Lisdexamfetamine Dimesylate

VYVANSE (lisdexamfetamine dimesylate), a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diaminoN-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O•(CH4O3S)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).

Information for VYVANSE Capsules

VYVANSE capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine).

Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.

Information for VYVANSE Chewable Tablets

VYVANSE chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine).

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, sucralose, artificial strawberry flavor.

VYVANSE® is indicated for the treatment of:

• Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies]
• Moderate to Severe Binge Eating Disorder (BED) in adults [see Clinical Studies].

Limitation Of Use

VYVANSE is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of VYVANSE for the treatment of obesity have not been established [see WARNINGS AND PRECAUTIONS].

Dosage Forms And Strengths

• Capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg)
• Capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg)
• Capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg)
• Capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg)
• Capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg)
• Capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg)
• Capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg)

• Chewable tablets 10 mg: White to off-white round shaped tablet debossed with ‘10’ on one side and ‘S489’ on the other
• Chewable tablets 20 mg: White to off-white hexagonal shaped tablet debossed with ‘20’ on one side and ‘S489’ on the other
• Chewable tablets 30 mg: White to off-white arc triangular shaped tablet debossed with ‘30’ on one side and ‘S489’ on the other
• Chewable tablets 40 mg: White to off-white capsule shaped tablet debossed with ‘40’ on one side and ‘S489’ on the other
• Chewable tablets 50 mg: White to off-white arc square shaped tablet debossed with ‘50’ on one side and ‘S489’ on the other
• Chewable tablets 60 mg: White to off-white arc diamond shaped tablet debossed with ‘60’ on one side and ‘S489’ on the other

Storage And Handling

• VYVANSE capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg), bottles of 100, NDC 59417-101-10
• VYVANSE capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg), bottles of 100, NDC 59417-102-10
• VYVANSE capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg), bottles of 100, NDC 59417-103-10
• VYVANSE capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg), bottles of 100, NDC 59417-104-10
• VYVANSE capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg), bottles of 100, NDC 59417-105-10
• VYVANSE capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg), bottles of 100, NDC 59417-106-10
• VYVANSE capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg), bottles of 100, NDC 59417-107-10

• VYVANSE chewable tablets 10 mg: White to off-white round shaped tablet debossed with ‘10’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-115-01
• VYVANSE chewable tablets 20 mg: White to off-white hexagonal shaped tablet debossed with ‘20’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-11601
• VYVANSE chewable tablets 30 mg: White to off-white arc triangular shaped tablet debossed with ‘30’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-11701
• VYVANSE chewable tablets 40 mg: White to off-white capsule shaped tablet debossed with ‘40’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-118-01
• VYVANSE chewable tablets 50 mg: White to off-white arc square shaped tablet debossed with ‘50’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-11901
• VYVANSE chewable tablets 60 mg: White to off-white arc diamond shaped tablet debossed with ‘60’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-12001

Storage And Handling

Dispense in a tight, light-resistant container as defined in the USP.

Store at room temperature, 20°C to 25° C (68°F to 77° F). Excursions permitted between 15°C and 30° C (59 to 86° F) [see USP Controlled Room Temperature].

Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired VYVANSE by a medicine take-back program.

Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421. Revised: Jul 2017

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Known hypersensitivity to amphetamine products or other ingredients of VYVANSE [see CONTRAINDICATIONS]
• Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS and DRUG INTERACTIONS]
• Drug Dependence [see BOX WARNING, WARNINGS AND PRECAUTIONS and Drug Abuse And Dependence]
• Serious Cardiovascular Reactions [see WARNINGS AND PRECAUTIONS]
• Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
• Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Suppression of Growth [see WARNINGS AND PRECAUTIONS]
• Peripheral Vasculopathy, including Raynaud’s phenomenon [see WARNINGS AND PRECAUTIONS]
• Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Attention Deficit Hyperactivity Disorder

The safety data in this section is based on data from the 4-week parallel-group controlled clinical studies of VYVANSE in pediatric and adult patients with ADHD [see Clinical Studies].

