Drugplain

Vyvanse 50 mg/1

lisdexamfetamine dimesylate · CAPSULE · Takeda Pharmaceuticals America, Inc.

1 Recall on RecordCurrently in Shortage
Plain English

Vyvanse is a capsule containing lisdexamfetamine dimesylate at 50 mg/1, taken oral. Manufactured by Takeda Pharmaceuticals America, Inc..

Key Facts

Brand Name
Vyvanse
Generic Name
lisdexamfetamine dimesylate
NDC Code (Product)
59417-105
Manufacturer
Takeda Pharmaceuticals America, Inc.
Strength
50 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
NDA021977
Marketing Start
02/23/2007

Recall History

1 Recall on Record
Class III09/02/2016

Shire

Presence of Foreign Tablets/Capsules

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE VYVANSE ® is 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) ] . VYVANSE is 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 VYVANSE 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 ) VYVANSE is not indicated 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 ( 5.2 ) Limitations of Use: The use of VYVANSE is not recommended in pediatric patients younger than 6 years of age because they had h…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION 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 VYVANSE, 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 VYVANSE [see Warnings and Precautions (5.8) ] . 2.2 General Administration Information Take VYVANSE orally in the morning with or without food; avoid afternoon doses because of the potential for insomnia. VYVANSE may be administered in one of the following ways: Information for VYVA…

Contraindications

4 CONTRAINDICATIONS VYVANSE is contraindicated in patients with: Known hypersensitivity to amphetamine products or other ingredients of VYVANSE. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports [see Adverse Reactions (6.2) ] . Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.7) and Drug Interactions (7.1) ] . Known hypersensitivity to amphetamine products or other ingredients in VYVANSE ( 4 ) Use with monoamine oxidase (MAO) inhibitor, or within 14 days of the last MAO inhibitor dose ( 4 , 7.1 )

Drug Interactions

7 DRUG INTERACTIONS Acidifying and Alkalinizing Agents: Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels. Adjust VYVANSE 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. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results. Intervention Do not administer VYVANSE during or within 14 days following the administration of MAOI [see Contraindications (4) ] . Serotonergic Drugs Clinical Impact The concomitant use of VYVANSE and serotonergic drugs increases the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during VYVANSE initiation or dos…

Adverse Reactions

6 ADVERSE REACTIONS 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 (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 …

Frequently Asked Questions

What is Vyvanse used for?

Vyvanse contains lisdexamfetamine dimesylate. It is a capsule taken oral. Consult your doctor for specific uses.

Is Vyvanse a controlled substance?

Yes, Vyvanse is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Vyvanse?

The generic name for Vyvanse is lisdexamfetamine dimesylate. There are 10 other brand versions of lisdexamfetamine dimesylate.

What is the NDC code for Vyvanse 50 mg/1?

The NDC (National Drug Code) for Vyvanse 50 mg/1 is 59417-105, listed by Takeda Pharmaceuticals America, Inc..

Product NDC

59417-105

Package NDC

59417-105-10

Other Vyvanse Dosages

Other Lisdexamfetamine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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