Adzenys XR ODT

Name: Adzenys XR ODT

Uses of Adzenys XR-ODT

Adzenys XR-ODT is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged 6 years and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Side Effects of Adzenys XR-ODT

Serious side effects have been reported with Adzenys XR-ODT. See the “Adzenys XR-ODT Precautions” section.

Common side effects of Adzenys XR-ODT include the following:

  • headache
  • abdominal pain
  • loss of appetite
  • fever
  • insomnia
  • dry mouth
  • anxiety
  • weight loss

This is not a complete list of Adzenys XR-ODT side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

 

Adzenys XR-ODT and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

The active ingredient in Adzenys XR-ODT has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Adzenys XR-ODT, women should not breastfeed during treatment with Adzenys XR-ODT. A choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Adzenys XR-ODT Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your age

The recommended dose range of Adzenys XR-ODT for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged 6 years and older is 6.3 mg - 18.8 mg taken by mouth, once daily in the morning.

Uses For Adzenys XR ODT

Amphetamine is used to treat narcolepsy (sleep disorder). It is also used to treat attention-deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Amphetamine is also used for weight reduction in obese patients.

Amphetamine works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with a doctor's prescription.

Adzenys XR ODT Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
  • Seeing, hearing, or feeling things that are not there
  • severe mental changes
Incidence not known
  • Agitation
  • blurred vision
  • confusion
  • diarrhea
  • dizziness
  • false or unusual sense of well-being
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever
  • headache
  • nervousness
  • overactive reflexes
  • pounding in the ears
  • restlessness
  • shakiness in the legs, arms, hands, or feet
  • shivering
  • slow or fast heartbeat
  • sweating
  • talking or acting with excitement you cannot control
  • trouble sleeping
  • twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  • uncontrolled vocal outbursts or tics (uncontrolled repeated body movements)

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Abdominal or stomach cramps
  • dark-colored urine
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea
  • seizures
  • sweating
  • unusual tiredness or weakness
  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Decreased interest in sexual intercourse
  • difficulty having a bowel movement (stool)
  • dry mouth
  • hives or welts, itching, or skin rash
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • loss of appetite
  • redness of the skin
  • unpleasant taste
  • weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What should I discuss with my healthcare provider before taking Adzenys XR-ODT (amphetamine)?

You should not use amphetamine if you are allergic to any stimulant medicine, or if you have:

  • moderate to severe high blood pressure;

  • overactive thyroid;

  • severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or

  • a history of drug or alcohol addiction.

Do not use amphetamine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Some medicines can interact with amphetamine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

  • heart problems or a congenital heart defect;

  • high blood pressure; or

  • a family history of heart disease or sudden death.

To make sure amphetamine is safe for you, tell your doctor if you or anyone in your family has ever had:

  • depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

  • problems with drug or alcohol abuse;

  • motor tics (muscle twitches) or Tourette's syndrome;

  • kidney disease;

  • a thyroid disorder;

  • seizures or epilepsy;

  • an abnormal brain wave test (EEG);

  • coronary artery disease (clogged arteries); or

  • blood circulation problems in the hands or feet.

It is not known whether this medicine will harm an unborn baby. However, taking the medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Amphetamine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Amphetamine is not approved for use by anyone younger than 6 years old.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Warnings and precautions

Potential for Abuse and Dependence

CNS stimulants, including Adzenys XR-ODT, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Boxed Warning, Drug Abuse and Dependence (9.2, 9.3)].

Serious Cardiovascular Reactions

Sudden death, stroke, and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Adzenys XR-ODT treatment.

Blood Pressure and Heart Rate Increases

CNS stimulants cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for potential tachycardia and hypertension.

Psychiatric Adverse Reactions

Exacerbation Pre-Existing Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Illness

CNS stimulants may induce a mixed or manic episode in patients with bipolar disorder. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or has a history of depressive symptoms or a family history of suicide, bipolar disorder, and depression).

