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ADDERALL XR- dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate capsule, extended release


  1. Distributed And Repackaged By:
  2. 1. Heart-related Problems:
  3. 2. Mental (psychiatric) Problems:
  4. Adderall Xr Should Not Be Taken If You Or Your Child:
  5. Adderall Xr May Not Be Right For You Or Your Child. Before Starting Adderall Xr Tell You Or Your Childs Doctor About All Health Conditions (or A Family History Of) Including If You Or Your Child:
  6. Can Adderall Xr Be Taken With Other Medicines?
  7. Your Doctor Will Decide Whether Adderall Xr Can Be Taken With Other Medicines.especially Tell Your Doctor If You Or Your Child Takes:
  8. How Should Adderall Xr Be Taken?
  9. What Are Possible Side Effects Of Adderall Xr?
  10. Active Ingredients:
  11. Inactive Ingredients:
  12. Patient Information

Distributed And Repackaged By: 


Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

1. Heart-related Problems: 

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting ADDERALL XR.

Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with ADDERALL XR.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking ADDERALL XR.

2. Mental (psychiatric) Problems: 

All Patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking ADDERALL XR, especially

ADDERALL XR is a once daily central nervous system stimulant prescription medicine.It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).ADDERALL XR may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

ADDERALL XR should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

ADDERALL XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep ADDERALL XR in a safe place to prevent misuse and abuse. Selling or giving away ADDERALL XR may harm others, and is against the law.

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.

Adderall Xr Should Not Be Taken If You Or Your Child: 

  • have heart disease or hardening of the arteries
  • have moderate to severe high blood pressure
  • have hyperthyroidism
  • have an eye problem called glaucoma
  • are very anxious, tense, or agitated
  • have a history of drug abuse
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  • is sensitive to, allergic to, or had a reaction to other stimulant medicines

ADDERALL XR has not been studied in children less than 6 years old.

Adderall Xr May Not Be Right For You Or Your Child. Before Starting Adderall Xr Tell You Or Your Childs Doctor About All Health Conditions (or A Family History Of) Including If You Or Your Child: 

  • have heart problems, heart defects, or high blood pressure
  • have mental problems including psychosis, mania, bipolar illness, or depression
  • have tics or Tourette's syndrome
  • have liver problems
  • have kidney problems
  • have end stage renal disease (ESRD)
  • have thyroid problems
  • have seizures or have had an abnormal brain wave test (EEG)
  • have circulation problems in fingers and toes
  • are pregnant or plan to become pregnant. It is not known if ADDERALL XR will harm your unborn baby.
    • There is a pregnancy registry for females who are exposed to ADDERALL XR during pregnancy. The purpose of the registry is to collect information about the health of females exposed to ADDERALL XR and their baby. If you or your child becomes pregnant during treatment with ADDERALL XR, talk to your healthcare provider about registering with the National Pregnancy Registry of Psychostimulants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinical-and -research-programs/pregnancyregistry/othermedications/.
    • are breastfeeding or plan to breastfeed. ADDERALL XR passes into breast milk. You or your child should not breastfeed during treatment with ADDERALL XR.

Can Adderall Xr Be Taken With Other Medicines? 

Tell your doctor about all of the medicines that you or your child takes including prescription and non-prescription medicines, vitamins, and herbal supplements.ADDERALL XR and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking ADDERALL XR.

Your Doctor Will Decide Whether Adderall Xr Can Be Taken With Other Medicines.especially Tell Your Doctor If You Or Your Child Takes: 

  • anti-depression medicines including MAOIs
  • anti-psychotic medicines
  • lithium
  • narcotic pain medicines
  • seizure medicines
  • blood thinner medicines
  • blood pressure medicines
  • stomach acid medicines
  • cold or allergy medicines that contain decongestants

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 first.

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.
  • Take ADDERALL XR once a day in the morning when you first wake up. ADDERALL XR is an extended release capsule. It releases medicine into your body throughout the day.
  • Swallow ADDERALL XR extended release capsules whole with water or other liquids. If you or your child cannot swallow the capsule, open it and sprinkle the medicine over a spoonful of applesauce. Swallow all of the applesauce and medicine mixture without chewing immediately. Follow with a drink of water or other liquid.Never chew or crush the capsule or the medicine inside the capsule.
  • ADDERALL XR can be taken with or without food.
  • 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 heart and blood pressure while taking ADDERALL XR. Children should have their height and weight checked often while taking ADDERALL XR. ADDERALL XR treatment may be stopped if a problem is found during these check-ups.
  • 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.

What Are Possible Side Effects Of Adderall Xr? 

  • Store ADDERALL XR in a safe place at room temperature, 59 to 86 F (15 to 30 C).
  • Keep ADDERALL XR and all medicines out of the reach of children.

General information about ADDERALL XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ADDERALL XR for a condition for which it was not prescribed. Do not give ADDERALL XR to other 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. 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 visit the website at http://www.adderallxr.com.

Active Ingredients: 

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate

Inactive Ingredients: 

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

Manufactured for Shire US Inc., 300 Shire Way, Lexington, MA 02421.
ADDERALL XRis a registered trademark of Shire LLC, a Takeda company.
2019 Takeda Pharmaceutical Company Limited. All Rights Reserved.

Rev. 7/2019

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Controlled Substance Status/Potential for Abuse, Misuse, and Dependence

Advise patients that ADDERALL XR is a federally controlled substance because it can be abused or lead to dependence. Additionally, emphasize that ADDERALL XR should be stored in a safe place to prevent misuse and/or abuse. Evaluate patient history (including family history) of abuse or dependence on alcohol, prescription medicines, or illicit drugs[seeWarnings and Precautions (5.1),Drug Abuse and Dependence (9)].

Serious Cardiovascular Risks

Advise patients of serious cardiovascular risk (including sudden death, myocardial infarction, stroke, and hypertension) with ADDERALL XR. 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[seeWarnings and Precautions (5.1)].

Psychiatric Risks

Prior to initiating treatment with ADDERALL XR, adequately screen patients with comorbid depressive symptoms 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/or depression. 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[seeWarnings and Precautions (5.2)].

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]

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. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking ADDERALL XR. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients[seeWarnings and Precautions (5.5)].

Serotonin Syndrome

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[seeContraindications (4),Warnings and Precautions (5.6)andDrug Interactions (7.1)]. Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.

Concomitant Medications

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[seeDrug Interactions (7.1)].

Growth

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[seeWarnings and Precautions (5.3)].

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADDERALL XR during pregnancy[seeUse in Specific Populations (8.1)].

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with ADDERALL XR. Advise patients of the potential fetal effects from the use of ADDERALL XR during pregnancy[seeUse in Specific Populations (8.1)].

Lactation

Advise women not to breastfeed if they are taking ADDERALL XR[seeUse in Specific Populations (8.2)].

Impairment in Ability to Operate Machinery or Vehicles

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.

Manufactured for Shire US Inc., 300 Shire Way, Lexington, MA 02421, Made in USA.
For more information call 1-800-828-2088
ADDERALL XRis a registered trademark of Shire LLC, a Takeda company
ADDERALLis a registered trademark of Shire LLC, a Takeda company, under license to Duramed Pharmaceuticals, Inc.

Copyright 2019 Takeda Pharmaceutical Company Limited. All rights reserved.



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