Drugs Details

Drugs Info of Adderall, Adderall XR
Drugs Details
  • Drugs Type  : FDA
  • Date : 28th Dec 2014 10:47 pm
  • Brand Name :  Adderall, Adderall XR
  • Generic Name : amphetamine and dextroamphetamine (Pronunciation: am FET a meen and DEX troe am FET a meen)
Descriptions

A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate.

EACH TABLET CONTAINS: 5 mg 7.5 mg 10 mg 12.5 mg 15 mg 20 mg 30 mg
Dextroamphetamine Saccharate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg
Amphetamine Aspartate Monohydrate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg
Dextroamphetamine Sulfate USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg
Amphetamine Sulfate USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg
Total amphetamine base equivalence 3.13 mg 4.7 mg 6.3 mg 7.8 mg 9.4 mg 12.6 mg 18.8 mg

Inactive Ingredients:

LACTITOL, MICROCRYSTALLINE CELLULOSE, COLLOIDAL SILICON DIOXIDE, MAGNESIUM STEARATE, AND OTHER INGREDIENTS.

Colors:

ADDERALL® (amphetamine, dextroamphetamine mixed salts) 5 MG IS A WHITE TO OFF-WHITE TABLET, WHICH CONTAINS NO COLOR ADDITIVES.
ADDERALL® (amphetamine, dextroamphetamine mixed salts) 7.5 MG AND 10 MG CONTAIN FD & C BLUE #1.
ADDERALL® (amphetamine, dextroamphetamine mixed salts) 12.5 MG, 15 MG, 20 MG AND 30 MG CONTAIN FD & C YELLOW #6 AS A COLOR ADDITIVE.

What are the possible side effects of amphetamine and dextroamphetamine (Adderall, Adderall XR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeats;
  • pain or burning when you urinate;
  • talking more than usual, feelings of extreme happiness or sadness;
  • tremors, hallucinations, unusual behavior, or motor tics (muscle twitches); or
  • dangerously high blood...

Read All Potential Side Effects and See Pictures of Adderall »

What are the precautions when taking amphetamine, dextroamphetamine mixed salts (Adderall)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to sympathomimetic drugs (such as epinephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (such as Raynaud's disease), certain mental/mood conditions (such as severe agitation, psychosis), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychotic disorder, suicidal thoughts), heart problems (including irregular heartbeat/rhythm, coronary artery disease, heart failure,...

Read All Potential Precautions of Adderall »


This monograph has been modified to include the generic and brand name in many instances.

Indications

ADDERALL® (amphetamine, dextroamphetamine mixed salts) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

Attention Deficit Hyperactivity Disorder (ADHD)

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, 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 child and not solely on the presence of the required number of DSM-IV® characteristics.

Need for Comprehensive Treatment Program:

ADDERALL® (amphetamine, dextroamphetamine mixed salts) 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 ADDERALL® (amphetamine, dextroamphetamine mixed salts) for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use ADDERALL® (amphetamine, dextroamphetamine mixed salts) for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Dosage Administration

Regardless of indication, amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia.

Attention Deficit Hyperactivity Disorder:

Not recommended for children under 3 years of age. In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In children 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

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

Narcolepsy:

Usual dose 5 mg to 60 mg per day in divided doses, depending on the individual patient response.

Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6-12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

How Supplied

ADDERALL® (amphetamine, dextroamphetamine mixed salts) 5 MG: A ROUND, FLAT-FACED BEVELED EDGE, WHITE TO OFF-WHITE TABLET, "5" EMBOSSED ON ONE SIDE WITH PARTIAL BISECT AND "AD" EMBOSSED ON THE OTHER SIDE, SUPPLIED AS FOLLOWS:

100 Tablets          Unit-of-use          NDC 0555-0762-02

ADDERALL® (amphetamine, dextroamphetamine mixed salts) 7.5 MG: AN OVAL, CONVEX, BLUE TABLET, "7.5" EMBOSSED ON ONE SIDE WITH A PARTIAL BISECT AND "AD" EMBOSSED ON THE OTHER SIDE WITH A FULL AND PARTIAL BISECT, SUPPLIED AS FOLLOWS:

100 Tablets          Unit-of-use          NDC 0555-0763-02

ADDERALL® (amphetamine, dextroamphetamine mixed salts) 10 MG: A ROUND, CONVEX, BLUE TABLET, "10" EMBOSSED ON ONE SIDE WITH A FULL AND PARTIAL BISECT AND "AD" EMBOSSED ON THE OTHER SIDE, SUPPLIED AS FOLLOWS:

