Lisdexamfetamine Dimesylate

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 lisdexamfetamine dimesylate capsules, 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 lisdexamfetamine dimesylate capsules [see Warnings and Precautions ( 5.8 )]. 2.2 General Administration Information Take lisdexamfetamine dimesylate capsules orally in the morning with or without food;
• avoid afternoon doses because of the potential for insomnia. Lisdexamfetamine dimesylate capsules may be administered in one of the following ways:
• Information for lisdexamfetamine dimesylate capsules:
• Swallow lisdexamfetamine dimesylate capsules whole, or
• Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. If the contents of the capsule include any compacted powder, a spoon may be used to break apart the powder. The contents should be mixed until completely dispersed. Consume the entire mixture immediately . It should not be stored. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed. Lisdexamfetamine dimesylate capsules can be substituted with lisdexamfetamine dimesylate chewable tablets on a unit per unit/mg per mg basis (for example, 30 mg capsules for 30 mg chewable tablet) [see Clinical Pharmacology ( 12.3 )].
• Do not take anything less than one capsule per day. A single dose should not be divided. 2.3 Dosage for Treatment of ADHD The recommended starting dosage in
• adults and pediatric patients 6 years and older is 30 mg once daily in the morning. Dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals up to maximum recommended dosage of 70 mg once daily [see Clinical Studies ( 14.1 )] . 2.4 Dosage for Treatment of Moderate to Severe BED in
• Adults The recommended starting dosage in
• adults is 30 mg once daily to be titrated in increments of 20 mg at approximately weekly intervals to achieve the recommended target dose of 50 mg to 70 mg once daily. The maximum recommended dosage is 70 mg once daily [see Clinical Studies ( 14.2 )] . Discontinue lisdexamfetamine dimesylate capsules if binge eating does not improve. 2.5 Dosage in Patients with Renal Impairment In patients with severe renal impairment (GFR 15 to <30 mL/min/1.73 m 2 ), the maximum dosage should not exceed 50 mg once daily. In patients with end stage renal disease (ESRD, GFR <15 mL/min/1.73 m 2 ), the maximum recommended dosage is 30 mg once daily [see Use in Specific Populations ( 8.6 )] . 2.6 Dosage Modifications due to Drug Interactions Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust lisdexamfetamine dimesylate capsules dosage accordingly [see Drug Interactions ( 7.1 )] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

• The safety and effectiveness of lisdexamfetamine dimesylate capsules have not been established in pediatric patients below the age of 6 years.
• ADHD Safety and effectiveness of lisdexamfetamine dimesylate capsules have been established in pediatric patients with ADHD ages 6 to 17 years [see Dosage and Administration ( 2.3 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.1 )] .
• Safety and efficacy of lisdexamfetamine dimesylate capsules were evaluated in a double-blind, randomized, parallel-group, placebo-controlled, fixed-dose study in pediatric patients ages 4 to 5 years with ADHD, followed by a 1-year open-label extension study.
• In these studies, patients experienced elevated rates of adverse reactions, including weight loss, decreased BMI, decreased appetite, insomnia, infections (upper respiratory and nasopharyngitis), irritability, and affect lability.
• With the same lisdexamfetamine dimesylate capsules dose, mean steady state exposure of dextroamphetamine was approximately 44% higher in pediatric patients ages 4 to 5 years compared to the pediatric patients ages 6 to 11 years.
• BED Safety and effectiveness of lisdexamfetamine dimesylate capsules have not been established in pediatric patients with BED less than 18 years of age.
• Growth Suppression Growth should be monitored during treatment with stimulants, including lisdexamfetamine dimesylate capsules, and pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions ( 5.5 ) and Adverse Reactions ( 6.1 )] .
• Juvenile Animal Data Studies conducted in juvenile rats and dogs at clinically relevant doses showed growth suppression that partially or fully reversed in dogs and female rats but not in male rats after a four-week drug-free recovery period.
• A study was conducted in which juvenile rats received oral doses of 4, 10, or 40 mg/kg/day of lisdexamfetamine dimesylate from day 7 to day 63 of age.
• These doses are approximately 0.3, 0.7, and 3 times the maximum recommended human daily dose of 70 mg on a mg/m 2 basis for a child.
• Dose-related decreases in food consumption, bodyweight gain, and crown-rump length were seen; after a four-week drug-free recovery period, bodyweights and crown-rump lengths had significantly recovered in females but were still substantially reduced in males.
• Time to vaginal opening was delayed in females at the highest dose, but there were no drug effects on fertility when the animals were mated beginning on day 85 of age.
• In a study in which juvenile dogs received lisdexamfetamine dimesylate for 6 months beginning at 10 weeks of age, decreased bodyweight gain was seen at all doses tested (2, 5, and 12 mg/kg/day, which are approximately 0.5, 1, and 3 times the maximum recommended human daily dose on a mg/m 2 basis for a child).
• This effect partially or fully reversed during a four- week drug-free recovery period.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical studies of lisdexamfetamine dimesylate capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
• Other reported clinical experience and pharmacokinetic data [see Clinical Pharmacology ( 12.3 )] have not identified differences in responses between the elderly and younger patients.
• In general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Quoted from the official label, section “Geriatric Use”.

