DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Vyvanse (Lisdexamfetamine Dimesylate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

The efficacy of Vyvanse in the treatment of ADHD was established on the basis of two controlled trials in children aged 6 to 12, who met DSM-IV® criteria for ADHD (see CLINICAL TRIALS ).

A diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, in social, academic, or occupational functioning, and be present in two or more settings, e.g., at school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go"; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations: Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV® characteristics.

Need for Comprehensive Treatment Program: Vyvanse is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.

Long-Term Use: The effectiveness of Vyvanse for long-term use, i.e., for more than 4 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Vyvanse for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

Dosage should be individualized according to the therapeutic needs and response of the patient. Vyvanse should be administered at the lowest effective dosage.

In children with ADHD who are 6-12 years of age and are either starting treatment for the first time or switching from another medication, 30 mg once daily in the morning is the recommended dose. If the decision is made to increase the dose beyond 30 mg/day, daily dosage may be adjusted in increments of 20 mg/day and at approximately weekly intervals. The maximum recommended dose for children is 70 mg/day; doses greater than 70 mg/day of Vyvanse have not been studied in children. Amphetamines are not recommended for children under 3 years of age. Vyvanse has not been studied in children under 6 or over 12 years of age.

Vyvanse should be taken in the morning. Afternoon doses should be avoided because of the potential for insomnia.

Vyvanse may be taken with or without food.

Vyvanse capsules may be taken whole, or the capsule may be opened and the entire contents dissolved in a glass of water. If the patient is using the solution administration method, the solution should be consumed immediately; it should not be stored. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

HOW SUPPLIED

Vyvanse capsules 30 mg: white body/orange cap (imprinted NRP104 30 mg), bottles of 100, NDC 59417-103-10

Vyvanse capsules 50 mg: white body/blue cap (imprinted NRP104 50 mg), bottles of 100, NDC 59417-105-10

Vyvanse capsules 70 mg: blue body/orange cap (imprinted NRP104 70 mg), bottles of 100, NDC 59417-107-10

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

Store at 25° C (77° F). Excursions permitted to 15 - 30° C (59-86° F) [see USP Controlled Room Temperature]

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014