Hypersensitivity (eg, angioedema, anaphylaxis) or idiosyncrasy to amphetamine, sympathomimetic amines or any component of the formulation during or within 14 days following MAOI (including linezolid or methylene blue).ĭocumentation of allergenic cross-reactivity for amphetamines is limited. Narcolepsy, daytime sleepiness (immediate release only): Treatment of narcolepsy. Use: Labeled IndicationsĪttention-deficit/hyperactivity disorder: Treatment of attention-deficit/hyperactivity disorder (ADHD) as part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect. Systemic exposure measured by AUC ∞ and C max decreased with increases in body weight, while apparent oral volume of distribution, apparent oral clearance, and elimination half-life increased with increases in body weight. Weight: Weight is the primary determinant of apparent differences in the pharmacokinetics of d- and l-amphetamine across the age range. Patients 6 to 12 years of age experienced higher systemic exposure (72% to 79% higher C max and 83% higher AUC), compared with adults. Upon dose normalization on a mg/kg basis, children showed 30% less systemic exposure compared with adults. However, children had higher systemic exposure to amphetamine (C max and AUC) than adults for a given dose of ER capsules, which was attributed to the higher dose administered to children on a mg/kg basis compared with adults. The elimination half-life is approximately 1 hour shorter for d-amphetamine and 2 hours shorter for l-amphetamine in children than in adults. Immediate-release tablet: 4 to 6 hours (Dopheide 2009) Adderall XR: 8 to 12 hours (Jain 2017) Mydayis: ≤16 hours Half-Life EliminationĬhildren 6 to 12 years: d-amphetamine: 9 hours l-amphetamine: 11 hoursĪdolescents 13 to 17 years: d-amphetamine: 11 hours l-amphetamine: 13 to 14 hoursĪdults: d-amphetamine: 10 hours l-amphetamine: 13 hours Use in Specific Populations Special Populations: ChildrenĬhildren eliminated amphetamine faster than adults. Immediate release: 3 hours Adderall XR: 7 hours Mydayis: 7 to 10 hours (children and adolescents 6 to 17 years), 8 hours (adults) Duration of Action Urine (highly dependent on urinary pH) excreted as unchanged amphetamine (30% to 40%, may range from ~1% in alkaline urine to ~75% in acidic urine), and derivatives of alpha-hydroxyamphetamine (50%) Time to Peak Cytochrome P450 2D6 is primarily responsible for the formation of 4-hydroxy-amphetamine. Hepatic oxidation via cytochrome P450 to 4-hydroxyamphetamine (active) norephedrine (active), and alpha-hydroxy-amphetamine with both active metabolites subsequently oxidized to 4-hydroxy-norephedrine. Pharmacokinetics/Pharmacodynamics AbsorptionĮxtended release: Food does not affect absorption but prolongs T max of Adderall XR by 2 to 3 hours and Mydayis by 4 to 5 hours. A less significant mechanism may include their ability to block the reuptake of catecholamines by competitive inhibition. Excipient information presented when available (limited, particularly for generics) consult specific product labeling.ĥ mg ġ0 mg ġ5 mg Ģ0 mg Ģ5 mg ģ0 mg ġ2.5 mg ģ7.5 mg ĥ0 mg ħ.5 mg ģ0 mg Pharmacology Mechanism of ActionĪmphetamines are noncatecholamine, sympathomimetic amines that promote release of catecholamines (primarily dopamine and norepinephrine) from their storage sites in the presynaptic nerve terminals.
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