arynta
Pharmaranks rates Arynta 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Arynta (Lisdexamfetamine Dimesylate) is a central nervous system stimulant used to treat Attention Deficit Disorder with Hyperactivity, Binge Drinking.
Lisdexamfetamine Dimesylate · by Azurity
Available as a generic: Lisdexamfetamine Dimesylate
⚠ FDA reports a current shortage of the capsule form — availability differs between suppliers — see drug shortages →Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Lisdexamfetamine Dimesylate
- Drug class
- Central Nervous System Stimulant
- Form
- Solution
- Strength
- Lisdexamfetamine Dimesylate 10MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Azurity
- Half-life
- less than 1 hour (parent drug) (how long it stays in your system)
- FDA application
- NDA219847
- FDA boxed warning
- Yes — see the boxed warning
What is Arynta?
From the FDA label:ARYNTA (lisdexamfetamine dimesylate), is a CNS stimulant. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15 H 25 N 3 O∙(CH 4 O 3 S) 2 , which corresponds to a molecular weight of 455.60. The chemical structure is: Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). The pH is 4.24. The pKa values are 10.21 and 15.89. ARYNTA oral solution is a clear colorless solution, contains 10 mg/mL of lisdexamfetamine dimesylate (equivalent to 5.8 mg of lisdexamfetamine). Inactive ingredients: dibasic sodium phosphate dihydrate, methylparaben sodium, monobasic sodium phosphate dihydrate, propylparaben sodium, propylene glycol, saccharin sodium, hydrochloric acid, sodium hydroxide and purified water. Lisdex Structure
How to use
Indicated Population Initial Dose Titration Schedule Recommended Dose Maximum Dose ADHD (Adults and pediatric patients 6 years and older) ( 2.2 ) 30 mg every morning 10 mg or 20 mg weekly 30 mg to 70 mg per day 70 mg per day BED (Adults) ( 2.3 ) 30 mg every morning 20 mg weekly 50 mg to 70 mg per day 70 mg per day • Prior to treatment, assess for presence of cardiac disease ( 2.4 ) • Severe renal impairment: Maximum dose is 50 mg/day ( 2.5 ) • End stage renal disease (ESRD): Maximum dose is 30 mg/day ( 2.5 ) 2.1 Pretreatment Screening Prior to treating patients with ARYNTA, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )] . • the family history and clinically evaluate patients for motor or verbal tics or Tourette's syndrome before initiating ARYNTA [see Warnings and Precautions ( 5.8 )] . 2.2 General Administration Information Take ARYNTA orally in the morning with or without food; avoid afternoon doses because of the potential for insomnia. Instruct caregivers/patients to read the ‘Instructions for Use’ for complete administration instructions. • Use the oral dosing syringe and bottle adapter provided with ARYNTA. • Ensure that the bottle adapter is firmly inserted into the bottle before first use and keep the adapter in place for…
Side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Known hypersensitivity to amphetamine products or other ingredients of ARYNTA [see Contraindications ( 4 )] • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications ( 4 ) and Drug Interactions ( 7.1 )] • Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions ( 5.1 ), and Drug Abuse and Dependence ( 9.2 , 9.3 )] • Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions ( 5.2 )] • Increased Blood Pressure and Heart Rate [see Warnings and Precautions ( 5.3 )] • Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.4 )] • Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions ( 5.5 )] • Peripheral Vasculopathy, including Raynaud's phenomenon [see Warnings and Precautions ( 5.6 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.7 )] • Motor and Verbal Tics, and Worsening of Tourette's Syndrome [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) in pediatric patients ages 6 to 17 years, and/or adults with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting. ( 6.1 ) Most…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
ABUSE, MISUSE, AND ADDICTION ARYNTA has 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 ARYNTA, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing ARYNTA, 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 ARYNTA treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 )]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. ARYNTA has 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 ARYNTA, can result in overdose and death ( 5.1 , 9.2 , 10 ): • Before prescribing ARYNTA, 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.