New Psychotic or Manic Symptoms

CNS stimulants, at recommended doses, may cause psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in patients without prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Adzenys XR-ODT. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in 0.1% of CNS stimulant-treated patients compared to 0% in placebo-treated patients.

Long-Term Suppression of Growth

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including Adzenys XR-ODT.

Peripheral Vasculopathy, including Raynaud's Phenomenon

Stimulants, including Adzenys XR-ODT, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Serotonin Syndrome

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 [see Drug Interactions (7.1)]. The co-administration with cytochrome P450 2D6 (CYP2D6) inhibitors may also increase the risk with increased exposure to Adzenys XR-ODT. In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see Drug Interactions (7.1)].

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Concomitant use of Adzenys XR-ODT with MAOI drugs is contraindicated [see Contraindications (4)].

Discontinue treatment with Adzenys XR-ODT and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of Adzenys XR-ODT with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Adzenys XR-ODT with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.

Potential for Overdose Due to Medication Errors

Medication errors, including substitution and dispensing errors, between Adzenys XR-ODT and other amphetamine products could occur, leading to possible overdosage. To avoid substitution errors and overdosage, do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles [see Dosage and Administration (2.5)].

Drug interactions

Drugs Having Clinically Important Interactions with Amphetamines

Table 5: Drugs having clinically important interactions with amphetamines.
MAO Inhibitors (MAOI)
Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.
Intervention Do not administer Adzenys XR-ODT during or within 14 days following the administration of MAOI [see Contraindications (4)].
Examples selegiline, isocarboxazid, phenelzine, tranylcypromine
Serotonergic Drugs
Clinical Impact The concomitant use of Adzenys XR-ODT and serotonergic drugs increases the risk of serotonin syndrome.
Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during Adzenys XR-ODT initiation or dosage increase. If serotonin syndrome occurs, discontinue Adzenys XR-ODT and the concomitant serotonergic drug(s) [see Warnings and Precautions (5.7)].
Examples selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort
Alkalinizing Agents
Clinical Impact Increase blood levels and potentiate the action of amphetamine.
Intervention Co-administration of Adzenys XR-ODT and gastrointestinal alkalinizing agents should be avoided.
Examples Gastrointestinal alkalinizing agents (e.g., sodium bicarbonate).
Urinary alkalinizing agents (e.g., acetazolamide, some thiazides).
Acidifying Agents
Clinical Impact Lower blood levels and efficacy of amphetamines.
Intervention Increase dose based on clinical response.
Examples Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid).
Tricyclic Antidepressants
Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.
Intervention Monitor frequently and adjust or use alternative therapy based on clinical response.
Examples desipramine, protriptyline

Drug/Laboratory Test Interactions

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

Use in specific populations

Pregnancy

Teratogenic Effects

Pregnancy Category C.

Amphetamine, in the enantiomer ratio present in Adzenys XR-ODT (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 2 and 12 times, respectively, the maximum recommended human dose (MRHD) for adolescents of 12.5 mg/day (as base), on a mg/m2 body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 10 times the MRHD for adolescents on a mg/m2 basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity.

A study was conducted in which pregnant rats received daily oral doses of amphetamine (d- to l- enantiomer ratio of 3:1, the same as in Adzenys XR-ODT) of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. These doses are approximately 0.8, 2, and 4 times the MRHD for adolescents of 12.5 mg/day (as base), on a mg/m2 basis. All doses caused hyperactivity and decreased weight gain in the dams. A decrease in pup survival was seen at all doses. A decrease in pup bodyweight was seen at 6 and 10 mg/kg which correlated with delays in developmental landmarks. Increased pup locomotor activity was seen at 10 mg/kg on day 22 postpartum but not at 5 weeks post-weaning. When pups were tested for reproductive performance at maturation, gestational weight gain, number of implantations, and number of delivered pups were decreased in the group whose mothers had been given 10 mg/kg.

