Mydayis

Last updated on RxList: 9/30/2019
Mydayis Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 9/30/2019

Mydayis (mixed salts of a single-entity amphetamine product) extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. Common side effects of Mydayis include:

  • insomnia,
  • decreased appetite,
  • decreased weight,
  • irritability,
  • nausea,
  • dry mouth,
  • increased heart rate,
  • anxiety,
  • feeling jittery,
  • tooth grinding,
  • depression,
  • diarrhea,
  • palpitations,
  • menstrual pain or cramping, and
  • erectile dysfunciton.

Central nervous system stimulants, including Mydayis, have a high potential for abuse and dependence.

The recommended starting dose of Mydayis for adults and children 13 to 17 years is 12.5 mg. Mydayis may interact with acidifying or alkalinizing agents (GI and urinary), monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort, quinidine, ritonavir, omeprazole, esomeprazole, pantoprazole, and cimetidine. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Mydayis; it may harm a fetus. It is believed Mydayis passes into breast milk. Because of the potential for adverse effects in nursing infants, breastfeeding is not recommended while using Mydayis. Withdrawal symptoms may occur if you suddenly stop taking Mydayis.

Our Mydayis (mixed salts of a single-entity amphetamine product) Extended-Release Capsules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

ADHD Symptoms in Children See Slideshow
Mydayis Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
  • signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
  • signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
  • a seizure (convulsions);
  • muscle twitches (tics); or
  • changes in your vision.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of stimulant medicine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

  • stomach pain, nausea, loss of appetite;
  • weight loss;
  • mood changes, feeling nervous or irritable;
  • fast heart rate;
  • headache, dizziness;
  • sleep problems (insomnia); or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mydayis (Mixed Salts of a Single-entity Amphetamine Product Capsules)

QUESTION

The abbreviated term ADHD denotes the condition commonly known as: See Answer
Mydayis Professional Information

SIDE EFFECTS

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.

MYDAYIS was studied in adults (18 to 55 years) and pediatric patients (13 to 17 years) who met Diagnostic and Statistical Manual of Mental Disorders, 4th ¬†or 5th ¬†editions (DSM-IV-TR® or DSM-5) criteria for ADHD. The safety data for adults were pooled from three randomized, double-blind, placebo-controlled studies in doses of 12.5 mg to 75 mg per day (1.5 times the maximum recommended dosage). Doses higher than 50 mg per day did not demonstrate additional clinical benefit and are not recommended.

The safety data for pediatric patients (13 to 17 years) is from 1 randomized, double-blind, placebocontrolled study of doses of 12.5 mg to 25 mg. The total exposure in patients treated with MYDAYIS totalled 704; this included pediatric patients, 78 adolescent patients and 626 adult patients from multiple well-controlled trials. The duration of use ranged from 4 to 7 weeks [see Clinical Studies].

Adverse Reactions Leading To Discontinuation Of Treatment

In pooled controlled trials of adult patients, 9% (54/626) of MYDAYIS-treated patients discontinued due to adverse reactions compared to 2% (7/328) of placebo-treated patients. The most frequent adverse reactions leading to discontinuation (i.e. leading to discontinuation in at least 1% of MYDAYIS-treated patients and at a rate at least twice that of placebo) were insomnia (2%, n=15), blood pressure increased (2%, n=10), decreased appetite (1%, n=5), and headache (1%, n= 4).

In a controlled trial including adolescent patients (13 to 17 years), 5% (4/78) of MYDAYIS-treated patients discontinued due to adverse reactions compared to 0% (0/79) of placebo-treated patients. The most frequent adverse reaction leading to discontinuation (i.e. leading to discontinuation in at least 1% of MYDAYIS-treated patients and at a rate at least twice that of placebo) were dizziness (1%, n=1), depression (1%, n=1), abdominal pain upper (1%, n=1), and viral infection (1%, n=1).

Adverse Reactions Occurring At An Incidence Of ≥2% And At Least Twice Placebo Among MYDAYIS Treated Adults In Clinical Trials

The most common adverse reactions reported in adults were insomnia, decreased appetite, dry mouth, decreased weight, heart rate increased, and anxiety. Table 1 lists the adverse reactions that occurred ≥2% compared to placebo. The most common adverse reaction (insomnia) generally occurred early during treatment with MYDAYIS.

Table 1 : Adverse Reactions Reported by 2% or More of Adults Taking MYDAYIS and at least Twice the Incidence in Patients Taking Placebo in 3 Clinical Trials (4, 6, and 7-Weeks )

Body System Adverse Reaction MYDAYIS*
(N= 626)
Placebo
(N= 328)
Nervous System
  Anxiety 7% 3%
  Feeling Jittery 2% 1%
  Agitation 2% 0%
  Bruxism 2% 0%
Psychiatric disorders
  Insomnia 31% 8%
  Depression 3% 0%
Metabolism and nutritional disorders
  Decreased 30% 4%
  Appetite
  Weight Decreased 9% 0%
Gastrointestinal System
  Dry Mouth 23% 4%
  Diarrhea 3% 1%
Cardiovascular System
  Heart Rate Increased 9% 0%
  Palpitations 4% 2%
Genitourinary System
  Dysmenorrhea† 4% 2%
  Erectile Dysfunction‡ 2% 1%
*Includes doses up to 75 mg (1.5 times the maximum recommended dosage).
†Dysmenorrhea was observed in 11 females
‡Erectile dysfunction was observed in 6 males

Adverse Reactions Occurring At An Incidence Of 2% Or More And At Least Twice Placebo Among MYDAYIS-Treated Adolescents (13 To 17 Years) In A 4-week Clinical Trial

The most common adverse reactions reported in adolescents were decreased appetite, nausea, insomnia, abdominal pain upper, irritability, and weight decreased. Table 2 lists the adverse reactions that occurred ≥2% compared to placebo.

Table 2 : Adverse Reactions Reported by ≥2% or More of Adolescents Taking MYDAYIS and at least Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial

Body Adverse System Reaction MYDAYIS
(N=78)
Placebo
(N= 79)
Nervous System
Dizziness 4% 0%
Metabolism and nutrition disorders
Decreased appetite 22% 6%
Weight decreased 5% 1%
Psychiatric disorders
Irritability 6% 3%
Insomnia* 8% 3%
Gastrointestinal disorders
Nausea 8% 4%
Abdominal pain
upper 4% 1%
*Insomnia includes terms: initial insomnia, middle insomnia, terminal insomnia and insomnia.

Adverse Reactions Associated With The Use Of Amphetamines

The following adverse reactions have been associated with the use of amphetamines. The following adverse reactions have been identified during post approval use of amphetamines. 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.

Cardiovascular: Dyspnea, sudden death. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, euphoria, dyskinesia, dysphoria, headache, tics, fatigue, aggression, anger, logorrhea, dermatillomania, and paresthesia (including formication).

Eye Disorders: Mydriasis.

Gastrointestinal: Unpleasant taste, constipation.

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, frequent or prolonged erections.

Skin: Alopecia.

Vascular Disorders: Raynaud's phenomenon.

Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis.

Read the entire FDA prescribing information for Mydayis (Mixed Salts of a Single-entity Amphetamine Product Capsules)

© Mydayis Patient Information is supplied by Cerner Multum, Inc. and Mydayis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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