Evekeo 10 mg/1

Amphetamine Sulfate · TABLET · Azurity Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Evekeo is a tablet containing amphetamine sulfate at 10 mg/1, taken oral. Manufactured by Azurity Pharmaceuticals, Inc..

Key Facts

Brand Name: Evekeo
Generic Name: Amphetamine Sulfate
NDC Code (Product): 24338-026
Manufacturer: Azurity Pharmaceuticals, Inc.
Strength: 10 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
DEA Schedule: Schedule II (Controlled)
Application #: ANDA200166
Marketing Start: 11/01/2015

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

toxicity to various agents605 reports

drug abuse460 reports

completed suicide176 reports

cardiac arrest117 reports

drug ineffective102 reports

cardio-respiratory arrest93 reports

respiratory arrest87 reports

headache70 reports

drug interaction64 reports

overdose58 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 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…

Dosage & Administration

DOSAGE AND ADMINISTRATION 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. Narcolepsy 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. Attention Deficit Disorder with Hyperactivity 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 interv…

Warnings

WARNINGS Abuse, Misuse, and Addiction Evekeo has a high potential for abuse and misuse. The use of Evekeo 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 (see DRUG ABUSE and DEPENDENCE ). Misuse and abuse of CNS stimulants, including Evekeo, 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 Evekeo, 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 Evekeo to anyone else. Throughout Evekeo 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 a…

Contraindications

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

Drug Interactions

Drug Interactions MAO inhibitors- 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. Serotonergic Drugs - 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). CYP2D6 Inhibitors- 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 synd…

Adverse Reactions

ADVERSE REACTIONS: 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 when amphetamines are used for other than the anorectic effect. Allergic Urticaria Endocrine Impotence, changes in libido, and frequent or prolonged erections. Musculoskeletal Rhabdomyolysis

Frequently Asked Questions

What is Evekeo used for?

Evekeo contains Amphetamine Sulfate. It is a tablet taken oral. Consult your doctor for specific uses.

Is Evekeo a controlled substance?

Yes, Evekeo is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Evekeo?

The generic name for Evekeo is Amphetamine Sulfate. There are 11 other brand versions of Amphetamine Sulfate.

What is the NDC code for Evekeo 10 mg/1?

The NDC (National Drug Code) for Evekeo 10 mg/1 is 24338-026, listed by Azurity Pharmaceuticals, Inc..

Product NDC

24338-026

Package NDC

24338-026-03

Other Amphetamine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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