Adderall 5mg Tablets

Manufacturer TEVA SELECT BRANDS 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
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
Jan 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 certain natural substances in the brain that help with focus and attention. It is primarily used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and narcolepsy (a sleep disorder).
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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. Examples of such products include cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like 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 medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. 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 by your doctor. Do not take more or less, or more often than directed.
  • Do not crush, chew, or break the tablets. Swallow them 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.
  • Maintain a healthy diet and regular sleep schedule.
  • Regularly monitor your blood pressure and heart rate as advised by your doctor.
  • For children, monitor growth (height and weight) regularly.

Dosing & Administration

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Adult Dosing

Standard Dose: ADHD: Initial 5 mg once or twice daily; may increase by 5 mg weekly. Narcolepsy: Initial 10 mg daily; may increase by 10 mg weekly.
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 (rarely up to 60 mg/day). Doses usually given in the morning and early afternoon.
Narcolepsy: Initial 10 mg daily, divided; may increase by 10 mg weekly to a maximum of 60 mg/day. Doses usually given in the morning, noon, and late afternoon.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (3-5 years): Initial 2.5 mg daily; may increase by 2.5 mg weekly. ADHD (6-12 years): Initial 5 mg once or twice daily; may increase by 5 mg weekly. Narcolepsy (6-12 years): Initial 5 mg daily; may increase by 5 mg weekly. Max 60 mg/day.
Adolescent: ADHD (13-17 years): Initial 10 mg daily; may increase by 10 mg weekly. Max 40 mg/day. Narcolepsy (13-17 years): Initial 10 mg daily; may increase by 10 mg weekly. Max 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but monitor for adverse effects.
Moderate: Consider lower initial doses and slower titration. Monitor for adverse effects.
Severe: Use with caution; consider lower doses and extended dosing intervals. Not recommended for end-stage renal disease.
Dialysis: Not recommended. Amphetamines are not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended, but use with caution due to potential for increased exposure if metabolism is significantly impaired.

Pharmacology

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Mechanism of Action

Amphetamines are non-catecholamine sympathomimetic amines that exert their therapeutic effect by increasing the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain, particularly in the prefrontal cortex. They also block the reuptake of these monoamines into the presynaptic neuron, leading to increased concentrations in the synaptic cleft. The exact mechanism by which they produce their therapeutic effects in ADHD and narcolepsy is not fully understood but is thought to involve modulation of attention, impulse control, and wakefulness.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 75% (oral)
Tmax: Dextroamphetamine: 3 hours; Amphetamine: 3 hours (for immediate-release tablets)
FoodEffect: Food does not significantly affect the extent of absorption, but may delay Tmax.

Distribution:

Vd: Dextroamphetamine: 2.5-4.8 L/kg; Amphetamine: 2.5-4.8 L/kg
ProteinBinding: Approximately 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Dextroamphetamine: 10-13 hours; Amphetamine: 9-11 hours (highly dependent on urinary pH)
Clearance: Highly variable, dependent on urinary pH. Acidic urine increases clearance.
ExcretionRoute: Renal (primarily unchanged drug and metabolites)
Unchanged: Approximately 30-50% (dependent on urinary pH; higher in acidic urine)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (for immediate-release tablets)
PeakEffect: 1-3 hours
DurationOfAction: 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. 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 immediate 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
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Other severe side effects, including:
+ Difficulty getting or maintaining an erection
+ Changes in sex interest
+ Seizures
+ Trouble controlling body movements
+ Trouble controlling 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 sensation in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or difficulty urinating

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 passing out

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:

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 the mouth
Weight loss

If any of these side effects or other symptoms bother you or persist, contact your doctor for guidance. Remember, this is not an exhaustive list of possible side effects. If you have concerns or questions, consult your doctor.

Reporting Side Effects

To report side effects, you can:

Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website 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)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • New or worsening aggression, hostility, or irritability
  • New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • New or worsening manic symptoms (e.g., extreme energy, racing thoughts)
  • Unexplained muscle pain, tenderness, or weakness (rare, but could indicate rhabdomyolysis)
  • Blurred vision or other vision changes
  • Severe headache
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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
Kidney disease
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
* Breast-feeding status: Do not breast-feed while taking this medication.

This list is not exhaustive. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Never start, stop, or change the dose of any medication without consulting your doctor.
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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 used to, 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 directed by your doctor, and have regular blood tests to check for any potential effects.

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. Additionally, do not take antacids while taking this medication, as they may interact with it.

