Adzenys XR 6.3mg ODT Tablets

Manufacturer NEOS THERAPEUTICS BRANDS Active Ingredient Amphetamine Orally Disintegrating Tablets(am FET a meen) Pronunciation 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 may be given to you for other reasons. Talk with the doctor.
đŸˇī¸
Drug Class
Central Nervous System (CNS) Stimulant
đŸ§Ŧ
Pharmacologic Class
Sympathomimetic Amine; Dopamine and Norepinephrine Reuptake Inhibitor and Releaser
🤰
Pregnancy Category
Not available
✅
FDA Approved
Jun 2015
âš–ī¸
DEA Schedule
Schedule II

Overview

â„šī¸

What is this medicine?

Adzenys XR ODT is an orally disintegrating tablet containing amphetamine, a stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It helps improve focus, attention, and control over impulsive behavior by affecting certain natural chemicals in the brain. The 'XR' means extended-release, providing effects throughout the day.
📋

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.

Take your medication early in the day to minimize the risk of sleep disturbances.
You can take this medication with or without food.
Do not remove the medication from the blister pack until you are ready to take it. Once the blister pack is opened, take the medication immediately. Do not store the removed medication for later use.
Use dry hands to open the blister pack. Remove the tablet from the pack as directed or according to the package insert. Place the tablet on your tongue and allow it to dissolve. You do not need water, and do not swallow the tablet whole. Also, do not chew, break, or crush the tablet.

Important Interactions and Precautions

Before using over-the-counter (OTC) products that may increase blood pressure, consult with your doctor. These products include cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, and certain natural products or aids.

If you are considering giving this medication to a child, discuss this with your doctor first, as different brands of this medication may be suitable for different age groups.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding bathrooms.
Keep the blister packs in the original plastic case provided with your medication.
Store your medication in a secure location where children cannot see or reach it, and where others cannot access it. A locked box or secure area can help keep your medication safe.
Keep all medications away from pets.

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 continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses.
💡

Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning.
  • Do not crush, chew, or break the tablet. Place it on your tongue and allow it to dissolve completely, then swallow with saliva.
  • Take in the morning to avoid sleep problems (insomnia).
  • Avoid alcohol consumption while taking this medication.
  • Store the medication securely to prevent misuse or diversion.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Report any new or worsening side effects to your doctor immediately.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 6.3 mg (equivalent to 20 mg mixed amphetamine salts XR) orally once daily in the morning
Dose Range: 3.1 - 18.8 mg

Condition-Specific Dosing:

initialDose: 6.3 mg once daily
maximumDose: 18.8 mg once daily
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial 3.1 mg once daily; titrate weekly in increments of 3.1 mg to a maximum of 12.5 mg (equivalent to 40 mg mixed amphetamine salts XR) once daily.
Adolescent: 13-17 years: Initial 6.3 mg once daily; titrate weekly in increments of 3.1 mg to a maximum of 12.5 mg (equivalent to 40 mg mixed amphetamine salts XR) once daily.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: Consider lower doses; monitor for adverse effects.
Severe: Use with caution; consider significant dose reduction or avoidance. Not well studied.
Dialysis: Not well studied; generally not recommended due to high potential for adverse effects and lack of data.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended, but use with caution due to hepatic metabolism.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Amphetamine is a non-catecholamine sympathomimetic amine that causes the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain. It also blocks the reuptake of these monoamines into the presynaptic neuron, thereby increasing their concentrations in the synaptic cleft.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 75%
Tmax: Biphasic: Initial peak at 1.5-2 hours, second peak at 5-6 hours.
FoodEffect: High-fat meal can delay Tmax by approximately 2.5 hours but does not significantly affect AUC.

Distribution:

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

Elimination:

HalfLife: 10-13 hours (adults); 9-11 hours (children). Varies with urine pH (shorter in acidic urine, longer in alkaline urine).
Clearance: Highly dependent on urine pH.
ExcretionRoute: Renal
Unchanged: 30-50% (higher in acidic urine)
âąī¸

Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes (for initial release)
PeakEffect: Biphasic: 1.5-2 hours and 5-6 hours
DurationOfAction: Up to 16 hours

Safety & Warnings

âš ī¸

BLACK BOX WARNING

CNS stimulants, including amphetamine products, have a high potential for abuse and dependence. Administration of CNS stimulants for prolonged periods of time may lead to drug dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.
âš ī¸

