Dextroamphetamine

Dextroamphetamine
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. * AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME 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 AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.

Overview

Dextroamphetamine is an amphetamine that is FDA approved for the treatment of narcolepsy, attention deficit disorder with hyperactivity. There is a Black Box Warning for this drug as shown here. Common adverse reactions include increased heart rate, myocardial infarction, peripheral vascular disease, raynaud's disease, sudden cardiac death, decreased body growth, cerebrovascular accident, intracranial hemorrhage, lowered convulsive threshold, aggressive behavior, psychotic disorder.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Narcolepsy
• Attention Deficit Disorder with Hyperactivity

• As an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.
• The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
• Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia.

Narcolepsy

• Usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
• Narcolepsy seldom occurs in pediatric patients under 12 years of age; however, when it does, DEXEDRINE tablets 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 an 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.

Attention Deficit Disorder with Hyperactivity

• Not recommended for pediatric patients under 3 years of age.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dextroamphetamine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dextroamphetamine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily, by tablet; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.
• In pediatric patients 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.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dextroamphetamine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dextroamphetamine in pediatric patients.

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).

Warnings

WARNING See full prescribing information for complete Boxed Warning. * AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME 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 AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.

Serious Cardiovascular Events

• Sudden Death in Patients with Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems

Children and Adolescents

• Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.
• Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

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.

Hypertension and other Cardiovascular Conditions

• Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure.
• Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.

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 a 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 3,482 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 likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or 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 seizures, 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.

Peripheral Vasculopathy, including Raynaud’s phenomenon

• Stimulants, including DEXEDRINE tablets, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment.
• Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Visual Disturbance

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

Adverse Reactions

Clinical Trials Experience

• Cardiovascular: Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
• Central Nervous System: Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome.
• Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.
• Allergic: Urticaria.
• Endocrine: Impotence, changes in libido.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Dextroamphetamine in the drug label.

Drug Interactions

• Acidifying agents

• Gastro-intestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines.
• Urinary acidifying agents (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 blockers

• Adrenergic blockers are inhibited by amphetamines.

• Alkalinizing agents

• Gastro-intestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. 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 reuptake, 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 and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.

• Lithium carbonate -The 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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• Pregnancy Category C.
• DEXEDRINE tablets have been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose.
• Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. While 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.
• DEXEDRINE tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dextroamphetamine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dextroamphetamine during labor and delivery.

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 pediatric patients have not been well established. Amphetamines are not recommended for use in pediatric patients under 3 years of age with Attention Deficit.
• Clinical experience suggests that in psychotic pediatric patients, administration of amphetamines may exacerbate symptoms of behavior disturbance and thought disorder.
• Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in pediatric patients and their families should precede use of stimulant medications.
• Data are inadequate to determine whether chronic administration of amphetamines may be associated with growth inhibition; therefore, growth should be monitored during treatment.
• Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the pediatric patient.
• The decision to prescribe amphetamines should depend on the physician's assessment of the chronicity and severity of the pediatric patient's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.
• When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.

Geriatic Use

There is no FDA guidance on the use of Dextroamphetamine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Dextroamphetamine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dextroamphetamine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dextroamphetamine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dextroamphetamine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dextroamphetamine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dextroamphetamine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

• All patients should be monitored for larger changes in heart rate and blood pressure.
• 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.
• Growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted especially in children

IV Compatibility

There is limited information regarding IV Compatibility of Dextroamphetamine in the drug label.

Overdosage

• Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce severe reactions, yet doses of 400 to 500 mg are not necessarily fatal.
• In rats, the oral LD50 of dextroamphetamine sulfate is 96.8 mg/kg.
• Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rhabdomyolysis, rapid respiration, hyperpyrexia, confusion, assaultiveness, hallucinations, panic states.
• 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.

Pharmacology

Dextroamphetamine
Systematic (IUPAC) name
(2S)-1-phenylpropan-2-amine
Identifiers
CAS number	51-64-9
ATC code	N06BA02
PubChem	5826
DrugBank	DB01576
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	135.20622
SMILES	eMolecules & PubChem
Physical data
Density	0.913 g/cm³
Boiling point	201.5 °C (395 °F)
Solubility in water	20 mg/mL (20 °C)
Pharmacokinetic data
Bioavailability	Oral 75–100%
Metabolism	CYP2D6, DBH, FMO3,XM-ligase,
Half life	10-12 hours
Excretion	Renal (45%); urinary pH-dependent
Therapeutic considerations
Licence data	Sulfate&SearchType=BasicSearch US
Pregnancy cat.	B3(AU) C(US)
Legal status	Controlled (S8)(AU) Schedule I(CA) Class B(UK) Schedule II(US)
Dependence Liability	Moderate to High
Routes	Oral (only medically-utilized route)

Mechanism of Action

There is limited information regarding Dextroamphetamine Mechanism of Action in the drug label.

