Lower blood levels and efficacy of amphetamines. (2.5) ... History of drug abuse (4) During or within 14 days following the administration of monoamine This Medication Guide does not take the place of talking to your doctor about you or your child's treatment with Adderall XR. Ask your doctor or pharmacist for more information. What form(s) does this medication come in? Do not start any new medicine while taking Adderall XR without talking to your doctor first. Adderall XR 30 mg capsule,extended release. If serotonin syndrome occurs, discontinue Adderall XR and the concomitant serotonergic drug(s), selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort. Do not administer Adderall XR concomitantly or within 14 days after discontinuing MAOI, selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. Your doctor will decide whether Adderall XR can be taken with other medicines. Fatal poisoning is usually preceded by convulsions and coma. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Adderall XR extended release capsules may be taken whole, or the capsule may be opened and the entire contents sprinkled on applesauce. A double-blind, randomized, multi-center, parallel-group, placebo-controlled study was conducted in adolescents aged 13-17 (N=327) who met DSM-IV® criteria for ADHD. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. The primary efficacy variable was the Attention Deficit Hyperactivity Disorder-Rating Scale IV (ADHD-RS-IV) total score for the primary cohort. Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder. Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Store at room temperature, 20º C to 25º C (68º F to 77º F). Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. Improvements in the primary cohort were statistically significantly greater in all four primary cohort active treatment groups (Adderall XR 10 mg, 20 mg, 30 mg, and 40 mg) compared with the placebo group. Systemic exposure measured by area under the curve to infinity (AUC∞) and maximum plasma concentration (Cmax) decreased with increases in body weight, while oral volume of distribution (VZ/F), oral clearance (CL/F), and elimination half-life (t1/2) increased with increases in body weight. Amphetamine (d- to l- enantiomer ratio of 3:1) had no apparent effects on embryofetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine. (Mixed Salts of A Single-Entity Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers taking amphetamines during pregnancy (see Clinical Considerations). Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized event categories. anti-depression medicines including MAOIs, cold or allergy medicines that contain decongestants. Formal pharmacokinetic studies for race have not been conducted. d,l-Amphetamine (1:1 enantiomer ratio) has been reported to produce a positive response in the mouse bone marrow micronucleus test, an equivocal response in the Ames test, and negative responses in the in vitro sister chromatid exchange and chromosomal aberration assays. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Adderall XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs. A diagnosis of ADHD (DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. Talk to your doctor if you or your child has side effects that are bothersome or do not go away. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. In a pharmacokinetic study of lisdexamfetamine in adult subjects with normal and impaired renal function, mean d-amphetamine clearance was reduced from 0.7 L/hr/kg in normal subjects to 0.4 L/hr/kg in subjects with severe renal impairment (GFR 15 to <30mL/min/1.73m2). In a separate placebo-controlled 4-week study in adolescents with ADHD, five patients (2.1%) discontinued treatment due to adverse events among Adderall XR-treated patients (N=233) compared to none who received placebo (N=54). Last updated on Dec 1, 2020. Adverse Reactions Occurring in Controlled Trials. Abusers of amphetamines may use other unapproved routes of administration which can result in overdose and death [see Overdosage (10)]. If no take-back program or authorized collector is available, mix Adderall XR with an undesirable, nontoxic substance to make it less appealing to children and pets. The latter doses are approximately 0.6, 2, and 6 times the MRHD of 30 mg/day, given to children on a mg/m2 basis. By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. This Medication Guide summarizes the most important information about Adderall XR. Advise patients of serious cardiovascular risk (including sudden death, myocardial infarction, stroke, and hypertension) with Adderall XR. Amphetamines, such as Adderall XR, cause vasoconstriction and thereby may decrease placental perfusion. Advise patients that Adderall XR is a federally controlled substance because it can be abused or lead to dependence. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Adderall XR during pregnancy [see Use in Specific Populations (8.1)]. Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see Drug Interactions (7.1)]. Doctors will start adults at a higher dose of 20 mg once daily. Amphetamine, in the enantiomer ratio d- to l- ratio of 3:1, did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day (approximately 8 times the maximum recommended human dose of 20 mg/day given to adolescents, on a mg/m2 basis). If you or your child takes too much Adderall XR or overdoses, call your doctor or poison control center right away, or get emergency treatment. The mean elimination half-life for d-amphetamine is 10 hours in adults; 11 hours in adolescents aged 13-17 years and weighing less than or equal to 75 kg/165 lbs; and 9 hours in children aged 6 to 12 years. 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 practice. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]: Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during treatment should undergo a prompt cardiac evaluation [see Warnings and Precautions (5.2)]. You or your child should not breastfeed during treatment with Adderall XR. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Stimulant medications like Adderall are typically the first choice to treat ADHD symptoms because they improve symptoms for 70-80% of people with ADHD. … After prescribing, keep careful prescription records, educate patients and their families about abuse and proper storage and disposal of CNS stimulants. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Monitor growth in children during treatment with stimulants. ... Adderall XR , Mydayis . When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. It is available in generic and brand versions. Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Treatment-emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without prior history of psychotic illness or mania can be caused by stimulants at usual doses. are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy, Prior to initiating treatment with Adderall XR, assess for the presence of cardiac disease (e.g., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam), Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy. Selling or giving away Adderall XR may harm others, and is against the law. In addition, adverse effects on reproductive performance were observed in pups whose mothers were treated with amphetamine. Caution patients about the risk of serotonin syndrome with concomitant use of Adderall XR and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see Contraindications (4), Warnings and Precautions (5.7) and Drug Interactions (7.1)]. 20 mg PO qAM initially or switching from another medication; May increase by increments of 5-10 mg/week; not to exceed 60 mg/day; Mydayis. All increases were transient, appeared maximal at 2 to 4 hours post dose and not associated with symptoms. Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases. In a classroom analogue study, patients (N=51) receiving fixed doses of 10 mg, 20 mg or 30 mg Adderall XR demonstrated statistically significant improvements in teacher-rated behavior and performance measures, compared to patients treated with placebo. https://www.webmd.com/drugs/2/drug-63164/adderall-xr-oral/details Titrate at weekly intervals to appropriate efficacy and tolerability as indicated. Pharmacokinetic studies of Adderall XR have been conducted in healthy adult and pediatric (children aged 6-12 yrs) subjects, and adolescent (13-17 yrs) and children with ADHD. What is the most important information I should know about Adderall XR? Adderall XR may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. Adderall XR… How does this medication work? Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Boxed Warning, Drug Abuse and Dependence (9.2, 9.3)]. Tablet: 5 mg PO qDay initially; may increase by 5-10 mg/day qWeek; administer daily dose in 2-3 doses; not to exceed 40 mg/day. This is not a complete list of possible side effects. Keep Adderall XR in a safe place to prevent misuse and abuse. Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. What are possible side effects of Adderall XR? Warning. Sometimes the doses of other medicines will need to be adjusted while taking Adderall XR. Dispose of remaining, unused, or expired Adderall XR at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. Advise patients of the potential fetal effects from the use of Adderall XR during pregnancy [see Use in Specific Populations (8.1)]. Appropriate educational placement is essential and psychosocial intervention is often helpful. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and/or depression. Read the Medication Guide that comes with Adderall XR before you or your child starts taking it and each time you get a refill. The time to reach maximum plasma concentration (Tmax) for Adderall XR is about 7 hours, which is about 4 hours longer compared to ADDERALL (immediate-release). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The significance of these findings to humans is unknown. The maximum recommended dose for children 6-12 years of age is 30 mg/day; doses greater than 30 mg/day have not been studied in children. Gelatin capsules contain edible inks, kosher gelatin, and titanium dioxide. In one placebo-controlled 4-week study among adults with ADHD with doses 20 mg to 60 mg, 23 patients (12.0%) discontinued treatment due to adverse events among Adderall XR-treated patients (N=191) compared to one patient (1.6%) who received placebo (N=64). Adderall XR treatment may be stopped if a problem is found during these check-ups. Adderall XR can be taken with or without food. Adderall XR 30 mg extended release capsules: Natural/orange (imprinted Adderall XR 30 mg), bottles of 100, NDC 54092-391-01 Dispense in a tight, light-resistant container as defined in the USP. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Keep Adderall XR and all medicines out of the reach of children. Additionally, Adderall XR therapy at usual doses may cause treatment-emergent psychotic or manic symptoms in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.3)]. Acute administration of high doses of amphetamine (d- or d,l-) has been shown to produce long-lasting neurotoxic effects, including irreversible nerve fiber damage, in rodents. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Tip: Search for the imprint first, then refine by color and/or shape if you have too many results. The most frequent adverse event leading to discontinuation and considered to be drug-related (i.e. The concomitant use of Adderall XR and serotonergic drugs increases the risk of serotonin syndrome. Safety data on all patients are included in the discussion that follows. Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism [see Clinical Pharmacology (12.3)]. Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated. Adderall XR should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. Elite Pharmaceuticals Announces Commercial Launch of Generic Adderall XR(R) with Marketing Partner Lannett Company. Individualize the dosage according to the therapeutic needs and response of the patient. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. leading to discontinuation in at least 1% of Adderall XR-treated patients and at a rate at least twice that of placebo) was insomnia (1.3%, n=3). Loading... View more photos. However, amphetamine pharmacokinetics appeared to be comparable among Caucasians (N=33), Blacks (N=8) and Hispanics (N=10). Adderall XR 5 mg extended release capsules: Clear/blue (imprinted Adderall XR 5 mg), bottles of 100, NDC 54092-381-01, Adderall XR 10 mg extended release capsules: Blue/blue (imprinted Adderall XR 10 mg), bottles of 100, NDC 54092-383-01, Adderall XR 15 mg extended release capsules: Blue/white (imprinted Adderall XR 15 mg), bottles of 100, NDC 54092-385-01, Adderall XR 20 mg extended release capsules: Orange/orange (imprinted Adderall XR 20 mg), bottles of 100, NDC 54092-387-01, Adderall XR 25 mg extended release capsules: Orange/white (imprinted Adderall XR 25 mg), bottles of 100, NDC 54092-389-01, Adderall XR 30 mg extended release capsules: Natural/orange (imprinted Adderall XR 30 mg), bottles of 100, NDC 54092-391-01. Adderall XR® is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc. That contain decongestants classify reported adverse reactions medicine mixture without chewing prescribing, keep prescription. 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