Adderall 10mg Tablets

Manufacturer TEVA Active Ingredient Dextroamphetamine and Amphetamine Tablets(deks troe am FET a meen & am FET a meen) Pronunciation ADD-er-all (deks-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 stimulant medication containing a combination of amphetamine salts. It works by increasing the levels of certain natural substances in the brain, like dopamine and norepinephrine, which helps improve focus, attention, and control over impulsive behavior in people with ADHD. It can also 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, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food. However, be sure to 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. If you have unused or expired medication, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, consult 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's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses, as this can increase the risk of side effects.
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Lifestyle & Tips

  • Take exactly as prescribed; do not take more or less than directed.
  • Do not crush, chew, or break the tablet; swallow whole.
  • Avoid alcohol consumption, as it can increase the risk of side effects.
  • Limit caffeine intake, as it can worsen stimulant side effects.
  • Maintain a healthy diet and regular sleep schedule.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not drive or operate heavy machinery until you know how this medication affects you.

Dosing & Administration

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Adult Dosing

Standard Dose: ADHD: Initial 5 mg once or twice daily. Narcolepsy: Initial 10 mg daily, divided into 2-3 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, typically 20-40 mg/day in divided doses. Max 60 mg/day.
Narcolepsy: Initial 10 mg daily, divided into 2-3 doses; titrate by 10 mg weekly. Max 60 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; titrate by 5 mg weekly to optimal response. Max 40 mg/day.
Adolescent: ADHD (13-17 years): Initial 10 mg once daily; titrate by 10 mg weekly to optimal response. Max 40 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor for adverse effects.
Moderate: Consider 50% dose reduction. Monitor for adverse effects.
Severe: Consider 50-75% dose reduction or avoid use. Monitor closely for adverse effects.
Dialysis: Not well studied. Avoid use or use with extreme caution and significant dose reduction, as amphetamines are not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, but use with caution.
Severe: No specific adjustment recommended, but use with caution due to potential for altered metabolism and increased exposure.

Pharmacology

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Mechanism of Action

Dextroamphetamine and amphetamine are non-catecholamine sympathomimetic amines that exert their therapeutic effects 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. This action is thought to modulate attention, executive function, and impulse control.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 75% for amphetamine, 90% for dextroamphetamine (oral)
Tmax: Amphetamine: 2-4 hours; Dextroamphetamine: 2-4 hours (for immediate-release)
FoodEffect: Food can delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Amphetamine: 3.5-4.5 L/kg; Dextroamphetamine: 3.5-4.5 L/kg
ProteinBinding: Approximately 15-26% (to albumin)
CnssPenetration: Yes

Elimination:

HalfLife: Amphetamine: 9-11 hours; Dextroamphetamine: 10-13 hours (highly dependent on urine pH)
Clearance: Highly dependent on urine pH; increased clearance with acidic urine, decreased with alkaline urine.
ExcretionRoute: Renal (primarily unchanged drug and metabolites)
Unchanged: Approximately 30-50% (dependent on urine pH; higher with 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)

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 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 experience 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
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to pass urine
+ Fever
+ Lower stomach pain or 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 feeling in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or trouble passing urine

Important Heart-Related Warnings

If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform 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 passing out

Other Possible Side Effects

Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any 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 your mouth
Weight loss

Reporting Side Effects

If you have questions or concerns about side effects, 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 (signs of heart problems)
  • Numbness, pain, or discoloration in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Severe headache or blurred vision
  • New or worsening mental problems (e.g., hallucinations, paranoia, aggression, agitation)
  • New or worsening tics (uncontrolled movements or sounds)
  • Unexplained fever, muscle stiffness, or confusion (signs of serotonin syndrome)
  • Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
A family history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ Previous instances of drug abuse or stroke
Kidney disease, as this may affect how your body processes the medication
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Drugs for depression or Parkinson's disease (such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) taken within the last 14 days, as this may increase the risk of very high blood pressure
+ Linezolid or methylene blue
If you are breast-feeding, as this medication is not recommended during breast-feeding

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure that it is safe for you to take this medication with your other treatments. Never start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

Important Warnings and Cautions

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

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

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and 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, regular use of this medication may cause dependence, and sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.

Heart-Related Precautions
You may need to undergo heart tests before starting this medication. If you have questions or concerns, discuss them with your doctor. This medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor.

Lab Tests and Monitoring
Regular blood work is necessary while taking this medication. Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.

Interactions with Other Medications
Do not take antacids with this medication, as it may interact with the medication's effectiveness.

Mental Health Precautions
New or worsening behavior and mood changes, such as altered thinking, anger, and 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. Immediately contact your doctor if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.

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.

Serotonin Syndrome
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. Seek immediate medical attention if you experience agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.

Growth Effects in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Different brands of this medication may be approved for use in different age groups. Consult your doctor before giving this medication to a child.

Alcohol Consumption
Discuss alcohol consumption with your doctor before drinking while taking this medication.

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
  • Aggression
  • Hallucinations
  • Panic states
  • Hyperpyrexia (very high fever)
  • Rhabdomyolysis (muscle breakdown)
  • Arrhythmias (irregular heartbeat)
  • Hypertension (high blood pressure) or hypotension (low blood pressure)
  • Circulatory collapse
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Management typically involves supportive care, including gastric lavage, activated charcoal, sedation for agitation/seizures, and management of hyperthermia and cardiovascular instability.

