However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty. Hypersensitivity to amphetamine or any component of the formulation, anaphylactic reactions and angioedema have been reported use during or within 14 days following MAO inhibitor (including linezolid or intravenous methylene blue).Įvekeo immediate-release tablet: Additional contraindications: Hypersensitivity or idiosyncrasy to amphetamine, other sympathomimetic amines, or any component of the formulation advanced arteriosclerosis symptomatic cardiovascular disease moderate to severe hypertension hyperthyroidism agitated states history of drug abuse use during or within 14 days following MAO inhibitor.ĭocumentation of allergenic cross-reactivity for amphetamines is limited. Narcolepsy (immediate-release tablet only): Treatment of narcolepsy Contraindications Use: Labeled IndicationsĪttention-deficit/hyperactivity disorder: Treatment of ADHDĮxogenous obesity (immediate-release tablet only): Short-term treatment of exogenous obesity as an adjunct to caloric restriction for patients refractory to alternative therapy (eg, repeated diets, group programs, other drugs) Oral: Immediate-release tablet: 16% (de la Torre 2004) Use in Specific Populations Special Populations Noteīody weight: Systemic exposure and maximum concentration of d- and l-amphetamine decrease as body weight increases volume of distribution, clearance, and half-life increase as body weight increases. Immediate-release orally-disintegrating tablet: Evekeo ODT: Adults: d-amphetamine 10 hours and l-amphetamine 11.7 hoursĮxtended-release orally-disintegrating tablet: Adzenys XR-ODT:Ĭhildren 6 to 12 years: d-amphetamine 9 to 10 hours and l-amphetamine 10 to 11 hoursĪdults: d-amphetamine 11 hours and l-amphetamine 14 hoursĬhildren 6 to 12 years: d-amphetamine 12.7 hours (mean) and l-amphetamine 15.3 hoursĪdults: d-amphetamine 11.4 hours and l-amphetamine 14.1 hoursĬhildren: d-amphetamine 10.43 ± 2.01 hours and l-amphetamine 12.14 ± 3.15 hoursĪdults: d-amphetamine 12.36 ± 2.95 hours and l-amphetamine 15.12 ± 4.4 hours Protein Binding Immediate-release tablet: 12 hours (de la Torre 2004) Immediate-release tablet: Evekeo: 4 to 6 hours (Jain 2017)Įxtended-release orally-disintegrating tablet: Adzenys XR-ODT: 10 to 12 hours Half-Life Elimination Immediate-release orally-disintegrating tablet: Evekeo ODT: Median time d-amphetamine and l-amphetamine 3.5 hours (with water) and 3 hours (without water) increased with food in adultsĮxtended-release orally-disintegrating tablet: Adzenys XR-ODT: Median time d-amphetamine 5 hours (7 hours with food) and l-amphetamine ~5.25 hours (7.75 hours with food)Īdzenys ER suspension: d-amphetamine and l-amphetamine: 5 hours (median) with or without foodĬhildren: Median time d-amphetamine 3.9 hours and l-amphetamine 4.5 hoursĪdults: 4 (2 to 7) hours Duration of Action Immediate-release tablet: Within 4 hours (de la Torre 2004) Urine (30% to 40% unchanged ~50% as metabolites) Time to Peak Hepatic via oxidation, deamination, and CYP2D6 Excretion Oral: Immediate-release tablet: V d: 3 to 4 L/kg (de la Torre 2004) Metabolism Immediate-release orally-disintegrating tablet: Evekeo ODT: C max and AUC comparable to equivalent immediate-release dose Distribution Immediate-release tablet: Rapid (de la Torre 2004) Pharmacokinetics/Pharmacodynamics Absorption The anorexigenic effect is probably secondary to the CNS-stimulating effect the site of action is probably the hypothalamic feeding center. A less significant mechanism may include their ability to block the reuptake of catecholamines by competitive inhibition. Tablet Extended Release Disintegrating, Oral, as base:Īdzenys XR-ODT: 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 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. Suspension Extended Release, Oral, as base:ĭyanavel XR: 2.5 mg/mL (464 mL) Įvekeo: 10 mg Įvekeo: 10 mg = Discontinued productĪdzenys ER: 1.25 mg/mL (450 mL) Excipient information presented when available (limited, particularly for generics) consult specific product labeling.
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