Adderall Xr [Takeda Pharmaceuticals America, Inc.]

ADDERALL XR, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. (1) Limitations of UseThe use of ADDERALL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4)1.1 Attention Deficit Hyperactivity DisorderADDERALL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.Limitations of UseThe use of ADDERALL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)].

ADDERALL XR administration is contraindicated in patients:known to be hypersensitive to amphetamine, or other components of ADDERALL XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions (6.2)]. 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 (5.8), Drug Interactions (7.1)].

Exacerbation of Pre-Existing PsychosisAdministration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder.Induction of a Manic Episode in Patients with Bipolar DiseaseCNS stimulants may induce a manic or mixed episode in patients. Prior to initiating ADDERALL XR 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, or depression).New Psychotic or Manic SymptomsCNS 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 ADDERALL XR.

The following adverse reactions are discussed in greater detail in other sections of the labeling:Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), 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)] Seizures [see Warnings and Precautions (5.6)] Peripheral Vasculopathy, including Raynaud’s Phenomenon [see Warnings and Precautions (5.7)] Serotonin Syndrome [see Warnings and Precautions (5.8)] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.9)]

The following adverse reactions have been identified during postapproval use of amphetamine, ADDERALL XR, or ADDERALL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.Cardiovascular: Palpitations. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, motor and verbal tics, aggression, anger, logorrhea, dermatillomania, paresthesia (including formication), and bruxism.Endocrine: Impotence, changes in libido, frequent or prolonged erections.Eye Disorders: Vision blurred, mydriasis.Gastrointestinal: Unpleasant taste, constipation, intestinal ischemia, and other gastrointestinal disturbances.Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis.Skin: Alopecia.Vascular Disorders: Raynaud’s phenomenon.

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 at appropriate intervals. (5.3)Psychiatric Adverse Reactions: Prior to initiating ADDERALL XR, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing ADDERALL XR. (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)Seizures: May lower the convulsive threshold. Discontinue in the presence of seizures. (5.6)Peripheral Vasculopathy, including Raynaud’s Phenomenon: Careful observation for digital changes is necessary during ADDERALL XR treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy. (5.7)Serotonin Syndrome: Increased risk when coadministered with serotonergic agents (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans), but also during overdosage situations. If it occurs, discontinue ADDERALL XR and initiate supportive treatment. (4, 5.8, 10)Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating ADDERALL XR, 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. (5.9)5.1 Abuse, Misuse, and AddictionADDERALL XR has a high potential for abuse and misuse. The use of ADDERALL XR exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. ADDERALL XR 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 ADDERALL XR, 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 ADDERALL XR, 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 ADDERALL XR in a safe place, preferably locked, and instruct patients to not give ADDERALL XR to anyone else. Throughout ADDERALL XR 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 DiseaseSudden 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 ADDERALL XR 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 RateCNS stimulants may cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm).Monitor all ADDERALL XR-treated patients for hypertension and tachycardia.5.4 Psychiatric Adverse ReactionsExacerbation of Pre-Existing PsychosisAdministration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder.Induction of a Manic Episode in Patients with Bipolar DiseaseCNS stimulants may induce a manic or mixed episode in patients. Prior to initiating ADDERALL XR 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, or depression).New Psychotic or Manic SymptomsCNS 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 ADDERALL XR.5.5 Long-Term Suppression of Growth in Pediatric PatientsADDERALL XR 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. Closely monitor growth (weight and height) in ADDERALL XR-treated pediatric patients treated with CNS stimulants.In a controlled trial of ADDERALL XR in adolescents, mean weight change from baseline within the initial 4 weeks of therapy was -1.1 lbs. and -2.8 lbs., respectively, for patients receiving 10 mg and 20 mg ADDERALL XR. Higher doses were associated with greater weight loss within the initial 4 weeks of treatment. Chronic use of amphetamines can be expected to cause a similar suppression of growth [see Adverse Reactions (6.1)].Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted.5.6 SeizuresThere is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in the absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, ADDERALL XR should be discontinued.5.7 Peripheral Vasculopathy, including Raynaud’s PhenomenonCNS stimulants, including ADDERALL XR, 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 postmarketing reports and at the therapeutic dosage 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 ADDERALL XR treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for ADDERALL XR-treated patients who develop signs or symptoms of peripheral vasculopathy.5.8 Serotonin SyndromeSerotonin 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 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)]. Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism [see Clinical Pharmacology (12.3)]. The potential for a pharmacokinetic interaction exists with the coadministration of CYP2D6 inhibitors which may increase the risk with increased exposure to ADDERALL XR. In these situations, consider an alternative nonserotonergic 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 ADDERALL XR with MAOI drugs is contraindicated [see Contraindications (4)].Discontinue treatment with ADDERALL XR and any concomitant serotonergic agents immediately if symptoms of serotonin syndrome occur, and initiate supportive symptomatic treatment. Concomitant use of ADDERALL XR with other serotonergic drugs or CYP2D6 inhibitors should be used only if the potential benefit justifies the potential risk. If clinically warranted, consider initiating ADDERALL XR with lower doses, monitoring patients for the emergence of serotonin syndrome during drug initiation or titration, and informing patients of the increased risk for serotonin syndrome.5.9 Motor and Verbal Tics, and Worsening of Tourette’s SyndromeCNS stimulants, including amphetamine, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported [see Adverse Reactions (6.2)].Before initiating ADDERALL XR, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor ADDERALL XR-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

