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Below you will find tools to help you calculate dosing for your patients, as well as reconstitution and dispensing information that pharmacists may find useful. There are also several resources and links for you to share with patients, parents, and caregivers to help them access information about ADHD, ADHD support programs, and Tris Pharma products.

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Dosing Calculators

DYANAVEL XR Liquid amphetamine extended-release oral suspension 2.5 mg/mL Logo/mL Logo
Dosing for DYANAVEL XR
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Quillivant XR methylphenidate HCl for extended-release oral suspension 25mg/5mL Logo
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QuilliChew ER methylphenidate HCl for extended-release chewable tablets 20mg, 30mg, 40mg Logo
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ONYDA XR Logo
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Information for Pharmacists

Dispensing

DYANAVEL XR (amphetamine) tablet is available in a 5-mg scored tablet and 10-, 15-, and 20-mg unscored tablets that can be taken with or without food. For full pharmacist instructions for dispensing and storage, see Full Prescribing Information for DYANAVEL XR.

Dosing for DYANAVEL XR
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DYANAVEL XR Tablet amphetamine extended-release tablets 5mg, 10mg, 15mg, 20mg Logo

Dispensing

DYANAVEL XR (amphetamine) oral suspension is supplied as a light beige to tan viscous oral suspension. DYANAVEL XR oral suspension is already flavored; DO NOT add any flavoring. For full pharmacist instructions for reconstitution, preparation, dispensing, and storage, see Full Prescribing Information for DYANAVEL XR.

Dosing for DYANAVEL XR
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DYANAVEL XR Liquid amphetamine extended-release oral suspension 2.5 mg/mL Logo/mL Logo

Reconstituting and dispensing

Quillivant XR (methylphenidate HCl) is supplied as a powder for oral suspension and MUST be reconstituted with water prior to dispensing. Quillivant XR is already flavored; DO NOT add any flavoring. For full pharmacist instructions for reconstitution, preparation, dispensing, and storage, see Full Prescribing Information for Quillivant XR.

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Quillivant XR methylphenidate HCl for extended-release oral suspension 25mg/5mL Logo

Dispensing

QuilliChew ER (methylphenidate HCl) is available in 20-mg scored, 30-mg scored, and 40-mg unscored tablets that can be taken with or without food. For full pharmacist instructions for dispensing and storage, see Full Prescribing Information for QuilliChew ER.

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QuilliChew ER methylphenidate HCl for extended-release chewable tablets 20mg, 30mg, 40mg Logo

Dispensing

ONYDA XR (clonidine HCI) is supplied in a 120 mL bottle with a child resistant closure in volumes of 30 mL or 60 mL. The 30 mL carton contains one press-in bottle adapter and one oral dosing dispenser. The 60 mL volume contains two press-in bottle adapters and two oral dosing dispensers. For full pharmacist instructions for dispensing see Full Prescribing Information for ONYDA XR.

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QuilliChew ER methylphenidate HCl for extended-release chewable tablets 20mg, 30mg, 40mg Logo

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ADHD Resources to Download

Pediatric patients and caregivers

Tris ADHD Medication Progress Guide
Progress Guide

Download this practical guide to help your patients taking a Tris ADHD medication track their symptoms and improvements.

Tris ADHD Teacher Discussion Guide
Teacher Discussion Guide

Download this useful guide to help parents and caregivers of elementary school–aged children with ADHD discuss with teachers:

  • Classroom management techniques for students with ADHD
  • How to motivate students with ADHD to learn
  • School accommodations for ADHD
Tris ADHD Caregivers Guide
Caregivers Guide

Download this educational guide to provide parents and caregivers with information about how to best address their child’s individual needs, including parenting techniques for ADHD and answers to questions they may have about ADHD, such as:

  • What does ADHD stand for?
  • What causes ADHD?
  • Can ADHD go away?
Tris ADHD DXRT Patient Brochure
DYANAVEL XR Tablet Patient Brochure

Download this guide for your patients so that they can learn more about ADHD, DYANAVEL XR tablet, support, and resources.

Tris ADHD Quillivant/QuilliChew Patient Brochure
Quillivant/QuilliChew Patient Brochure

Download this guide for your patients so that they can learn more about ADHD, Quillivant XR, QuilliChew ER, support, and resources.

Tris ADHD DXR OS Patient Brochure
DYANAVEL XR Oral Suspension Patient Brochure

Download this guide for your patients so that they can learn more about ADHD, DYANAVEL XR oral suspension, support, and resources.

Tris ADHD ONYDA XR Patient Brochure
ONYDA XR Patient Brochure

Download this guide for your patients so that they can learn more about ADHD, ONYDA XR, support, and resources

ADHD Community Resources

AAP/Healthy Children

Healthy Children is the official American Academy of Pediatrics (AAP) website for parents, hosting a variety of articles that address common questions and issues in diagnosing and treating ADHD in children. Search for ADHD at healthychildren.org for information about topics like:

  • ADHD Myths and Misconceptions
  • ADHD Medications Daily Routines
  • Causes of ADHD: What We Know Today

ADDA

The Attention Deficit Disorder Association (ADDA) is the world’s leading adult ADHD association, dedicated to helping adults with ADHD lead better lives. Visit add.org to learn more about:

  • Adult ADHD Self-Screening Questionnaire
  • Virtual Peer Support Groups
  • Educational Resources

ADDitude Magazine

Online magazine for caregivers of children with attention deficit disorders. Visit additudemag.com to learn more.