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.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome (relative contraindication, requires careful monitoring).
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Major Interactions

  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine reabsorption and prolong half-life, leading to increased effects and toxicity.
  • Antacids (e.g., aluminum hydroxide, magnesium hydroxide) - increase amphetamine absorption, leading to increased effects.
  • Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of amphetamines.
  • Antihypertensives - amphetamines may antagonize the hypotensive effects of guanethidine and other antihypertensive agents.
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Moderate Interactions

  • Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase amphetamine absorption.
  • CYP2D6 inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure and risk of adverse effects.
  • Serotonergic drugs (e.g., SSRIs, SNRIs) - increased risk of serotonin syndrome, requires careful monitoring.
  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.
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Minor Interactions

  • Not typically categorized as minor for this drug due to its narrow therapeutic index and potential for serious interactions.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To identify pre-existing cardiovascular conditions and establish baseline for monitoring stimulant-induced changes.

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

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

Timing: Prior to initiation of therapy (if indicated).

Height and Weight (Pediatric patients)

Rationale: To establish baseline for monitoring potential growth suppression.

Timing: Prior to initiation of therapy.

Psychiatric History and Mental Status Exam

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

Timing: Prior to initiation of therapy.

Drug Abuse History

Rationale: To assess risk of misuse, abuse, or diversion.

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/sex; monitor for significant increases.

Action Threshold: Sustained elevation (e.g., >10-20 mmHg increase in SBP/DBP or HR >100 bpm) warrants further evaluation and potential dose adjustment/discontinuation.

Height and Weight (Pediatric patients)

Frequency: Every 3-6 months

Target: Maintain expected growth trajectory.

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

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

Frequency: At each visit

Target: Stable mood, absence of new or worsening psychotic symptoms, tics, or severe anxiety.

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

Efficacy (ADHD/Narcolepsy symptoms)

Frequency: At each visit

Target: Improvement in core symptoms (e.g., attention, hyperactivity, impulsivity, wakefulness) with minimal side effects.

Action Threshold: Lack of efficacy or intolerable side effects warrants dose adjustment or consideration of alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Palpitations
  • Syncope
  • Unexplained wounds on fingers/toes (peripheral vasculopathy)
  • Numbness or tingling in extremities
  • Severe headache
  • Blurred vision
  • Agitation
  • Aggression
  • Hallucinations
  • Paranoia
  • New or worsening tics
  • Changes in mood or behavior
  • Excessive weight loss or poor appetite
  • Sleep disturbances

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Amphetamines cross the placenta. Neonates exposed to amphetamines in utero may be at increased risk of premature birth, low birth weight, and withdrawal symptoms (e.g., agitation, irritability, poor feeding, tremor) after birth.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations, though data are limited and inconsistent.
Second Trimester: Risk of fetal growth restriction and premature birth.
Third Trimester: Risk of neonatal withdrawal symptoms and persistent pulmonary hypertension of the newborn.
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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, potential long-term neurodevelopmental effects), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: L3 (Moderately safe, but caution advised). Potential for irritability, poor feeding, sleep disturbances, and possible long-term effects on infant development. Monitor infant closely for adverse effects.
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Pediatric Use

Safety and efficacy have been established in children 6 years and older for ADHD. Not recommended for children under 3 years for narcolepsy. Monitor growth (height and weight) carefully due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics) and cardiovascular effects.

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Geriatric Use

Use with caution in elderly patients due to increased sensitivity to sympathomimetic amines, particularly regarding cardiovascular adverse effects (e.g., hypertension, tachycardia, arrhythmias). Start with lower doses and titrate slowly. Monitor renal function closely.

Clinical Information

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Clinical Pearls

  • Prior to initiating Adderall, conduct a thorough cardiovascular assessment, including family history, and consider an ECG if there are concerns.
  • Educate patients and caregivers about the high abuse potential and the importance of storing the medication securely to prevent diversion.
  • Monitor growth parameters (height and weight) in pediatric patients regularly, as growth suppression can occur. Consider drug holidays if growth is significantly impacted.
  • Assess for new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression, tics) during treatment, especially in patients with a history of psychiatric disorders.
  • Advise patients to avoid abrupt discontinuation, as this can lead to withdrawal symptoms (e.g., fatigue, depression, sleep disturbances).
  • Inform patients about the potential for peripheral vasculopathy, including Raynaud's phenomenon, and to report any unexplained wounds or changes in finger/toe color.
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta, Focalin)
  • Atomoxetine (Strattera)
  • Guanfacine extended-release (Intuniv)
  • Clonidine extended-release (Kapvay)
  • Bupropion (Wellbutrin) - off-label for ADHD
  • Non-pharmacological therapies (e.g., Cognitive Behavioral Therapy, behavioral therapy, lifestyle modifications)
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Cost & Coverage

Average Cost: $30 - $150 per 30 tablets (10mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand/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. It is crucial to read this guide carefully and review it again whenever 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, seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.