MYDAYIS Dosage & Rx Info | Uses, Side Effects

Mydayis Generic Name & Formulations

Legal Class

CII

General Description

Mixed salts of a single-entity amphetamine product (each cap contains equal parts dextroamphetamine saccharate, dextroamphetamine sulfate, amphetamine aspartate monohydrate, amphetamine sulfate); 12.5mg, 25mg, 37.5mg, 50mg; ext-rel caps.

Pharmacological Class

CNS stimulant.

How Supplied

Caps—100

Manufacturer

Takeda Pharmaceutical Company

Generic Availability

Mechanism of Action

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD is not known.

Mydayis Indications

Indications

Attention deficit hyperactivity disorder.

Limitations of Use

Higher plasma exposure and rates of adverse reactions (eg, insomnia, decreased appetite) in patients ≤12yrs than ≥13yrs at the same dose.

Mydayis Dosage and Administration

Adult

Swallow caps whole or may open and sprinkle contents onto applesauce, then consume immediately; do not chew beads. Individualize. Avoid late evening doses; give in the AM upon awakening. 13–17yrs: initially 12.5mg once daily; may increase by 12.5mg at weekly intervals; max 25mg/day.18–55yrs: initially 12.5mg or 25mg once daily; may increase by 12.5mg at weekly intervals; max 50mg/day. Severe renal impairment (GFR 15–<30mL/min/1.73m²): initially 12.5mg daily; max 25mg/day or 12.5mg/day (for 13–17yrs) if tolerated. ESRD (GFR <15mL/min/1.73m²): not recommended. Do not substitute for other amphetamine products on a mg-per-mg basis. Switching from other amphetamine products: see full labeling.

Children

≤12yrs: not established.

Mydayis Contraindications

Contraindications

During or within 14 days of MAOIs.

Mydayis Boxed Warnings

Boxed Warning

Abuse, misuse, and addiction.

Mydayis Warnings/Precautions

Warnings/Precautions

High potential for abuse, misuse, and addiction; assess patient’s risk before prescribing. Assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other cardiac disease. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors in developing manic episode prior to initiating. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for seizures, serotonin syndrome; discontinue if occurs. Assess family history and evaluate for tics or Tourette’s syndrome before initiating; monitor for emergence or worsening, and discontinue if clinically appropriate. Peripheral vasculopathy, including Raynaud’s phenomenon; monitor for digital changes. Monitor BP, HR, growth in children. Reevaluate periodically. Renal impairment: see full labeling. Labor & delivery. Pregnancy: monitor for neonatal withdrawal symptoms. Nursing mothers: not recommended.

Mydayis Pharmacokinetics

Absorption

Peak plasma concentrations: ~7 to 10 hours (pediatric patients) and ~8 hours (adults) for both d-amphetamine and l-amphetamine. Steady-state is achieved between Days 7 and 8 of dosing with mean accumulation ratio of 1.6.

Metabolism

Hepatic.

Elimination

Renal. Half-life: 10–11 hours (d-amphetamine), 10–13 hours (l-amphetamine).

Mydayis Interactions

Interactions

See Contraindications. Hypertensive crisis with MAOIs (eg, selegiline, isocarboxazid, phenelzine, tranylcypromine). Increased risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort), CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, ritonavir); consider alternatives; if needed, initiate with lower doses and monitor. Potentiated by alkalinizers (eg, sodium bicarbonate, PPIs, acetazolamide, some thiazides); caution. Antagonized by acidifiers (eg, guanethidine, reserpine, glutamic acid HCl, ascorbic acid, ammonium chloride, sodium acid phosphate, methenamine salts); increase dose. May potentiate TCAs, sympathomimetics (eg, desipramine, protriptyline); adjust dose or use alternatives. Monitor effects when concomitant PPIs or cimetidine. May interfere with urinary steroid levels.

Mydayis Adverse Reactions

Adverse Reactions

Insomnia, decreased appetite, decreased weight, irritability, nausea; also adults: dry mouth, increased heart rate, anxiety.

Mydayis Clinical Trials

See Literature

Mydayis Note

Not Applicable

Mydayis Patient Counseling