Buy Adderall xr 10 mg may cause serious side effects including:
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Adderall xr 10 mg. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-909-545-6717.
POTENTIAL FOR ABUSE
Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Pay particular attention to the possibility of subjects obtaining amphetamines for nontherapeutic use or distribution to others and the drugs should be prescribed or dispensed sparingly [see Drug Abuse And Dependence].
Misuse of amphetamine may cause sudden death and serious cardiovascular adverse reactions.
Adderall xr 10 mg is a once daily extended-release, single-entity amphetamine product. Adderall xr 10 mg combines the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d,l-amphetamine aspartate monohydrate. The Adderall xr 10 mg capsule contains two types of drug-containing beads designed to give a double-pulsed delivery of amphetamines, which prolongs the release of amphetamine from Adderall xr 10 mg compared to the conventional ADDERALL (immediate-release) tablet formulation.
Each capsule contains: 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg
Dextroamphetamine Saccharate 1.25 mg 2.5mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg
Amphetamine Aspartate Monohydrate 1.25 mg 2.5mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg
Dextroamphetamine Sulfate USP 1.25 mg 2.5mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg
Amphetamine Sulfate USP 1.25 mg 2.5mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg
Total amphetamine base equivalence 3.1 mg 6.3mg 9.4 mg 12.5mg 15.6 mg 18.8 mg
Inactive Ingredients and Colors
The inactive ingredients in Adderall xr 10 mg capsules include: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, sugar spheres, talc, and triethyl citrate. Gelatin capsules contain edible inks, kosher gelatin, and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #2. The 20 mg, 25 mg, and 30 mg capsules also contain red iron oxide and yellow iron oxide.
Attention Deficit Hyperactivity Disorder
Adderall xr 10 mg® is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).
The efficacy of Adderall xr 10 mg 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 [see Clinical Studies].
A diagnosis of 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, 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 recredits. 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-IV® characteristics.
Need for Comprehensive Treatment Program
Adderall xr 10 mg 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 10 mg 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 10 mg for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
The abbreviated term ADHD denotes the condition commonly known as:
DOSAGE AND ADMINISTRATION
Dosing Considerations For All Patients
Individualize the dosage according to the therapeutic needs and response of the patient. Administer Adderall xr 10 mg 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 xr 10 mg at the same total daily dose taken once daily. Titrate at weekly intervals to appropriate efficacy and tolerability as indicated.
Adderall xr 10 mg 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 10 mg may be taken with or without food.
Adderall xr 10 mg should be given upon awakening. Afternoon doses should be avoided because of the potential for insomnia.
Where possible, Adderall xr 10 mg 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 10 mg have not been studied in children. Adderall xr 10 mg 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 xr 10 mg 5 mg capsules: Clear/blue (imprinted Adderall xr 10 mg 5 mg)
Adderall xr 10 mg 10 mg capsules: Blue/blue (imprinted Adderall xr 10 mg 10 mg)
Adderall xr 10 mg 15 mg capsules: Blue/white (imprinted Adderall xr 10 mg 15 mg)
Adderall xr 10 mg 20 mg capsules: Orange/orange (imprinted Adderall xr 10 mg 20 mg)
Adderall xr 10 mg 25 mg capsules: Orange/white (imprinted Adderall xr 10 mg 25 mg)
Adderall xr 10 mg 30 mg capsules: Natural/orange (imprinted Adderall xr 10 mg 30 mg)
Storage And Handling
Adderall xr 10 mg 5 mg capsules: Clear/blue (imprinted Adderall xr 10 mg 5 mg), bottles of 100, NDC 54092-381-01
Adderall xr 10 mg 10 mg capsules: Blue/blue (imprinted Adderall xr 10 mg 10 mg), bottles of 100, NDC 54092-383-01
Adderall xr 10 mg 15 mg capsules: Blue/white (imprinted Adderall xr 10 mg 15 mg), bottles of 100, NDC 54092-385-01
Adderall xr 10 mg 20 mg capsules: Orange/orange (imprinted Adderall xr 10 mg 20 mg), bottles of 100, NDC 54092-387-01
Adderall xr 10 mg 25 mg capsules: Orange/white (imprinted Adderall xr 10 mg 25 mg), bottles of 100, NDC 54092-389-01
Adderall xr 10 mg 30 mg capsules: Natural/orange (imprinted Adderall xr 10 mg 30 mg), bottles of 100, NDC 54092-391-01
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]
Manufactured for Shire US Inc., Wayne, PA 19087. Revised: Apr 2015
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Studies Experience
The premarketing development program for Adderall xr 10 mg included exposures in a total of 1315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy adult subjects). Of these, 635 patients (ages 6 to 12) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N= 40). Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse reactions, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.
