Dextroamphetamine 5mg/5ml Solution

Manufacturer TRIS Active Ingredient Dextroamphetamine Oral Solution(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 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 to help improve focus, attention, and reduce impulsivity or excessive daytime sleepiness.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most out of your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
To avoid sleep problems, try to take your medication earlier in the day, rather than late in the day.
Do not take your medication with fruit juice.
Take your medication at the same time every day to establish a routine.
If you are taking a liquid dose, measure it carefully using the measuring device provided with your medication. If you don't have one, ask your pharmacist for a device to measure your medication accurately.

Storing and Disposing of Your Medication

To keep your medication safe and effective:

Store your medication at room temperature, away from light and moisture.
Keep your medication in a dry place, such as a closet or drawer.
Do not store your medication in a bathroom.
Keep your medication out of reach of children and pets, and store it in a secure location where others cannot access it. Consider using a locked box or area.
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.
Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about any drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take the missed dose as soon as you remember.
If it's almost time for your next dose, skip the missed dose and continue with your regular schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed by your doctor. Do not take more or less, or more often than prescribed.
  • Do not share this medication with anyone else, as it has a high potential for abuse.
  • Avoid taking doses late in the day to prevent sleep problems (insomnia).
  • 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 exercise, as appetite suppression and weight loss can occur.
  • 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: Highly individualized. For ADHD, typically 5 mg once or twice daily, titrating up to 40 mg/day in divided doses. For Narcolepsy, 5-60 mg/day in divided doses.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

ADHD: Initial: 5 mg once or twice daily. Titrate by 5 mg weekly to optimal response, usually 5-40 mg/day in 1-3 divided doses.
Narcolepsy: Initial: 10 mg daily. Titrate by 10 mg weekly to optimal response, usually 5-60 mg/day in divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (6 years and older): Initial 2.5-5 mg once or twice daily. Titrate by 2.5-5 mg weekly to optimal response, usually 5-40 mg/day in 1-3 divided doses. Narcolepsy (6-12 years): Initial 5 mg daily. Titrate by 5 mg weekly to optimal response, usually 5-30 mg/day in divided doses. Narcolepsy (12 years and older): Initial 10 mg daily. Titrate by 10 mg weekly to optimal response, usually 5-60 mg/day in divided doses.
Adolescent: ADHD (13-17 years): Initial 5 mg once or twice daily. Titrate by 5 mg weekly to optimal response, usually 5-40 mg/day in 1-3 divided doses. Narcolepsy (12 years and older): Initial 10 mg daily. Titrate by 10 mg weekly to optimal response, usually 5-60 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 end of dosing range.
Severe: Use with caution. Consider lower initial doses and slower titration due to reduced excretion. Monitor for adverse effects.
Dialysis: Not available (limited data, likely not dialyzable to a significant extent due to protein binding and volume of distribution).

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: Use with caution. Consider lower initial doses and slower titration.
Severe: Use with caution. Consider lower initial doses and slower titration due to potential for altered metabolism.

Pharmacology

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Mechanism of Action

Dextroamphetamine is a sympathomimetic amine that acts as a central nervous system (CNS) stimulant. Its primary mechanism of action is thought to be 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 believed to be mediated through these actions in the CNS.
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Pharmacokinetics

Absorption:

Bioavailability: High (approximately 75-100%)
Tmax: Oral solution: 2-4 hours
FoodEffect: Food can delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 3-5 L/kg
ProteinBinding: Approximately 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Adults: 10-12 hours (pH-dependent); Children: 9-11 hours (pH-dependent)
Clearance: Highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine.
ExcretionRoute: Renal
Unchanged: Approximately 30-50% (highly dependent on urinary pH)
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Pharmacodynamics

OnsetOfAction: Oral solution: 30-60 minutes
PeakEffect: Oral solution: 2-4 hours
DurationOfAction: Oral solution: 4-6 hours
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 MUST 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 PRESCRIBING OR DISPENSING CONTROLLED SUBSTANCES SHOULD BE OBSERVED. 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 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
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 trouble 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. 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 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're concerned about any side effects or have questions, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention)
  • New or worsening aggression, hostility, paranoia, or hallucinations
  • New or worsening tics (uncontrolled movements or sounds)
  • Numbness, tingling, or coldness in fingers or toes (Raynaud's phenomenon)
  • Unexplained fever, muscle stiffness, or severe confusion (signs of serotonin syndrome)
  • 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 you experienced, including the symptoms that occurred.
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
Any past health issues, such as:
+ Drug abuse
+ Stroke
Current medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (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 Precautions

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 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.

Cardiovascular Monitoring
You may need to undergo heart tests before starting this medication. If you have any questions or concerns, discuss them with your doctor. This medication may cause high blood pressure, so it is crucial to 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 it is essential to inform all your healthcare providers and lab workers that you are taking this medication. Additionally, this medication may increase the risk of seizures in some individuals, particularly those 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 and mood, including hallucinations, anger, and changes in thinking. 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.

Growth Effects in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary, 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
  • Aggressiveness
  • Hallucinations
  • Panic states
  • High fever
  • Rhabdomyolysis
  • 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 Poison Control at 1-800-222-1222. Management typically involves supportive care, including gastric lavage, activated charcoal, and symptomatic treatment for cardiovascular and CNS effects.

