Dextroamphetamine 30mg Tablets

Manufacturer WILSHIRE 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 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 alertness. It can help people with ADHD improve their attention and reduce hyperactivity and impulsivity. For narcolepsy, it helps people stay awake during the day.
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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 take 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. Keep it in a dry place, avoiding storage in a bathroom. It's essential to keep your medication in a safe and secure location, out of reach of children and pets, and inaccessible to others. Consider using a locked box or area to store your medication. 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 or explore 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 by your doctor. Do not take more or less than directed.
  • Take the first dose in the morning to avoid sleep problems. If taking multiple doses, ensure the last dose is taken several hours before bedtime.
  • Avoid alcohol while taking this medication, as it can increase side effects.
  • Maintain a healthy diet and regular exercise. For children, monitor growth and weight regularly.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not stop taking this medication suddenly without consulting your doctor, as withdrawal symptoms may occur.
  • Store in a safe place, away from children and others, due to its potential for abuse.

Dosing & Administration

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Adult Dosing

Standard Dose: For Narcolepsy: Initial 10 mg daily, increased by 10 mg weekly until optimal response. Usual range 10-60 mg/day in divided doses. For ADHD: Initial 5 mg once or twice daily, increased by 5 mg weekly. Usual range 5-40 mg/day in divided doses.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

Narcolepsy: Initial 10 mg daily, increased by 10 mg weekly. Max 60 mg/day.
ADHD: Initial 5 mg once or twice daily, increased by 5 mg weekly. Max 40 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (6-12 years): Initial 5 mg once or twice daily, increased by 5 mg weekly. Max 40 mg/day. Narcolepsy (6-12 years): Initial 5 mg daily, increased by 5 mg weekly. Max 60 mg/day.
Adolescent: ADHD (>12 years): Initial 10 mg daily, increased by 10 mg weekly. Max 40 mg/day. Narcolepsy (>12 years): Initial 10 mg daily, increased by 10 mg weekly. Max 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment guidelines; monitor for adverse effects.
Moderate: Consider lower initial doses and slower titration; monitor for adverse effects.
Severe: Use with caution; consider significant dose reduction or avoidance due to renal excretion. Monitor for toxicity.
Dialysis: Not available; likely not dialyzable to a significant extent due to high volume of distribution.

Hepatic Impairment:

Mild: No specific adjustment guidelines.
Moderate: No specific adjustment guidelines; use with caution.
Severe: No specific adjustment guidelines; use with caution, as metabolism may be impaired.

Pharmacology

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Mechanism of Action

Dextroamphetamine is a sympathomimetic amine that acts as a non-catecholamine indirect-acting adrenergic agonist. It primarily exerts its effects by increasing the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain and by blocking their reuptake. This leads to increased concentrations of these neurotransmitters in the synaptic cleft, enhancing neurotransmission in areas of the brain associated with attention, impulse control, and wakefulness.
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Pharmacokinetics

Absorption:

Bioavailability: 75-100%
Tmax: 2-4 hours (oral)
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: 3-5 L/kg
ProteinBinding: 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: 10-12 hours (adults), 6-8 hours (children)
Clearance: Not available
ExcretionRoute: Renal (urine)
Unchanged: 30-40% (highly dependent on urine pH; increased in acidic urine, decreased in alkaline urine)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 2-4 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 AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF PATIENTS OBTAINING AMPHETAMINES FOR NONTHERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUG 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 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
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
Frequent or prolonged erections
Changes in skin color, such as pale, blue, gray, purple, or red hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the fingers or toes

Important Heart-Related Warnings

If you have a pre-existing heart condition or 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

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
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, 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 your mouth
Feeling nervous and excitable
Hair loss

If you experience any of these side effects or any other unusual symptoms, 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 heart problems (e.g., palpitations, irregular heartbeat)
  • New or worsening mental problems (e.g., seeing or hearing things that are not real, believing things that are not true, suspiciousness, aggression, hostility)
  • New or worsening tics (uncontrolled movements or sounds)
  • Numbness, pain, or discoloration in fingers or toes (Raynaud's phenomenon)
  • Unexplained fever, muscle stiffness, or confusion (signs of serotonin syndrome or neuroleptic malignant syndrome-like reaction)
  • 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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction 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 medical conditions, 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 they may cause 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 you determine if it is safe to take this medication with your existing treatments 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. This will help ensure your safety and prevent potential interactions with other medications or medical procedures.

Caution with Daily Activities

Until you know how this medication affects you, avoid driving and engaging in activities that require alertness or clear vision. This will help prevent accidents and ensure your safety.

Tolerance and Dependence

Long-term or high-dose use of this medication can lead to tolerance, where the medication may not work as well, and you may need higher doses 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, long-term or regular use of this medication can cause dependence. Stopping the medication abruptly may lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.

Monitoring and Follow-up

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

Blood Pressure Monitoring

This medication may cause high blood pressure. Monitor your blood pressure and heart rate as directed by your doctor. If you experience severe headache, dizziness, fainting, or changes in vision, contact your doctor immediately.

Interactions with Other Medications

Certain over-the-counter (OTC) products, such as cough or 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 Test Interactions

This medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication.

Seizure Risk

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 Precautions

New or worsening behavior and mood changes, such as changes in 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.

Growth Effects in Children and Teens

This medication may affect growth in children and teens. They may require regular growth checks. Consult your doctor to discuss the potential risks and benefits.