100 Tablets          Unit-of-use          NDC 0555-0764-02

ADDERALL® (amphetamine, dextroamphetamine mixed salts) 12.5 MG: A ROUND, FLAT-FACED BEVELED EDGE, ORANGE TABLET, "12.5" EMBOSSED ON ONE SIDE AND "AD" EMBOSSED ON THE OTHER SIDE WITH A FULL AND PARTIAL BISECT, SUPPLIED AS FOLLOWS:

100 Tablets          Unit-of-use          NDC 0555-0765-02

ADDERALL® (amphetamine, dextroamphetamine mixed salts) 15 MG: AN OVAL, CONVEX, ORANGE TABLET, "15" EMBOSSED ON ONE SIDE WITH A PARTIAL BISECT AND "AD" EMBOSSED ON THE OTHER SIDE WITH A FULL AND PARTIAL BISECT, SUPPLIED AS FOLLOWS:

100 Tablets          Unit-of-use          NDC 0555-0766-02

ADDERALL® (amphetamine, dextroamphetamine mixed salts) 20 MG: A ROUND, CONVEX, ORANGE TABLET, "20" EMBOSSED ON ONE SIDE WITH A FULL AND PARTIAL BISECT AND "AD" EMBOSSED ON THE OTHER SIDE, SUPPLIED AS FOLLOWS:

100 Tablets          Unit-of-use          NDC 0555-0767-02

ADDERALL® (amphetamine, dextroamphetamine mixed salts) 30 MG: A ROUND, FLAT-FACED BEVELED EDGE, ORANGE TABLET, "30" EMBOSSED ON ONE SIDE WITH A FULL AND PARTIAL BISECT AND "AD" EMBOSSED ON THE OTHER SIDE, SUPPLIED AS FOLLOWS:

100 Tablets          Unit-of-use          NDC 0555-0768-02

DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER.
STORE AT 20° TO 25°C (68° TO 77°F) [SEE USP CONTROLLED ROOM TEMPERATURE].

MANUFACTUREDBY: DSMPHARMACEUTICALS INC.,5900 NW GREENVILLE BLVD.,GREENVILLE, NC 27834 FOR
BARR LABORATORIES, INC., POMONA, NY 10970
Revised MARCH 2007
FDA rev date: 6/7/2007


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Cardiovascular:

Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System:

Psychotic episodes at recommended doses, overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, depression, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome, seizures, stroke.

Gastrointestinal:

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic:

Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported.

Endocrine:

Impotence, changes in libido.

Drug Abuse and Dependence

ADDERALL® (amphetamine, dextroamphetamine mixed salts) is a Schedule II controlled substance.

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 include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

Read the Adderall (amphetamine, dextroamphetamine mixed salts) Side Effects Center for a complete guide to possible side effects

Interactions

Acidifying agents

-Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines.

Urinary acidifying agent

-(ammonium chloride, sodium acid phosphate, etc.) 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.

Adrenergic blocker

-Adrenergic blockers are inhibited by amphetamines.

Alkalinizing agents

-Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. Co-administration of ADDERALL® (amphetamine, dextroamphetamine mixed salts) and gastrointestinal alkalizing 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.

Antidepressants, tricyclic

-Amphetamines may enhance the activity of tricyclic 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.

MAO inhibitors

-MAOI antidepressants, as well as a metabolite of furazolidone, 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 neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results.

Antihistamines

-Amphetamines may counteract the sedative effect of antihistamines.

Antihypertensives

-Amphetamines may antagonize the hypotensive effects of antihypertensives.

Chlorpromazine

-Chlorpromazine blocks dopamine and norepinephrine receptors, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.

Ethosuximide

-Amphetamines may delay intestinal absorption of ethosuximide.

Haloperidol

-Haloperidol blocks dopamine receptors, thus inhibiting the central stimulant effects of amphetamines.

Lithium carbonate

-The anorectic and stimulatory effects of amphetamines may be inhibited by lithium carbonate.

Meperidine

-Amphetamines potentiate the analgesic effect of meperidine.

Methenamine therapy

-Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.

Norepinephrine

-Amphetamines enhance the adrenergic effect of norepinephrine.

Phenobarbital

-Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action.

Phenytoin

-Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action.

Propoxyphene

-In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Veratrum alkaloids

-Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

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.

Read the Adderall Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

 

Warnings

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 structural heart problems alone may carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known 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).

Adults

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) [see ADVERSE REACTIONS], 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).

