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AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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® 5 mg is a white to off-white tablet, which contains no color additives.
Adderall ® 7.5 mg and 10 mg contain FD&C Blue #1.
Adderall ® 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 as a color additive.
ADDERALL is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
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.
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.
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.
Prior to treating patients with ADDERALL, assess:
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 to 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.
ADDERALL 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 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 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 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 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 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 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].
Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. Revised: Oct 2023.
Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, motor and verbal tics, aggression, anger, logorrhea, dermatillomania.
Vision blurred, mydriasis.
Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia, and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.
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.
Alopecia.
Rhabdomyolysis.
Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer ADDERALL concomitantly or within 14 days after discontinuing MAOI [see CONTRAINDICATIONS and WARNINGS].
The concomitant use of ADDERALL and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during ADDERALL initiation or dosage increase. If serotonin syndrome occurs, discontinue ADDERALL and the concomitant serotonergic drug(s) [see WARNINGS and PRECAUTIONS].
The concomitant use of ADDERALL and CYP2D6 inhibitors may increase the exposure of ADDERALL compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during ADDERALL initiation and after a dosage increase. If serotonin syndrome occurs, discontinue ADDERALL and the CYP2D6 inhibitor [see WARNINGS, OVERDOSE].
Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents and urinary acidifying agents.
Adrenergic blockers are inhibited by amphetamines.
Increase blood levels and potentiate the action of amphetamine. Co-administration of ADDERALL and gastrointestinal alkalinizing agents should be avoided. Examples of alkalinizing agents include gastrointestinal alkalinizing agents and urinary alkalinizing agents.
May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Monitor frequently and adjust or use alternative therapy based on clinical response.
Amphetamines may counteract the sedative effect of antihistamines.
Amphetamines may antagonize the hypotensive effects of antihypertensives.
Chlorpromazine blocks dopamine and norepinephrine receptors, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.
Amphetamines may delay intestinal absorption of ethosuximide.
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.
Amphetamines potentiate the analgesic effect of meperidine.
Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.
Amphetamines enhance the adrenergic effect of norepinephrine.
Amphetamines may delay intestinal absorption of phenobarbital; coadministration of phenobarbital may produce a synergistic anticonvulsant action.
Amphetamines may delay intestinal absorption of phenytoin; coadministration of phenytoin may produce a synergistic anticonvulsant action.
In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.
Time to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone. Monitor patients for changes in clinical effect and adjust therapy based on clinical response. An example of a proton pump inhibitor is omeprazole.
Amphetamines inhibit the hypotensive effect of veratrum alkaloids.
ADDERALL contains amphetamine, a Schedule II controlled substance.
ADDERALL has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction [see WARNINGS and PRECAUTIONS]. ADDERALL can be diverted for non-medical use into illicit channels or distribution.
Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.
Misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including ADDERALL, can result in overdose and death [see OVERDOSE], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Physical Dependence
ADDERALL may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including ADDERALL include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
Tolerance
ADDERALL may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).
ADDERALL has a high potential for abuse and misuse. The use of ADDERALL exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. ADDERALL can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse And Dependence: Abuse]. Misuse and abuse of CNS stimulants, including ADDERALL, can result in overdose and death [see OVERDOSE], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing ADDERALL, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give ADDERALL to anyone else. Throughout ADDERALL treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulant treatment at the recommended ADHD dosages.
Avoid ADDERALL use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Some patients may have larger increases. Monitor all ADDERALL-treated patients for potential tachycardia and hypertension.
CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).
CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulanttreated patients, compared with 0% of placebo-treated patients. If such symptoms occur, consider discontinuing ADDERALL.
CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in ADDERALL-treated pediatric patients treated with CNS stimulants.
Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see PRECAUTIONS, Pediatric Use].
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.
Stimulants, including ADDERALL, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports and at the therapeutic dosage of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during ADDERALL treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for ADDERALL-treated patients who develop signs or symptoms of peripheral vasculopathy.
Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort [see DRUG INTERACTIONS]. The coadministration with cytochrome P450 (CYP2D6) inhibitors increase the risk with increased exposure to ADDERALL. In these situations, consider an alternative nonserotonergic drug or an alternative drug that does not inhibit CYP2D6 [see DRUG INTERACTIONS].
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
Concomitant use of ADDERALL with MAOI drugs is contraindicated [see CONTRAINDICATIONS].