In the controlled trial in patients ages 6 to 12 years (Study 1), 8% (18/218) of VYVANSE-treated patients discontinued due to adverse reactions compared to 0% (0/72) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, decreased appetite and rash [2 instances for each adverse reaction, i.e., 2/218 (1%)]. Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included abdominal pain upper, dry mouth, weight decreased, dizziness, somnolence, logorrhea, chest pain, anger and hypertension.

In the controlled trial in patients ages 13 to 17 years (Study 4), 3% (7/233) of VYVANSE-treated patients discontinued due to adverse reactions compared to 1% (1/77) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were decreased appetite (2/233; 1%) and insomnia (2/233; 1%). Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included irritability, dermatillomania, mood swings, and dyspnea.

In the controlled adult trial (Study 7), 6% (21/358) of VYVANSE-treated patients discontinued due to adverse reactions compared to 2% (1/62) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were insomnia (8/358; 2%), tachycardia (3/358; 1%), irritability (2/358; 1%), hypertension (4/358; 1%), headache (2/358; 1%), anxiety (2/358; 1%), and dyspnea (3/358; 1%). Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included palpitations, diarrhea, nausea, decreased appetite, dizziness, agitation, depression, paranoia and restlessness.

The most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) reported in children, adolescents, and/or adults were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting.

Adverse reactions reported in the controlled trials in pediatric patients ages 6 to 12 years (Study 1), adolescent patients ages 13 to 17 years (Study 4), and adult patients (Study 7) treated with VYVANSE or placebo are presented in Tables 1, 2, and 3 below.

Table 1: Adverse Reactions Reported by 2% or More of Children (Ages 6 to 12 Years) with ADHD Taking VYVANSE and at least Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 1)

Table 2: Adverse Reactions Reported by 2% or More of Adolescent (Ages 13 to 17 Years) Patients with ADHD Taking VYVANSE and at least Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 4)

Table 3: Adverse Reactions Reported by 2% or More of Adult Patients with ADHD Taking VYVANSE and at least Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 7)

In addition, in the adult population erectile dysfunction was observed in 2.6% of males on VYVANSE and 0% on placebo; decreased libido was observed in 1.4% of subjects on VYVANSE and 0% on placebo.

In a controlled trial of VYVANSE in children ages 6 to 12 years (Study 1), mean weight loss from baseline after 4 weeks of therapy was -0.9, -1.9, and -2.5 pounds, respectively, for patients receiving 30 mg, 50 mg, and 70 mg of VYVANSE, compared to a 1 pound weight gain for patients receiving placebo. Higher doses were associated with greater weight loss with 4 weeks of treatment. Careful follow-up for weight in children ages 6 to 12 years who received VYVANSE over 12 months suggests that consistently medicated children (i.e. treatment for 7 days per week throughout the year) have a slowing in growth rate, measured by body weight as demonstrated by an age-and sex-normalized mean change from baseline in percentile, of -13.4 over 1 year (average percentiles at baseline and 12 months were 60.9 and 47.2, respectively). In a 4-week controlled trial of VYVANSE in adolescents ages 13 to 17 years, mean weight loss from baseline to endpoint was -2.7, -4.3, and -4.8 lbs., respectively, for patients receiving 30 mg, 50 mg, and 70 mg of VYVANSE, compared to a 2.0 pound weight gain for patients receiving placebo.

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e. treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. In a controlled trial of amphetamine (d-to l-enantiomer ratio of 3:1) in adolescents, mean weight change from baseline within the initial 4 weeks of therapy was -1.1 pounds and -2.8 pounds, respectively, for patients receiving 10 mg and 20 mg of amphetamine. Higher doses were associated with greater weight loss within the initial 4 weeks of treatment [see WARNINGS AND PRECAUTIONS].

