FERAN B

Amphetamine sulfate is a sympathomimetic amino of the amphetamine group.

It is a white, odorless crystalline powder.

It has a slightly bitter taste.

Its solutions are acid to litmus, having a pH of 5.0 to 8.0.

It is freely soluble in water and slightly soluble in alcohol.

Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate.

Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose, silicon dioxide, and stearic acid.

The 10 mg tablet also contains FD&C Blue #1.

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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.

Amphetamine, as the racemic form, differs from dextroamphetamine in a number of ways.

The l-isomer is more potent than the d-isomer in cardiovascular activity, but much less potent in causing CNS excitatory effects.

The racemic mixture also is less effective as an appetite suppressant when compared to dextroamphetamine.

There is neither specific evidence which clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how those effects relate to the condition of the central nervous system.

Drugs in this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression.

Other central nervous system actions or metabolic effects may be involved, for example.

Adult obese subjects instructed in dietary management and treated with "anorectic" drugs lose more weight on the average than these treated with placebo and diet, as determined in relatively short-term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week.

The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks.

The origins of the increased weight loss due to the various possible drug effects are not established.

The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician-investigator, the population treated, and the diet prescribed.

Studies do not permit conclusions as to the relative importance of the drug and nondrug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

Carbonic anhydrase 1 inhibitor Humans.

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Clinical Effects of Overdose Overdose of

CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension.

Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death.

Takotsubo cardiomyopathy may develop.

CNS effects including psychomotor agitation, confusion, and hallucinations.

Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur.

Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop.

Consider the possibility of multiple drug ingestion.

D-amphetamine is not dialyzable.

Consider contacting the Poison

Help line or a medical toxicologist for additional overdose management recommendations.

Abuse, Misuse, and Addiction Amphetamine sulfate tablets have a high potential for abuse and misuse.

The use of amphetamine 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 can be diverted for non-medical use into illicit channels or distribution.

Misuse and abuse of

CNS stimulants, including amphetamine sulfate tablets, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing amphetamine 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 in a safe place, preferably locked, and instruct patients to not give amphetamine sulfate tablets to anyone else.

Throughout amphetamine 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.

Risks to Patients with Serious Cardiac Disease 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 amphetamine 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 to 4 mm Hg) and heart rate (mean increase about to 6 bpm).

Monitor all patients for potential tachycardia and hypertension.

Psychiatric Adverse Reactions 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 amphetamine sulfate tablets, 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 stimulant-treated patients, compared with 0% of placebo-treated patients.

If such symptoms occur, consider discontinuing amphetamine sulfate tablets.

Long-Term Suppression of Growth in Pediatric Patients CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.

Closely monitor growth (weight and height) in amphetamine sulfate tablets-treated pediatric patients treated with CNS stimulants.

Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

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.

Vasculopathy, Including Raynaud's Phenomenon Stimulants, including amphetamine 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 ulceration and/or soft tissue breakdown.

Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports 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 amphetamine sulfate tablets treatment.

Further clinical evaluation (e.g., rheumatology referral) may be appropriate for 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.

The co-administration with cytochrome

P450 (CYP2D6) inhibitors may also increase the risk with increased exposure to amphetamine sulfate tablets.

In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6.

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 amphetamine sulfate tablets with MAOI drugs is contraindicated See CONTRAINDICATIONS.

Discontinue treatment with amphetamine sulfate tablets and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment.

If concomitant use of amphetamine sulfate tablets with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate amphetamine 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.

Tics, and Worsening of Tourette’s 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.

Assess the family history and clinically evaluate patients for tics or Tourette’s syndrome before initiating amphetamine sulfate tablets.

Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome with amphetamine sulfate tablets, and discontinue treatment if clinically appropriate.

Known hypersensitivity to amphetamine products.

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

Regardless of indication, amphetamine should be administered at the lowest effective dosage and dosage should be individually adjusted.

Late evening doses should be avoided because of resulting insomnia.

Usual dose is to 60 milligrams 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, amphetamine sulfate tablets may be used.

The suggested initial dose for patients aged to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response 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 the first dose on awakening; additional doses (5 or 10 mg) at intervals of to 6 hours.

Not recommended for children under 3 years of age.

In children from 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 or 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 milligrams per day. With tablets give first dose on awakening; additional doses (1 to 2) at intervals of 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 amphetamine sulfate tablets assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) See WARNINGS. the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome See WARNINGS.

Usual dosage is up to 30 mg daily, taken in divided doses of to 10 mg, 30 to 60 minutes before meals.

Not recommended for this use in children under 12 years of age.

USP are supplied as follows: 5 mg: White, round tablet, debossed "M" on one side, and "5" with a score on the other side in bottles of 100 tablets, NDC 0406-1219-01. 10 mg: Blue, round tablet, debossed "M" on one side, and "10" with double scores on the other side in bottles of 100 tablets, NDC 0406-1220-01.

Store at 20° to 25°C (68° to 77°F).

Dispense in a well-closed container, as defined in the USP.

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2023 Mallinckrodt.

Dextroamphetamine sulfate 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.

There are no adequate and well-controlled studies in pregnant women.

Amphetamine sulfate tablets 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 as anorectic agents in children under 12 years of age, or in children under 3 years of age with Attention Deficit Disorder with Hyperactivity described under INDICATIONS AND USAGE.

Clinical experience suggests that in psychotic children, administration of amphetamines may exacerbate symptoms of behavior disturbance and thought disorder.

Data is 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 child.

The decision to prescribe amphetamines should depend on the physician's assessment of the chronicity and severity of the child'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.