Adzenys XR ODT

Name: Adzenys XR ODT

Adzenys XR-ODT Interactions

Avoid drinking alcohol while you are taking this medicine.

Avoid drinking fruit juices or taking vitamin C at the same time you take amphetamine. These can make your body absorb less of the medicine.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Many drugs can interact with amphetamine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • omeprazole;
  • lithium, or other medicine to treat mental illness;
  • reserpine, or other blood pressure medication;
  • an antidepressant;
  • an antacid or other stomach acid medicine (including Alka-Seltzer or baking soda);
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • a cold or allergy medicine that contains a decongestant such as pseudoephedrine or phenylephrine;
  • a diuretic or "water pill";
  • narcotic pain medicine; or
  • seizure medicine.

This list is not complete. Other drugs may interact with amphetamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What is Adzenys XR-ODT (amphetamine)?

Amphetamine is a central nervous system stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Amphetamine is used to treat attention deficit hyperactivity disorder (ADHD).

The Evekeo brand of amphetamine is used to treat ADHD and also narcolepsy. Evekeo is sometimes used to treat obesity in people who have not lost weight with diets or other treatments.

Amphetamine may also be used for purposes not listed in this medication guide.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amphetamine could be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, hostility, violence, panic, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Overdose may also cause seizure or coma.

What should I avoid while taking Adzenys XR-ODT (amphetamine)?

Avoid drinking alcohol while you are taking this medicine.

Avoid drinking fruit juices or taking vitamin C at the same time you take amphetamine. These can make your body absorb less of the medicine.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What do I need to tell my doctor BEFORE I take Adzenys XR-ODT?

  • If you have an allergy to Adzenys XR-ODT or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you or a family member have any of these health problems: Blood vessel disease, high blood pressure, heart structure problems or other heart problems, or Tourette's syndrome or tics.
  • If you have any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
  • If you have ever had any of these health problems: Drug abuse or stroke.
  • If you are taking acetazolamide.
  • If you are taking sodium bicarbonate.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking Adzenys XR-ODT within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with Adzenys XR-ODT.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Shakiness.
  • Change in eyesight.
  • Seizures.
  • Trouble controlling body movements.
  • Change in color of hands or feet from pale to blue or red.
  • Numbness, pain, tingling, or cold feeling of the hands or feet.
  • Any sores or wounds on the fingers or toes.
  • Dark urine.
  • Not able to pass urine or change in how much urine is passed.
  • Muscle pain or weakness.
  • Change in sex ability.
  • Lowered interest in sex.
  • For males, erections (hard penis) that happen often or that last a long time.
  • Heart attacks, strokes, and sudden deaths have happened in adults taking Adzenys XR-ODT (amphetamine extended-release orally disintegrating tablets). Sudden deaths have also happened in children with very bad heart problems or heart defects. Call your doctor right away if you have a change in strength on 1 side that is greater than the other, trouble speaking or thinking, change in balance, drooping on 1 side of the face, change in eyesight, chest pain or pressure, shortness of breath, or very bad dizziness or passing out.

Dosage forms and strengths

Adzenys XR-ODT 3.1 mg Amphetamine Extended Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A1 on one side)

Adzenys XR-ODT 6.3 mg Amphetamine Extended Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A2 on one side)

Adzenys XR-ODT 9.4 mg Amphetamine Extended Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A3 on one side)

Adzenys XR-ODT 12.5 mg Amphetamine Extended Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A4 on one side)

Adzenys XR-ODT 15.7 mg Amphetamine Extended Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A5 on one side)

Adzenys XR-ODT 18.8 mg Amphetamine Extended Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A6 on one side)

Contraindications

Adzenys XR-ODT is contraindicated:

  • In patients known to be hypersensitive to amphetamine, or other components of Adzenys XR-ODT. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions (6.2)].
  • Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such a linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.7), Drug Interactions 7.1]

Drug abuse and dependence

Controlled Substance

Adzenys XR-ODT contains amphetamine, which is a Schedule II controlled substance in the U.S. Controlled Substance Act (CSA).

Abuse

Adzenys XR-ODT, is a CNS stimulant that contains amphetamine which has a high potential for abuse. Abuse is characterized by impaired control of drug use, compulsive use despite harm, and craving.