In the controlled adult trial (Study 7), mean weight loss after 4 weeks of therapy was 2.8 pounds, 3.1 pounds, and 4.3 pounds, for patients receiving final doses of 30 mg, 50 mg, and 70 mg of VYVANSE, respectively, compared to a mean weight gain of 0.5 pounds for patients receiving placebo.

Binge Eating Disorder

The safety data in this section is based on data from two 12 week parallel group, flexible-dose, placebo-controlled studies in adults with BED [see Clinical Studies]. Patients with cardiovascular risk factors other than obesity and smoking were excluded.

In controlled trials of patients ages 18 to 55 years, 5.1% (19/373) of VYVANSE-treated patients discontinued due to adverse reactions compared to 2.4% (9/372) of placebo-treated patients. No single adverse reaction led to discontinuation in 1% or more of VYVANSE-treated patients. Less commonly reported adverse reactions (less than 1% or less than twice rate of placebo) included increased heart rate, headache, abdominal pain upper, dyspnea, rash, insomnia, irritability, feeling jittery and anxiety.

The most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) reported in adults were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.

Adverse reactions reported in the pooled controlled trials in adult patients (Study 11 and 12) treated with VYVANSE or placebo are presented in Table 4 below.

Table 4: Adverse Reactions Reported by 2% or More of Adult Patients with BED Taking VYVANSE and at least Twice the Incidence in Patients Taking Placebo in 12-Week Clinical Trials (Study 11 and 12)

Postmarketing Experience

The following adverse reactions have been identified during post approval use of VYVANSE. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events are as follows: cardiomyopathy, mydriasis, diplopia, difficulties with visual accommodation, blurred vision, eosinophilic hepatitis, anaphylactic reaction, hypersensitivity, dyskinesia, dysgeusia, tics, bruxism, depression, dermatillomania, alopecia, aggression, Stevens-Johnson Syndrome, chest pain, angioedema, urticaria, seizures, libido changes, frequent or prolonged erections, constipation, and rhabdomyolysis.

Read the entire FDA prescribing information for Vyvanse (Lisdexamfetamine Dimesylate)

• ADHD Medication for Children
• ADHD Medications for Adults
• Adult ADHD (Attention Deficit Hyperactivity Disorder)
• Binge Eating Disorder

Contraindications

• Contraindicated in patients with advanced arteriosclerosis,1 5 28 symptomatic cardiovascular disease,1 5 28 moderate to severe hypertension,1 5 28 hyperthyroidism,1 5 28 known hypersensitivity or idiosyncrasy to sympathomimetic amines,1 5 glaucoma,1 5 28 or a history of drug abuse;1 5 28 within 14 days of MAO inhibitor therapy;1 5 28 and in agitated patients.1 28

• Although amphetamines generally should not be used in patients with a history of drug abuse,1 5 some experts state that this is not an absolute contraindication, provided the patient can be monitored more carefully than would otherwise be indicated.5

Warnings/Precautions

Warnings

Sudden unexplained death, stroke, and MI reported in adults with ADHD receiving usual dosages of stimulants; sudden death also reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of the drugs.1 9

Epidemiologic data suggest a possible association between use of stimulants and sudden unexplained death in healthy children and adolescents.31 32 33 FDA unable to conclude that these data affect evaluation of overall risk and benefit of stimulants used to treat ADHD in children and adolescents.31 FDA is conducting an ongoing safety review of amphetamines and other stimulants to evaluate possible link between use of these agents and sudden death in children.31 32 33 Pediatric patients with ADHD and their parents should avoid discontinuing the child’s use of such stimulants before consulting a clinician.31

Thoroughly review medical history (including evaluation for family history of sudden death or ventricular arrhythmia) and perform physical examination in all children, adolescents, and adults being considered for stimulant therapy; if initial findings suggest presence of cardiac disease, perform further cardiac evaluation (e.g., ECG, echocardiogram).1 5 6

In general, avoid use of CNS stimulants in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, CAD, or other serious cardiac conditions.1 6 8 9 (See Contraindications under Cautions.)

