DailyMed Label: Evekeo

DailyMed Label: Evekeo

2023

DailyMed Prescription

Evekeo

Amphetamine Sulfate

AZURITY PHARMACEUTICALS, INC.

NDC: 24338-022

NDC: 24338-022

NDC: 24338-026

NDC: 24338-026

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 6.0. 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 and stearic acid. The 10 mg tablet also contains FD&C Blue #1. Structural Formula: C 18 H 28 N 2 SO 4                                                                                   MW 368.49 Chemical Structure

Evekeo ® (amphetamine sulfate tablets, USP) is indicated for: 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 children with 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 the 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 not be warranted. Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY ) should be weighed against possible risks inherent in use of the drug, such as those described below.

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 5 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, Evekeo 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 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 4 to 6 hours. 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 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 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 Evekeo 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 5 to 10 mg, 30 to 60 minutes before meals. Not recommended for this use in children under 12 years of age.

Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) (see WARNINGS ).

Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. Advise the patient to read the FDA-approved patient labeling (Medication Guide). Educate patients and their families about the risks of abuse, misuse, and addiction of Evekeo, which can lead to overdose and death, and proper disposal of any unused drug (see WARNINGS , DRUG ABUSE AND DEPENDENCE , and OVERDOSAGE ) . Advise patients to store Evekeo in a safe place, preferably locked, and instruct patients to not give Evekeo to anyone else. Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with Evekeo 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 Evekeo can elevate blood pressure and heart rate (see WARNINGS ) . Advise patients that Evekeo, 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 Evekeo, may cause slowing of growth including weight loss (see WARNINGS ) . Instruct patients beginning treatment with Evekeo about the risk of peripheral vasculopathy, including Raynaud's Phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Evekeo. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients. Caution patients about the risk of serotonin syndrome with concomitant use of Evekeo 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 Evekeo. 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 vehicle; the patient should therefore be cautioned accordingly. MAOI antidepressants, as well as a metabolic 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. The concomitant use of Evekeo 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 Evekeo initiation or dosage increase. If serotonin syndrome occurs, discontinue Evekeo and the concomitant serotonergic drug(s) (see WARNING and PRECAUTIONS ). The concomitant use of Evekeo and CYP2D6 inhibitors may increase the exposure of Evekeo 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 Evekeo initiation and after a dosage increase. If serotonin syndrome occurs, discontinue Evekeo and the CYP2D6 inhibitor (see WARNING , OVERDOSAGE ). Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. 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 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 are inhibited by amphetamines. 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 action of amphetamines. 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. Amphetamines may counteract the sedative effect of antihistamines. Amphetamines may antagonize the hypotensive effects of antihypertensives. Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamine, and can be used to treat amphetamine poisoning. Amphetamines may delay intestinal absorption of ethosuximide. Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines. The antiobesity 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. Co- administration of phenobarbital may produce a synergistic anticonvulsant action. Amphetamines may delay intestinal absorption of phenytoin; co- administration of phenytoin may produce a synergistic anticonvulsant action. In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur. Amphetamines inhibit the hypotensive effect of veratrum alkaloids. Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations. Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of amphetamine sulfate have not been performed. 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. Evekeo 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.

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

MAOI antidepressants, as well as a metabolic 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. The concomitant use of Evekeo 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 Evekeo initiation or dosage increase. If serotonin syndrome occurs, discontinue Evekeo and the concomitant serotonergic drug(s) (see WARNING and PRECAUTIONS ). The concomitant use of Evekeo and CYP2D6 inhibitors may increase the exposure of Evekeo 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 Evekeo initiation and after a dosage increase. If serotonin syndrome occurs, discontinue Evekeo and the CYP2D6 inhibitor (see WARNING , OVERDOSAGE ). Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. 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 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 are inhibited by amphetamines. 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 action of amphetamines. 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. Amphetamines may counteract the sedative effect of antihistamines. Amphetamines may antagonize the hypotensive effects of antihypertensives. Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamine, and can be used to treat amphetamine poisoning. Amphetamines may delay intestinal absorption of ethosuximide. Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines. The antiobesity 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. Co- administration of phenobarbital may produce a synergistic anticonvulsant action. Amphetamines may delay intestinal absorption of phenytoin; co- administration of phenytoin may produce a synergistic anticonvulsant action. In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur. Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Evekeo (amphetamine sulfate tablets, USP) is supplied as follows: 5 mg: White, round tablet, debossed "EVK" on one side, and "5" with a score on the other side in:   Bottles of 30 tablets, NDC 24338-022-03 10 mg: Blue, round tablet, debossed "EVK" on one side, and "10" with double scores on the other side in:   Bottles of 30 tablets, NDC 24338-026-03 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a well-closed container, as defined in the USP.

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.

NDC 24338-022-03 30 tablets Evekeo ® (amphetamine sulfate tablets, USP) CII Rx only 5 mg Pharmacist: Dispense the Medication Guide provided separately to each patient. Mfd. for Arbor Pharmaceuticals, LLC Atlanta, GA 30328 PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label - 30 Tablet