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

Pre-Existing Psychosis

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder.

Bipolar Illness

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 placebo-treated patients.

Aggression

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

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. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they will likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted.

Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizure, in patients with prior EEG abnormalities in 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, the drug should be discontinued.

Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

Precautions

General:

The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. ADDERALL® (amphetamine, dextroamphetamine mixed salts) should be used with caution in patients who use other sympathomimetic drugs.

Tics:

Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in children and their families should precede use of stimulant medications.

Information for Patients:

Amphetamines 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.

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with amphetamine or dextroamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for ADDERALL® (amphetamine, dextroamphetamine mixed salts) .

The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Carcinogenesis/Mutagenesis and 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 of 30 mg/day [child] on a mg/m2 body surface area basis.

Amphetamine, in the enantiomer ratio present in ADDERALL® (amphetamine, dextroamphetamine mixed salts) (immediate-release)(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® (amphetamine, dextroamphetamine mixed salts) (immediate-release)(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 5 times the maximum recommended human dose of 30 mg/day on a mg/m2 body surface area basis).

Pregnancy

Teratogenic Effects:

Pregnancy Category C.

Amphetamine, in the enantiomer ratio present in ADDERALL® (amphetamine, dextroamphetamine mixed salts) (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 1.5 and 8 times, respectively, the maximum recommended human dose of 30 mg/day [child] 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 6 times that of a human dose of 30 mg/day [child] on a mg/m2 basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity.

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.

Nonteratogenic Effects:

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.

Usage in Nursing Mothers:

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Pediatric Use:

Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Hyperactivity Disorder described under INDICATIONS AND USAGE.

Geriatric Use:

ADDERALL® (amphetamine, dextroamphetamine mixed salts) has not been studied in the geriatric population.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

Individual patient response to amphetamines varies widely. Toxic symptoms may occur idiosyncratically at low doses.

Symptoms:

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 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.

Treatment:

Consult with a Certified Poison Control Center for up to date guidance and advice. Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic and sedation. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute, severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved. Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat amphetamine intoxication.

ContrainDications

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Pharmacodynamics

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Pharmacokinetics

ADDERALL® (amphetamine, dextroamphetamine mixed salts) tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of a single dose 10 or 30 mg of ADDERALL® (amphetamine, dextroamphetamine mixed salts) to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and l-amphetamine. The mean elimination half-life (t½) for d-amphetamine was shorter than the t½ of the l-isomer (9.77-11 hours vs. 11.5-13.8 hours). The PK parameters (Cmax, AUC0-inf) of d-and l-amphetamine increased approximately three-fold from 10 mg to 30 mg indicating dose-proportional pharmacokinetics.

The effect of food on the bioavailability of ADDERALL® (amphetamine, dextroamphetamine mixed salts) has not been studied.

Metabolism and Excretion:

Amphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4-hydroxyamphetamine, or on the side chain a or ß carbons to form alpha-hydroxy-amphetamine or norephedrine, respectively. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine. Alpha-hydroxy-amphetamine undergoes deamination to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid. Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2D6 is known to be involved with formation of 4-hydroxy-amphetamine. Since CYP2D6 is genetically polymorphic, population variations in amphetamine metabolism are a possibility.

Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated. In vitro experiments with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. However, due to the probability of auto-inhibition and the lack of information on the concentration of these metabolites relative to in vivo concentrations, no predications regarding the potential for amphetamine or its metabolites to inhibit the metabolism of other drugs by CYP isozymes in vivo can be made.

With normal urine pHs approximately half of an administered dose of amphetamine is recoverable in urine as derivatives of alpha-hydroxy-amphetamine and approximately another 30%-40% of the dose is recoverable in urine as amphetamine itself. Since amphetamine has a pKa of 9.9, urinary recovery of amphetamine is highly dependent on pH and urine flow rates. Alkaline urine pHs result in less ionization and reduced renal elimination, and acidic pHs and high flow rates result in increased renal elimination with clearances greater than glomerular filtration rates, indicating the involvement of active secretion. Urinary recovery of amphetamine has been reported to range from 1% to 75%, depending on urinary pH, with the remaining fraction of the dose hepatically metabolized. Consequently, both hepatic and renal dysfunction have the potential to inhibit the elimination of amphetamine and result in prolonged exposures. In addition, drugs that effect urinary pH are known to alter the elimination of amphetamine, and any decrease in amphetamine's metabolism that might occur due to drug interactions or genetic polymorphisms is more likely to be clinically significant when renal elimination is decreased, (See PRECAUTIONS).


