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Adderall (Dextroamphetamine Saccharate / Amphetamine Aspartate Monohydrate / Dextroamphetamine Sulfate / Amphetamine Sulfate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Adderall® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

Attention Deficit Hyperactivity Disorder (ADHD)

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV® characteristics.

Need for Comprehensive Treatment Program

Adderall® is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. 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.

Long-Term Use

The effectiveness of Adderall® for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Adderall® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

Regardless of indication, amphetamines should be administered at the lowest effective dosage, and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia.

Attention Deficit Hyperactivity Disorder

Not recommended for children under 3 years of age. In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In children 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Narcolepsy

Usual dose 5 mg to 60 mg per day in divided doses, depending on the individual patient response.

Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

HOW SUPPLIED

Adderall® (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets) 5 mg: White to off-white, round, flat-faced, beveled edge tablet with four partial bisects debossed with 5 on one side and debossed with dp on the other side. Available in bottles of 100.

Adderall® (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets) 7.5 mg: Blue, oval, biconvex tablet with two partial bisects debossed with 7.5 on one side and one full bisect and two partial bisects debossed with d | p on the other side. Available in bottles of 100.

Adderall® (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets) 10 mg: Blue, round, biconvex tablet with one full bisect and two partial bisects debossed with 1 | 0 on one side and debossed with dp on the other side. Available in bottles of 100.

Adderall®(Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets) 12.5 mg: Peach, round, flat-faced, beveled edge tablet debossed with 12.5 on one side and one full bisect and two partial bisects debossed with d | p on the other side. Available in bottles of 100.

Adderall® (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets) 15 mg: Peach, oval, biconvex tablet with two partial bisects debossed with 15 on one side and one full bisect and two partial bisects debossed with d | p on the other side. Available in bottles of 100.

Adderall® (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets) 20 mg: Peach, round, biconvex tablet with one full bisect and two partial bisects debossed with 2 | 0 on one side and debossed with dp on the other side. Available in bottles of 100.

Adderall® (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets) 30 mg: Peach, round, flat-faced, beveled edge tablet with one full bisect and 2 partial bisects debossed with 3 | 0 on one side and dp on the other side. Available in bottles of 100.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. B 5/2012

 

MEDICATION GUIDE

Adderall ®  (ADD-ur-all) (CII)
(Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets)
 

Read the Medication Guide that comes with Adderall® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about you or your child’s treatment with Adderall®.

What is the most important information I should know about Adderall®

The following have been reported with use of Adderall® and other stimulant medicines. 

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®.

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Adderall®.

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

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®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.   

What is Adderall®?

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

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

Adderall® is also used in the treatment of a sleep disorder called narcolepsy.

Adderall® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Adderall® in a safe place to prevent misuse and abuse. Selling or giving away Adderall® 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.

 Who should not take Adderall®?

Adderall ®   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.
  • are sensitive to, allergic to, or had a reaction to other stimulant medicines

Adderall® is not recommended for use in children less than 3 years old.

Adderall ®    may not be right for you or your child. Before starting Adderall ®   tell your or your child’s doctor about all health conditions (or a family history of) including: 

  • heart problems, heart defects, high blood pressure
  • mental problems including psychosis, mania, bipolar illness, or depression
  • tics or Tourette’s syndrome
  • liver or kidney problems
  • thyroid problems
  • seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child are pregnant, planning to become pregnant, or breastfeeding.

Can Adderall ®  be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Adderall® 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®.

Your doctor will decide whether Adderall® can be taken with other medicines.

Especially tell your doctor if you or your child take:

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

Know the medicines that you or your child take. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Adderall ®   without talking to your doctor first.

How should Adderall ®   be taken? 

  • Take Adderall ®   exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • Adderall® tablets are usually taken two to three times a day. The first dose is usually taken when you first wake in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.
  • Adderall® can be taken with or without food.
  • From time to time, your doctor may stop Adderall® treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking Adderall®. Children should have their height and weight checked often while taking Adderall®. Adderall® treatment may be stopped if a problem is found during these check-ups.
  • If you or your child take too much Adderall ®   or overdose, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Adderall®?

See “What is the most important information I should know about Adderall ® ?” for information on reported heart and mental problems.

Other serious side effects include:

  • slowing of growth (height and weight) in children
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision

Common side effects include:

  • headache
  • stomach ache
  • trouble sleeping
  • decreased appetite
  • nervousness
  • dizziness

Adderall® may affect your or your child’s ability to drive or do other dangerous activities.

Talk to your doctor if you or your child have side 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.

How should I store Adderall ® ?  

  • Store Adderall® in a safe place at room temperature, 20° to 25°C (68° to 77°F).
  • Keep Adderall ®   and all medicines out of the reach of children.

General information about Adderall ®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Adderall® for a condition for which it was not prescribed. Do not give Adderall® 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®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Adderall® that was written for healthcare professionals. For more information about Adderall®, please contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872, X6351.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What are the ingredients in Adderall®?

Active Ingredients: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, USP, and amphetamine sulfate, USP

Inactive Ingredients: colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, microcrystalline cellulose and saccharin sodium, USP. The 5 mg is a white to off-white tablet, which contains no color additive. The 7.5 and 10 mg also contain FD&C Blue #1 aluminum lake. The 12.5, 15, 20 and 30 mg also contain FD&C Yellow #6 aluminum lake.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. B 5/2012

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