Signs and symptoms of amphetamine abuse may include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. Abusers of amphetamines may use other unapproved routes of administration which can result in overdose and death [see Overdosage (10)].

To reduce the abuse of Adzenys XR-ODT, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and proper storage and disposal of CNS stimulants, monitor for signs of abuse while on therapy, and re-evaluate the need for Adzenys XR-ODT use.

Dependence

Tolerance

Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug's desired and/or undesired effects over time) may occur during the chronic therapy of CNS stimulants including Adzenys XR-ODT.

Dependence

Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants including Adzenys XR-ODT. Withdrawal symptoms after abrupt cessation following prolonged high dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

PRINCIPAL DISPLAY PANEL - 3.1 mg Tablet Blister Pack Carton

NDC 70165-005-30

Contains:
30 Tablets (5 x 6-count blister cards)
Travel Case

Rx Only

Adzenys XR-ODT™CII
Amphetamine Extended-Release
Orally Disintegrating Tablets

Do not crush or chew tablets

Each tablet contains 3.1 mg of amphetamine
(equivalent to that in a 5 mg strength mixed salts
of a single-entity amphetamine product)

3.1 mg

NEOS™
Therapeutics

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Warnings

Black Box Warnings

Amphetamines have a high potential for abuse

Administration for prolonged periods of time may lead to drug dependence and must be avoided

Pay attention to the possibility of subjects obtaining amphetamines for nontherapeutic use or distribution to others

Prescribe/dispense sparingly according to law

Misuse may cause sudden death and serious cardiovascular adverse events

Contraindications

Advanced arteriosclerosis, symptomatic cardiovascular disease, or moderate-to-severe hypertension

Hyperthyroidism

Known hypersensitivity or idiosyncrasy to the sympathomimetic amines

Agitated states

Patients with a history of drug abuse

During or within 14 days following the administration of MAOIs (hypertensive crises may result)

Cautions

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems

Causes a modest increase in average blood pressure (~2-4 mmHg) and average heart rate (~3-6 bpm); caution with hypertension and other cardiovascular conditions

Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease

May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder

Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients

Treatment emergent psychotic or manic symptoms (eg, hallucinations, delusional thinking, mania) in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses

Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD; although there is no systematic evidence that stimulants cause aggressive behavior or hostility, monitor for the appearance of or worsening of aggressive behavior or hostility

Childhood growth should be monitored during treatment; patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted

May lower seizure threshold in patients with prior history of seizures

Stimulants are associated with peripheral vasculopathy, including Raynaud’s phenomenon

Visual disturbances reported (eg, difficulties with accommodation, blurred vision)

Drug interaction overview

  • Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort
  • Amphetamines are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism; potential for a pharmacokinetic interaction exists with coadministration of CYP2D6 inhibitors which may increase risk with increased exposure to amphetamines; in these situations, consider alternative non-serotonergic drug or alternative drug that does not inhibit CYP2D6
  • If concomitant use with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate therapy with lower doses, monitor patients for emergence of serotonin syndrome during drug initiation or titration, and inform patients of increased risk for serotonin syndrome

For Healthcare Professionals

Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet disintegrating extended release

Cardiovascular

Frequency not reported: Palpitations, tachycardia, elevated blood pressure, cardiomyopathy
Postmarketing reports: Peripheral vasculopathy[Ref]

Psychiatric

Rare (less than 0.1%): Psychotic episodes
Frequency not reported: Euphoria, dysphoria, insomnia, restlessness[Ref]

Nervous system

Frequency not reported: Overstimulation, dizziness, dyskinesia, tremor, headache, exacerbation of motor/phonic tics and Tourette's syndrome[Ref]

Musculoskeletal

Postmarketing reports: Rhabdomyolysis[Ref]

Gastrointestinal

Common (1% to 10%): Upper abdominal pain
Frequency not reported: Dry mouth, unpleasant taste, diarrhea, constipation, other GI disturbances[Ref]

Endocrine

Frequency not reported: Impotence, libido changes, frequent or prolonged erections[Ref]

Immunologic

Frequency not reported: Urticaria[Ref]

Metabolic

Frequency not reported: Anorexia, weight loss[Ref]

Respiratory

Common (1% to 10%): Epistaxis, allergic rhinitis[Ref]

Some side effects of Adzenys XR-ODT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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