Adderall/Adderall-XR (amphetamine mixture)Generic name: Amphetamine mixturesAvailable strengths: 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg immediate-release tablets; 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg extended-release capsules (Adderall-XR)Available in generic: Yes, in immediate-release tablets onlyDrug class: StimulantGeneral InformationAdderall (dextroamphetamine and amphetamine mixtures) and Adderall-XR (extended-release) arepsychostimulants, or better known as stimulants.Adderall is used primarily in treating attention-deficit/hyperactivity disorder (ADHD) and narcolepsy, a condition characterized by daytime somnolence in whichthe patient periodically falls into a deep sleep during the day.Narcolepsy is a disorder of the sleep wake con-trol mechanisms within the brain that interferes with both daytime wakefulness and nighttime sleep.The use of a medication for its approved indication is called its labeleduse.In clinical practice, however,physicians often prescribe medications for unlabeled (off-label) uses when published clinical studies, case re-ports, or their own clinical experiences support the efficacy and safety of these medications for these un-approved indications.
Adderall is often used to augment antidepressants in treating refractory depression.Forpatients with chronic treatment-resistant depression, for example, Adderall in combination with antidepres-sants can provide symptomatic relief and improvement beyond that experienced with antidepressants alone.In numerous clinical studies and decades of clinical experience, Adderall has clearly demonstrated im-provement in outcome for children with ADHD.Adderall increases the childs ability to concentrate, extendsattention span, and decreases hyperactivity.Adults with ADHD also benefit from therapy with Adderall.Adderall helps them concentrate and remain focused on their tasks, increases their attention span, and de-creases impulsivity and hyperactivity.Adderall and Adderall-XR are mixtures of amphetamine and dextroamphetamine salts in different combi-nations.
For example, a 20-mg tablet of Adderall contains 5 mg of dextroamphetamine sulfate, 5 mg of dex-troamphetamine saccharate, 5 mg of amphetamine sulfate, and 5 mg of amphetamine asparate.The givenstrength of an Adderall tablet or capsule is the sum of all the stimulants in the mixture.Adderall has a durationof action of approximately 5 hours, whereas Adderall-XR lasts about 9 hours.STIMULANTSDosing InformationFor adults, the recommended starting dosage for Adderall is 5 mg twice a day.The dosage is adjusted basedon the individuals response.The usual therapeutic dosage may range from 10 mg/day to 40 mg/day, admin-istered two times a day.The maximum dosage should not exceed 60 mg/day.Adderall may be converted to once-daily dosing with Adderall-XR using an equivalent dosage of the ex-tended-release form.However, the maximum recommended dosage is 30 mg/day with Adderall-XR.
The cap-sules should be swallowed whole and not chewed or crushed.The capsules may be opened and sprinkled inapplesauce and swallowed without chewing.Common Side EffectsThe common side effects associated with taking Adderall are rapid heart rate, palpitations, nervousness, rest-lessness, insomnia, dry mouth, constipation, nausea, diarrhea, loss of appetite, weight loss, and elevation ofblood pressure.Adverse Reactions and PrecautionsAdderall has a high potential for abuse.Individuals with a history of alcohol and substance abuse may be atrisk for abusing stimulants.Individuals who abuse Adderall develop tolerance and psychological dependencethat may result in addiction.
With long-term abuse of Adderall and the resulting sleepless nights, the individ-ual may develop psychotic symptoms.Adderall may increase blood pressure.Individuals with a history of high blood pressure or heart diseaseshould be cautious about taking Adderall because it can exacerbate these conditions.Uncontrolled high bloodpressure can have serious consequences, including stroke and heart attacks.Patients taking Adderall shouldroutinely check their blood pressure.Individuals with a history of seizure disorder should be cautious while taking Adderall, because it can lowerthe seizure threshold.In children and adolescents who are still in their growth period, Adderall can suppress linear growth.
Phy-sicians commonly interrupt treatment, if possible, on weekends and holidays, when children are not in school,for growth catch-up
Children and adolescents taking Adderall require close monitoring for growth suppres-sion and periodic measuring of their height.However, this is not a concern in the adult population.Adderall may make tics worse in individuals with a tic disorder (i.e., twitching of a muscle group, especiallyin the face).Adderall should be avoided, or used with caution, by patients with a diagnosis of schizophrenia or bipolardisorder.Stimulants are frequently abused in this population, and high doses of stimulants may trigger psy-chosis and mania.Possible Drug InteractionsAdderall should not be taken in combination with a group of antidepressants known as monoamine oxidaseinhibitors.The combination may precipitate increases in blood pressure.This and other significant druginteractions reported with Adderall are summarized in the table on the next page.Page 2 of 4Adderall/Adderall-XR (amphetamine mixture)Use in Pregnancy and Breastfeeding: Pregnancy Category CAdderall has not been tested in women to determine its safety in pregnancy.
The effects of the medication onthe developing fetus in pregnant women are unknown.Women who are pregnant or may become pregnantshould discuss this with their physician.Nursing mothers should not take any stimulant, because small amounts will pass into breast milk and beingested by the baby.
If stopping the stimulant is not an alternative, breastfeeding should not be started orshould be discontinue
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00; 00;Tell your doctor about all of the medicines that you or your child takes including prescription and non
ADDERALL XR and some medicines may interact with each other and cause serious side effects.Sometimes the doses of other medicines will can be taken with other medicines including MAOIs anti-psychotic medicines narcotic pain medicines seizure medicines blood thinner medicines blood pressure medicines stomach acid medicines cold or allergy medicines that contain Know the medicines that you or your child takes.
Keep a list of your medicines with you to show your doctor and pharmacist.Do not start any new medicine while taking ADDERALL XR without talking to your doctor How should ADDERALL XR be taken? Take ADDERALL XR exactly as prescribed.
Your doctor may adjust the dose until it is right for you or your child.morning when you first wake up.
ADDERALL XR is an extended release capsule.It releases medicine into your body throughout the day.
the medicine over a spoonful of applesauce.
Swallow all of the applesauce and medicine mixture without chewing immediately.
Follow From time to time, your doctor may stop ADDERALL XR treatment for a while to check ADHD symptoms.Your doctor may do regular checks of the blood, ADDERALL XR.Children should have their ADDERALL XR.
ADDERALL XR treatment may be stopped if a problem is found during If you or your child takes too much ADDERALL XR or overdoses, call your XR? should know about ADDERALL XR? information on reported heart and mental problems.seizures, mainly in patients with a history of stomach ache mood swings weight loss dizziness dry mouth ADDERALL XR may affect you or your childs effects that are bothersome or do not go away.This is not a complete list of possible side effects.
Ask your doctor or pharmacist for more information
Call your doctor for medical advice about side effects.You may report side effects to FDA at 1How should I store ADDERALL XR? temperature, 59 to 86 F (15 to 30 C).
Keep ADDERALL XR and all medicines out General information about ADDERALL XR Medicines are sometimes prescribed for purposes people, even if they have the same condition.
It may harm them and it is against the law.
This Medication Guide summarizes the most important information about ADDERALL XR.If you would like more information, talk with your doctor.
00; 00;You can ask your doctor or pharmacist for information about ADDERALL XR that was written for healthcare professionals.For more information, you may also contact Shire Pharmaceuticals (the maker of ADDERALL XR) at 1-800-828-2088 or http://www.adderallxr.com.What are the ingredients in ADDERALL XR? dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, USP, amphetamine hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, sugar spheres, talc, and 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 Manufactured for Shire US Inc., Wayne, PA 19087.Trademark Office.
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