CHADD

Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD) is a nationally recognized nonprofit organization providing education, advocacy, and support for individuals with ADHD. Visit chadd.org

CDC

The Centers for Disease Control and Prevention (CDC) has published facts, research, statistics, and a wide array of other tools for parents to educate themselves about ADHD. Visit cdc.gov/ncbddd/adhd to learn more.

NIMH

The National Institute of Mental Health (NIMH), a component of the US Department of Health and Human Services, provides in-depth information and resources on ADHD diagnosis and treatment at nimh.nih.gov.

Pharmacy Locator

To find a nearby pharmacy with Tris ADHD products in stock, search pharmacies by ZIP code below.

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Sign up to receive additional information and product updates, or to request a representative.

ADHD, Attention Deficit Hyperactivity Disorder; CNS, central nervous system.

References: 1. ONYDA XR [package insert]. Tris Pharma, Inc., Monmouth Junction, NJ

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IMPORTANT SAFETY INFORMATION

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WARNING: ABUSE, MISUSE, AND ADDICTION

DYANAVEL XR, Quillivant XR and QuilliChew ER have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, Quillivant XR, QuilliChew ER, can result in overdose and death. Before prescribing DYANAVEL XR, Quillivant XR, QuilliChew ER, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

IMPORTANT SAFETY INFORMATION

INDICATION

DYANAVEL® XR (amphetamine), Quillivant XR® (methylphenidate HCl), and QuilliChew ER® (methylphenidate HCl) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

WARNING: ABUSE, MISUSE, AND ADDICTION

DYANAVEL XR, Quillivant XR and QuilliChew ER have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, Quillivant XR, QuilliChew ER, can result in overdose and death. Before prescribing DYANAVEL XR, Quillivant XR, QuilliChew ER, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

  • DYANAVEL XR, Quillivant XR, and QuilliChew ER are contraindicated:
    • in patients known to be hypersensitive to amphetamine, methylphenidate, or other components of DYANAVEL XR, Quillivant XR, and QuilliChew ER. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported.
    • in patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of risk of hypertensive crisis.
  • Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD doses. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with DYANAVEL XR, Quillivant XR, and QuilliChew ER, assess for the presence of cardiac disease. Avoid DYANAVEL XR, Quillivant XR, and QuilliChew ER use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during DYANAVEL XR, Quillivant XR, and QuilliChew ER treatment.
  • CNS stimulants cause increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for tachycardia and hypertension.
  • Use of CNS stimulants may cause exacerbation of pre-existing psychosis and may induce a manic or mixed episode in patients with bipolar disorder. In patients without prior history of psychotic illness or mania, CNS stimulants may cause new psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) at the recommended dosage. Prior to initiating DYANAVEL XR, Quillivant XR, and QuilliChew ER treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing DYANAVEL XR, Quillivant XR, and QuilliChew ER.
  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD; monitor weight and height during treatment with DYANAVEL XR, Quillivant XR, and QuilliChew ER. Treatment may need to be interrupted in children not growing or gaining weight as expected.
  • CNS stimulants including DYANAVEL XR, Quillivant XR, and QuilliChew ER are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for DYANAVEL XR, Quillivant XR, and QuilliChew ER-treated patients who develop signs or symptoms of peripheral vasculopathy.
  • CNS stimulants, including amphetamine and methylphenidate products have been associated with the onset or exacerbation of motor and verbal tics and worsening of Tourette’s syndrome. Before initiating DYANAVEL XR, Quillivant XR, and QuilliChew ER, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate.
  • Cases of priapism have been reported with methylphenidate use and during a period of withdrawal in both adult and pediatric male patients. Immediate medical attention should be sought in QuilliChew ER and Quillivant XR treated patients who develop abnormally sustained or frequent and painful erections.
  • Serotonin syndrome risk is increased when DYANAVEL XR is co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue DYANAVEL XR and any concomitant serotonergic agents immediately, and initiate supportive treatment.
  • QuilliChew ER contains phenylalanine, a component of aspartame, and can be harmful to patients with phenylketonuria (PKU). Before prescribing QuilliChew ER in patients with PKU, consider the combined daily amount of phenylalanine from all sources, including QuilliChew ER.
  • Quillivant XR and QuilliChew ER treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
  • Quillivant XR and QuilliChew ER should be prescribed to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Close monitoring of patients with a history of increased IOP or open angle glaucoma is necessary.
  • Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia.
  • Based on limited experience with DYANAVEL XR in controlled trials, the adverse reaction profile of DYANAVEL XR appears similar to other amphetamine extended-release products. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6 to 12 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).
  • Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are: appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, blood pressure increased.
  • There is limited experience with Quillivant XR and QuilliChew ER in controlled trials.
    • Quillivant XR: The most common (≥2% in the Quillivant XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6 to 12 years) in Quillivant XR compared to placebo were affect lability (9% Quillivant XR, 2% placebo), excoriation (4%, 0%), initial insomnia (2%, 0%), tic (2%, 0%), decreased appetite (2%, 0%), vomiting (2%, 0%), motion sickness (2%, 0%), eye pain (2%, 0%), and rash (2%, 0%).
    • QuilliChew ER: The most common (≥2% in the QuilliChew ER group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 90 pediatric subjects (ages 6 to 12 years) in QuilliChew ER compared to placebo were decreased appetite (2.4% QuilliChew ER, 0% placebo), aggression (2.4%, 0%), emotional poverty (2.4%, 0%), nausea (2.4%, 0%), headache (2.4%, 0%), and weight decreased (2.4%, 0%).
  • DYANAVEL XR use during pregnancy may cause fetal harm and because of the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended during treatment with DYANAVEL XR.
  • There are limited studies on the use of methylphenidate in pregnant women. However, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for Quillivant XR and QuilliChew ER and any potential adverse effects on the breastfed infant from Quillivant XR and QuilliChew ER or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
  • To monitor pregnancy outcomes in women exposed to ADHD medications during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
  • To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information for DYANAVEL XR, Quillivant XR, and QuilliChew ER, including Boxed Warning regarding Abuse, Misuse, and Addiction.