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 lisdexamfetamine dimesylate capsules [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 common adverse reactions (incidence ≥5% and at a rate at least twice placebo) in
• adults with BED were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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 controlled parallel-group clinical studies of lisdexamfetamine dimesylate capsules in pediatric and adult patients with ADHD [see Clinical Studies ( 14.1 )] . Adverse Reactions Associated with Discontinuation of Treatment in ADHD Clinical Trials In the controlled trial in pediatric patients ages 6 to 12 years (Study 1), 8% (18/218) of lisdexamfetamine dimesylate capsules-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 pediatric patients ages 13 to 17 years (Study 4), 3% (7/233) of lisdexamfetamine dimesylate capsules-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 lisdexamfetamine dimesylate capsules-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. Adverse Reactions Occurring at an Incidence of ≥5% or More Among Lisdexamfetamine Dimesylate Capsules Treated Patients with ADHD in Clinical Trials The most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) reported in pediatric patients ages 6 to 17 years, and/or
• adults were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting. Adverse Reactions Occurring at an Incidence of 2% or More Among Lisdexamfetamine Dimesylate Capsules Treated Patients with ADHD in Clinical Trials Adverse reactions reported in the controlled trials in pediatric patients ages, 6 to 12 years (Study 1), pediatric patients ages 13 to 17 years (Study 4), and adult patients (Study 7) treated with lisdexamfetamine dimesylate capsules or placebo are presented in Tables 1, 2 and 3 below. Table 1 Adverse Reactions Reported by 2% or More of Pediatric Patients Ages 6 to 12 Years with ADHD Taking Lisdexamfetamine Dimesylate Capsules and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 1) Lisdexamfetamine Dimesylate Capsules (n=218) Placebo (n=72) Decreased Appetite 39% 4% Insomnia 22% 3% Abdominal Pain Upper 12% 6% Irritability 10% 0% Vomiting 9% 4% Weight Decreased 9% 1% Nausea 6% 3% Dry Mouth 5% 0% Dizziness 5% 0% Affect lability 3% 0% Rash 3% 0% Pyrexia 2% 1% Somnolence 2% 1% Tic 2% 0% Anorexia 2% 0% Table 2 Adverse Reactions Reported by 2% or More of Pediatric Patients Ages 13 to 17 Years with ADHD Taking Lisdexamfetamine Dimesylate Capsules and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 4) Lisdexamfetamine Dimesylate Capsules (n=233) Placebo (n=77) Decreased Appetite 34% 3% Insomnia 13% 4% Weight Decreased 9% 0% Dry Mouth 4% 1% Palpitations 2% 1% Anorexia 2% 0% Tremor 2% 0% Table 3 Adverse Reactions Reported by 2% or More of Adult Patients with ADHD Taking Lisdexamfetamine Dimesylate Capsules and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 7) Lisdexamfetamine Dimesylate Capsules (n=358) Placebo (n=62) Decreased Appetite 27% 2% Insomnia 27% 8% Dry Mouth 26% 3% Diarrhea 7% 0% Nausea 7% 0% Anxiety 6% 0% Anorexia 5% 0% Feeling Jittery 4% 0% Agitation 3% 0% Increased Blood Pressure 3% 0% Hyperhidrosis 3% 0% Restlessness 3% 0% Decreased Weight 3% 0% Dyspnea 2% 0% Increased Heart Rate 2% 0% Tremor 2% 0% Palpitations 2% 0% In addition, in the adult population erectile dysfunction was observed in 2.6% of males on lisdexamfetamine dimesylate capsules and 0% on placebo; decreased libido was observed in 1.4% of subjects on lisdexamfetamine dimesylate capsules and 0% on placebo. Weight Loss and Slowing Growth Rate in Pediatric Patients with ADHD In a controlled trial of lisdexamfetamine dimesylate capsules in pediatric patients 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 lisdexamfetamine dimesylate capsules, 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 pediatric patients ages 6 to 12 years who received lisdexamfetamine dimesylate capsules over 12 months suggests that consistently medicated pediatric patients (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 lisdexamfetamine dimesylate capsules in pediatric patients 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 lisdexamfetamine dimesylate capsules, compared to a 2.0 pound weight gain for patients receiving placebo. Careful follow-up of weight and height in pediatric patients 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 pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated pediatric patients ages 7 to 13 years (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 pediatric patients ages 13 to 17 years, 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 ( 5.5 )] . Weight Loss in
