Evekeo ODT Uses

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What is Evekeo ODT?

Evekeo ODT is used to treat narcolepsy (sleep disorder). It is also used to treat attention-deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Evekeo ODT is also used for weight reduction in obese patients.

Evekeo ODT works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. Evekeo ODT is used as part of a total treatment program that also includes social, educational, and psychological treatment.

Evekeo ODT is available only with a doctor's prescription.

Evekeo ODT indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Evekeo ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

How should I use Evekeo ODT?

Use Evekeo ODT as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Evekeo ODT.

Uses of Evekeo ODT in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Evekeo ODT belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat a certain sleeping disorder (narcolepsy). It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.

How to use Evekeo ODT

Read the Medication Guide provided by your pharmacist before you start taking Evekeo ODT and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Taking this medication after noon may cause trouble sleeping (insomnia).

Keep the medication in the original package until you are ready to take a dose. Dry your hands before handling the medication. Peel back the foil layer of the blister pack to remove a tablet. Do not push the tablet through the foil because it may get damaged. Place the tablet on your tongue, allow it to dissolve, and swallow with your saliva. You do not need to take this medication with water or other liquid. Do not crush or chew the tablet.

The dosage is based on your medical condition and response to treatment. Your doctor may adjust your dose to find the dose that is best for you. Follow your doctor's instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

During treatment, your doctor may sometimes stop the medication for a short time to see if the medication is still needed.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (including severe tiredness, sleep problems, mental/mood changes such as depression) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your condition does not get better or if it gets worse.

Evekeo ODT description

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Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. By mimicking the structures of the catecholamine neurotransmitters, noradrenaline and dopamine, amphetamines modulate monoamine release, reuptake, and signalling within the brain. Although "Evekeo ODT" is used as a descriptor of its own structural class, Evekeo ODT properly refers to a racemic free base composed of equal parts of its two optical antipodes: levo-Evekeo ODT and dextro-Evekeo ODT. Used in the past for the treatment of depression, stress, and for concentration improvement, it is currently available as a prescription drug for the treatment of attention hyperactivity disorder (ADHD), narcolepsy, and as an adjunct in the treatment of exogenous obesity. Evekeo ODT is also available in a mixed salt/mixed enantiomer form (Adderall), where d-Evekeo ODT and l-Evekeo ODT are available in a ratio of 3:1. It is also available in a prodrug form as lisdexamfetamine.

Evekeo ODT dosage

Evekeo ODT Dosage

Generic name: Evekeo ODT 2.5mg in 1mL

Dosage form: suspension, extended release

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

2.1 Important Information Prior to Initiating Treatment

Prior to treating children, adolescents, and adults with CNS stimulants, including Evekeo ODT, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam).

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for Evekeo ODT use.

2.2 General Dosing Information

Evekeo ODT should be orally administered once daily in the morning with or without food. The dose should be individualized according to the needs and responses of the patient. Before administering the dose, shake the bottle of Evekeo ODT.

In children 6 years of age and older, start with 2.5 mg or 5 mg once daily in the morning. The dose may be increased in increments of 2.5 mg to 10 mg per day every 4 to 7 days up to a maximum dose of 20 mg per day.

Pharmacological treatment of ADHD may be needed for extended periods. Healthcare providers should periodically re-evaluate the long-term use of Evekeo ODT, and adjust dosage as needed.

2.3 Switching from other Evekeo ODT Products

If switching from other Evekeo ODT products, discontinue that treatment, and titrate with Evekeo ODT using the above titration schedule.

Do not substitute for other Evekeo ODT products on a milligram-per-milligram basis, because of different Evekeo ODT base compositions and differing pharmacokinetic profiles.

2.4 Dosage Modifications due to Drug Interactions

Agents that alter urinary pH can impact urinary excretion and alter blood levels of Evekeo ODT. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust Evekeo ODT dosage accordingly.

More about Evekeo ODT (Evekeo ODT)

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Professional resources

Related treatment guides

Evekeo ODT interactions

See also:
What other drugs will affect Evekeo ODT?

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Drugs Having Clinically Important Interactions With Amphetamines

Table 5: Drugs having clinically important interactions with amphetamines.

MAO Inhibitors (MAOI)
Clinical Impact MAOI antidepressants slow Evekeo ODT metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.
Intervention Do not administer Evekeo ODT during or within 14 days following the administration of MAOI.
Examples selegiline, isocarboxazid, phenelzine, tranylcypromine
Alkalinizing Agents
Clinical Impact Increase blood levels and potentiate the action of Evekeo ODT.
Intervention Co-administration of Evekeo ODT and gastrointestinal alkalinizing agents should be avoided.
Examples Gastrointestinal alkalinizing agents (e.g., sodium bicarbonate).