Patients who develop exertional chest pain, unexplained syncope, or other manifestations suggestive of cardiac disease during stimulant therapy should undergo prompt cardiac evaluation.1 28

Other Warnings and Precautions

Least amount of lisdexamfetamine feasible should be prescribed or dispensed at one time in order to minimize possible overdosage.1

Possible modest increases in average BP (i.e., by about 2–4 mm Hg) and heart rate (i.e., by about 3–6 bpm); larger increases may occur.1 28 Modest increases not expected to have short-term sequelae; however, monitor all patients for larger changes in BP and heart rate.1

Caution advised in patients with underlying medical conditions that might be affected by increases in BP or heart rate (e.g., hypertension, heart failure, recent MI, ventricular arrhythmia).1

May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.1 5

Psychotic symptoms (e.g., hallucinations, delusional thinking) may occur with usual dosages in children and adolescents without prior history of psychotic illness.1 6 If psychotic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.1 6

May precipitate mixed or manic episodes in ADHD patients with comorbid bipolar disorder; use with caution in these patients.1 Prior to initiating therapy, carefully screen patients with ADHD and comorbid depressive symptoms to identify risk for bipolar disorder; screening should include a detailed psychiatric history (e.g., family history of suicide, bipolar disorder, or depression).1

Manic symptoms may occur with usual dosages in children and adolescents without prior history of mania.1 If manic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.1

Aggressive behavior and hostility (frequently observed in children and adolescents with ADHD) reported in patients receiving drug therapy for ADHD.1 No systematic evidence that stimulants cause these adverse effects; however, monitor patients beginning treatment for ADHD for onset or worsening of aggressive behavior or hostility.1 6

Long-term (i.e., >12 months) administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.1 6 Dose-related weight loss reported in children during 4 weeks of therapy with lisdexamfetamine.1

Manufacturer recommends monitoring growth during treatment; patients not growing or gaining weight as expected may require temporary discontinuance of treatment.1 6 28 However, AAP states that studies of stimulants in children found little or no decrease in expected height, with any decrease in growth early in treatment being compensated for later on.7

Possible lowering of seizure threshold in patients with history of seizures, in those with prior EEG abnormalities but no history of seizures, and, very rarely, in those without history of seizures and with no prior evidence of EEG abnormalities.1 28 If seizures occur, discontinue therapy.1

Visual disturbances (e.g., difficulty with accommodation, blurred vision) reported with stimulants.1 28

Amphetamines reported to exacerbate motor and phonic tics and Tourette’s syndrome.1 However, a history of tics or their development during therapy is not an absolute contraindication to continued use.1 5 7 Nevertheless, evaluate for presence of tics and Tourette’s syndrome in children and their families prior to initiating stimulant therapy.1

Amphetamines may impair the ability to engage in potentially hazardous activities (e.g., operating machinery or vehicles).1

Specific Populations

Category C.1 25

Risk of prematurity, low birth weight, and withdrawal symptoms (e.g., dysphoria, lassitude, agitation) in infants born to dependent women.1 25

Distributed into milk; discontinue nursing or the drug.1 25

Safety and efficacy of lisdexamfetamine not established in children 3–5 years of age.1 Amphetamines not recommended for ADHD in children <3 years of age.1 5 6 Not studied to date in adolescents.1

Aggressive behavior, hostility, and psychotic (e.g., hallucinations, delusional thinking) or manic symptoms reported in children and adolescents receiving stimulants for management of ADHD.1 (See Warnings under Cautions.)

Sudden death reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of stimulants.1 Epidemiologic data also suggest a possible association between use of stimulants and sudden death in healthy children and adolescents.31 32 33 (See Sudden Death and Serious Cardiovascular Events under Cautions.)

Long-term administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.1 (See Growth Suppression under Cautions.)