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

MEDICATION GUIDE

ADDERALL® (amphetamine, dextroamphetamine mixed salts)
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

READ THE MEDICATION GUIDE THAT COMES WITH ADDERALL® (amphetamine, dextroamphetamine mixed salts) BEFORE YOU OR YOUR CHILD STARTS TAKING IT AND EACH TIME YOU GET A REFILL. THERE MAY BE NEW INFORMATION. THIS MEDICATION GUIDE DOES NOT TAKE THE PLACE OF TALKING TO YOUR DOCTOR ABOUT YOU OR YOUR CHILD'S TREATMENT WITH ADDERALL® (amphetamine, dextroamphetamine mixed salts) .

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ADDERALL® (amphetamine, dextroamphetamine mixed salts) ?

THE FOLLOWING HAVE BEEN REPORTED WITH USE OF ADDERALL® (amphetamine, dextroamphetamine mixed salts) AND OTHER
STIMULANT MEDICINES.

1. HEART-RELATED PROBLEMS:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

TELL YOUR DOCTOR IF YOU OR YOUR CHILD HAVE ANY HEART PROBLEMS, HEART DEFECTS, HIGH BLOOD PRESSURE, OR A FAMILY HISTORY OF THESE PROBLEMS.
YOUR DOCTOR SHOULD CHECK YOU OR YOUR CHILD CAREFULLY FOR HEART PROBLEMS BEFORE STARTING ADDERALL® (amphetamine, dextroamphetamine mixed salts) .
YOUR DOCTOR SHOULD CHECK YOUR OR YOUR CHILD'S BLOOD PRESSURE AND HEART RATE REGULARLY DURING TREATMENT WITH ADDERALL® (amphetamine, dextroamphetamine mixed salts) .

CALL YOUR DOCTOR RIGHT AWAY IF YOU OR YOUR CHILD HAVE ANY SIGNS OF HEART PROBLEMS SUCH AS CHEST PAIN, SHORTNESS OF BREATH, OR FAINTING WHILE TAKING ADDERALL® (amphetamine, dextroamphetamine mixed salts).

2. MENTAL (PSYCHIATRIC) PROBLEMS:
ALL PATIENTS

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

CHILDREN AND TEENAGERS

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

TELL YOUR DOCTOR ABOUT ANY MENTAL PROBLEMS YOU OR YOUR CHILD HAVE, OR ABOUT A FAMILY HISTORY OF SUICIDE, BIPOLAR ILLNESS, OR DEPRESSION.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking ADDERALL® (amphetamine, dextroamphetamine mixed salts) , especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

WHAT IS ADDERALL® (amphetamine, dextroamphetamine mixed salts) ?

ADDERALL® (amphetamine, dextroamphetamine mixed salts) IS A CENTRAL NERVOUS SYSTEM STIMULANT PRESCRIPTION MEDICINE. IT IS USED FOR THE TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD). ADDERALL® (amphetamine, dextroamphetamine mixed salts) MAY HELP INCREASE ATTENTION AND DECREASE IMPULSIVENESS AND HYPERACTIVITY IN PATIENTS WITH ADHD.
ADDERALL® (amphetamine, dextroamphetamine mixed salts) SHOULD BE USED AS A PART OF A TOTAL TREATMENT PROGRAM FOR ADHD THAT MAY INCLUDE COUNSELING OR OTHER THERAPIES.
ADDERALL® (amphetamine, dextroamphetamine mixed salts) IS ALSO USED IN THE TREATMENT OF A SLEEP DISORDER CALLED NARCOLEPSY.

ADDERALL® (amphetamine, dextroamphetamine mixed salts) IS A FEDERALLY CONTROLLED SUBSTANCE (CII) BECAUSE IT CAN BE ABUSED OR LEAD TO DEPENDENCE. KEEP ADDERALL® (amphetamine, dextroamphetamine mixed salts) IN A SAFE PLACE TO PREVENT MISUSE AND ABUSE. SELLING OF GIVING AWAY ADDERALL® (amphetamine, dextroamphetamine mixed salts) MAY HARM OTHERS AND IS AGAINST THE LAW.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

WHO SHOULD NOT TAKE ADDERALL® (amphetamine, dextroamphetamine mixed salts) ?