Adverse reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized event categories. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse reactions.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed.
Adverse Reactions Leading to Discontinuation of Treatment
In two placebo-controlled studies of up to 5 weeks duration among children with ADHD, 2.4% (10/425) of Adderall xr 10 mg-treated patients discontinued due to adverse reactions (including 3 patients with loss of appetite, one of whom also reported insomnia) compared to 2.7% (7/259) receiving placebo.
The most frequent adverse reactions leading to discontinuation of Adderall xr 10 mg in controlled and uncontrolled, multiple-dose clinical trials of children (N=595) were anorexia (loss of appetite) (2.9%), insomnia (1.5%), weight loss (1.2%), emotional lability (1%), and depression (0.7%). Over half of these patients were exposed to Adderall xr 10 mg for 12 months or more.
In a separate placebo-controlled 4-week study in adolescents with ADHD, five patients (2.1%) discontinued treatment due to adverse events among Adderall xr 10 mg-treated patients (N=233) compared to none who received placebo (N=54). The most frequent adverse event leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of Adderall xr 10 mg-treated patients and at a rate at least twice that of placebo) was insomnia (1.3%, n=3). In one placebo-controlled 4-week study among adults with ADHD with doses 20 mg to 60 mg, 23 patients (12.0% ) discontinued treatment due to adverse events among Adderall xr 10 mg-treated patients (N=191) compared to one patient (1.6%) who received placebo (N=64). The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of Adderall xr 10 mg-treated patients and at a rate at least twice that of placebo) were insomnia (5.2%, n=10), anxiety (2.1%, n=4), nervousness(1.6%, n=3), dry mouth (1.6%, n=3), anorexia (1.6%, n=3), tachycardia (1.6%, n=3), headache (1.6%, n=3), and asthenia (1.0%, n=2).
Adverse Reactions Occurring in Controlled Trials
Adverse reactions reported in a 3-week clinical trial of children and a 4-week clinical trial in adolescents and adults, respectively, treated with Adderall xr 10 mg or placebo are presented in the tables below.
Table 1 : Adverse Reactions Reported by 2% or More of Children (6-12 Years Old) Receiving Adderall xr 10 mg with Higher Incidence Than on Placebo in a 584-Patient Clinical Study
Body System Preferred Term Adderall xr 10 mg
General Abdominal Pain (stomachache) 14% 10%
Fever 5% 2%
Infection 4% 2%
Accidental Injury 3% 2%
Asthenia (fatigue) 2% 0%
Digestive System Loss of Appetite 22% 2%
Vomiting 7% 4%
Nausea 5% 3%
Dyspepsia 2% 1%
Nervous System Insomnia 17% 2%
Emotional Lability 9% 2%
Nervousness 6% 2%
Dizziness 2% 0%
Metabolic/ Nutritional Weight Loss 4% 0%
Table 2 : Adverse Reactions Reported by 5% or More of Adolescents (13-17 Years Old) Weighing ≤ 75 kg/165 lbs Receiving Adderall xr 10 mg with Higher Incidence Than Placebo in a 287 Patient Clinical Forced Weekly-Dose Titration Study*
Body System Preferred Term Adderall xr 10 mg
General Abdominal Pain (stomachache) 11% 2%
Digestive System Loss of Appetiteb 36% 2%
Nervous System Insomniab 12% 4%
Nervousness 6% 6%a
Metabolic/ Nutritional Weight Lossb 9% 0%
*Included doses up to 40 mg
a Appears the same due to rounding
b Dose-related adverse reactions
Note: The following reactions did notmeet the criterion for inclusion in Table 2 but were reported by 2% to 4% of adolescent patients receiving Adderall xr 10 mg with a higher incidence than patients receiving placebo in this study: accidental injury, asthenia (fatigue), dry mouth, dyspepsia, emotional lability, nausea, somnolence, and vomiting.