Pediatric patients (ages 6 to 17): 10 mg once daily in the morning. Maximum dose for children 6 to 12 years of age is 30 mg once daily. (2.2, 2.3, 2.4) Adults: 20 mg once daily in the morning. (2.5)Pediatric patients (ages 6 to 17) with severe renal impairment: 5 mg once daily in the morning. Maximum dose for children 6 to 12 years of age with severe renal impairment is 20 mg once daily. (2.6, 8.6)Adults with severe renal impairment: 15 mg once daily in the morning. (2.6, 8.6)Patients with end stage renal disease (ESRD): Not recommended. (2.6, 8.6)2.1 Pretreatment ScreeningPrior to treating patients with ADDERALL XR, 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 ADDERALL XR [see Warnings and Precautions (5.9)].2.2 General Administration Information Individualize the dosage according to the therapeutic needs and response of the patient. Administer ADDERALL XR at the lowest effective dosage.Based on bioequivalence data, patients taking divided doses of immediate-release ADDERALL, (for example, twice daily), may be switched to ADDERALL XR at the same total daily dose taken once daily. Titrate at weekly intervals to appropriate efficacy and tolerability as indicated.ADDERALL XR extended-release capsules may be taken whole, or the capsule may be opened and the entire contents sprinkled on applesauce. If the patient is using the sprinkle administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.ADDERALL XR may be taken orally with or without food.ADDERALL XR should be given upon awakening. Afternoon doses should be avoided because of the potential for insomnia.2.3 Recommended Dosage in Pediatric Patients 6 to 12 YearsIn pediatric patients 6 to 12 years of age with ADHD and are either starting treatment for the first time or switching from another medication, start with 10 mg once daily in the morning; daily dosage may be adjusted in increments of 5 mg or 10 mg at weekly intervals. When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with 5 mg once daily in the morning. The maximum recommended dose for children 6 to 12 years of age is 30 mg/day; doses greater than 30 mg/day have not been studied in children. ADDERALL XR has not been studied in children under 6 years of age.2.4 Recommended Dosage in Pediatric Patients 13 to 17 YearsThe recommended starting dose for pediatric patients 13 to 17 years of age with ADHD and are either starting treatment for the first time or switching from another medication is 10 mg/day. The dose may be increased to 20 mg/day after one week if ADHD symptoms are not adequately controlled.2.5 Recommended Dosage in AdultsIn adults with ADHD who are either starting treatment for the first time or switching from another medication, the recommended dose is 20 mg/day.2.6 Dosage in Patients with Renal ImpairmentIn adult patients with severe renal impairment (GFR 15 to <30 mL/min/1.73 m2), the recommended dose is 15 mg once daily in the morning. In pediatric patients (6 to 17 years of age) with severe renal impairment, the recommended dose is 5 mg once daily. The maximum dose for children 6 to 12 years of age with severe renal impairment is 20 mg once daily. ADDERALL XR is not recommended in patients with end stage renal disease (ESRD) (GFR <15 mL/min/1.73 m2) [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].2.7 Dosage Modification due to Drug InteractionsAgents that alter urinary pH can impact excretion and alter blood levels of amphetamines. Acidifying agents (e.g., ascorbic acid) decrease blood levels; adjust ADDERALL XR dosage based on clinical response [see Drug Interactions (7)].

In pediatric patients 6 to 12 years of age with ADHD and are either starting treatment for the first time or switching from another medication, start with 10 mg once daily in the morning; daily dosage may be adjusted in increments of 5 mg or 10 mg at weekly intervals. When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with 5 mg once daily in the morning. The maximum recommended dose for children 6 to 12 years of age is 30 mg/day; doses greater than 30 mg/day have not been studied in children. ADDERALL XR has not been studied in children under 6 years of age.

The recommended starting dose for pediatric patients 13 to 17 years of age with ADHD and are either starting treatment for the first time or switching from another medication is 10 mg/day. The dose may be increased to 20 mg/day after one week if ADHD symptoms are not adequately controlled.

In adults with ADHD who are either starting treatment for the first time or switching from another medication, the recommended dose is 20 mg/day.

In adult patients with severe renal impairment (GFR 15 to <30 mL/min/1.73 m2), the recommended dose is 15 mg once daily in the morning. In pediatric patients (6 to 17 years of age) with severe renal impairment, the recommended dose is 5 mg once daily. The maximum dose for children 6 to 12 years of age with severe renal impairment is 20 mg once daily. ADDERALL XR is not recommended in patients with end stage renal disease (ESRD) (GFR <15 mL/min/1.73 m2) [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Agents that alter urinary pH can impact excretion and alter blood levels of amphetamines. Acidifying agents (e.g., ascorbic acid) decrease blood levels; adjust ADDERALL XR dosage based on clinical response [see Drug Interactions (7)].