A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d, l-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.

There are no adequate and well-controlled studies in pregnant women. There are limited published data on the use of amphetamine in pregnant women. These data are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Amphetamines, such as Adzenys XR-ODT, may cause vasoconstriction, including vasoconstriction of placental blood vessels, and may increase the risk for intrauterine growth restriction. In addition, amphetamines can stimulate uterine contractions increasing the risk of premature delivery. Premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. Monitor infants born to mothers taking amphetamines for symptoms of withdrawal, such as feeding difficulties, irritability, agitation, and excessive drowsiness.

Labor and Delivery

The effect of Adzenys XR-ODT on labor and delivery in humans is unknown.

Nursing Mothers

Based on limited case reports in published literature, amphetamine (d- or d, l-) is present in human milk at relative infant doses of 2% to 13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9 and 7.5. There are no reports of adverse effects on the breastfed infant and no effects on milk production. However, long-term neurodevelopmental effects on infants from stimulant exposure are unknown. Because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with Adzenys XR-ODT.

Pediatric Use

Safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years of age in three adequate and well-controlled clinical trials of up to 4 weeks in duration [see Adverse Reactions (6.1), Clinical Pharmacology (12), Clinical Studies (14)]. Safety and efficacy in pediatric patients younger than 6 years of age with ADHD have not been established.

Long-Term Growth Suppression

Growth should be monitored during treatment with stimulants, including Adzenys XR-ODT, in pediatric patients aged 6 to 17 years who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.5)].

Juvenile Animal Data

In a juvenile developmental study, rats received daily oral doses of amphetamine (d to l enantiomer ratio of 3:1, the same as in Adzenys XR-ODT) of 2, 6, or 20 mg/kg on days 7 to 13 of age; from day 14 to approximately day 60 of age these doses were given twice daily for total daily doses of 4, 12, or 40 mg/kg. The latter doses are approximately 0.6, 2, and 6 times the maximum recommended human dose for children of 18.8 mg/day (as base), on a mg/m2 basis. Post dosing hyperactivity was seen at all doses; motor activity measured prior to the daily dose was decreased during the dosing period but the decreased motor activity was largely absent after an 18 day drug-free recovery period. Performance in the Morris water maze test for learning and memory was impaired at the 40 mg/kg dose, and sporadically at the lower doses, when measured prior to the daily dose during the treatment period; no recovery was seen after a 19 day drug-free period. A delay in the developmental milestones of vaginal opening and preputial separation was seen at 40 mg/kg but there was no effect on fertility.

Geriatric Use

Adzenys XR-ODT has not been studied in the geriatric population.

Overdosage

Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice for treatment of overdosage. Individual patient response to amphetamines varies widely. Toxic symptoms may occur idiosyncratically at low doses.

Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Other reactions include arrhythmias, hypertension or hypotension, circulatory collapse, nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

How supplied/storage and handling

How Supplied

Adzenys XR-ODT 3.1 mg Extended Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A1 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-005-30

Adzenys XR-ODT 6.3 mg Extended Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A2 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-010-30

Adzenys XR-ODT 9.4 mg Extended Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A3 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-015-30

Adzenys XR-ODT 12.5 mg Extended Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A4 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-020-30

Adzenys XR-ODT 15.7 mg Extended Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A5 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-025-30

Adzenys XR-ODT 18.8 mg Extended Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A6 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-030-30

Storage

Store at 20°C to 25º C (68°F to 77º F). Excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature]

Store Adzenys XR-ODT blister packages in the rigid, plastic travel case provided after removal from the carton. To obtain additional travel cases, patients and health care professionals can call Neos Therapeutics, Inc., at 1-888-236-6816.

Disposal

Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Adzenys XR-ODT at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Adzenys XR-ODT with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Adzenys XR-ODT in the household trash.

Administrative Information

LactMed Record Number

433

Last Revision Date

20170808

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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