ADDERALL INDICATIONS AND USAGE
- Attention Deficit Hyperactivity Disorder
ADDERALL XR® is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). The efficacy of ADDERALL XR in the treatment of ADHD was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met DSM-IV® criteria for ADHD. A diagnosis of ADHD (DSM-IVÒ) 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, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., 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 patient and not solely on the presence of the required number of DSM-IVÒ characteristics.
Need for Comprehensive Treatment Program
ADDERALL XR 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 patients with this syndrome. Stimulants are not intended for use in the patient 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.
The effectiveness of ADDERALL XR for long-term use, i.e., for more than 3 weeks in children and 4 weeks in adolescents and adults, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use ADDERALL XR for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
DOSAGE and ADMINISTRATION
- Dosing Considerations for all Patients
Individualize the dosage according to the therapeutic needs and response of the patient. Administer ADDERALL XR at the lowest effective dosage. Based on bioequivalence data, patients taking divided doses of immediate-release ADDERALL,(for example, twice daily), may be switched to ADDERALL XRat the same total daily dose taken once daily. Titrate at weekly intervals to appropriate efficacy and tolerability as indicated. ADDERALL XR capsules may be taken whole, or the capsule may be opened and the entire contents sprinkled on applesauce. If the patient is using the sprinkle administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. 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. ADDERALL XR may be taken with or without food. ADDERALL XR should be given upon awakening. Afternoon doses should be avoided because of the potential for insomnia. Where possible, ADDERALL XR therapy should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.
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, start with 10 mg once daily in the morning; daily dosage may be adjusted in increments of 5 mg or 10 mg at weekly intervals. When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with 5 mg once daily in the morning. The maximum recommended dose for children is 30 mg/day; doses greater than 30 mg/day of ADDERALL XR have not been studied in children. ADDERALL XR has not been studied in children under 6 years of age.
The recommended starting dose for adolescents with ADHD who are 13-17 years of age and are either starting treatment for the first time or switching from another medication is 10 mg/day. The dose may be increased to 20 mg/day after one week if ADHD symptoms are not adequately controlled.
In adults with ADHD who are either starting treatment for the first time or switching from another medication, the recommended dose is 20 mg/day.
DOSAGE FORMS AND STRENGTHS
- ADDERALL XR5 mg capsules: Clear/blue (imprinted ADDERALL XR 5 mg)
- ADDERALL XR10 mg capsules: Blue/blue (imprinted ADDERALL XR 10 mg)
- ADDERALL XR15 mg capsules: Blue/white (imprinted ADDERALL XR 15 mg)
- ADDERALL XR20 mg capsules: Orange/orange (imprinted ADDERALL XR 20 mg)
- ADDERALL XR25 mg capsules: Orange/white (imprinted ADDERALL XR 25 mg)
- ADDERALL XR30 mg capsules: Natural/orange (imprinted ADDERALL XR 30 mg)
ADDERALL XR administration is contraindicated in patients with the following conditions:
· Advanced arteriosclerosis
· Symptomatic cardiovascular disease
· Moderate to severe hypertension
· Known hypersensitivity or idiosyncrasy to the sympathomimetic amines (e.g., anaphylaxis, angioedema, serious skin rashes)
· Agitated states
· History of drug abuse
· During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result)
WARNINGS AND PRECAUTIONS
- Serious Cardiovascular Events
- Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems
Children and Adolescents
Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
People who take stimulant drugs for ADHD at the usual doses have died suddenly, had a stroke, or had a heart attack. Even though the role of stimulants in these cases of adults is also unknown, adults are more likely than kids to have serious structural.
Hypertension and Other Heart and Blood Vessel Problems
Average increases in blood pressure (about 2-4 mmHg) and heart rate (about 3-6 bpm) from stimulant drugs can be small or large, depending on the person. Even though the mean changes probably won't have any short-term effects on their own, all patients should be checked for bigger changes in their heart rate and blood pressure. Patients whose underlying medical conditions could be hurt by an increase in blood pressure or heart rate should be treated with care. This includes people who already have high blood pressure, heart failure, a recent myocardial infarction, or ventricular arrhythmia.
Checking the heart health of people who are being treated with stimulant drugs
Children, teens, or adults who are thinking about taking stimulant medications should have a careful history and physical exam to check for heart disease. This should include looking for a family history of sudden death or ventricular arrhythmia. If the history and exam show signs of heart disease, the person should get a full cardiac evaluation (e.g. electrocardiogram and echocardiogram). During stimulant treatment, patients who start having chest pain when they work out, fainting for no apparent reason, or other signs of heart disease should get a cardiac evaluation right away.
5.2 Bad Psychiatric Events
Psychosis from before
If a person already has a psychotic disorder, giving them stimulants may make their behavior problems and thought problems worse.
When using stimulants to treat ADHD in people who also have bipolar disorder, extra care should be taken to avoid triggering a mixed/manic episode in these people. Before starting treatment with a stimulant, people who also have depressive symptoms should be properly screened to see if they are at risk for bipolar disorder. This screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
New psychotic or manic symptoms show up
Stimulants at normal doses can cause psychotic or manic symptoms to appear during treatment, such as hallucinations, delusions, or mania, in children and teens who have never had psychotic illness or mania before. If these symptoms happen, the stimulant may be to blame, and the treatment may need to be stopped. In a pooled analysis of several short-term, placebo-controlled studies, these symptoms happened in about 0.1% (4 out of 3482 patients who took methylphenidate or amphetamine at normal doses for a few weeks) of stimulant-treated patients, but not in any placebo-treated patients.
Children and teens with ADHD often show aggressive or hostile behavior. This has been reported in clinical trials and after the drugs were sold to treat ADHD. Even though there isn't a lot of evidence that stimulants cause aggressive or hostile behavior, people with ADHD who start taking stimulants should be watched for the start of or worsening of aggressive or hostile behavior.
5.3 Slowing down growth in the long run
Watch how much children grow while they are taking stimulants. If a person is not growing or gaining weight as expected, their treatment may need to be stopped. Careful follow-up of weight and height in children ages 7 to 10 who were randomly assigned to methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average). In a controlled trial of ADDERALL XR in teenagers, the average weight change from the start of treatment to 4 weeks later was 1.1 lbs. for those taking 10 mg and 2.8 lbs. for those taking 20 mg. In the first 4 weeks of treatment, people who took higher doses lost more weight. You can expect the same thing to happen if you use amphetamines for a long time.