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MYDAYIS is a brand name for Amphetamine (also known as Amfetamine). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE MYDAYIS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14) ] . MYDAYIS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION MYDAYIS should be administered once daily upon awakening . 5 mg weekly 25 mg In adult patients with severe renal impairment the maximum dose should not exceed 25 mg daily. Use in adult patients with ESRD is not recommended.
5 mg daily. Use in pediatric patients with ESRD is not recommended. 6 ) Patients are advised to take consistently either with or without food. 2 ) Administer upon awakening because the effects may last up to 16 hours and there is the potential for insomnia.
2 ) Prior to treatment, assess for presence of cardiac disease. 1 ) To avoid substitution errors and overdosage, do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles.
2 General Administration Information Because the effects of MYDAYIS may last up to 16 hours and there is potential for insomnia, administer once daily in the morning upon awakening. In the event of a missed dose, do not administer later in the day.
1) , Clinical Studies (14) ] . 3 Administration Instructions Administer MYDAYIS orally with or without food. 3) ] .
MYDAYIS may be administered in one of the following ways:
Swallow MYDAYIS capsules whole, or Open capsule and sprinkle the entire contents over a spoonful of applesauce. The sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the sprinkled applesauce in its entirety without chewing.
The dose of a single capsule should not be divided. 5 mg once daily in the morning upon awakening. Initial doses of 25 mg once daily may be considered for some patients. 5 mg no sooner than weekly, up to a maximum dose of 50 mg once daily, based on the therapeutic needs and response of the patient.
Doses above 50 mg daily have shown no additional clinically meaningful benefit. 5 mg once daily in the morning upon awakening. 5 mg no sooner than weekly, up to a recommended maximum dose of 25 mg once daily. The dose should be individualized according to the needs and response of the patient.
Doses higher than 25 mg have not been evaluated in clinical trials in pediatric patients. 5 Dosage Modifications Due to Drug Interactions Agents that alter gastrointestinal and urinary pH can impact urinary excretion and alter blood levels of amphetamine.
10) ] Most common adverse reactions in patients with ADHD (incidence ≥5% and at a rate at least twice placebo) are: Pediatrics (13 years and older): insomnia, decreased appetite, decreased weight, irritability, and nausea. 1 ) Adults: insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate, and anxiety.
, Inc. gov/medwatch . 1 Clinical Trials 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, 4 th or 5 th editions (DSM-IV-TR ® or DSM-5) criteria for ADHD. 5 times the maximum recommended dosage).
Doses higher than 50 mg per day did not demonstrate additional clinical benefit and are not recommended. 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 (14) ] . 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.
, 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. , 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).
5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
2 ) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. 3 ) Psychiatric Adverse Reactions: Prior to initiating MYDAYIS, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing MYDAYIS.
4 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted.
5 ) Peripheral Vasculopathy, Including Raynaud’s Phenomenon: Careful observation for digital changes is necessary during MYDAYIS treatment. , rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy.
6 ) Seizures: May lower the convulsive threshold. If a seizure occurs, discontinue MYDAYIS. , SSRIs, SNRIs, triptans), but also during overdosage situations. If it occurs, discontinue MYDAYIS and initiate supportive treatment. 8 ) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating MYDAYIS, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome.
Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate. 1 Abuse, Misuse, and Addiction MYDAYIS has a high potential for abuse and misuse. The use of MYDAYIS exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction.
2) ] . Misuse and abuse of CNS stimulants, including MYDAYIS, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
4 CONTRAINDICATIONS MYDAYIS is contraindicated in patients with: Known hypersensitivity to amphetamine, or other components of MYDAYIS. 2) ] . 1) ] . Known hypersensitivity to amphetamine products or other ingredients in MYDAYIS. ( 4 ) Use with monoamine oxidase (MAO) inhibitors, or within 14 days of the last MAO inhibitor dose.
1 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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, sodium bicarbonate) increase blood levels. 1) ] . 5 mg daily with a maximum recommended dose of 25 mg daily. 73 m 2 ). 3) ] . 4) ] . 3) ] .
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. 5 times the maximum recommended dosage). (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 Appetite 30% 4% - 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 Dysmenorrhea was observed in 11 females.
4% 2% - Erectile Dysfunction Erectile dysfunction was observed in 6 males. 2% 1% 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 System Adverse 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 Insomnia includes terms: initial insomnia, middle insomnia, terminal insomnia and insomnia.
2 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 postapproval 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.
Allergic:
Urticaria, rash, hypersensitivity reactions, including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
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), motor and verbal tics.
Endocrine:
Impotence, changes in libido, frequent or prolonged erections.
Eye Disorders:
Mydriasis.
Gastrointestinal:
Unpleasant taste, constipation, intestinal ischemia.
Musculoskeletal and Connective Tissue Disorders:
Rhabdomyolysis.
Skin:
Alopecia.
Vascular Disorders:
Raynaud’s phenomenon.
Before prescribing MYDAYIS, 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 MYDAYIS in a safe place, preferably locked, and instruct patients to not give MYDAYIS to anyone else.
Throughout MYDAYIS treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 2 Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.
Avoid MYDAYIS use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. 3 Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mmHg) and heart rate (mean increase about 3 to 6 bpm).
Some patients may have larger increases. 1) ] . 4 Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed episode in patients with bipolar disorder. , comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, and depression).
, hallucinations, delusional thinking, or mania in patients without a prior history of psychotic illness or mania. 1% of CNS stimulant-treated patients compared to 0% of placebo-treated patients. If such symptoms occur, consider discontinuing MYDAYIS.
5 Long-Term Suppression of Growth in Pediatric Patients CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. 1) ] . Closely monitor growth (weight and height) in MYDAYIS-treated pediatric patients.
Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted. 4) ] . 6 Peripheral Vasculopathy, Including Raynaud’s Phenomenon CNS stimulants, including MYDAYIS, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon.
Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports and at the therapeutic dosage of CNS stimulants in all age groups throughout the course of treatment.
Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during MYDAYIS treatment. , rheumatology referral) may be appropriate for MYDAYIS-treated patients who develop signs or symptoms of peripheral vasculopathy.
7 Seizures MYDAYIS may lower the convulsive threshold in patients with prior history of seizure, in patients with prior EEG abnormalities in the absence of seizures, and in patients without a history of seizures and no prior EEG evidence of seizures.
In the presence of seizures, MYDAYIS should be discontinued. 8 Serotonin Syndrome Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St.
1) ] . The coadministration with cytochrome P450 2D6 (CYP2D6) inhibitors may also increase the risk with increased exposure to MYDAYIS. 1) ] . , nausea, vomiting, diarrhea). Concomitant use of MYDAYIS with MAOI drugs is contraindicated [see Contraindications (4) ] .
Discontinue treatment with MYDAYIS and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of MYDAYIS with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate MYDAYIS with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.
9 Potential for Overdose Due to Medication Errors Medication errors, including substitution and dispensing errors, between MYDAYIS and other amphetamine products could occur, leading to possible overdosage. 7) , Overdosage (10) ] . 10 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome CNS stimulants, including amphetamine, have been associated with the onset or exacerbation of motor and verbal tics.
2) ] . Before initiating MYDAYIS, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor MYDAYIS-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.