ADDERALL® (amphetamine, dextroamphetamine mixed salts) SHOULD NOT BE TAKEN IF YOU OR YOUR CHILD:

  • have heart disease or hardening of the arteries
  • have moderate to severe high blood pressure
  • have hyperthyroidism
  • have an eye problem called glaucoma
  • are very anxious, tense, or agitated
  • have a history of drug abuse
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  • are sensitive to, allergic to, or had a reaction to other stimulant medicines

ADDERALL® (amphetamine, dextroamphetamine mixed salts) IS NOT RECOMMENDED FOR USE IN CHILDREN LESS THAN 3 YEARS OLD.
ADDERALL® (amphetamine, dextroamphetamine mixed salts) MAY NOT BE RIGHT FOR YOU OR YOUR CHILD. BEFORE STARTING ADDERALL® (amphetamine, dextroamphetamine mixed salts) TELL YOUR OR YOUR CHILD'S DOCTOR ABOUT ALL HEALTH CONDITIONS (OR A FAMILY HISTORY OF) INCLUDING:

  • heart problems, heart defects, high blood pressure
  • mental problems including psychosis, mania, bipolar illness, or depression
  • tics or Tourette's syndrome
  • liver or kidney problems
  • thyroid problems
  • seizures or have had an abnormal brain wave test (EEG)

TELL YOUR DOCTOR IF YOU OR YOUR CHILD ARE PREGNANT, PLANNING TO BECOME PREGNANT,OR BREASTFEEDING.

CAN ADDERALL® (amphetamine, dextroamphetamine mixed salts) BE TAKEN WITH OTHER MEDICINES?

PRESCRIPTION AND NONPRESCRIPTION MEDICINES, VITAMINS, AND HERBAL SUPPLEMENTS. ADDERALL® (amphetamine, dextroamphetamine mixed salts) AND SOME MEDICINES MAY INTERACT WITH EACH OTHER AND CAUSE SERIOUS SIDE EFFECTS. SOMETIMES THE DOSES OF OTHER MEDICINES WILL NEED TO BE ADJUSTED WHILE TAKING ADDERALL® (amphetamine, dextroamphetamine mixed salts) .
YOUR DOCTOR WILL DECIDE WHETHER ADDERALL® (amphetamine, dextroamphetamine mixed salts) CAN BE TAKEN WITH OTHER MEDICINES.
ESPECIALLY TELL YOUR DOCTOR IF YOU OR YOUR CHILD TAKE:

  • anti-depression medicines including MAOIs
  • blood pressure medicines
  • seizure medicines
  • blood thinner medicines
  • cold or allergy medicines that contain decongestants
  • stomach acid medicines

KNOW THE MEDICINES THAT YOU OR YOUR CHILD TAKE. KEEP A LIST OF YOUR MEDICINES WITH YOU TO SHOW YOUR DOCTOR AND PHARMACIST.

DO NOT START ANY NEW MEDICINE WHILE TAKING ADDERALL® (amphetamine, dextroamphetamine mixed salts) WITHOUT TALKING TO YOUR DOCTOR FIRST.

HOW SHOULD ADDERALL® (amphetamine, dextroamphetamine mixed salts) BE TAKEN?

  • Take ADDERALL® (amphetamine, dextroamphetamine mixed salts) exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • ADDERALL® (amphetamine, dextroamphetamine mixed salts) tablets are usually taken two to three times a day. The first dose is usually taken when you first wake in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.
  • ADDERALL® (amphetamine, dextroamphetamine mixed salts) can be taken with or without food.
  • From time to time, your doctor may stop ADDERALL® (amphetamine, dextroamphetamine mixed salts) treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking ADDERALL® (amphetamine, dextroamphetamine mixed salts) . Children should have their height and weight checked often while taking ADDERALL® (amphetamine, dextroamphetamine mixed salts) . ADDERALL® (amphetamine, dextroamphetamine mixed salts) treatment may be stopped if a problem is found during these check-ups.
  • If you or your child take too much ADDERALL® (amphetamine, dextroamphetamine mixed salts) or overdoses, call your doctor or poison control center right away, or get emergency treatment.

WHAT ARE POSSIBLE SIDE EFFECTS OF ADDERALL® (amphetamine, dextroamphetamine mixed salts) ?

SEE "WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ADDERALL® (amphetamine, dextroamphetamine mixed salts) ?" FOR INFORMATION ON REPORTED HEART AND MENTAL PROBLEMS.

