Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine. (Generic for ADDERALL XR) QTY 30 â¢ 20 MG â¢ Capsule ER 24H â¢ Near 77381; Add to Medicine Chest; Set Price Alert; More Ways to Save; AMPHETAMINE; DEXTROAMPHETAMINE (am FET a meen; dex troe am FET a meen) is used to treat attention-deficit hyperactivity disorder (ADHD). Select one or more newsletters to continue. Advise patients of the potential fetal effects from the use of Adderall XR during pregnancy [see Use in Specific Populations (8.1)]. Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. You or your child should not breastfeed during treatment with Adderall XR. Adderall XR is indicated for use in children 6 years of age and older. Amphetamine Product), Vyvanse, Adderall, Concerta, methylphenidate, amphetamine / dextroamphetamine, Ritalin, modafinil. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Adderall XR. There may be new information. This Medication Guide summarizes the most important information about Adderall XR. Monitor growth in children during treatment with Adderall XR, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.4)]. In children with ADHD who are 6-12 years of age and are either starting treatment for the first time or switching from another medication, start with 10 mg once daily in the morning; daily dosage may be adjusted in increments of 5 mg or 10 mg at weekly intervals. Adderall XR belongs to a class of drugs called stimulants. How does this medication work? The following adverse reactions have been identified during post-approval use of amphetamine, Adderall XR, or ADDERALL. Adderall XR. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Adderall XR during pregnancy. However, children had higher systemic exposure to amphetamine (Cmax and AUC) than adults for a given dose of Adderall XR, which was attributed to the higher dose administered to children on a mg/kg body weight basis compared to adults. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. Concomitant use of Adderall XR with other serotonergic drugs or CYP2D6 inhibitors should be used only if the potential benefit justifies the potential risk. Adderall XR extended release capsules may be taken whole, or the capsule may be opened and the entire contents sprinkled on applesauce. Patients were randomized to fixed-dose treatment groups receiving final doses of 10, 20, or 30 mg of Adderall XR or placebo once daily in the morning for three weeks. A delay in the developmental milestones of vaginal opening and preputial separation was seen at 40 mg/kg but there was no effect on fertility. The starting dose of Adderall XR for children and adolescents between 6 and 17 years old is 10 mg once a day in the morning. 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. Advise patients that Adderall XR is a federally controlled substance because it can be abused or lead to dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy, sudden death in patients who have heart problems or heart defects, new or worse behavior and thought problems, new or worse aggressive behavior or hostility, new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms, Fingers or toes may feel numb, cool, painful, Fingers or toes may change from pale, to blue, to red. Adderall® 30 mg: A round, flat-faced beveled edge, orange tablet, â30â embossed on one side with a full and partial bisect and âADâ embossed on the other side, supplied as follows: 100 Tablets Unit-of-use NDC 0555-0768-02. Fatigue and depression usually follow the central nervous system stimulation. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Is Adzenys XR-ODT the same as Adderall XR? Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. All doses caused hyperactivity and decreased weight gain in the dams. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products, Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis, have heart disease or hardening of the arteries, have moderate to severe high blood pressure. Growth should be monitored during treatment with stimulants, including Adderall XR, and pediatric patients aged 6 to 17 years who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.4)]. Adderall XR passes into breast milk. This Medication Guide has been approved by the U.S. Food and Drug Administration. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems. On a mg/kg weight basis, children eliminated amphetamine faster than adults. XR: Age 6 to 12 Years (starting treatment for the first time or switching from another medication):-Initial Dose: 5 or 10 mg orally once a day in the morning-Maintenance Dose: Daily dose may be raised in 5 to 10 mg increments at weekly intervals.-Maximum Dose: 30 mg/day -Maximum Dose: Only in rare cases will it be necessary to exceed 40 mg per day. Are there any other precautions or warnings for this medication? When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with 5 mg once daily in the morning. Adderall XR treatment may be stopped if a problem is found during these check-ups. 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. Adderall and Mydayis are trade names for a combination drug containing four salts of amphetamine.The mixture is composed of equal parts racemic amphetamine and dextroamphetamine, which produces a (3:1) ratio between dextroamphetamine and levoamphetamine, the two enantiomers of amphetamine. Available data from published epidemiologic studies and postmarketing reports on use of prescription amphetamine in pregnant women have not identified a drug-associated risk of major birth defects and miscarriage (see Data). 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). The efficacy of Adderall XR in the treatment of ADHD was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met DSM-IV® criteria for ADHD [see Clinical Studies (14)]. If youâre searching for an Adderall dosage chart, the following infographic provides a general overview of what an Adderall dosage might look like. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. for information on reported heart and mental problems. 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. Due to reduced clearance of amphetamines in patients with severe renal impairment (GFR 15 to <30 mL/min/1.73m2), the recommended dose should be reduced. are breastfeeding or plan to breastfeed. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported. 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) [see Warnings and Precautions (5.2)]. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse reactions. If you or your child cannot swallow the capsule, open it and sprinkle the medicine over a spoonful of applesauce. Adderall XR and some medicines may interact with each other and cause serious side effects. Administer Adderall XR at the lowest effective dosage. electrocardiogram and echocardiogram). and −2.8 lbs., respectively, for patients receiving 10 mg and 20 mg Adderall XR. Impairment in Ability to Operate Machinery or Vehicles. Swallow Adderall XR extended release capsules whole with water or other liquids. Enter the imprint code that appears on the pill. The elimination half-life (t1/2) is approximately 1 hour shorter for d-amphetamine and 2 hours shorter for l-amphetamine in children than in adults. Instruct patients beginning treatment with Adderall XR about the risk of peripheral vasculopathy, including Raynaud's Phenomenon, and in associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. 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. The mode of therapeutic action in ADHD is not known. Certain states have imposed restrictions on the use of prescription drug coupons and, therefore, the RxSaver coupons are void where prohibited by law. There are no reports of adverse effects on the breastfed infant. Your doctor may do regular checks of the heart and blood pressure while taking Adderall XR. 7. Adderall XR® is a registered trademark of Dispose of remaining, unused, or expired Adderall XR at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. The symptoms must not be better accounted for by another mental disorder. Evaluate patient history (including family history) of abuse or dependence on alcohol, prescription medicines, or illicit drugs [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9)]. Adderall XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Adderall XR should not be taken if you or your child: Adderall XR has not been studied in children less than 6 years old. 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. Dispense in a tight, light-resistant container. 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 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), 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 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. 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. 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, ANALYSIS(54092-389, 54092-391, 54092-381, 54092-383, 54092-385, 54092-387), API MANUFACTURE(54092-381, 54092-385, 54092-387, 54092-389, 54092-391, 54092-383), PACK(54092-389, 54092-391, 54092-381, 54092-383, 54092-385, 54092-387), ANALYSIS(54092-381, 54092-383, 54092-385, 54092-387, 54092-389, 54092-391), LABEL(54092-381, 54092-383, 54092-385, 54092-387, 54092-389, 54092-391), MANUFACTURE(54092-381, 54092-383, 54092-385, 54092-387, 54092-389, 54092-391), PACK(54092-381, 54092-383, 54092-385, 54092-387, 54092-389, 54092-391), ANALYSIS(54092-383, 54092-385, 54092-387, 54092-389, 54092-391), MANUFACTURE(54092-383, 54092-385, 54092-387, 54092-389, 54092-391), LABEL(54092-381, 54092-383, 54092-385, 54092-387, 54092-389, 54092-391), PACK(54092-381, 54092-383, 54092-385, 54092-387, 54092-389, 54092-391), In patients known to be hypersensitive to amphetamine, or other components of Adderall XR. 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