Urinary alkalinizing agents (e.g., acetazolamide, some thiazides).

Acidifying Agents
Clinical Impact Lower blood levels and efficacy of amphetamines.
Intervention Increase dose based on clinical response.
Examples Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid).
Tricyclic Antidepressants
Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-Evekeo ODT in the brain; cardiovascular effects can be potentiated.
Intervention Monitor frequently and adjust or use alternative therapy based on clinical response.
Examples desipramine, protriptyline
Proton Pump Inhibitors
Clinical Impact Time to maximum concentration (Tmax) of Evekeo ODT is increased compared to when administered alone.
Intervention Monitor patients for changes in clinical effect and adjust therapy based on clinical response.
Example omeprazole

Drug/Laboratory Test Interactions

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

Drug Abuse And Dependence

Controlled Substance

Evekeo ODT contains Amphetamine, which is a Schedule II controlled substance in the U.S. Controlled Substance Act (CSA).

Abuse

Evekeo ODT, is a CNS stimulant that contains Amphetamine which has a high potential for abuse. Abuse is characterized by impaired control of drug use, compulsive use despite harm, and craving.

Signs and symptoms of Evekeo ODT abuse may include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. Abusers of amphetamines may use other unapproved routes of administration which can result in overdose and death.

To reduce the abuse of Evekeo ODT, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and proper storage and disposal of CNS stimulants, monitor for signs of abuse while on therapy, and re-evaluate the need for Evekeo ODT use.

Dependence

Tolerance

Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug’s desired and/or undesired effects over time) may occur during the chronic therapy of CNS stimulants including Evekeo ODT.

Dependence

Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants including Evekeo ODT. Withdrawal symptoms after abrupt cessation following prolonged high dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Evekeo ODT side effects

See also:
What are the possible side effects of Evekeo ODT?

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trials Experience With Other Evekeo ODT Products In Pediatric Patients And Adults With ADHD

Cardiovascular: Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic Evekeo ODT use.

Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea.

Eye Disorders: Vision blurred, mydriasis.

Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

Endocrine: Impotence, changes in libido.

Skin: Alopecia.

Clinical Trials Experience With Evekeo ODT In Pediatric Patients With ADHD

There is limited experience with Evekeo ODT in controlled trials. Based on this limited experience, the adverse reaction profile of Evekeo ODT appears similar to other Evekeo ODT extended-release products. The most common ( ≥ 2% in the Evekeo ODT group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6–12 years) were: epistaxis, allergic rhinitis and upper abdominal pain.

Table 1: Common adverse reactions occurring in ≥ 2% of Subjects on Evekeo ODT and greater than Placebo during the double blind phase.

Preferred Term DYANAVELXR

(N=52)

Placebo

(N=48)

Respiratory, thoracic and mediastinal disorders
Epistaxis 3.8% 0%
Rhinitis allergic 3.8% 0%
Gastrointestinal disorders
Abdominal pain upper 3.8% 2.1%

Postmarketing Experience

The following adverse reactions have been identified during post approval use of other Evekeo ODT products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Endocrine: frequent or prolonged erections.

Musculoskeletal, Connective Tissue, and Bone Disorders: rhabdomyolysis.

Psychiatric Disorders: dermatillomania.

Evekeo ODT contraindications

See also:
What is the most important information I should know about Evekeo ODT?

Evekeo ODT extended-release oral suspension is contraindicated:

Active ingredient matches for Evekeo ODT:

Amphetamine

Amphetamine SULFATE 5mg

Amphetamine Orally Disintegrating Tablets


List of Evekeo ODT substitutes (brand and generic names)

Sort by popularity
Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral; Amphetamine 10 mg
Tablet; Oral; Amphetamine Sulfate 5 mg
Tablet; Oral; Amphetamine Sulfate 10 mg
Dyanavel XR suspension, extended release 2.5 mg/mL (Tris Pharma Inc (US))
Evekeo tablet 5 mg/1 (Arbor Pharmaceuticals, Inc. (US))
Evekeo tablet 10 mg/1 (Arbor Pharmaceuticals, Inc. (US))

References

  1. DailyMed. "AMPHETAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "AMPHETAMINE". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "AMPHETAMINE". http://www.drugbank.ca/drugs/DB00182 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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