Table 3 : Adverse Reactions Reported by 5% or More of Adults Receiving Adderall xr 10 mg with Higher Incidence Than on Placebo in a 255 Patient Clinical Forced Weekly-Dose Titration Study*
Body System Preferred Term Adderall xr 10 mg
General Headache 26% 13%
Asthenia 6% 5%
Digestive System Dry Mouth 35% 5%
Loss of Appetite 33% 3%
Nausea 8% 3%
Diarrhea 6% 0%
Nervous System Insomnia 27% 13%
Agitation 8% 5%
Anxiety 8% 5%
Dizziness 7% 0%
Nervousness 13% 13%a
Cardiovascular System Tachycardia 6% 3%
Metabolic/ Nutritional Weight Loss 10% 0%
Urogenital System Urinary Tract Infection 5% 0%
*Included doses up to 60 mg.
a Appears the same due to rounding
Note: The following reactions did not meet the criterion for inclusion in Table 3 but were reported by 2% to 4% of adult patients receiving Adderall xr 10 mg with a higher incidence than patients receiving placebo in this study: infection, photosensitivity reaction, constipation, tooth disorder (e.g., teeth clenching, tooth infection), emotional lability, libido decreased, somnolence, speech disorder (e.g., stuttering, excessive speech), palpitation, twitching, dyspnea, sweating, dysmenorrhea, and impotence.
[see WARNINGS AND PRECAUTIONS]
In a controlled 4-week outpatient clinical study of adolescents with ADHD, isolated systolic blood pressure elevations ≥ 15 mmHg were observed in 7/64 (11%) placebotreated patients and 7/100 (7%) patients receiving Adderall xr 10 mg 10 or 20 mg. Isolated elevations in diastolic blood pressure ≥ 8 mmHg were observed in 16/64 (25%) placebo-treated patients and 22/100 (22%) Adderall xr 10 mg-treated patients. Similar results were observed at higher doses.
In a single-dose pharmacokinetic study in 23 adolescents with ADHD, isolated increases in systolic blood pressure (above the upper 95% CI for age, gender, and stature) were observed in 2/17 (12%) and 8/23 (35%), subjects administered 10 mg and 20 mg Adderall xr 10 mg, respectively. Higher single doses were associated with a greater increase in systolic blood pressure. All increases were transient, appeared maximal at 2 to 4 hours post dose and not associated with symptoms.
Adverse Reactions Associated With The Use of Amphetamine, Adderall xr 10 mg, Or ADDERALL
The following adverse reactions have been associated with the use of amphetamine, Adderall xr 10 mg, or ADDERALL:
Palpitations. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
Central Nervous System
Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania, paresthesia (including formication), and bruxism.
Vision blurred, mydriasis.
Unpleasant taste, constipation, other gastrointestinal disturbances.
Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.
Impotence, changes in libido, frequent or prolonged erections.
Musculoskeletal and Connective Tissue Disorders
ADHD Symptoms in Children
Agents That Increase Blood Levels Of Amphetamines
MAOI antidepressants slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results. Do not administer Adderall xr 10 mg during or within 14 days following the administration of monoamine oxidase inhibitors [see CONTRAINDICATIONS].
Gastrointestinal alkalinizing agents (e.g., sodium bicarbonate) increase absorption of amphetamines. Co-administration of Adderall xr 10 mg and gastrointestinal alkalinizing agents, such as antacids, should be avoided. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentiate the actions of amphetamines.
Agents That Lower Blood Levels Of Amphetamines
Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid) lower absorption of amphetamines. Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts) increase the concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines.
Agents Whose Effects May Be Reduced By Amphetamines
Amphetamines may reduce the cardiovascular effects of adrenergic blockers.
Amphetamines may counteract the sedative effect of antihistamines.
Amphetamines may antagonize the hypotensive effects of antihypertensives.
Amphetamines inhibit the hypotensive effect of veratrum alkaloids.
Amphetamines may delay intestinal absorption of phenobarbital.
Amphetamines may delay intestinal absorption of phenytoin.
Amphetamines may delay intestinal absorption of ethosuximide.
Agents Whose Effects May Be Potentiated By Amphetamines
Amphetamines may enhance the activity of tricyclic antidepressants or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.
Amphetamines potentiate the analgesic effect of meperidine.
Amphetamines may enhance the adrenergic effect of norepinephrine.
Agents That May Reduce The Effects Of Amphetamines
Chlorpromazine blocks dopamine and norepinephrine receptors, thus inhibiting the central stimulant effects of amphetamines.
Haloperidol blocks dopamine receptors, thus inhibiting the central stimulant effects of amphetamines.
The anorectic and stimulatory effects of amphetamines may be inhibited by lithium carbonate.
Agents That May Potentiate The Effects Of Amphetamines
Norepinephrine may enhance the adrenergic effect of amphetamine.
In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.