Structure

There is limited information regarding Dextroamphetamine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Dextroamphetamine in the drug label.

Pharmacokinetics

• The pharmacokinetics of the tablets and sustained-release capsules were compared in 12 healthy subjects. The extent of bioavailability of the sustained-release capsule was similar compared to the immediate-release tablet. Following administration of three 5 mg tablets, average maximal dextroamphetamine plasma concentrations (Cmax) of 36.6 ng/mL were achieved at approximately 3 hours.
• Following administration of one 15 mg sustained-release capsule, maximal dextroamphetamine plasma concentrations were obtained approximately 8 hours after dosing. The average Cmax was 23.5 ng/mL. The average plasma T1/2 was similar for both the tablet and sustained-release capsule and was approximately 12 hours.
• In 12 healthy subjects, the rate and extent of dextroamphetamine absorption were similar following administration of the sustained-release capsule formulation in the fed (58 to 75 gm fat) and fasted state.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Dextroamphetamine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Dextroamphetamine in the drug label.

How Supplied

• DEXEDRINE tablets, 5 mg are pink, round compressed tablets debossed cor over 215 on one side and Bisect on the other side. They are supplied as follows:
• Bottles of 100 (NDC 52054-215-10)
• DEXEDRINE tablets, 10 mg are pink, round compressed tablets debossed cor over 216 on one side and Quadrisect on the other side. * They are supplied as follows:
• Bottles of 100 (NDC 52054-216-10)
• Dispense in a tight container as defined in the USP.

Storage

• Store at 20° to 25°C (68° to 77°F).

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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Patient Counseling Information

• Read the Medication Guide that comes with DEXEDRINE tablets 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 your or your child's treatment with DEXEDRINE tablets.

This image is provided by the National Library of Medicine.

What are DEXEDRINE tablets?

• DEXEDRINE tablets are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
• DEXEDRINE tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
• DEXEDRINE tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
• DEXEDRINE tablets are also used in the treatment of a sleep disorder called narcolepsy.

Who should not take DEXEDRINE tablets?

• DEXEDRINE tablets 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.
• Is sensitive to, allergic to, or had a reaction to other stimulant medicines

• DEXEDRINE tablets are not recommended for use in children less than 3 years old.
• DEXEDRINE tablets may not be right for you or your child. Before starting DEXEDRINE tablets 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
• Thyroid problems
• Seizures or have had an abnormal brain wave test (EEG)

• Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can DEXEDRINE tablets be taken with other medicines?

• Tell your doctor about all of the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements.
• DEXEDRINE tablets 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 DEXEDRINE tablets.
• Your doctor will decide whether DEXEDRINE tablets can be taken with other medicines.
• Especially tell your doctor if you or your child takes:

• Anti-depression medicines including MAOIs
• Blood pressure medicines
• Antacids
• Seizure medicines

• Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
• Do not start any new medicine while taking DEXEDRINE tablets without talking to your doctor first.

How should DEXEDRINE tablets be taken?

• Take DEXEDRINE tablets exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
• DEXEDRINE tablets are usually taken two to three times a day. The first dose is usually taken in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.
• From time to time, your doctor may stop DEXEDRINE tablets treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking DEXEDRINE tablets. Children should have their height and weight checked often while on DEXEDRINE tablets. DEXEDRINE tablets treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much DEXEDRINE tablets or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of DEXEDRINE tablets?

• See "What is the most important information I should know about DEXEDRINE tablets?" 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:

• Fast heart beat
• Decreased appetite
• Tremors
• Headache
• Trouble sleeping
• Dizziness
• Stomach upset
• Weight loss
• Dry mouth

• DEXEDRINE tablets may affect you or your child's ability to drive or do other dangerous activities.
• Talk to your doctor if you or your child has 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. 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 DEXEDRINE tablets?

• Store DEXEDRINE tablets in a safe place at room temperature, 20° to 25°C (68° to 77°F).
• Keep DEXEDRINE tablets and all medicines out of the reach of children.
• General information about DEXEDRINE tablets
• Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DEXEDRINE tablets for a condition for which it was not prescribed. Do not give DEXEDRINE tablets 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 DEXEDRINE tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DEXEDRINE tablets that was written for healthcare professionals. For more information about DEXEDRINE tablets, you may also contact Amedra Pharmaceuticals LLC at 1-888-894-6528.

What are the ingredients in DEXEDRINE tablets?

• Active Ingredients: dextroamphetamine sulfate
• Inactive Ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and D&C Red # 27 Aluminum Lake.

Precautions with Alcohol

• Alcohol-Dextroamphetamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• DEXEDRINE ®

Look-Alike Drug Names

There is limited information regarding Dextroamphetamine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.