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Dextroamphetamine PI 202006 HIGHLIGHTS OF PRESCRIBING INFORMATION • Glaucoma (4) 5.4 Long-Term Suppression of Growth Cardiovascular • Agitated states (4) Monitor growth in children during treatment with stimulants. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted. Palpitations. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. These highlights do not include all the information needed to use DEXTROAMPHETAMINE saccharate, AMPHET- • History of drug abuse (4) Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over Central Nervous System AMINE aspartate monohydrate, DEXTROAMPHETAMINE sulfate, AMPHETAMINE sulfate extended-release capsules • During or within 14 days following the administration of monoamine oxidase inhibitors (MAOI) (4, 7.1) 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, safely and effectively. See full prescribing information for DEXTROAMPHETAMINE saccharate, AMPHETAMINE aspar- suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of logorrhea, dermatillomania, paresthesia (including formication), and bruxism. tate monohydrate, DEXTROAMPHETAMINE sulfate, AMPHETAMINE sulfate extended-release capsules. ----------------------------------------------------------- WARNINGS AND PRECAUTIONS ----------------------------------------------------------- about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Eye Disorders Vision blurred, mydriasis. • Serious Cardiovascular Reactions: Sudden death has been reported with usual doses of CNS stimulants in children and In a controlled trial of Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended- DEXTROAMPHETAMINE saccharate, AMPHETAMINE aspartate monohydrate, DEXTROAMPHETAMINE sulfate, adolescents with structural cardiac abnormalities or other serious heart problems; sudden death, stroke, and myocardial release in adolescents, mean weight change from baseline within the initial 4 weeks of therapy was -1.1 lbs. and -2.8 lbs., respectively, for patients receiving 10 mg Gastrointestinal AMPHETAMINE sulfate (Mixed Salts of a Single-Entity Amphetamine Product) extended-release capsules, for infarction have been reported in adults taking CNS stimulants at usual doses. Stimulant drugs should not be used in and 20 mg Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release. Higher doses Unpleasant taste, constipation, other gastrointestinal disturbances. oral use patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery were associated with greater weight loss within the initial 4 weeks of treatment. Chronic use of amphetamines can be expected to cause a similar suppression of growth. Allergic Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal disease, or other serious heart problems. (5.1) 5.5 Seizures necrolysis have been reported. Initial U.S. Approval: 2001 There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in the • Increase in Blood Pressure: Monitor blood pressure and pulse at appropriate intervals. Use with caution in patients for whom Endocrine blood pressure increases may be problematic. (5.2) absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, Dextroamphetamine WARNING: ABUSE AND DEPENDENCE saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release should be discontinued. Impotence, changes in libido, frequent or prolonged erections. • Psychiatric Adverse Events: Stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no Skin See full prescribing information for complete boxed warning prior history, or exacerbation of symptoms in patients with pre-existing psychosis. Evaluate for bipolar disorder prior to stim- 5.6 Peripheral Vasculopathy, including Raynaud’s Phenomenon Alopecia. ulant use. Monitor for aggressive behavior. (5.3) Stimulants, including Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release, used • CNS stimulants, including Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextro- to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare Vascular Disorders • Long-Term Suppression of Growth: Monitor height and weight at appropriate intervals. (5.4) sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing Raynaud’s phenomenon. amphetamine sulfate, amphetamine sulfate extended-release, other amphetamine-containing products, and • Seizures: May lower the convulsive threshold. Discontinue in the presence of seizures. (5.5) methylphenidate, have a high potential for abuse and dependence (5.1, 9.3) reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose Musculoskeletal and Connective Tissue Disorders • Peripheral Vasculopathy, including Raynaud’s phenomenon: Stimulants used to treat ADHD are associated with peripheral or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology Rhabdomyolysis • Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with referral) may be appropriate for certain patients. 7 DRUG INTERACTIONS (9.2, 9.3). ADHD stimulants. (5.6) 5.7 Serotonin Syndrome • Serotonin Syndrome: Increased risk when coadministered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic 7.1 Clinically Important Interactions with Amphetamines -------------------------------------------------------------- RECENT MAJOR CHANGES -------------------------------------------------------------- during overdosage situations. If it occurs, discontinue Dextroamphetamine saccharate, amphetamine aspartate monohy- neurotransmitter systems such as MAOIs, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic Boxed Warning 7/2019 Table 4: Drugs Having Clinically Important Interactions with Amphetamines drate, dextroamphetamine sulfate, amphetamine sulfate extended-release and initiate supportive treatment (4, 5.7, 10). antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort [see Drug Interactions (7.1)]. Amphetamines and amphetamine derivatives are Dosage and Administration (2.1) 7/2019 • Visual Disturbance: Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. (5.8) known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism [see Clinical Pharmacology (12.3)]. Monoamine Oxidase Inhibitors (MAOIs) Warnings and Precautions (5.1) 7/2019 The potential for a pharmacokinetic interaction exists with the co-administration of CYP2D6 inhibitors which may increase the risk with increased exposure to Dextro- Clinical Impact Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial • Tics: May exacerbate tics. Evaluate for tics and Tourette’s syndrome prior to stimulant administration. (5.9) amphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release. In these situations, consider an infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see Drug Interactions (7.1)]. Serotonin syndrome symptoms may include mental --------------------------------------------------------------- INDICATIONS AND USAGE --------------------------------------------------------------- ----------------------------------------------------------------- ADVERSE REACTIONS ----------------------------------------------------------------- Intervention Do not administer Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate,
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