Lisdexamfetamine has not been studied in this population.1

Not specifically studied in hepatic impairment.27

Not specifically studied in renal impairment.27

Common Adverse Effects

Children 6–12 years of age: Decreased appetite,1 6 28 29 30 insomnia,1 6 28 29 30 upper abdominal pain,1 28 30 irritability,1 6 28 30 vomiting, 1 28 weight loss,1 6 28 30 nausea,1 28 dry mouth,1 28 dizziness,1 28 30 affect lability,1 rash,1 tic,1 pyrexia,1 somnolence.1

Adults: Decreased appetite,1 insomnia,1 dry mouth,1 diarrhea,1 nausea,1 anxiety,1 anorexia,1 jitteriness,1 increased BP,1 agitation,1 restlessness,1 hyperHIDrosis,1 increased heart rate,1 tremor,1 dyspnea.1

Active metabolite (dextroamphetamine) inhibits MAO.1

Lisdexamfetamine is not metabolized by CYP isoenzymes.1 In vitro studies suggest only minor inhibition of CYP isoenzymes 1A2, 2D6, and 3A4 by amphetamine and/or its metabolites.1

Specific Drugs, Tests, and Foods

Absorption

Bioavailability

Lisdexamfetamine (a prodrug of dextroamphetamine) is rapidly absorbed from the GI tract.1 28 Peak plasma concentrations of lisdexamfetamine occur in approximately 1 hour; concentrations are low and transient; nonquantifiable by 8 hours after administration.1 Peak plasma concentrations of dextroamphetamine occur in approximately 3.5–3.7 hours.1 3 30

Onset

Occurs within 2 hours after oral administration.3

Duration

Approximately 10–12 hours.1 8 27

Food

Food (high-fat meal) delays time to peak plasma concentration of dextroamphetamine by about 1 hour but does not affect magnitude of peak plasma concentration or AUC of dextroamphetamine.1

Distribution

Extent

Amphetamines readily cross the blood-brain barrier and are distributed into most body tissues.26

Amphetamines are distributed into milk in concentrations 3–7 times maternal blood concentrations.21 25

Elimination

Metabolism

Lisdexamfetamine (a prodrug of dextroamphetamine) is converted to l-lysine and dextroamphetamine by first-pass intestinal and/or hepatic metabolism.1

Lisdexamfetamine is not metabolized by CYP isoenzymes.1

Elimination Route

Excreted principally in urine.1 Approximately 96% of a 70-mg radiolabeled oral dose of lisdexamfetamine was recovered in urine; parent drug accounted for about 2% of the recovered radioactivity.1

Changes in urinary pH may alter excretion of amphetamines.1 (See Specific Drugs, Tests, and Foods under Interactions.)

Half-life

Lisdexamfetamine: <1 hour;1 8 dextroamphetamine: 9.4–13 hours.3 8 30

• Provide patient or caregiver with a copy of the manufacturer’s patient information (medication guide); discuss and answer questions about its contents as needed.1 Instruct patient or caregiver to read and understand contents of medication guide before initiating therapy and each time the prescription is refilled.1

• Advise parents with concerns about long-term effects (e.g., effects on weight) and the need for continued therapy that drug holidays can be considered in consultation with the patient’s clinician.5 6 7 However, the benefits versus risks of such interruptions in therapy have not been established.7

• Question about possible substance abuse, including in other family members (since they may abuse the patient’s medication supply).1

• Advise to take drug in the morning to minimize insomnia.1

• Advise that appetite suppression may occur.1 5 Giving the morning dose with a meal and providing a high-caloric drink or snack late in the evening when the stimulant effects have subsided may be helpful.5

• Advise to inform clinician immediately if adverse cardiovascular (e.g., chest pain, shortness of breath, fainting) or psychiatric effects (e.g., hallucinations, delusional thinking, mania) occur.1

• Instruct about the potential for amphetamines to impair patient’s ability to perform potentially hazardous activities, such as driving or operating heavy machinery.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, dietary supplements, and herbal products, as well as any concomitant illnesses/conditions (e.g., cardiac/cardiovascular disease, thyroid disease, glaucoma, suicidal ideation or behaviors, mental/psychiatric disorder, seizures).1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)