OTHER SERIOUS SIDE EFFECTS INCLUDE:
  • slowing of growth (height and weight) in children
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision
COMMON SIDE EFFECTS INCLUDE:
  • headache
  • stomach ache
  • trouble sleeping
  • decreased appetite
  • nervousness
  • dizziness

ADDERALL® (amphetamine, dextroamphetamine mixed salts) MAY AFFECT YOUR OR YOUR CHILD'S ABILITY TO DRIVE OR DO OTHER DANGEROUS ACTIVITIES. TALK TO YOUR DOCTOR IF YOU OR YOUR CHILD HAVE SIDE EFFECTS THAT ARE BOTHERSOME OR DO NOT GO AWAY.
THIS IS NOT A COMPLETE LIST OF POSSIBLE SIDE EFFECTS. ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION.

HOW SHOULD I STORE ADDERALL® (amphetamine, dextroamphetamine mixed salts)

  • Store ADDERALL® (amphetamine, dextroamphetamine mixed salts) in a safe place at room temperature, 20° to 25°C (68° to 77°F).
  • Keep ADDERALL® (amphetamine, dextroamphetamine mixed salts) and all medicines out of the reach of children.

GENERAL INFORMATION ABOUT ADDERALL® (amphetamine, dextroamphetamine mixed salts)

MEDICINES ARE SOMETIMES PRESCRIBED FOR PURPOSES OTHER THAN THOSE LISTED IN A MEDICATION GUIDE. DO NOT USE ADDERALL® (amphetamine, dextroamphetamine mixed salts) FOR A CONDITION FOR WHICH IT WAS NOT PRESCRIBED. DO NOT GIVE ADDERALL® (amphetamine, dextroamphetamine mixed salts) TO OTHER PEOPLE, EVEN IF THEY HAVE THE SAME CONDITION. IT MAY HARM THEM AND IT IS AGAINST THE LAW. THIS MEDICATION GUIDE SUMMARIZES THE MOST IMPORTANT INFORMATION ABOUT ADDERALL® (amphetamine, dextroamphetamine mixed salts) . IF YOU WOULD LIKE MORE INFORMATION, TALK WITH YOUR DOCTOR. YOU CAN ASK YOUR DOCTOR OR PHARMACIST FOR INFORMATION ABOUT ADDERALL® (amphetamine, dextroamphetamine mixed salts) THAT WAS WRITTEN FOR HEALTHCARE PROFESSIONALS. FOR MORE INFORMATION ABOUT ADDERALL® (amphetamine, dextroamphetamine mixed salts) , PLEASE CONTACT BARR LABORATORIES, INC. AT 1-800-BARRLAB(227- 7522).

WHAT ARE THE INGREDIENTS IN ADDERALL® (amphetamine, dextroamphetamine mixed salts) ?

ACTIVE INGREDIENT: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, USP, AMPHETAMINE SULFATE, USP

INACTIVE INGREDIENTS: LACTITOL, MICROCRYSTALLINE CELLULOSE, COLLOIDAL SILICON DIOXIDE, MAGNESIUM STEARATE, AND OTHER INGREDIENTS.

THIS MEDICATION GUIDE HAS BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

DEXTROAMPHETAMINE/AMPHETAMINE- ORAL

 

(am-FET-a-meen/DEX-troe-am-FET-a-meen)

 

COMMON BRAND NAME(S): Adderall

 

WARNING: Misuse or abuse of amphetamine may cause serious (possibly fatal) heart and blood pressure problems. Amphetamine-type medications can be habit-forming. Use only as directed. If you use this drug for a long time, you may become dependent on it and may have withdrawal symptoms after stopping the drug. Consult your doctor or pharmacist for more details. (See also How to Use section).

 

USES: This combination medication is used to treat attention deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, concentrate, stay focused, and stop fidgeting.

This product is a combination of stimulants (amphetamine and dextroamphetamine). It is thought to work by restoring the balance of certain natural substances (neurotransmitters) in the brain.

This drug may also be used to treat a certain sleeping disorder (narcolepsy) to help you stay awake during the day. It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.

 

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking amphetamine/dextroamphetamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually 1 to 3 times a day. The first dose is usually taken when you wake up in the morning. If more doses are prescribed, take them as directed by your doctor, usually 4-6 hours apart. Taking this medication late in the day may cause trouble sleeping (insomnia).

The dosage is based on your medical condition and response to treatment. Your doctor may adjust your dose to find the dose that is best for you. Follow your doctor's instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

During treatment, your doctor may occasionally recommend stopping the medication for a short time to see whether there are any changes in your behavior and whether the medication is still needed.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (including severe tiredness, sleep problems, mental/mood changes such as depression) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction. Do not increase your dose or use this drug more often or for longer than prescribed. Properly stop this medication when so directed.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition does not improve or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Loss of appetite, weight loss, dry mouth, stomach upset/pain, nausea/vomiting, dizziness, headache, diarrhea, fever, nervousness, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor of any high results.