Warnings
Important safety information
Risks to Patients with Serious Cardiac Disease : Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease ( 5.2 ) • Increased Blood Pressure and Heart Rate : Monitor blood pressure and pulse. ( 5.3 ) • Psychiatric Adverse Reactions : Prior to initiating ARYNTA, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing ARYNTA. ( 5.4 ) • Long-Term Suppression of Growth in Pediatric Patients : Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted. ( 5.5 ) • Peripheral Vasculopathy, including Raynaud's phenomenon : Careful observation for digital changes is necessary during ARYNTA treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy. ( 5.6 ) • Serotonin Syndrome : Increased risk when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during overdosage situations. If it occurs, discontinue ARYNTA and initiate supportive treatment. ( 4 , 5.7 , 10 ) • Motor and Verbal Tics, and Worsening of Tourette's Syndrome : Before initiating ARYNTA, 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. ( 5.8 ) 5.1 Abuse, Misuse, and Addiction ARYNTA has a high potential for abuse and misuse. The use of ARYNTA exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. ARYNTA can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence ( 9.2 )] . Misuse and abuse of CNS stimulants, including ARYNTA, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing ARYNTA, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store ARYNTA in a safe place, preferably locked, and instruct patients to not give ARYNTA to anyone else. Throughout ARYNTA treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 5.2 Risks to Patients with Serious Cardiac Disease 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 dosage. Avoid ARYNTA use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. 5.3 Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Some patients may have larger increases. Monitor all ARYNTA -treated patients for potential tachycardia and hypertension. 5.4 Psychiatric Adverse Reactions Exacerbation of 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 Disorder CNS stimulants may induce a manic or mixed episode. Prior to initiating ARYNTA treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms CNS stimulants, at the recommended dosage, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients compared to 0% of placebo-treated patients. If such symptoms occur, consider discontinuing ARYNTA. 5.5 Long-Term Suppression of Growth in Pediatric Patients ARY NTA is not approved for use and is not recommended in pediatric patients below 6 years of age [see Use in Specific Populations ( 8.4 )] . CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. In a 4-week, placebo-controlled trial of ARYNTA in pediatric patients ages 6 to 12 years old with ADHD, there was a dose-related decrease in weight in the ARYNTA groups compared to weight gain in the placebo group. Additionally, in studies of another stimulant, there was slowing of the increase in height [see Adverse Reactions ( 6.1 )] . Closely monitor growth (weight and height) in ARYNTA-treated pediatric patients. Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. 5.6 Peripheral Vasculopathy, including Raynaud's Phenomenon CNS stimulants, including ARYNTA, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports and at the therapeutic dosages of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during ARYNTA treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for ARYNTA-treated patients who develop signs or symptoms of peripheral vasculopathy. 5.7 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 the active metabolite of ARYNTA (dextroamphetamine). 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 ARYNTA with MAOI drugs is contraindicated [see Contraindications ( 4 )] . Discontinue treatment with ARYNTA and any concomitant serotonergic agents immediately if symptoms of serotonin syndrome occur, and initiate supportive symptomatic treatment. If concomitant use of ARYNTA with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate ARYNTA 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. 5.8 Motor and…
Who should not take Arynta
ARYNTA is contraindicated in patients with: • Known hypersensitivity to amphetamine products or other ingredients of ARYNTA. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports [see Adverse Reactions ( 6.2 )]. • Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions ( 5.7 ) and Drug Interactions ( 7.1 )]. • Known hypersensitivity to amphetamine products or other ingredients in ARYNTA ( 4 ) • Use with monoamine oxidase (MAO) inhibitor, or within 14 days of the last MAO inhibitor dose ( 4 , 7.1 )
Overdose — what happens if you take too much
Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: • Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. • CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. • Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of ARYNTA should be considered when treating patients with overdose. Lisdexamfetamine and d-amphetamine are not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Acidifying and Alkalinizing Agents : Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels. Adjust ARYNTA dosage accordingly. ( 2.6 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions with Amphetamines Table 5 Drugs Having Clinically Important Interactions with Amphetamines MAO Inhibitors (MAOI) Prevention or Management Do not administer ARYNTA during or within 14 days following the administration of MAOI [see Contraindications ( 4 )] . Mechanism and Clinical Effect(s) 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. Serotonergic Drugs Prevention or Management Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during ARYNTA initiation or dosage increase. If serotonin syndrome occurs, discontinue ARYNTA and the concomitant serotonergic drug(s) [see Warnings and Precautions ( 5.7 )] . Mechanism and Clinical Effect(s) The concomitant use of lisdexamfetamine dimesylate and serotonergic drugs increases the risk of serotonin syndrome. CYP2D6 Inhibitors Prevention or Management Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during ARYNTA initiation and after a dosage increase. If serotonin syndrome occurs, discontinue ARYNTA and the CYP2D6 inhibitor [see Warnings and Precautions ( 5.7 ) and Overdosage ( 10 )]. Mechanism and Clinical Effect(s) The concomitant use of lisdexamfetamine dimesylate and CYP2D6 inhibitors may increase the exposure of dextroamphetamine, the active metabolite of lisdexamfetamine dimesylate compared to the use of the drug alone and increase the risk of serotonin syndrome. Alkalinizing Agents Prevention or Management Co-administration of ARYNTA and urinary alkalinizing agents should be avoided. Mechanism and Clinical Effect(s) Urinary alkalinizing agents can increase blood levels and potentiate the action of amphetamine. Acidifying Agents Prevention or Management Increase dose based on clinical response. Mechanism and Clinical Effect(s) Urinary acidifying agents can lower blood levels and efficacy of amphetamines. Tricyclic Antidepressants Prevention or Management Monitor frequently and adjust or use alternative therapy based on clinical response. Mechanism and Clinical Effect(s) 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.
How long does Lisdexamfetamine Dimesylate stay in your body?
The elimination half-life of lisdexamfetamine dimesylate is less than 1 hour (parent drug) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Lisdexamfetamine is an inactive prodrug: the parent's own elimination half-life is under 1 hour and it is essentially undetectable in blood by 8 hours. The clinically meaningful effect comes from its active metabolite, dextroamphetamine, which has a much longer elimination half-life of about 10 to 11 hours in healthy adults (about 8.6 to 9.5 hours in children 6 to 12).
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: VYVANSE- lisdexamfetamine dimesylate capsule / chewable tablet (DailyMed).
Drug class
How this class works, per Stimulants — StatPearls, NCBI Bookshelf (NIH).
May treat (source: NIH RxClass)
See how Arynta ranks — best-rated central nervous system stimulant for:
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Arynta treat?
- Arynta (Lisdexamfetamine Dimesylate) may be used to treat attention deficit disorder with hyperactivity, binge drinking, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Arynta work?
- Arynta is a central nervous system stimulant. CNS stimulants raise the levels of the brain's signaling chemicals dopamine and norepinephrine, either by releasing more of them or by blocking their reuptake. This heightened activity in attention and arousal circuits increases alertness, energy, and focus.
- How is Arynta rated?
- pharmaranks gives Arynta a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Arynta?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Arynta. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Arynta?
- Arynta is marketed by Azurity. You can see Azurity's full profile, rating, and other products on pharmaranks.
- Is Arynta a brand-name or generic drug?
- Arynta is a brand-name product with the active ingredient Lisdexamfetamine Dimesylate. Lower-cost generic equivalents containing Lisdexamfetamine Dimesylate are available — ask your pharmacist.
- Is Arynta available over the counter?
- No. Arynta is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Arynta come in?
- Arynta is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Arynta?
- Arynta is classified as central nervous system stimulant, per the FDA's Established Pharmacologic Class.
- Is Arynta FDA-registered?
- Arynta is on record with the U.S. FDA under application number NDA219847. You can verify this on its official FDA label.
- Has Arynta been recalled by the FDA?
- Arynta has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Arynta safe?
- There's no single safe-or-not verdict. pharmaranks gives Arynta a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Arynta?
- Arynta's side effects are taken directly from its FDA label. From the label: The following adverse reactions are discussed in greater detail in other sections of the labeling: • Known hypersensitivity to amphetamine products or other ingredients of ARYNTA [see Contraindications ( 4 )] • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contra… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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arynta
70/100