Lisdexamfetamine dimesylate

Lisdexamfetamine dimesylate capsules are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1) ] Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2) ] . Lisdexamfetamine dimesylate capsules are a central nervous system (CNS) stimulant indicated for the treatment of ( 1 ): Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older Moderate to severe binge eating disorder (BED) in adults Limitations of Use : The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years …

• Indicated Population Initial Dose Titration Schedule Recommended Dose Maximum Dose ADHD (Adults and pediatric patients 6 years and older) 30 mg every morning 10 mg or 20 mg weekly 30 mg to 70 mg per day 70 mg per day BED (Adults) 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 Severe renal impairment: Maximum dose is 50 mg/day End stage renal disease (ESRD): Maximum dose is 30 mg/day 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 ] . 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 ] General Instructions for Use 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. …

Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg ( 3 ) Lisdexamfetamine Dimesylate Capsules: Capsules 10 mg: Size 3 hard gelatin capsule with Opaque pink cap and body (imprinted with E0550 in black ink on cap and 10 mg on body) Capsules 20 mg: Size 3 hard gelatin capsule with Opaque Ivory cap and body (imprinted with E0551 in black ink on cap and 20 mg on body) Capsules 30 mg: Size 3 hard …

• 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 , Adverse Reactions , Clinical Pharmacology , and Clinical Studies ] . …

Clinical studies of lisdexamfetamine dimesylate 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. …

• 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 , Drug Abuse and Dependence , Overdosage ]
• 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. …

• Lisdexamfetamine dimesylate capsules are contraindicated in patients with: Known hypersensitivity to amphetamine products or other ingredients of lisdexamfetamine dimesylate capsules
• Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports [see Adverse Reactions ] . …

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 lisdexamfetamine dimesylate capsules 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) Clinical Impact 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. …

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 lisdexamfetamine dimesylate capsules, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing lisdexamfetamine dimesylate capsules. ( 5.4 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. …

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 Warn …

8.1 Pregnancy Risk Summary The limited available data from published literature and postmarketing reports on use of lisdexamfetamine dimesylate capsules in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers dependent on amphetamines [see Clinical Considerations ] . …

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. …

9.1 Controlled Substance Lisdexamfetamine Dimesylate Capsules contain lisdexamfetamine, a prodrug of amphetamine, a Schedule II controlled substance. 9.2 Abuse Lisdexamfetamine Dimesylate Capsules have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1 ] . Lisdexamfetamine Dimesylate Capsules can be diverted for non-medical use into illicit channels or distribution. …

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

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.