INDICATION

ONYDA™ XR (clonidine HCI) is a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications:

ONYDA XR is contraindicated in patients with history of a hypersensitivity reaction to clonidine.

Warnings & Precautions

  • Hypotension/Bradycardia: Treatment with ONYDA XR can cause dose-related decreases in blood pressure and heart rate. Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated.
  • Somnolence/Sedation: Somnolence and sedation were commonly reported adverse reactions in clinical studies with clonidine hydrochloride extended-release tablets. Caution patients against operating heavy equipment or driving until they know how they respond to treatment with ONYDA XR. Advise patients to avoid use with alcohol.
  • Rebound Hypertension: Abrupt discontinuation of ONYDA XR can cause rebound hypertension. Withdrawal symptoms include headache, tachycardia, nausea, flushing, warm feeling, brief lightheadedness, tightness in chest, and anxiety. To minimize the risk of rebound hypertension, gradually reduce the dose of ONYDA XR in decrements of no more than 0.1 mg every 3 to 7 days. Patients should be instructed not to discontinue ONYDA XR therapy without consulting their physician due to the potential risk of withdrawal effects.
  • Cardiac Conduction Abnormalities: The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There have been post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring intravenous (IV) atropine, IV isoproterenol, and temporary cardiac pacing while taking clonidine. Titrate ONYDA XR slowly and monitor vital signs frequently in patients with cardiac conduction abnormalities or patients concomitantly treated with other sympatholytic drugs.

Adverse Reactions:

  • Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as monotherapy in ADHD: somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth.
  • Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as adjunct therapy to psychostimulant in ADHD: somnolence, fatigue, decreased appetite, dizziness.

Clinically Important Drug Interactions:

  • CNS Depressants: Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates, or other sedating drugs. Avoid concomitant use of CNS depressants with ONYDA XR.
  • Tricyclic Antidepressants: Concomitant use of tricyclic antidepressants with clonidine can increase blood pressure and may counteract the hypotensive effects of clonidine. Monitor blood pressure and adjust dosage of ONYDA XR as needed.
  • Drugs Known to Affect Sinus Node Function or AV Nodal Conduction: Avoid use of ONYDA XR with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers, and beta-blockers) due to a potential for additive effects such as bradycardia and AV block.
  • Antihypertensive Drugs: Concomitant use of antihypertensive drugs with clonidine potentiates the hypotensive effects of clonidine. Monitor blood pressure and heart rate and adjust dosage of ONYDA XR accordingly in patients treated concomitantly with antihypertensives.

Use in Specific Populations:

  • Use in Patients with Renal Impairment: The impact of renal impairment on the pharmacokinetics of clonidine in pediatric patients has not been assessed. The dosage of ONYDA XR must be adjusted according to the degree of impairment, and patients should be carefully monitored.
  • Use During Pregnancy: Prolonged experience with clonidine in pregnant women over several decades, based on published literature—including controlled trials, a retrospective cohort study, and case reports—has not identified a drug-associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes.
    To monitor pregnancy outcomes in women exposed to ADHD medications, including ONYDA XR, during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/adhd-medications/.
  • Use During Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ONYDA XR and any potential adverse effects on the breastfed child from ONYDA XR or from the underlying maternal condition. Monitor breastfeeding infants exposed to ONYDA XR through breast milk for symptoms of hypotension and/or bradycardia such as sedation, lethargy, tachypnea, and poor feeding.

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information for ONYDA XR.

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