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)
  • Linezolid (MAOI activity)
  • Methylene Blue (MAOI activity)
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Major Interactions

  • Acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease absorption and increase excretion of amphetamines, reducing efficacy.
  • Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase absorption and decrease excretion of amphetamines, increasing effects and toxicity.
  • Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of amphetamines.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, tramadol) - increased risk of serotonin syndrome.
  • Antihypertensives - amphetamines may antagonize the hypotensive effects.
  • Adrenergic blockers (e.g., guanethidine) - amphetamines may reduce the hypotensive effect of guanethidine.
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Moderate Interactions

  • Antacids (e.g., aluminum hydroxide, magnesium hydroxide) - may increase absorption of amphetamines.
  • Proton Pump Inhibitors (PPIs) - may increase absorption of amphetamines.
  • Phenothiazines - may inhibit the stimulant effects of amphetamines.
  • Haloperidol - may inhibit the stimulant effects of amphetamines.
  • Lithium - may inhibit the stimulant effects of amphetamines.
  • Opioids - potential for additive CNS depression and respiratory depression.
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Minor Interactions

  • Not available (most interactions are moderate to major due to the drug's mechanism)

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 of therapy.

Height and Weight

Rationale: Risk of growth suppression in pediatric patients and weight loss in all patients.

Timing: Prior to initiation of therapy.

Psychiatric History (including family history of sudden death, ventricular arrhythmia)

Rationale: Risk of new or worsening psychiatric symptoms (e.g., psychosis, mania) and identification of cardiac risk factors.

Timing: Prior to initiation of therapy.

ECG (Electrocardiogram)

Rationale: Consider for patients with pre-existing cardiac conditions or significant risk factors for cardiac disease.

Timing: Prior to initiation, if indicated.

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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; significant increases warrant investigation.

Action Threshold: Sustained elevation above normal range; symptomatic changes.

Height and Weight

Frequency: Every 3-6 months (pediatric patients); annually (adults).

Target: Normal growth trajectory (pediatric); stable weight (adults).

Action Threshold: Significant growth deceleration or unexplained weight loss.

Psychiatric Status (e.g., mood, anxiety, psychosis, aggression)

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

Target: Stable or improved psychiatric symptoms.

Action Threshold: Emergence of new or worsening psychiatric symptoms (e.g., hallucinations, paranoia, mania, severe anxiety).

Sleep Patterns

Frequency: At each visit.

Target: Adequate sleep duration and quality.

Action Threshold: Significant insomnia or sleep disturbances.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Fainting
  • Palpitations
  • Unexplained weight loss
  • Changes in mood or behavior (e.g., agitation, aggression, paranoia, hallucinations, mania)
  • New or worsening tics
  • Numbness, tingling, or coldness in fingers or toes (Raynaud's phenomenon)
  • Blurred vision
  • Severe headache

Special Patient Groups

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Pregnancy

Generally not recommended during pregnancy unless the potential benefit outweighs the potential risk to the fetus. Amphetamines may cause adverse pregnancy outcomes, including premature birth and low birth weight. Neonatal withdrawal symptoms have been reported.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be ruled out.
Second Trimester: Risk of premature birth and low birth weight.
Third Trimester: Risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, tremor, feeding difficulties).
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Lactation

Dextroamphetamine is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, poor feeding, weight loss), 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.

Infant Risk: Risk level: L3 (Moderately safe; caution advised). Monitor infant for irritability, poor feeding, sleep disturbances, and weight gain.
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Pediatric Use

Use in children under 6 years of age for ADHD or narcolepsy is not recommended. Monitor growth (height and weight) carefully, as growth suppression can occur. Monitor for cardiovascular effects (BP, HR) and emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression).

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Geriatric Use

Use with caution in elderly patients. Start with lower doses and titrate slowly due to increased sensitivity to adverse effects, particularly cardiovascular and psychiatric effects. Monitor for pre-existing cardiovascular conditions.

Clinical Information

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Clinical Pearls

  • Dextroamphetamine oral solution (5mg/5ml) is often preferred for patients who have difficulty swallowing tablets or require precise dose adjustments.
  • The half-life of dextroamphetamine is highly dependent on urinary pH. Acidic urine increases excretion, while alkaline urine decreases it. This can be clinically relevant when co-administering drugs that alter urinary pH.
  • Patients should be educated on the high abuse potential and the importance of storing the medication securely.
  • Regular monitoring of cardiovascular parameters (BP, HR) and growth (in children) is crucial due to potential adverse effects.
  • Be vigilant for signs of new or worsening psychiatric symptoms, including psychosis or mania, especially in patients with a history of psychiatric disorders.
  • Consider a 'drug holiday' or dose reduction if growth suppression is observed in pediatric patients, under medical supervision.
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Alternative Therapies

  • Methylphenidate (Ritalin, Concerta, Focalin)
  • Atomoxetine (Strattera) - non-stimulant
  • Guanfacine extended-release (Intuniv) - non-stimulant
  • Clonidine extended-release (Kapvay) - non-stimulant
  • Bupropion (Wellbutrin) - off-label for ADHD
  • Behavioral therapy (e.g., CBT, parent training)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$100+ per 300ml (5mg/5ml solution)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic; Tier 3 or higher for brand names. Coverage varies by insurance plan.
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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 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 details about the medication taken, the amount, and the time it occurred.