DEXTROAMPHETAMINE SULFATE- dextroamphetamine sulfate tablet
SpecGx LLC
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Dextroamphetamine sulfate tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dextroamphetamine sulfate tablets, can result in overdose and death (see OVERDOSAGE), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing dextroamphetamine sulfate tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout dextroamphetamine sulfate tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction (see WARNINGS, DRUG ABUSE AND DEPENDENCE).
Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate as the neutral sulfate. The structural formula is as follows:
Each tablet, for oral administration, contains dextroamphetamine sulfate USP, 5 mg or 10 mg. Each tablet also contains the following inactive ingredients: microcrystalline cellulose, povidone, silicon dioxide, and stearic acid.
Amphetamines are non-catecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action.
There is neither specific evidence which clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.
Pharmacokinetics
The pharmacokinetics of the tablet and sustained-release capsule 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.
Dextroamphetamine sulfate tablets are indicated for:
Known hypersensitivity to amphetamine products.
During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).
Dextroamphetamine sulfate tablets have a high potential for abuse and misuse. The use of dextroamphetamine sulfate tablets exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Amphetamine sulfate tablets can be diverted for non-medical use into illicit channels or distribution (see DRUG ABUSE AND DEPENDENCE). Misuse and abuse of CNS stimulants, including dextroamphetamine sulfate tablets, can result in overdose and death (see OVERDOSAGE), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing dextroamphetamine sulfate tablets, 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 tablets in a safe place, preferably locked, and instruct patients to not give dextroamphetamine sulfate tablets to anyone else. Throughout dextroamphetamine sulfate tablets 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 are treated with CNS stimulants at the recommended ADHD dosages.
Avoid dextroamphetamine sulfate tablets 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). Monitor all patients for potential tachycardia and hypertension.
Exacerbation of Pre-Existing Psychosis – CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
Induction of a Manic Episode in Patients with Bipolar 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).
New Psychotic or Manic Symptoms – 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 stimulant-treated patients, compared with 0% of placebo-treated patients. If such symptoms occur, consider discontinuing dextroamphetamine sulfate tablets.
CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients, including dextroamphetamine sulfate tablets. Closely monitor growth (weight and height) in dextroamphetamine sulfate tablets-treated pediatric patients treated with CNS stimulants.
Pediatric patients who are who are not growing or gaining height or 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 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.
Stimulants, including dextroamphetamine sulfate 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 ulcerations and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports at and at the therapeutic dosages 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 dextroamphetamine sulfate tablets treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for dextroamphetamine sulfate tablets-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 co-administration of cytochrome P450 (CYP2D6) inhibitors may also increase the risk with increased exposure to dextroamphetamine sulfate tablets. In these situations, consider an alternative non-serotonergic 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 dextroamphetamine sulfate tablets with MAOI drugs is contraindicated (see CONTRAINDICATIONS).
Discontinue treatment with dextroamphetamine sulfate tablets and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of dextroamphetamine sulfate tablets with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate dextroamphetamine sulfate tablets 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 dextroamphetamine sulfate tablets, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported.
Assess the family history and clinically evaluate patients for tics or Tourette’s syndrome before initiating dextroamphetamine sulfate tablets. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome with dextroamphetamine sulfate tablets, and discontinue treatment if clinically appropriate.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Abuse, Misuse, and Addiction – Educate patients and their families about the risks of abuse, misuse, and addiction of dextroamphetamine sulfate tablets, which can lead to overdose and death, and proper disposal of any unused drug (see WARNINGS, DRUG ABUSE AND DEPENDENCE, OVERDOSAGE). Advise patients to store dextroamphetamine sulfate tablets in a safe place, preferably locked, and instruct patients to not give dextroamphetamine sulfate tablets to anyone else.
Risks to Patients with Serious Cardiac Disease – Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with dextroamphetamine sulfate tablets 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).
Increased Blood Pressure and Heart Rate – Advise patients that dextroamphetamine sulfate tablets can elevate blood pressure and heart rate (see WARNINGS).
Psychiatric Adverse Reactions – Advise patients that dextroamphetamine sulfate tablets, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania (see WARNINGS).
Long-Term Suppression of Growth in Pediatric Patients – Advise patients that dextroamphetamine sulfate tablets may cause slowing of growth including weight loss (see WARNINGS).
Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon]
Serotonin Syndrome – Caution patients about the risk of serotonin syndrome with concomitant use of dextroamphetamine sulfate tablets 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, DRUG INTERACTIONS). Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.
Motor and Verbal Tics, and Worsening of Tourette’s Syndrome – Advise patients that motor and verbal tics and worsening of Tourette’s syndrome may occur during treatment with dextroamphetamine sulfate tablets. Instruct the patients to notify their healthcare provider if emergence or worsening of tics or Tourette’s syndrome occurs (see WARNINGS).
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.
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.
Serotonergic Drugs – The concomitant use of dextroamphetamine sulfate tablets 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 dextroamphetamine sulfate tablets initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate tablets and the concomitant serotonergic drug(s) (see WARNINGS, PRECAUTIONS). Examples of serotonergic drugs include selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort.
CYP2D6 Inhibitors – The concomitant use of dextroamphetamine sulfate tablets and CYP2D6 inhibitors may increase the exposure of dextroamphetamine sulfate tablets 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 dextroamphetamine sulfate tablets initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate tablets and the CYP2D6 inhibitor (see WARNINGS, OVERDOSAGE).
Acidifying Agents – Gastrointestinal 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 – Gastrointestinal 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.
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.
Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of dextroamphetamine sulfate have not been performed.
Teratogenic Effects. Pregnancy Category C - Dextroamphetamine has 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, tracheoesophageal 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. Dextroamphetamine 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.
Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.