ADDERALL XR 5 mg extended-release capsules: Clear/blue (imprinted ADDERALL XR 5 mg)ADDERALL XR 10 mg extended-release capsules: Blue/blue (imprinted ADDERALL XR 10 mg) ADDERALL XR 15 mg extended-release capsules: Blue/white (imprinted ADDERALL XR 15 mg)ADDERALL XR 20 mg extended-release capsules: Orange/orange (imprinted ADDERALL XR 20 mg)ADDERALL XR 25 mg extended-release capsules: Orange/white (imprinted ADDERALL XR 25 mg)ADDERALL XR 30 mg extended-release capsules: Natural/orange (imprinted ADDERALL XR 30 mg)

Agents that alter urinary pH can impact excretion and alter blood levels of amphetamines. Acidifying agents (e.g., ascorbic acid) decrease blood levels; adjust ADDERALL XR dosage based on clinical response [see Drug Interactions (7)].

Alkalinizing agents (GI antacids and urinary): These agents increase blood levels of amphetamine. (2.7, 7.1)Acidifying agents (GI and urinary): These agents reduce blood levels of amphetamine. (7.1)7.1 Clinically Important Interactions with AmphetaminesTable 4: Drugs Having Clinically Important Interactions with AmphetaminesMonoamine Oxidase Inhibitors (MAOIs)Clinical ImpactConcomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.InterventionDo not administer ADDERALL XR concomitantly or within 14 days after discontinuing MAOI [see Contraindications (4)].Serotonergic DrugsClinical ImpactThe concomitant use of ADDERALL XR and serotonergic drugs increases the risk of serotonin syndrome.InterventionInitiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during ADDERALL XR initiation or dosage increase. If serotonin syndrome occurs, discontinue ADDERALL XR and the concomitant serotonergic drug(s) [see Warnings and Precautions (5.8)].CYP2D6 InhibitorsClinical ImpactThe concomitant use of ADDERALL XR and CYP2D6 inhibitors may increase the exposure of ADDERALL XR compared to the use of the drug alone and increase the risk of serotonin syndrome.InterventionInitiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during ADDERALL XR initiation and after a dosage increase. If serotonin syndrome occurs, discontinue ADDERALL XR and the CYP2D6 inhibitor [see Warnings and Precautions (5.8), Overdosage (10)].Alkalinizing AgentsClinical ImpactIncrease blood levels and potentiate the action of amphetamine.InterventionCoadministration of ADDERALL XR and gastrointestinal or urinary alkalinizing agents should be avoided.Acidifying AgentsClinical ImpactLower blood levels and efficacy of amphetamines.InterventionIncrease dose based on clinical response.Tricyclic AntidepressantsClinical ImpactMay 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.InterventionMonitor frequently and adjust or use alternative therapy based on clinical response.Proton Pump InhibitorsClinical ImpactTime to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone.InterventionMonitor patients for changes in clinical effect and adjust therapy based on clinical response.7.2 Interference with Laboratory TestsAmphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.Allow for an adequate washout period between administration of ADDERALL XR and radioactive diagnostic agents used for dopamine transporter (DAT) visualization. ADDERALL XR can interfere with the test results of a radioactive diagnostic agent (ioflupane I-123) that is used for DAT visualization by binding and internalization of the DAT, which may result in lower DAT in the striatum. This may lead to false-positive diagnostic results.

Table 4: Drugs Having Clinically Important Interactions with AmphetaminesMonoamine Oxidase Inhibitors (MAOIs)Clinical ImpactConcomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.InterventionDo not administer ADDERALL XR concomitantly or within 14 days after discontinuing MAOI [see Contraindications (4)].Serotonergic DrugsClinical ImpactThe concomitant use of ADDERALL XR and serotonergic drugs increases the risk of serotonin syndrome.InterventionInitiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during ADDERALL XR initiation or dosage increase. If serotonin syndrome occurs, discontinue ADDERALL XR and the concomitant serotonergic drug(s) [see Warnings and Precautions (5.8)].CYP2D6 InhibitorsClinical ImpactThe concomitant use of ADDERALL XR and CYP2D6 inhibitors may increase the exposure of ADDERALL XR compared to the use of the drug alone and increase the risk of serotonin syndrome.InterventionInitiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during ADDERALL XR initiation and after a dosage increase. If serotonin syndrome occurs, discontinue ADDERALL XR and the CYP2D6 inhibitor [see Warnings and Precautions (5.8), Overdosage (10)].Alkalinizing AgentsClinical ImpactIncrease blood levels and potentiate the action of amphetamine.InterventionCoadministration of ADDERALL XR and gastrointestinal or urinary alkalinizing agents should be avoided.Acidifying AgentsClinical ImpactLower blood levels and efficacy of amphetamines.InterventionIncrease dose based on clinical response.Tricyclic AntidepressantsClinical ImpactMay 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.InterventionMonitor frequently and adjust or use alternative therapy based on clinical response.Proton Pump InhibitorsClinical ImpactTime to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone.InterventionMonitor patients for changes in clinical effect and adjust therapy based on clinical response.

Source: DailyMed, U.S. National Library of Medicine. Additional information compiled from online sources.