Proton Pump Inhibitors (PPI)
PPIs act on proton pumps by blocking acid production, thereby reducing gastric acidity. When Adderall xr 10 mg (20 mg single-dose) was administered concomitantly with the proton pump inhibitor, omeprazole (40 mg once daily for 14 days), the median Tmax of d-amphetamine was decreased by 1.25 hours (from 4 to 2.75 hours), and the median Tmax of l-amphetamine was decreased by 2.5 hours (from 5.5 to 3 hours), compared to Adderall xr 10 mg administered alone. The AUC and Cmax of each moiety were unaffected. Therefore, co-administration of Adderall xr 10 mg and proton pump inhibitors should be monitored for changes in clinical effect.
Drug/Laboratory Test Interactions
Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.
Drug Abuse And Dependence
Adderall xr 10 mg is a Schedule II controlled substance.
Abuse And Dependence
Amphetamines have been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have occurred. There are reports of patients who have increased the dosage to levels many times higher than recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines may include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.
Warnings & Precautions
Included as part of the PRECAUTIONS section.
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 [see CONTRAINDICATIONS].
Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs [see CONTRAINDICATIONS].
Hypertension and Other Cardiovascular Conditions
Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia [see CONTRAINDICATIONS and ADVERSE REACTIONS].
Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications
Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g. electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.
Psychiatric Adverse Events
Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder.
Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
Emergence of New Psychotic or Manic Symptoms
Treatment-emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebotreated patients.
Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.
Long-Term Suppression Of Growth
Monitor growth in children during treatment with stimulants. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted. Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either 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 (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.
In a controlled trial of Adderall xr 10 mg in adolescents, mean weight change from baseline within the initial 4 weeks of therapy was –1.1 lbs. and –2.8 lbs., respectively, for patients receiving 10 mg and 20 mg Adderall xr 10 mg. Higher doses were associated with greater weight loss within the initial 4 weeks of treatment. Chronic use of amphetamines can be expected to cause a similar suppression of growth.
There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in the absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, Adderall xr 10 mg should be discontinued.
Peripheral Vasculopathy, Including Raynaud's phenomenon
Stimulants, including Adderall xr 10 mg, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.
Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in patients and their families should precede use of stimulant medications.
Prescribing And Dispensing
The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Adderall xr 10 mg should be used with caution in patients who use other sympathomimetic drugs.
Patient Counseling Information
Information On Medication Guide
Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Adderall xr 10 mg and should counsel them in its appropriate use. A patient Medication Guide is available for Adderall xr 10 mg. Instruct patients, their families, and their caregivers to read the Medication Guide and assist them in understanding its contents. Give patients the opportunity to discuss the contents of theMedication Guide and to obtain answers to any questions theymay have. The complete text of the Medication Guide is reprinted at the end of this document.
Controlled Substance Status/Potential For Abuse, Misuse, And Dependence
Advise patients that Adderall xr 10 mg is a federally controlled substance because it can be abused or lead to dependence. Additionally, emphasize that Adderall xr 10 mg should be stored in a safe place to prevent misuse and/or abuse. Evaluate patient history (including family history) of abuse or dependence on alcohol, prescription medicines, or illicit drugs [see Drug Abuse And Dependence].
Serious Cardiovascular Risks
Advise patients of serious cardiovascular risk (including sudden death, myocardial infarction, stroke, and hypertension) with Adderall xr 10 mg. Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during treatment should undergo a prompt cardiac evaluation [see WARNINGS AND PRECAUTIONS].
Prior to initiating treatment with Adderall xr 10 mg, adequately screen patients with comorbid depressive symptoms to determine if they are at risk for bipolar disorder. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and/or depression. Additionally, Adderall xr 10 mg therapy at usual doses may cause treatment-emergent psychotic or manic symptoms in patients without prior history of psychotic symptoms or mania [see WARNINGS AND PRECAUTIONS].
Circulation Problems In Fingers And Toes [Peripheral vasculopathy, including Raynaud's phenomenon]
Instruct patients beginning treatment with Adderall xr 10 mg about the risk of peripheral vasculopathy, including Raynaud's Phenomenon, and in associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Adderall xr 10 mg. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see WARNINGS AND PRECAUTIONS].
Monitor growth in children during treatment with Adderall xr 10 mg, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see WARNINGS AND PRECAUTIONS].
Advise patients to notify their physicians if they become pregnant or intend to become pregnant during treatment [see Use In Specific Populations].
Advise patients not to breast feed if they are taking Adderall xr 10 mg [see Use In Specific Populations].