Discontinue treatment with ADDERALL and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of ADDERALL with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate ADDERALL with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.
CNS stimulants, including amphetamine sulfate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating ADDERALL, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome with ADDERALL, and discontinue treatment if clinically appropriate.
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).
Educate patients and their families about the risks of abuse, misuse, and addiction of ADDERALL, which can lead to overdose and death, and proper disposal of any unused drug [see WARNINGS, Drug Abuse And Dependence, OVERDOSE]. Advise patients to store ADDERALL in a safe place, preferably locked, and instruct patients to not give ADDERALL to anyone else.
Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with ADDERALL use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see WARNINGS].
Advise patients that ADDERALL can elevate blood pressure and heart rate [see WARNINGS].
Advise patients that ADDERALL, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see WARNINGS].
Advise patients that ADDERALL may cause slowing of growth including weight loss [see WARNINGS].
Caution patients about the risk of serotonin syndrome with concomitant use of ADDERALL and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see CONTRAINDICATIONS, WARNINGS and DRUG INTERACTIONS]. Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.
Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with ADDERALL. Instruct the patients to notify their healthcare provider if emergence or worsening of tics or Tourette’s syndrome occurs [see WARNINGS].
Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.
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 (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 (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).
Amphetamine, in the enantiomer ratio present in ADDERALL (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.
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.
Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.
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.
ADDERALL has not been studied in the geriatric population.
Overdose of CNS stimulants is characterized by the following sympathomimetic effects:
Consider the possibility of multiple drug ingestion. D-amphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
In patients known to be hypersensitive to amphetamine, or other components of ADDERALL. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see ADVERSE REACTIONS].
Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see WARNINGS and DRUG INTERACTIONS].
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.
ADDERALL 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 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 (t1/2) for damphetamine was shorter than the t1/2 of the l-isomer (9.77 to 11 hours vs. 11.5 to 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 has not been studied.
Amphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4- hydroxyamphetamine, or on the side chain α or β 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% to 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 affect 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].
ADDERALL
(ADD-ur-all)
(Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets),
What is the most important information I should know about ADDERALL?
Adderall may cause serious side effects, including:
Your healthcare provider should check you or your child carefully for heart problems before starting treatment with ADDERALL. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with ADDERALL.
Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with ADDERALL.
Tell your healthcare provider about any mental problems you or your child have or about a family history of suicide, bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with ADDERALL, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
What is ADDERALL?
ADDERALL is a central nervous system (CNS) stimulant prescription medicine used for the treatment of:
It is not known if ADDERALL is safe and effective in children with ADHD under 3 years of age.
It is not known if ADDERALL is safe and effective in children with Narcolepsy under 6 years of age.
ADDERALL is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep ADDERALL in a safe place to protect it from theft. Never give your ADDERALL to anyone else because it may cause death or harm them. Selling or giving away ADDERALL may harm others and is against the law.
Do not take ADDERALL if you or your child:
Before taking ADDERALL, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:
Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADDERALL and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with ADDERALL.
Your healthcare provider will decide if ADDERALL can be taken with other medicines.
Especially tell your healthcare provider if you or your child take:
Know the medicines that you or your child take. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.
Do not start any new medicine during treatment with ADDERALL without talking to your healthcare provider first.
How should ADDERALL be taken?
What are possible side effects of ADDERALL?
ADDERALL may cause serious side effects, including:
See “What is the most important information I should know about ADDERALL?”
Tell your healthcare provider if you have or your child has any numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
Call your healthcare provider right away if you have or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with ADDERALL.
The most common side effects of ADDERALL include:
Talk to your healthcare provider if you or your child have side effects that are bothersome or do not go away.
These are not all the possible side effects of ADDERALL.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ADDERALL?
Keep ADDERALL and all medicines out of the reach of children.
General information about the safe and effective use of ADDERALL
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ADDERALL for a condition for which it was not prescribed. Do not give ADDERALL to other people, even if they have the same condition. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about ADDERALL that was written for healthcare professionals.
What are the ingredients in ADDERALL?
Active Ingredients: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Inactive Ingredients: lactitol, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, and other ingredients. FD&C Blue #1 (7.5 mg and 10 mg tablets), FD&C Yellow #6 (12.5 mg, 15 mg, 20 mg, and 30 mg tablets).
This Medication Guide has been approved by the U.S. Food and Drug Administration.
