The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Pre-Treatment Screening
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).
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 use.
Dosing Considerations For All Patients
Evekeo may be taken with or without food. Individualize the dosage according to the therapeutic needs and response of the patient.
Evekeo should be taken as follows:
The tablet should remain in the blister pack until the patient is ready to take it.
The patient or caregiver should use dry hands to open the blister.
Tear along the perforation, bend the blister where indicated and peel back the blister’s labeled backing to take out the tablet. The tablet should not be pushed through the foil.
As soon as the blister is opened, the tablet should be removed and placed on the patient’s tongue.
The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing.
The tablet will disintegrate in saliva so that it can be swallowed.
Pediatric Patients
The recommended starting dosage is 6.3 mg once daily in the morning. Increase in increments of 3.1 mg or 6.3 mg at weekly intervals. The maximum recommended dose is 18.8 mg daily for patients 6 to 12 years, and 12.5 mg daily for patients 13 to 17 years.
Adults
The recommended dose is Evekeo 12.5 mg daily.
Switching From Other Evekeo Products
Patients taking ADDERALL XR may be switched to Evekeo at the equivalent dose taken once daily. Refer to Table 1 for equivalent doses of Evekeo and ADDERALL XR. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, Evekeo aspartate monohydrate, and Evekeo extended-release capsules) is also referred to as mixed salts of a single-entity Evekeo product extended-release capsules (MAS ER).
Table 1: Equivalent Doses of Evekeo and ADDERALL XR (Mixed Salts of a Single-Entity Evekeo Product) Extended-Release Capsules
Mixed salts of a single-entity Evekeo product extended-release capsules (MAS ER)
If switching from any other Evekeo products, discontinue that treatment, and titrate with Evekeo using the titration schedule.
Do not substitute for other Evekeo products on a milligram-per-milligram basis because of different Evekeo base compositions and differing pharmacokinetic profiles.
Dosage Modifications Due To Drug Interactions
Agents that alter urinary pH can impact urinary excretion and alter blood levels of Evekeo. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust Evekeo dosage accordingly.
How supplied
Dosage Forms And Strengths
Evekeo 3.1 mg Evekeo Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A1 on one side)
Evekeo 6.3 mg Evekeo Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A2 on one side)
Evekeo 9.4 mg Evekeo Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A3 on one side)
Evekeo 12.5 mg Evekeo Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A4 on one side)
Evekeo 15.7 mg Evekeo Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A5 on one side)
Evekeo 18.8 mg Evekeo Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A6 on one side)
Storage And Handling
Evekeo 3.1 mg Extended Release
Orally Disintegrating Tablet
: round, orange to light orange mottled (debossed A1 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-005-30
Evekeo 6.3 mg Extended Release
Orally Disintegrating Tablet
: round, orange to light orange mottled (debossed A2 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-010-30
Evekeo 9.4 mg Extended Release
Orally Disintegrating Tablet
: round, orange to light orange mottled (debossed A3 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-015-30
Evekeo 12.5 mg Extended Release
Orally Disintegrating Tablet
: round, orange to light orange mottled (debossed A4 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-020-30
Evekeo 15.7 mg Extended Release
Orally Disintegrating Tablet
: round, orange to light orange mottled (debossed A5 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-025-30
Evekeo 18.8 mg Extended Release
Orally Disintegrating Tablet
: round, orange to light orange mottled (debossed A6 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-030-30
Storage
Store at 20°C to 25° C (68°F to 77° F). Excursions permitted to 15-30° C (59-86° F)
Store Evekeo blister packages in the rigid, plastic travel case provided after removal from the carton. To obtain additional travel cases, patients and health care professionals can call Neos Therapeutics, Inc., at 1-XXX-XXX-XXXX.
Disposal
Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Evekeo at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Evekeo with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Evekeo in the household trash.
Manufactured by: Neos Therapeutics, LP., Grand Prairie, TX 75050. Made in USA. Revised: Jan 2016
What other drugs will affect Evekeo?
Do not take Evekeo if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last 14 days.
Before taking Evekeo, tell your doctor if you are taking any of the following medicines:
insulin or another medicine to treat diabetes;
guanethidine (Ismelin) or reserpine (Diutensin-R);
doxazosin (Cardura), terazosin (Hytrin), prazosin (Minipress), or guanadrel(Hylorel);
a tricyclic antidepressant such as amitriptyline (Elavil), amoxapine (Asendin), doxepin (Sinequan), nortriptyline (Pamelor), imipramine (Tofranil), clomipramine (Anafranil), protriptyline (Vivactil), or desipramine (Norpramin)
a phenothiazine such as chlorpromazine (Thorazine);
lithium (Lithobid, Lithonate, Eskalith, others); or
haloperidol (Haldol).
You may not be able to take Evekeo, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with Evekeo. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.
Evekeo interactions
Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Evekeo, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Drugs Having Clinically Important Interactions With Amphetamines
Table 2: Drugs having clinically important interactions with amphetamines.
MAO Inhibitors (MAOI)
Clinical Impact
MAOI antidepressants slow Evekeo 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 during or within 14 days following the administration of MAOI.
May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-Evekeo 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 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 contains Amphetamine, which is a Schedule II controlled substance in the U.S. Controlled Substance Act (CSA).
Abuse
Evekeo, is a CNS stimulant that contains Amphetamine which has a high potential for abuse. Abuse is characterized by impaired control over drug use, compulsive use, continued use despite harm, and craving.
Signs and symptoms of Evekeo 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, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants, monitor for signs of abuse while on therapy, and re-evaluate the need for Evekeo 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.
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. 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.
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References
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).
European Chemicals Agency - ECHA. "Amphetamine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Evekeo are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Evekeo. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
1 consumer reported frequency of use
How frequently do I need to take Evekeo? It was reported by ndrugs.com website users that Evekeo should ideally be taken 3 times in a day as the most common frequency of the Evekeo. You should you adhere strictly to the instructions and guidelines provided by your doctor on how frequently this Evekeo should be taken. Get another patient's view on how frequent the capsule should be used by clicking here.
Users
%
3 times in a day
1
100.0%
4 consumers reported doses
What doses of Evekeo drug you have used? The drug can be in various doses. Most anti-diabetic, anti-hypertensive drugs, pain killers, or antibiotics are in different low and high doses and prescribed by the doctors depending on the severity and demand of the condition suffered by the patient. In our reports, ndrugs.com website users used these doses of Evekeo drug in following percentages. Very few drugs come in a fixed dose or a single dose. Common conditions, like fever, have almost the same doses, e.g., [acetaminophen, 500mg] of drug used by the patient, even though it is available in various doses.
Users
%
6-10mg
2
50.0%
11-50mg
2
50.0%
Consumer reviews
There are no reviews yet. Be the first to write one!
Information checked by Dr. Sachin Kumar, MD Pharmacology