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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Shakiness
Changes in vision
Seizures
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color (hands, feet, or other areas) that may turn pale, blue, gray, purple, or red
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
Erectile dysfunction or changes in sex drive
Prolonged or frequent erections
If you have a heart condition or defect, you may be at risk for sudden death. Inform your doctor if you have any heart problems or if a family member has a history of abnormal heart rhythms or sudden death. Seek immediate medical attention if you experience chest pain, irregular heartbeat, shortness of breath, or severe dizziness or fainting.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Dizziness, fatigue, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Sleep disturbances
Headache
Weight loss
Unpleasant taste in the mouth
* Feeling anxious or restless

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Chest pain
  • Shortness of breath
  • Fainting
  • Unexplained weakness or numbness on one side of the body
  • Severe headache
  • Blurred vision
  • New or worsening aggressive behavior
  • Hallucinations (seeing or hearing things that are not real)
  • Paranoia (feeling suspicious or distrustful)
  • New or worsening tics (uncontrolled movements or sounds)
  • Seizures
  • Unexplained fever with muscle rigidity
📋

Before Using This Medicine

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

It is crucial 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.
A family history of or personal experience with:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
Existing health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, such as:
+ Drug abuse
+ Stroke
Current medications, especially:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken within 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 essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure it is safe to take this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.
âš ī¸

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.

Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This is crucial to prevent accidents and ensure your safety.

Long-term or high-dose use of this medication can lead to tolerance, where the drug 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 increase the risk of adverse effects.

Prolonged or regular use of this medication may cause dependence, and stopping it abruptly can lead to withdrawal symptoms. If you need to reduce the dose or stop taking the 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 high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you will need to have regular blood tests to check for any potential effects on your blood work. Inform your doctor about any concerns or unusual results.

Certain laboratory tests may be affected by this medication, so it is essential to inform all your healthcare providers and lab personnel that you are taking it.

You may need to avoid consuming alcohol while taking this medication, depending on the specific product. Consult your doctor or pharmacist to determine if alcohol consumption is safe for you.

This medication may cause changes in behavior and mood, including hallucinations, anger, and altered thinking. 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. If you experience any unusual symptoms, such as hallucinations, changes in behavior, or mood swings, contact your doctor immediately.

This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. Discuss your risk with your doctor to determine if you need to take any precautions.

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, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, or vomiting, or severe headache.

In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary to monitor any potential effects. Discuss this with your doctor to determine the best course of action.

If you are pregnant or plan to become pregnant, inform your doctor to discuss the potential benefits and risks of taking this medication during pregnancy. Taking this medication during pregnancy may lead to withdrawal symptoms in the newborn.
🆘

Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia
  • Rapid breathing
  • Confusion
  • Assaultiveness
  • Hallucinations
  • Panic states
  • Hyperpyrexia (very high fever)
  • Rhabdomyolysis (muscle breakdown)
  • Arrhythmias (irregular heartbeats)
  • Hypertension or hypotension (high or low blood pressure)
  • Circulatory collapse
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma

What to Do:

Call 911 or Poison Control (1-800-222-1222) immediately.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
  • Linezolid
  • Methylene blue (intravenous)
🔴

Major Interactions

  • Tricyclic Antidepressants (TCAs) (may increase cardiovascular effects of amphetamine)
  • Serotonergic drugs (SSRIs, SNRIs, triptans, fentanyl, lithium, tramadol, St. John's Wort) (risk of serotonin syndrome)
  • Antihypertensives (amphetamine may reduce their effect)
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) (increase amphetamine blood levels and prolong half-life)
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) (decrease amphetamine blood levels and shorten half-life)
  • Proton Pump Inhibitors (PPIs) and H2-receptor antagonists (can alter absorption and Tmax of amphetamine)
🟡

Moderate Interactions

  • Antacids (may increase amphetamine absorption)
  • Phenothiazines (may antagonize stimulant effects)
  • Haloperidol (may antagonize stimulant effects)
  • Lithium (may antagonize stimulant effects)
  • Other CNS stimulants (additive effects, increased risk of adverse events)
đŸŸĸ

Minor Interactions

  • Not typically categorized for amphetamine, but general caution with other CNS active drugs.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Cardiovascular assessment (blood pressure, heart rate, ECG if clinically indicated)

Rationale: To identify pre-existing cardiac conditions that may be exacerbated by stimulant use.