Impairment In Ability To Operate Machinery Or Vehicles
Adderall xr 10 mg may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.
For more information call 1-800-828-2088
Pharmacist: Medication Guide to be dispensed to patients
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No evidence of carcinogenicity was found in studies in which d,l-amphetamine (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats. These doses are approximately 2.4, 1.5, and 0.8 times, respectively, the maximum recommended human dose for children of 30 mg/day, on a mg/m² body surface area basis.
Amphetamine, in the enantiomer ratio present in Adderall xr 10 mg (d- to l- ratio of 3:1), was not clastogenic in the mouse bone marrow micronucleus test in vivo and was negative when tested in the E. coli component of the Ames test in vitro. d,l-Amphetamine (1:1 enantiomer ratio) has been reported to produce a positive response in the mouse bone marrow micronucleus test, an equivocal response in the Ames test, and negative responses in the in vitro sister chromatid exchange and chromosomal aberration assays.
Amphetamine, in the enantiomer ratio present in Adderall xr 10 mg (d- to l- ratio of 3:1), did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day (approximately 8 times the maximum recommended human dose for adolescents of 20 mg/day, on a mg/m² body surface area basis).
Use In Specific Populations
Pregnancy Category C
Amphetamine, in the enantiomer ratio present in Adderall xr 10 mg (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 2 and 12 times, respectively, the maximum recommended human dose (MRHD) for adolescents of 20 mg/day, on a mg/m² body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 10 times the MRHD for adolescents on a mg/m² basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity.
A study was conducted in which pregnant rats received daily oral doses of amphetamine (d- to l- enantiomer ratio of 3:1, the same as in Adderall xr 10 mg) of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. These doses are approximately 0.8, 2, and 4 times the MRHD for adolescents of 20 mg/day, on a mg/m² basis. All doses caused hyperactivity and decreased weight gain in the dams. A decrease in pup survival was seen at all doses. A decrease in pup bodyweight was seen at 6 and 10 mg/kg which correlated with delays in developmental landmarks. Increased pup locomotor activity was seen at 10 mg/kg on day 22 postpartum but not at 5 weeks postweaning. When pups were tested for reproductive performance at maturation, gestational weight gain, number of implantations, and number of delivered pups were decreased in the group whose mothers had been given 10 mg/kg.
A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d, l-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.
There are no adequate and well-controlled studies in pregnant women. There has been one report of severe congenital bony deformity, tracheo-esophageal fistula, and anal atresia (vater association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.
Labor And Delivery
The effects of Adderall xr 10 mg on labor and delivery in humans is unknown.
Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.
Adderall xr 10 mg is indicated for use in children 6 years of age and older.
The safety and efficacy of Adderall xr 10 mg in children under 6 years of age have not been studied. Long-termeffects of amphetamines in children have not been well established.
In a juvenile developmental study, rats received daily oral doses of amphetamine (d to l enantiomer ratio of 3:1, the same as in Adderall xr 10 mg) of 2, 6, or 20 mg/kg on days 7-13 of age; from day 14 to approximately day 60 of age these doses were given b.i.d. for total daily doses of 4, 12, or 40 mg/kg. The latter doses are approximately 0.6, 2, and 6 times the maximum recommended human dose for children of 30 mg/day, on a mg/m² basis. Post dosing hyperactivity was seen at all doses; motor activity measured prior to the daily dose was decreased during the dosing period but the decreased motor activity was largely absent after an 18 day drug-free recovery period. Performance in the Morris water maze test for learning and memory was impaired at the 40 mg/kg dose, and sporadically at the lower doses, when measured prior to the daily dose during the treatment period; no recovery was seen after a 19 day drug-free period. A delay in the developmental milestones of vaginal opening and preputial separation was seen at 40 mg/kg but there was no effect on fertility.
Adderall xr 10 mg has not been studied in the geriatric population.
Individual patient response to amphetamines varies widely. Toxic symptoms may occur idiosyncratically at low doses.
Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.
Consult with a Certified Poison Control Center for up to date guidance and advice. The prolonged release of mixed amphetamine salts from Adderall xr 10 mg should be considered when treating patients with overdose.
Adderall xr 10 mg administration is contraindicated in patients with the following conditions:
Symptomatic cardiovascular disease
Moderate to severe hypertension
Known hypersensitivity or idiosyncrasy to the sympathomimetic amines (e.g., anaphylaxis, angioedema, serious skin rashes) [see ADVERSE REACTIONS]
History of drug abuse
During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) [see DRUG INTERACTIONS]