• Adults with ADHD 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 lisdexamfetamine dimesylate capsules, 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 14.2 ] . Patients with cardiovascular risk factors other than obesity and smoking were excluded. Adverse Reactions Associated with Discontinuation of Treatment in BED Clinical Trials In controlled trials of patients ages 18 to 55 years, 5.1% (19/373) of lisdexamfetamine dimesylate capsules-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 lisdexamfetamine dimesylate capsules-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. Adverse Reactions Occurring at an Incidence of 5% or More and At Least Twice Placebo Among Lisdexamfetamine Dimesylate Capsules Treated Patients with BED in Clinical Trials 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 Occurring at an Incidence of 2% or More and At Least Twice Placebo Among Lisdexamfetamine Dimesylate Capsules Treated Patients with BED in Clinical Trials Adverse reactions reported in the pooled controlled trials in adult patients (Study 11 and 12) treated with lisdexamfetamine dimesylate capsules or placebo are presented in Table 4 below. Table 4 Adverse Reactions Reported by 2% or More of Adult Patients with BED Taking Lisdexamfetamine Dimesylate Capsules and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in 12-Week Clinical Trials (Study 11 and 12) Lisdexamfetamine Dimesylate Capsules (N=373) Placebo (N=372) Dry Mouth 36% 7% Insomnia 1 20% 8% Decreased Appetite 8% 2% Increased Heart Rate 2 7% 1% Feeling Jittery 6% 1% Constipation 6% 1% Anxiety 5% 1% Diarrhea 4% 2% Decreased Weight 4% 0% Hyperhidrosis 4% 0% Vomiting 2% 1% Gastroenteritis 2% 1% Paresthesia 2% 1% Pruritus 2% 1% Upper Abdominal Pain 2% 0% Energy Increased 2% 0% Urinary Tract Infection 2% 0% Nightmare 2% 0% Restlessness 2% 0% Oropharyngeal Pain 2% 0% 1 Includes all preferred terms containing the word “insomnia.” 2 Includes the preferred terms “heart rate increased” and “tachycardia.” 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of lisdexamfetamine dimesylate capsules. 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. These events are as follows:
• cardiomyopathy, mydriasis, diplopia, difficulties with visual accommodation, blurred vision, eosinophilic hepatitis, anaphylactic reaction, hypersensitivity, dyskinesia, dysgeusia, motor and verbal tics, bruxism, depression, dermatillomania, alopecia, aggression, Stevens- Johnson Syndrome, chest pain, angioedema, urticaria, seizures, libido changes, frequent or prolonged erections, constipation, rhabdomyolysis, and intestinal ischemia.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Medication Guide).
• Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of lisdexamfetamine dimesylate capsules, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 ), Overdosage ( 10 )].
• Advise patients to store lisdexamfetamine dimesylate capsules in a safe place, preferably locked, and instruct patients to not give lisdexamfetamine dimesylate capsules to anyone else.
• Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with lisdexamfetamine dimesylate capsules use.
• Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions ( 5.2 )] .
• Increased Blood Pressure and Heart Rate Instruct patients that lisdexamfetamine dimesylate capsules can cause elevations of their blood pressure and pulse rate and they should be monitored for such effects.
• Psychiatric Adverse Reactions Advise patients that lisdexamfetamine dimesylate capsules at recommended doses may cause psychotic or manic symptoms even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions ( 5.4 )] .
• Long-Term Suppression of Growth in Pediatric Patients Advise patients that lisdexamfetamine dimesylate capsules may cause slowing of growth including weight loss [see Warnings and Precautions ( 5.5 )] .
• Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon] Instruct patients beginning treatment with lisdexamfetamine dimesylate capsules about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms:
• fingers or toes may feel numb, cool, painful, and/or may change from pale, to blue, to red.
• Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
• Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking lisdexamfetamine dimesylate capsules.
• Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions ( 5.6 )] .
• Serotonin Syndrome Caution patients about the risk of serotonin syndrome with concomitant use of lisdexamfetamine dimesylate capsules and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St.
• John’s Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see Contraindications ( 4 ), Warnings and Precautions ( 5.7 ) and Drug Interactions ( 7.1 )] .
• Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.
• Concomitant Medications Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see Drug Interactions ( 7.1 )] .
• Advise patient or caregiver of steps to take with lisdexamfetamine dimesylate capsules when a laboratory imaging procedure is ordered [see Drug Interactions ( 7.2 )] .
• Motor and Verbal Tics, and Worsening of Tourette’s Syndrome Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with lisdexamfetamine dimesylate capsules.
• Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions ( 5.8 )] .
• Pregnancy Advise patients of the potential fetal effects from the use of lisdexamfetamine dimesylate capsules during pregnancy.
• Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with lisdexamfetamine dimesylate capsules [see Use in Specific Populations ( 8.1 )] .
• Lactation Advise women not to breastfeed if they are taking lisdexamfetamine dimesylate capsules [see Use in Specific Populations ( 8.2 )] .
• Administration Instructions Capsules:
• Advise patients to take the capsules whole or empty and mix the entire contents with yogurt, water, or orange juice.
• Advise patients to consume the mixture immediately and not to store for future use [see Dosage and Administration ( 2.2 )].
• Manufactured by:
• Prinston Laboratories Charlotte, NC 28206, USA Distributed by:
• Solco Healthcare US, LLC Somerset, NJ 08873, USA For more information call 1-866-257-2597 Revised:
• 05/2026 9040750-02