Some individuals taking this medication may experience changes in behavior or mood, such as altered thinking, anger, or hallucinations. If you or a family member have a history of mental health issues, such as depression or bipolar disorder, 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, such as 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 seizure disorders. 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 some cases, this medication may affect growth in children and adolescents. 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 suitable for 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 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:

Call 911 immediately or go to the nearest emergency room. For poison control, call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis (do not use within 14 days of MAOI)
  • Linezolid (reversible MAOI activity)
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Major Interactions

  • Serotonergic drugs (SSRIs, SNRIs, TCAs, fentanyl, lithium, tramadol, triptans, St. John's Wort) - risk of serotonin syndrome
  • Antihypertensives - may reduce hypotensive effects
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - increase amphetamine excretion, decrease efficacy
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease amphetamine excretion, increase toxicity
  • Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase amphetamine absorption and exposure
  • Antipsychotics (e.g., haloperidol, chlorpromazine) - may antagonize stimulant effects
  • Propoxyphene - risk of seizures and psychosis
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Moderate Interactions

  • Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines
  • Antacids - may increase amphetamine absorption
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, ritonavir) - may increase amphetamine exposure and risk of adverse effects
  • Alcohol - may increase risk of adverse cardiovascular events
  • Opioids - potential for additive CNS depression
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Minor Interactions

  • Caffeine - additive stimulant effects
  • Decongestants (e.g., pseudoephedrine, phenylephrine) - additive sympathomimetic effects

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Amphetamines can cause dose-related increases in BP and HR. Baseline assessment is crucial to identify pre-existing cardiovascular risk.

Timing: Prior to initiation of therapy

Height and Weight (Pediatric Patients)

Rationale: Stimulants have been associated with growth suppression in pediatric patients.

Timing: Prior to initiation of therapy

Psychiatric History (including family history of suicide, bipolar disorder, depression)

Rationale: To assess risk for emergence or exacerbation of psychiatric symptoms (e.g., psychosis, mania, aggression).

Timing: Prior to initiation of therapy

Cardiovascular History (including family history of sudden cardiac death, arrhythmias)

Rationale: To identify pre-existing cardiac conditions that may contraindicate or require caution with stimulant use.

Timing: Prior to initiation of therapy

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or at least every 3-6 months

Target: Within normal limits for age/individual

Action Threshold: Persistent elevation above normal range; consider dose reduction, discontinuation, or referral to cardiology.

Height and Weight (Pediatric Patients)

Frequency: Every 3-6 months

Target: Consistent growth trajectory

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

Psychiatric Status (mood, behavior, thought processes)

Frequency: At each visit

Target: Stable, improved ADHD symptoms, absence of new psychiatric symptoms

Action Threshold: Emergence or worsening of aggression, psychosis, mania, severe anxiety, or depression; consider dose adjustment or discontinuation.

Abuse Potential Assessment

Frequency: Periodically, especially at follow-up visits

Target: No signs of drug-seeking behavior or misuse

Action Threshold: Signs of misuse, diversion, or dependence; consider discontinuation and referral for substance abuse treatment.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Depression
  • Unexplained weight loss
  • Growth deceleration (in children)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)

Special Patient Groups

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Pregnancy

Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Amphetamines may cause fetal harm.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations (e.g., cardiac defects, oral clefts) based on some studies, though data are conflicting.
Second Trimester: Risk of premature birth, low birth weight, and withdrawal symptoms in the neonate.
Third Trimester: Risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, tremor, feeding difficulties, respiratory distress) if used near term.
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Lactation

Amphetamines are excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, growth suppression, cardiovascular effects), breastfeeding is not recommended during treatment with Adderall.

Infant Risk: Moderate risk (L3). Potential for irritability, poor feeding, sleep disturbances, and long-term effects on growth and development. Consider alternative feeding methods or alternative therapy for the mother.
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Pediatric Use

Safety and efficacy established for ADHD in children 3 years and older, and for narcolepsy in children 6 years and older. Long-term use in children has been associated with growth suppression (weight and height). Monitor growth regularly.

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Geriatric Use

Use with caution in elderly patients. Elderly patients may be more sensitive to the cardiovascular and CNS stimulant effects. Consider lower initial doses and slower titration. Monitor for adverse effects, especially cardiovascular and psychiatric.

Clinical Information

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Clinical Pearls

  • Individualize dosage: Start low and titrate slowly based on patient response and tolerability.
  • Timing of doses: Administer the last dose of the day at least 4-6 hours before bedtime to minimize insomnia.
  • Drug holidays: Consider periodic drug holidays (e.g., weekends, school breaks) to assess the need for continued therapy, minimize growth suppression in children, and reduce tolerance.
  • Monitor for diversion and abuse: Due to Schedule II classification and abuse potential, monitor for signs of misuse, abuse, or diversion.
  • Cardiovascular risk: Screen all patients for pre-existing cardiac conditions and monitor BP/HR regularly. Avoid use in patients with symptomatic cardiovascular disease or moderate to severe hypertension.
  • Psychiatric risk: Monitor for emergence or worsening of psychiatric symptoms, especially in patients with a history of psychosis, bipolar disorder, or severe anxiety.
  • Growth monitoring: Essential for pediatric patients on long-term therapy.
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta, Focalin)
  • Lisdexamfetamine (Vyvanse)
  • Atomoxetine (Strattera)
  • Guanfacine extended-release (Intuniv)
  • Clonidine extended-release (Kapvay)
  • Bupropion (Wellbutrin) - off-label for ADHD
  • Modafinil/Armodafinil (for narcolepsy)
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Cost & Coverage

Average Cost: Varies widely, typically $50-$200+ per 30 tablets (5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or Tier 4 (brand) for most commercial insurance plans. May require prior authorization.
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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 and effective treatment, 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. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

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