Lisdexamfetamine dimesylate 30 mg/1
Lisdexamfetamine dimesylate · CAPSULE · Sandoz Inc
Lisdexamfetamine dimesylate is a capsule containing lisdexamfetamine dimesylate at 30 mg/1, taken oral. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Lisdexamfetamine dimesylate
- Generic Name
- Lisdexamfetamine dimesylate
- NDC Code (Product)
0781-2477- Manufacturer
- Sandoz Inc
- Strength
- 30 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA202836
- Marketing Start
- 09/16/2025
Recall History
Shire
Presence of Foreign Tablets/Capsules
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lannett Company Inc.
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lannett Company Inc.
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 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 ) Lisdexamfetamine dimesylate capsules are 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 lisdexamfetamine dimesylate capsules for the treatment of obesity have not been e…
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 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 Instructions for Use Take lisdexamfetamine dimesylate capsules orally in the morning with or without food; avoid afternoon doses because of the potential for insomnia.…
Contraindications
4 CONTRAINDICATIONS 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 (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 lisdexamfetamine dimesylate capsules ( 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 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. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results. Intervention Do not administer lisdexamfetamine dimesylate capsules during or within 14 days following the administration of MAOI [see Contraindications (4) ] . Serotonergic Drugs Clinical Impact The concomitant use of lisdexamfetamine dimesylate capsules and serotonergic drugs increases the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for s…
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 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…
Frequently Asked Questions
What is Lisdexamfetamine dimesylate used for?
Lisdexamfetamine dimesylate contains Lisdexamfetamine dimesylate. It is a capsule taken oral. Consult your doctor for specific uses.
Is Lisdexamfetamine dimesylate a controlled substance?
Yes, Lisdexamfetamine dimesylate is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Lisdexamfetamine dimesylate?
The generic name for Lisdexamfetamine dimesylate is Lisdexamfetamine dimesylate. There are 8 other brand versions of Lisdexamfetamine dimesylate.
What is the NDC code for Lisdexamfetamine dimesylate 30 mg/1?
The NDC (National Drug Code) for Lisdexamfetamine dimesylate 30 mg/1 is 0781-2477, listed by Sandoz Inc.
Other Lisdexamfetamine Brands
See all →- LISDEXAMFETAMINE DIMESYLATE10 mg/172162-2451
- LISDEXAMFETAMINE DIMESYLATE30 mg/172162-2454
- lisdexamfetamine dimesylate60 mg/10480-9744
- LISDEXAMFETAMINE DIMESYLATE60 mg/131722-326
- LISDEXAMFETAMINE DIMESYLATE40 mg/142858-164
- Vyvanse50 mg/159417-105
- Vyvanse60 mg/159417-106
- Lisdexamfetamine Dimesylate60 mg/160505-4744
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)