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Lisdexamfetamine dimesylate capsules:
• Capsules 10 mg: SIZE “3” Capsule, opaque pink body/opaque pink cap (imprinted with S6 10)
• Capsules 20 mg:
• SIZE “3” Capsule, opaque ivory body/opaque ivory cap (imprinted with S6 20)
• Capsules 30 mg:
• SIZE “3” Capsule, opaque white body/opaque orange cap (imprinted with S6 30)
• Capsules 40 mg:
• SIZE “3” Capsule, opaque white body/opaque blue green cap (imprinted with S6 40)
• Capsules 50 mg:
• SIZE “3” Capsule, opaque white body/opaque blue cap (imprinted with S6 50)
• Capsules 60 mg:
• SIZE “3” Capsule, opaque aqua blue body/opaque aqua blue cap (imprinted with S6 60)
• Capsules 70 mg:
• SIZE “3” Capsule, opaque blue body/opaque orange cap (imprinted with S6 70)
• Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied Lisdexamfetamine dimesylate capsules:
• Lisdexamfetamine dimesylate capsules 10 mg:
• SIZE “3” Capsule, opaque pink body/opaque pink cap (imprinted with S6 10), bottles of 100, NDC 43547-602-10
• Lisdexamfetamine dimesylate capsules 20 mg:
• SIZE “3” Capsule, opaque ivory body/opaque ivory cap (imprinted with S6 20), bottles of 100, NDC 43547-603-10
• Lisdexamfetamine dimesylate capsules 30 mg:
• SIZE “3” Capsule, opaque white body/opaque orange cap (imprinted with S6 30), bottles of 100, NDC 43547-604-10
• Lisdexamfetamine dimesylate capsules 40 mg:
• SIZE “3” Capsule, opaque white body/opaque blue green cap (imprinted with S6 40), bottles of 100, NDC 43547-605-10
• Lisdexamfetamine dimesylate capsules 50 mg:
• SIZE “3” Capsule, opaque white body/opaque blue cap (imprinted with S6 50), bottles of 100, NDC 43547-606-10
• Lisdexamfetamine dimesylate capsules 60 mg:
• SIZE “3” Capsule, opaque aqua blue body/opaque aqua blue cap (imprinted with S6 60), bottles of 100, NDC 43547-607-10
• Lisdexamfetamine dimesylate capsules 70 mg:
• SIZE “3” Capsule, opaque blue body/opaque orange cap (imprinted with S6 70), bottles of 100, NDC 43547-608-10 16.2 Storage and Handling Dispense in a tight, light-resistant container as defined in the USP.
• Store at room temperature, 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted between 15ºC and 30ºC (59ºF and 86ºF) [see USP Controlled Room Temperature] .
• Lisdexamfetamine dimesylate capsules:
• Lisdexamfetamine dimesylate capsules 10 mg:
• SIZE “3” Capsule, opaque pink body/opaque pink cap (imprinted with S6 10), bottles of 100, NDC 43547-602-10
• Lisdexamfetamine dimesylate capsules 20 mg:
• SIZE “3” Capsule, opaque ivory body/opaque ivory cap (imprinted with S6 20), bottles of 100, NDC 43547-603-10
• Lisdexamfetamine dimesylate capsules 30 mg:
• SIZE “3” Capsule, opaque white body/opaque orange cap (imprinted with S6 30), bottles of 100, NDC 43547-604-10
• Lisdexamfetamine dimesylate capsules 40 mg:
• SIZE “3” Capsule, opaque white body/opaque blue green cap (imprinted with S6 40), bottles of 100, NDC 43547-605-10
• Lisdexamfetamine dimesylate capsules 50 mg:
• SIZE “3” Capsule, opaque white body/opaque blue cap (imprinted with S6 50), bottles of 100, NDC 43547-606-10
• Lisdexamfetamine dimesylate capsules 60 mg:
• SIZE “3” Capsule, opaque aqua blue body/opaque aqua blue cap (imprinted with S6 60), bottles of 100, NDC 43547-607-10
• Lisdexamfetamine dimesylate capsules 70 mg:
• SIZE “3” Capsule, opaque blue body/opaque orange cap (imprinted with S6 70), bottles of 100, NDC 43547-608-10

