Adderall XR Capsules
"The US Food and Drug Administration (FDA) has approved the amphetamine Dyanavel XR (Tris Pharma Inc), a once-daily extended-release oral liquid, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years "...
(mixed salts of a single-entity amphetamine) Capsules
POTENTIAL FOR ABUSE
Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Pay particular attention to the possibility of subjects obtaining amphetamines for nontherapeutic use or distribution to others and the drugs should be prescribed or dispensed sparingly [see Drug Abuse And Dependence].
Misuse of amphetamine may cause sudden death and serious cardiovascular adverse reactions.
ADDERALL XR is a once daily extended-release, single-entity amphetamine product. ADDERALL XR combines the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d,l-amphetamine aspartate monohydrate. The ADDERALL XR capsule contains two types of drug-containing beads designed to give a double-pulsed delivery of amphetamines, which prolongs the release of amphetamine from ADDERALL XR compared to the conventional ADDERALL (immediate-release) tablet formulation.
|Each capsule contains:||5 mg||10 mg||15 mg||20 mg||25 mg||30 mg|
|Dextroamphetamine Saccharate||1.25 mg||2.5mg||3.75 mg||5.0 mg||6.25 mg||7.5 mg|
|Amphetamine Aspartate Monohydrate||1.25 mg||2.5mg||3.75 mg||5.0 mg||6.25 mg||7.5 mg|
|Dextroamphetamine Sulfate USP||1.25 mg||2.5mg||3.75 mg||5.0 mg||6.25 mg||7.5 mg|
|Amphetamine Sulfate USP||1.25 mg||2.5mg||3.75 mg||5.0 mg||6.25 mg||7.5 mg|
|Total amphetamine base equivalence||3.1 mg||6.3mg||9.4 mg||12.5mg||15.6 mg||18.8 mg|
Inactive Ingredients and Colors
The inactive ingredients in ADDERALL XR capsules include: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, sugar spheres, talc, and triethyl citrate. Gelatin capsules contain edible inks, kosher gelatin, and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #2. The 20 mg, 25 mg, and 30 mg capsules also contain red iron oxide and yellow iron oxide.
What are the possible side effects of amphetamine and dextroamphetamine (Adderall, Adderall XR)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have a serious side effect such as:
- fast, pounding, or uneven heartbeats;
- pain or burning when you urinate;
- talking more than usual, feelings of extreme happiness or sadness;
- tremors, hallucinations, unusual behavior, or motor tics (muscle twitches); or
- dangerously high blood...
What are the precautions when taking amphetamine, dextroamphetamine mixed salts (Adderall XR)?
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic drugs (such as lisdexamfetamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (such as Raynaud's disease), certain mental/mood conditions (such as agitation, psychosis), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychotic disorder, suicidal thoughts), heart problems (including irregular heartbeat/rhythm, coronary artery disease, heart failure, cardiomyopathy,...
Last reviewed on RxList: 1/21/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Adderall XR Information
Adderall XR - User Reviews
Adderall XR User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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