Pregnancy and Breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor. You will need 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 or your local emergency number immediately. For poison control, call 1-800-222-1222. Seek immediate medical attention. Treatment is generally supportive and symptomatic, including gastric lavage, activated charcoal, and management of hyperthermia, seizures, and cardiovascular effects.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use) - risk of hypertensive crisis.
  • Linezolid (MAOI activity)
  • Methylene blue (MAOI activity)
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Major Interactions

  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome.
  • Antihypertensives (e.g., guanethidine, reserpine) - reduced hypotensive effect.
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increased dextroamphetamine levels and prolonged half-life.
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decreased dextroamphetamine levels and shortened half-life.
  • Tricyclic Antidepressants (TCAs) - increased cardiovascular effects of dextroamphetamine.
  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects.
  • Propoxyphene - increased dextroamphetamine levels.
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Moderate Interactions

  • Adrenergic blockers (e.g., beta-blockers) - may reduce stimulant effects.
  • Antacids (containing magnesium or aluminum hydroxide) - increased absorption of dextroamphetamine.
  • Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase absorption of dextroamphetamine.
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may increase dextroamphetamine exposure.
  • Alcohol - may exacerbate CNS adverse effects and increase risk of overdose.
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Minor Interactions

  • Caffeine - additive stimulant effects.
  • Nicotine - additive stimulant effects.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Stimulants can increase BP and HR; screen for pre-existing cardiovascular conditions.

Timing: Prior to initiation

Weight and Height (especially in pediatric patients)

Rationale: Stimulants can cause appetite suppression and growth suppression.

Timing: Prior to initiation

Psychiatric History (e.g., bipolar disorder, psychosis, tics)

Rationale: Stimulants can exacerbate or unmask psychiatric conditions.

Timing: Prior to initiation

Family History of Sudden Cardiac Death or Arrhythmias

Rationale: To identify individuals at higher risk for cardiovascular events.

Timing: Prior to initiation

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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/sex

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

Weight and Height (pediatric patients)

Frequency: Every 3-6 months

Target: Consistent growth trajectory

Action Threshold: Significant growth deceleration or weight loss warrants nutritional assessment and potential drug holiday or alternative therapy.

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

Frequency: At each visit

Target: Stable mood and behavior

Action Threshold: Emergence of new or worsening psychiatric symptoms warrants immediate evaluation and potential discontinuation.

ADHD/Narcolepsy Symptom Control

Frequency: At each visit

Target: Improved focus, reduced hyperactivity/impulsivity, improved wakefulness

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

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening tics
  • Aggression
  • Hostility
  • Psychotic symptoms (hallucinations, delusions)
  • Manic symptoms (elevated mood, decreased need for sleep, racing thoughts)
  • Severe headache
  • Blurred vision
  • Numbness or weakness in limbs
  • Unexplained weight loss
  • Sleep disturbances

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 the third trimester may experience withdrawal symptoms.

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: Less data available, but continued exposure may contribute to fetal growth restriction.
Third Trimester: Risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, respiratory distress) if used close to delivery.
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Lactation

Dextroamphetamine is excreted into breast milk. The American Academy of Pediatrics considers amphetamines to have 'unknown effect on nursing infant; potential for concern'. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, weight loss, 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. Monitoring the infant for adverse effects is recommended if use is unavoidable.

Infant Risk: L3 (Moderate risk - probably compatible, but monitor infant for adverse effects)
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Pediatric Use

Dextroamphetamine is approved for ADHD and narcolepsy in children 6 years and older. Close monitoring of growth (height and weight) is essential due to potential for growth suppression. Cardiovascular and psychiatric monitoring is also crucial, as children may be more susceptible to these side effects. Not recommended for children under 3 years of age for ADHD or under 6 years for narcolepsy.

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Geriatric Use

Use with caution in elderly patients, generally starting at lower doses and titrating slowly, due to increased sensitivity to stimulant effects and potential for comorbidities (e.g., cardiovascular disease, glaucoma, hyperthyroidism) that may be exacerbated by stimulants. Renal function should be considered, as excretion may be reduced in the elderly.

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 several hours before bedtime to minimize insomnia.
  • Monitor blood pressure and heart rate regularly, especially in patients with pre-existing cardiovascular conditions.
  • Monitor growth parameters (height and weight) in pediatric patients due to the risk of growth suppression.
  • Educate patients and caregivers about the signs of psychiatric adverse events (e.g., psychosis, mania, aggression) and the importance of reporting them immediately.
  • Avoid co-administration with MAOIs due to the risk of hypertensive crisis.
  • Urine pH significantly affects dextroamphetamine excretion; acidic urine increases excretion, while alkaline urine decreases it, potentially leading to higher drug levels.
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Alternative Therapies

  • Methylphenidate (Ritalin, Concerta)
  • Dexmethylphenidate (Focalin)
  • Atomoxetine (Strattera)
  • Guanfacine (Intuniv)
  • Clonidine (Kapvay)
  • Modafinil (Provigil) - for narcolepsy
  • Armodafinil (Nuvigil) - for narcolepsy
  • Sodium oxybate (Xyrem) - for narcolepsy
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Cost & Coverage

Average Cost: $30 - $150 per 30 tablets (30mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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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 consumed, and the time it occurred.