Tell your doctor right away if you have any serious side effects, including: numbness/pain/skin color change/sensitivity to temperature in the fingers or toes, mental/mood/behavior changes (such as agitation, aggression, mood swings, depression, abnormal thoughts), uncontrolled movements, continuous chewing movements/teeth grinding, outbursts of words/sounds, change in sexual ability/desire, frequent/prolonged erections (in males).

Get medical help right away if you have any very serious side effects, including: shortness of breath, chest/jaw/left arm pain, fainting, severe headache, fast/pounding/irregular heartbeat, seizures, swelling of the ankles/feet, extreme tiredness, blurred vision, weakness on one side of the body, slurred speech, confusion.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Adderall (amphetamine, dextroamphetamine mixed salts) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to sympathomimetic drugs (such as epinephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (such as Raynaud's disease), certain mental/mood conditions (such as severe agitation, psychosis), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychotic disorder, suicidal thoughts), heart problems (including irregular heartbeat/rhythm, coronary artery disease, heart failure, cardiomyopathy, problems with the heart structure such as valve problems), family history of heart problems (such as sudden death/irregular heartbeat/rhythm), history of stroke, high blood pressure, overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), seizures, personal or family history of regular use/abuse of drugs/alcohol, personal or family history of uncontrolled muscle movements (such as Tourette's syndrome), kidney disease, liver disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially weight loss. This medication may slow down a child's growth. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child's weight and height. Consult your doctor or pharmacist for more details.

Older adults may be more sensitive to the side effects of this drug, especially chest pain, trouble sleeping, or weight loss.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who are dependent on this medication may be born too soon (premature) and have low birth weight. They may also have withdrawal symptoms. Tell your doctor immediately if you notice possible mood changes, agitation, or unusual tiredness in your newborn.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Check the labels on all your medicines (such as cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about using these products safely.

Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking over-the-counter products that contain caffeine. Caffeine can increase the side effects of this medication.

Dextroamphetamine is very similar to lisdexamfetamine. Do not use medications containing lisdexamfetamine while using dextroamphetamine.

This medication may interfere with certain medical/laboratory tests (including blood and urine steroid levels, brain scan for Parkinson's disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe mental/mood changes, seizures, severe/persistent headache, severe restlessness, fast breathing.

 

NOTES: Do not share this medication with others. It is against the law.

Laboratory and/or medical tests (such as blood pressure, heart rate, growth monitoring in children) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember in the morning hours. If it is late in the afternoon or near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised January 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Adderall, Adderall XR

Generic Name: amphetamine and dextroamphetamine (Pronunciation: am FET a meen and DEX troe am FET a meen)

  • What is amphetamine and dextroamphetamine (Adderall)?
  • What are the possible side effects of amphetamine and dextroamphetamine (Adderall)?
  • What is the most important information I should know about amphetamine and dextroamphetamine (Adderall)?
  • What should I discuss with my doctor before taking amphetamine and dextroamphetamine (Adderall)?
  • How should I take amphetamine and dextroamphetamine (Adderall)?
  • What happens if I miss a dose (Adderall)?
  • What happens if I overdose (Adderall)?
  • What should I avoid while taking amphetamine and dextroamphetamine (Adderall)?
  • What other drugs will affect amphetamine and dextroamphetamine (Adderall)?
  • Where can I get more information?

What is amphetamine and dextroamphetamine (Adderall)?

Amphetamine and dextroamphetamine are central nervous system stimulants that affect chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

The combination of amphetamine and dextroamphetamine is used to treat narcolepsy and attention deficit hyperactivity disorder (ADHD).

Amphetamine and dextroamphetamine may also be used for purposes not listed in this medication guide.

Adderall 10 mg

round, blue, imprinted with AD, 1 0

What are the possible side effects of amphetamine and dextroamphetamine (Adderall)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeats;
  • pain or burning when you urinate;
  • talking more than usual, feelings of extreme happiness or sadness;
  • tremors, hallucinations, unusual behavior, or motor tics (muscle twitches); or
  • dangerously high blood pressure (severe headache, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • headache, weakness, dizziness, blurred vision;
  • feeling restless, irritable, or agitated,
  • sleep problems (insomnia);
  • dry mouth or an unpleasant taste in your mouth;
  • diarrhea, constipation, stomach pain, nausea, vomiting;
  • fever;
  • hair loss, loss of appetite, weight loss; or
  • loss of interest in sex, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Adderall (amphetamine, dextroamphetamine mixed salts) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about amphetamine and dextroamphetamine (Adderall)?