Timing: Prior to initiation of therapy.

Psychiatric history (screening for bipolar disorder, psychosis, tics, substance abuse)

Rationale: To identify risk factors for psychiatric adverse events or misuse.

Timing: Prior to initiation of therapy.

Height and weight (especially in pediatric patients)

Rationale: To establish baseline for monitoring growth suppression.

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Blood pressure and heart rate

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

Target: Within normal limits for age and clinical status.

Action Threshold: Sustained elevation, significant changes from baseline, or symptoms of cardiovascular distress.

Weight and height (pediatric patients)

Frequency: Every 3-6 months.

Target: Normal growth trajectory.

Action Threshold: Significant growth suppression or weight loss.

Psychiatric symptoms (mood, anxiety, aggression, psychosis, tics)

Frequency: At each visit.

Target: Stable or improved symptoms; absence of new or worsening psychiatric symptoms.

Action Threshold: Emergence of new psychotic or manic symptoms, severe anxiety, aggression, or tics.

đŸ‘ī¸

Symptom Monitoring

  • Chest pain
  • Palpitations
  • Shortness of breath
  • Syncope
  • Unexplained weakness or numbness
  • Severe headache
  • Blurred vision
  • New or worsening aggressive behavior
  • Hallucinations
  • Paranoia
  • Mania
  • Tics
  • Seizures
  • Insomnia
  • Anorexia
  • Dry mouth

Special Patient Groups

🤰

Pregnancy

Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Amphetamine can cause fetal growth restriction and withdrawal symptoms in neonates.

Trimester-Specific Risks:

First Trimester: Limited data on congenital malformations; some studies suggest a possible increased risk of cardiac malformations.
Second Trimester: Risk of fetal growth restriction and premature birth.
Third Trimester: Risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, irritability, poor feeding, tremor, hypertonia, somnolence) if used near term.
🤱

Lactation

Amphetamine is excreted into breast milk. Breastfeeding is generally not recommended due to potential for serious adverse reactions in the infant.

Infant Risk: L3 (Moderate risk) - potential for irritability, poor feeding, insomnia, weight loss, and cardiovascular effects in the infant.
đŸ‘ļ

Pediatric Use

Approved for children 6 years and older. Monitor growth, cardiovascular effects, and psychiatric symptoms closely. Long-term safety and efficacy in children younger than 6 years have not been established.

👴

Geriatric Use

Not typically used in the geriatric population for ADHD. Use with caution due to increased risk of cardiovascular events and other comorbidities. Start with lower doses and titrate slowly if use is deemed necessary.

Clinical Information

💎

Clinical Pearls

  • Adzenys XR ODT is an extended-release formulation designed to provide effects for up to 16 hours, offering once-daily dosing convenience.
  • The orally disintegrating tablet (ODT) formulation does not require water, making it suitable for patients who have difficulty swallowing pills or for on-the-go administration.
  • Adzenys XR ODT is bioequivalent to mixed amphetamine salts extended-release capsules (e.g., Adderall XR) but has different dosing strengths (e.g., 6.3 mg Adzenys XR ODT is equivalent to 20 mg mixed amphetamine salts XR).
  • Patients should be instructed not to chew, crush, or break the tablet, but to allow it to dissolve completely on the tongue before swallowing.
  • Regular monitoring for signs of abuse, misuse, and diversion is crucial due to the high potential for dependence.
  • Consider drug holidays (brief periods off medication) if growth suppression or other dose-related side effects are concerning, under medical supervision.
  • Acidic foods or drinks (e.g., citrus juices, vitamin C) can decrease amphetamine absorption, while alkaline foods or drinks (e.g., antacids) can increase absorption and prolong its half-life.
  • Patients should be screened for cardiac abnormalities, including a thorough history and physical exam, prior to initiation of stimulant therapy.
🔄

Alternative Therapies

  • Other stimulant medications (e.g., methylphenidate formulations like Concerta, Ritalin, Daytrana; lisdexamfetamine (Vyvanse); dextroamphetamine (Dexedrine))
  • Non-stimulant medications (e.g., atomoxetine (Strattera), guanfacine XR (Intuniv), clonidine XR (Kapvay), viloxazine (Qelbree))
  • Behavioral therapy
  • Psychotherapy
💰

Cost & Coverage

Insurance Coverage: Tier 2 or 3 (preferred or non-preferred brand)
📚

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, a patient fact sheet that provides crucial information. 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. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.