant deviation from expected growth curve; consider drug holiday or alternative therapy.

Psychiatric Status (e.g., emergence of new or worsening psychosis, mania, aggression, anxiety)

Frequency: At each visit

Target: Stable mood and behavior

Action Threshold: Emergence of new or worsening psychiatric symptoms; consider dose adjustment or discontinuation.

Peripheral Vasculopathy (e.g., Raynaud's phenomenon)

Frequency: Periodically, or if symptoms reported

Target: Absence of symptoms

Action Threshold: New onset or worsening of symptoms; consider discontinuation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
  • Unexplained weight loss
  • Growth deceleration (in children)
  • Numbness, coolness, or pain in fingers or toes
  • Skin color changes in fingers or toes (from pale to blue to red)

Special Patient Groups

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Pregnancy

Dextroamphetamine is classified as Pregnancy Category C. 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. Amphetamines have been associated with adverse pregnancy outcomes including premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations, though data are limited and inconsistent.
Second Trimester: Risk of premature delivery and low birth weight.
Third Trimester: Risk of premature delivery, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor).
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Lactation

Dextroamphetamine is excreted into human breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, growth suppression, cardiovascular 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.

Infant Risk: Moderate risk (L3). Potential for irritability, poor feeding, sleep disturbances, and long-term effects on growth and development.
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Pediatric Use

Dextroamphetamine is approved for use in children 6 years and older for ADHD and narcolepsy. Close monitoring of growth (height and weight) is essential due to the potential for growth suppression. Cardiovascular and psychiatric monitoring are also crucial. Long-term safety and efficacy in children under 6 years have not been established.

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Geriatric Use

Clinical studies of dextroamphetamine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may be more sensitive to the cardiovascular and CNS stimulant effects.

Clinical Information

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Clinical Pearls

  • Dextroamphetamine has a high potential for abuse and dependence; prescribe with caution and monitor for signs of misuse.
  • Immediate-release formulations typically require multiple daily doses due to their shorter duration of action.
  • Monitor growth in pediatric patients carefully; consider drug holidays if growth suppression is significant.
  • Assess for pre-existing cardiac conditions or family history of sudden cardiac death before initiating therapy.
  • Educate patients and caregivers on the signs of cardiovascular and psychiatric adverse events.
  • Avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms (e.g., extreme fatigue, depression, sleep disturbances).
  • Urinary pH significantly affects dextroamphetamine excretion; avoid concurrent use with urinary acidifiers or alkalinizers unless carefully managed.
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta)
  • Lisdexamfetamine (Vyvanse)
  • Mixed amphetamine salts (e.g., Mydayis)
  • Non-stimulants for ADHD: Atomoxetine (Strattera), Guanfacine extended-release (Intuniv), Clonidine extended-release (Kapvay)
  • Modafinil/Armodafinil (for narcolepsy)
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Cost & Coverage

Average Cost: $20 - $100+ per 30 tablets (15mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, 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 when you first receive your medication and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.