Do not use amphetamine and dextroamphetamine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

You should not use this medication if you are allergic to amphetamine and dextroamphetamine, or if you have hardened arteries (arteriosclerosis), heart disease, moderate to severe high blood pressure (hypertension), overactive thyroid, glaucoma, severe anxiety or agitation, or a history of drug or alcohol addiction.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking amphetamine and dextroamphetamine, tell your doctor if you have any type of heart problems.

Long-term use of amphetamine and dextroamphetamine can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Amphetamine and dextroamphetamine may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it. Using this medication improperly can cause death or serious side effects on the heart.

Side Effects Centers
  • Adderall XR Capsules
  • Adderall

Patient Detailed How Take

What should I discuss with my doctor before taking amphetamine and dextroamphetamine (Adderall)?

Do not use amphetamine and dextroamphetamine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

You should not use this medication if you are allergic to amphetamine and dextroamphetamine or if you have:

  • heart disease or moderate to severe high blood pressure (hypertension);
  • arteriosclerosis (hardening of the arteries);
  • overactive thyroid;
  • glaucoma;
  • severe anxiety, tension, or agitation; or
  • if you have a history of drug or alcohol addiction.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking this medication, tell your doctor if you have:

  • a congenital heart defect;
  • high blood pressure;
  • heart failure, heart rhythm disorder, or recent heart attack;
  • a personal or family history of mental illness, psychotic disorder, bipolar illness, depression, or suicide attempt;
  • epilepsy or other seizure disorder; or
  • tics (muscle twitches) or Tourette's syndrome.

Amphetamine and dextroamphetamine may be habit forming and should be used only by the person for whom it was prescribed. Never share amphetamine and dextroamphetamine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Using this medication improperly can cause death or serious side effects on the heart.

FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. It could cause premature birth, low birth weight, or withdrawal symptoms in a newborn if the mother takes amphetamine and dextroamphetamine during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Amphetamine and dextroamphetamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using this medication.

Long-term use of amphetamine and dextroamphetamine can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

How should I take amphetamine and dextroamphetamine (Adderall)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Do not take amphetamine and dextroamphetamine in the evening because it may cause sleep problems (insomnia).

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using amphetamine and dextroamphetamine.

Store at room temperature away from moisture, heat, and light.

Keep track of the amount of medicine used from each new bottle. Amphetamine and dextroamphetamine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Side Effects Centers
  • Adderall XR Capsules
  • Adderall

Patient Detailed Avoid Taking

What happens if I miss a dose (Adderall)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose, or if it is already evening. Taking this medicine late in the day can cause sleep problems. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Adderall)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amphetamine and dextroamphetamine can be fatal.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking amphetamine and dextroamphetamine (Adderall)?

Amphetamine and dextroamphetamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Do not take amphetamine and dextroamphetamine late in the day. A dose taken too late in the day can cause sleep problems (insomnia).

Avoid drinking fruit juices or taking vitamin C at the same time you take amphetamine and dextroamphetamine. These can make your body absorb less of the medicine.

What other drugs will affect amphetamine and dextroamphetamine (Adderall)?

Tell your doctor about all other medicines you use, especially:

  • heart or blood pressure medications;
  • a diuretic (water pill);
  • cold or allergy medicines (antihistamines);
  • acetazolamide (Diamox);
  • chlorpromazine (Thorazine);
  • ethosuximide (Zarontin);
  • haloperidol (Haldol);
  • lithium (Eskalith, Lithobid);
  • meperidine (Demerol);
  • methenamine (Hiprex, Mandelamine, Urex);
  • phenytoin (Dilantin), phenobarbital (Luminal, Solfoton);
  • reserpine;
  • ammonium chloride, ascorbic acid (vitamin C), potassium phosphate (K-Phos);
  • antacids, sodium bicarbonate (Alka-Seltzer), potassium citrate (K-Lyte, Urocit-K), sodium citrate and citric acid (Bicitra, Oracit), or sodium citrate and potassium (Citrolith, Polycitra);
  • stomach acid reducers such as cimetidine (Tagamet),esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), or ranitidine (Zantac); or
  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others.

This list is not complete and other drugs may interact with amphetamine and dextroamphetamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about amphetamine and dextroamphetamine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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