Quoted from the official label, section “How Supplied”.

How to store it

• Dispense in a tight, light-resistant container as defined in the USP.
• Store at room temperature, 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted between 15ºC and 30ºC (59ºF and 86ºF) [see USP Controlled Room Temperature] .

Quoted from the official label, section “Storage and Handling”.

What is in it

• Lisdexamfetamine dimesylate capsules, a CNS stimulant, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino‑ N -[(1 S )-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). Information for lisdexamfetamine dimesylate capsules:
• Lisdexamfetamine dimesylate 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:
• croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The imprinting ink for all strengths contain D&C yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, iron oxide black, potassium hydroxide, propylene glycol and shellac glaze. The capsule shells of each strength contain ingredients as below:
• Strength Ingredients 10 mg FD&C Blue 1, FD&C Red 3, gelatin, sodium lauryl sulfate and titanium dioxide 20 mg gelatin, Iron Oxide Yellow, sodium lauryl sulfate and titanium dioxide 30 mg FD&C Red 3, FD&C Yellow 6, gelatin, sodium lauryl sulfate and titanium dioxide 40 mg FD&C Blue 1, gelatin, Iron Oxide Black, Iron Oxide Yellow, sodium lauryl sulfate and titanium dioxide 50 mg FD&C Blue 1, gelatin, sodium lauryl sulfate and titanium dioxide 60 mg FD&C Blue 1, gelatin, sodium lauryl sulfate and titanium dioxide 70 mg FD&C Blue 1, FD&C Red 3, FD&C Yellow 6, gelatin, sodium lauryl sulfate and titanium dioxide chemical structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

159 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Lisdexamfetamine Dimesylate Capsules