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 Disorder with Hyperactivity described under INDICATIONS AND USAGE.
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.
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 verbal tics and Tourette's syndrome.
Gastrointestinal – Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.
Allergic – Urticaria.
Endocrine – Impotence, changes in libido, frequent or prolonged erections.
Musculoskeletal – Rhabdomyolysis.
Dextroamphetamine sulfate tablets have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see WARNINGS). Dextroamphetamine sulfate tablets 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 healthcare 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 dextroamphetamine sulfate tablets, can result in overdose and death (see OVERDOSAGE), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Physical Dependence – Dextroamphetamine sulfate tablets 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 dextroamphetamine sulfate tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
Tolerance – Dextroamphetamine sulfate tablets 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).
Overdose of CNS stimulants is characterized by the following sympathomimetic effects:
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.
Usual dose is 5 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 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 an 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.
Not recommended for pediatric patients under 3 years of age.
In pediatric patients 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 an 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 an 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.
Prior to treating patients with dextroamphetamine sulfate tablets assess:
Each Dextroamphetamine Sulfate Tablet USP (5 mg) contains dextroamphetamine sulfate 5 mg. It is available as triangle shaped, white to off white tablet debossed with a number “5” and a bisect on one side and an “M” in a box on the other.
Bottles of 100 ........................NDC 0406-8958-01
Each Dextroamphetamine Sulfate Tablet USP (10 mg) contains dextroamphetamine sulfate 10 mg. It is available as diamond shaped, white to off white tablet debossed with a number “10” and a partial quadrisect on one side and an “M” in a box on the other.
Bottles of 100 ........................NDC 0406-8959-01
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in well-closed containers with a child-resistant closure as defined in the USP.
Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.
© 2023 Mallinckrodt.
SpecGx LLC
Webster Groves, MO 63119 USA
Rev 09/2023
Mallinckrodt™
Pharmaceuticals
An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20D10.pdf or by calling 1-800-778-7898 for alternate delivery options.
MEDICATION GUIDE |
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What is the most important information I should know about Dextroamphetamine Sulfate Tablets? Dextroamphetamine sulfate tablets may cause serious side effects, including:
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 dextroamphetamine sulfate tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. |
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What are Dextroamphetamine Sulfate Tablets? Dextroamphetamine sulfate tablets are a central nervous system (CNS) stimulant prescription medicine used for the treatment of:
It is not known if dextroamphetamine sulfate tablets are safe and effective in children under 6 years of age. Dextroamphetamine sulfate tablets are a federally controlled substance (CII) because it contains dextroamphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep dextroamphetamine sulfate tablets in a safe place to protect it from theft. Never give your dextroamphetamine sulfate tablets to anyone else because it may cause death or harm them. Selling or giving away dextroamphetamine sulfate tablets may harm others and is against the law. |
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Do not take Dextroamphetamine Sulfate Tablets if you or your child:
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Before taking Dextroamphetamine Sulfate Tablets, 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. Dextroamphetamine sulfate tablets 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 dextroamphetamine sulfate tablets. Your healthcare provider will decide if dextroamphetamine sulfate tablets can be taken with other medicines. Especially tell your healthcare provider if you or your child take: |
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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 dextroamphetamine sulfate tablets without talking to your healthcare provider first. |
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How should Dextroamphetamine Sulfate Tablets be taken?
If you or your child take too many dextroamphetamine sulfate tablets, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. |
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What should I avoid while taking Dextroamphetamine Sulfate Tablets? Do not drive, operate heavy machinery, or do other potentially dangerous activities until you know how dextroamphetamine sulfate tablets affect you. |
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What are possible side effects of Dextroamphetamine Sulfate Tablets? Dextroamphetamine sulfate tablets may cause serious side effects, including: See “What is the most important information I should know about Dextroamphetamine Sulfate Tablets?”
The most common side effects of dextroamphetamine sulfate tablets include:
These are not all of the possible side effects of dextroamphetamine sulfate tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store Dextroamphetamine Sulfate Tablets?
Keep dextroamphetamine sulfate tablets and all medicines out of the reach of children. |
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General information about the safe and effective use of Dextroamphetamine Sulfate Tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dextroamphetamine sulfate tablets for a condition for which they were not prescribed. Do not give dextroamphetamine sulfate tablets to other people, even if they have the same symptoms that you or your child have. It may harm them and it is against the law. You can ask your pharmacist or healthcare provider for information about dextroamphetamine sulfate tablets that is written for health professionals. |
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What are the ingredients in Dextroamphetamine Sulfate Tablets? Active ingredient: Dextroamphetamine sulfate USP Inactive ingredients: microcrystalline cellulose, povidone, silicon dioxide, and stearic acid Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2023 Mallinckrodt. Mallinckrodt™ For more information about dextroamphetamine sulfate tablets visit www.mallinckrodt.com or call 1-800-778-7898. |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 09/2023
NDC 0406-8958-01
100 TABLETS
Dextroamphetamine Sulfate
Tablets USP
5 mg
CII
Rx only
Each tablet contains: Dextroamphetamine Sulfate USP . . . . . . . 5 mg
PHARMACIST: Dispense the Medication Guide provided separately to each patient.
Mallinckrodt™
L00D14
Rev 09/2017
NDC 0406-8959-01
100 TABLETS
Dextroamphetamine Sulfate
Tablets USP
10 mg
CII
Rx only
Each tablet contains: Dextroamphetamine Sulfate USP . . . . . . . 10 mg
PHARMACIST: Dispense the Medication Guide provided separately to each patient.
Mallinckrodt™
L00D17
Rev 09/2017
DEXTROAMPHETAMINE SULFATE
dextroamphetamine sulfate tablet |
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DEXTROAMPHETAMINE SULFATE
dextroamphetamine sulfate tablet |
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Labeler - SpecGx LLC (080679498) |