Consumer Information for: DEXTROAMPHETAMINE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

DEXTROAMPHETAMINE (dextroamphetamine sulfate), a drug in the class of amphetamines (central nervous system stimulant), is used along with other therapies, for the treatment of:

  • narcolepsy (a disorder that caused excessive sleepiness during the day and frequent and uncontrollable episodes of falling asleep).
  • Attention-deficit Hyperactivity Disorder (ADHD) (a disorder characterized by a very short attention span, impulsiveness, and hyperactivity). DEXTROAMPHETAMINE should be used as a part of a total treatment program for ADHD that may include counselling or other therapies.

What it does

DEXTROAMPHETAMINE causes a lessening of fatigue, an increase in mental activity, an elevation of mood, and a general feeling of well-being.

DEXTROAMPHETAMINE helps increase attention (including the ability to follow directions and finish tasks) and decrease impulsiveness and hyperactivity in patients with ADHD.

When it should not be used

You or your child should NOT take DEXTROAMPHETAMINE if you or your child:

  • have cardiovascular disease;
  • have moderate to severe high blood pressure;
  • have advanced arteriosclerosis (hardened arteries);
  • have hyperthyroidism (an overactive thyroid gland);
  • have allergies to DEXTROAMPHETAMINE or to any ingredient in the formulation or component of the container;
  • are sensitive to, allergic to, or had a reaction to other stimulant medicines or sympathomimetic amines;
  • have glaucoma, an eye disease;
  • have very anxious, tense, or agitated states;
  • have motor tics (hard to control, repeat twitching of any parts of the body) or verbal tics (hard to control repeating of sounds or words) or Tourette’s syndrome;
  • have relatives with motor tics or verbal tics or Tourette’s syndrome;
  • are taking drugs from the group called Monoamine Oxidase Inhibitors (MAOI) or have taken a MAOI within the last 14 days;
  • have a history of drug abuse.

DEXTROAMPHETAMINE is not recommended for use in children under 6 years of age.

Talk to your doctor if you believe any of these conditions apply to you or your child.

What the medicinal ingredient is

DEXTROAMPHETAMINE contains dextroamphetamine sulfate as the medicinal ingredient.

What the non-medicinal ingredients are

DEXTROAMPHETAMINE 5 mg tablets contain the following nonmedicinal ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, D&C yellow # 10 aluminum lake 14- 18%, magnesium stearate, microcrystalline cellulose and sunset yellow aluminum lake 40%

What dosage form it comes in

DEXTROAMPHETAMINE is available as 5 mg tablets.

Warnings and precautions

Serious Warnings and Precautions

  • Drug Dependence
    Abuse of any amphetamine like DEXTROAMPHETAMINE can lead to dependence. Tell your doctor if you have ever abused or been dependent on alcohol or drugs, or if you are now abusing or dependent on alcohol or drugs.

The following have been reported with use of DEXTROAMPHETAMINE and other medicines used to treat ADHD:

  1. 1. Heart-related problems:
    • sudden death in patients who have heart problems and heart defects
    • stroke and heart attack in adults
    • increased blood pressure and heart rate

    Sudden death has been reported in association with stimulant drugs for ADHD treatment in children with structural heart abnormalities. DEXTROAMPHETAMINE generally should not be used in children, adolescents or adults with known structural heart abnormalities.

    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 may wish to check you or your child carefully for heart problems before starting DEXTROAMPHETAMINE.

    Your doctor may wish to check you or your child’s blood pressure and heart rate regularly during treatment with DEXTROAMPHETAMINE.

    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 DEXTROAMPHETAMINE.

  2. Mental (Psychiatric) problems:

    3. All patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • 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.

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

Amphetamines may impair the ability to perform potentially hazardous activities such as operating machinery or driving.

BEFORE you use DEXTROAMPHETAMINE talk to your doctor or pharmacist if you or your child:

  • have mild high blood pressure;
  • have a family history of sudden death or death related to heart problems;
  • have heart disease or structural heart abnormalities;
  • have mental problems including psychosis, mania, bipolar illness, depression, or a family history of suicide;
  • have tics or Tourette’s syndrome;
  • have thyroid problems;
  • have seizures or have had an abnormal brain wave test (EEG);
  • do strenuous exercise;
  • take other drugs for ADHD;
  • have diabetes mellitus;
  • have kidney disease
  • have an allergy to aspirin;
  • is pregnant or plans to become pregnant;
  • is breast feeding or plans to breastfeed;
  • if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.
  • Have circulation problems in fingers and toes, including numbness, feeling cold or pain (this is also known as Raynaud’s phenomenon).

Amphetamines have been subject to extensive abuse. Tolerance, extreme psychological dependence, and severe social disability can occur. It is important that DEXTROAMPHETAMINE be taken only as directed by your doctor.

Interactions with this medication

It is important to tell your doctor or pharmacist about all medicines that you or your child are taking including other medicines that a doctor has prescribed, medicines that you buy yourself without a prescription, and any herbal remedies that you or your child are taking, especially:

  • medicines that make urine or digestive contents more acidic (e.g., guanethidine, reserpine, ascorbic acid, ammonium chloride, sodium acid phosphate)
  • medicines that make urine or digestive contents more alkaline (e.g., sodium bicarbonate, acetazolamide, thiazides)
  • medicines used to treat depression including monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin and noradrenaline reuptake inhibitors (SNRIs) and certain tricyclic antidepressants (TCAs)
  • Other medicines that can affect serotonin, such as lithium, drugs containing tryptophan, St. John’s Wort, triptans used to treat migraines and certain medicines used to treat pain, such as fentanyl, tramadol, tapentadol, meperidine, methadone
  • Medicines used to reduce your blood pressure (such as guanethidine and veratrum alkaloids)
  • Medicines used to treat allergy symptoms (antihistamines)
  • Antipsychotic medicines (such as chlorpromazine and haloperidol)
  • Insulin (a drug used to treat diabetes)
  • Lithium carbonate (a drug used to treat bipolar disorder)
  • Medicines used to treat pain (such as meperidine and propoxyphene)
  • Norepinephrine
  • Phenobarbital (a drug used to help you fall asleep or treat anxiety)
  • Antacids such as Proton Pump Inhibitors
  • Seizure medicines (such as ethosuximide, phenytoin)

While on DEXTROAMPHETAMINE do not start taking a new medicine or herbal remedy before checking with your doctor.

Proper use of this medication

Usual Dose

In order to receive the most benefit from DEXTROAMPHETAMINE, it is important that DEXTROAMPHETAMINE be taken only as directed by your doctor. The doctor may adjust the amount of drug taken by you or your child until it is right for you or your child. From time to time, the doctor may interrupt treatment to check you or your child’s symptoms while you or your child are not taking the drug.

Your doctor may do regular checks of the blood, heart, and blood pressure while taking DEXTROAMPHETAMINE. Children should have their height and weight checked often while taking DEXTROAMPHETAMINE. DEXTROAMPHETAMINE treatment may be stopped if a problem is found during these check-ups

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you forget to take your medicine, take it as soon as you remember. Then continue as before. Do not take a double dose to make up for forgotten individual doses.

Side effects and what to do about them

Along with its desired effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur, talk to your or your child’s doctor.

Some of the side effects observed during treatment with stimulant medications such as dextroamphetamine sulfate were slowing of growth (height and weight) in children, seizures (mainly in patients with a history of seizures), eye sight changes, tremors, headache, dizziness, loss of appetite, dry mouth, stomach upset, difficulty falling asleep, high blood pressure, irregular heartbeat, and irritability.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Common
Uneven heart beat (palpitations)   ✔  
Slowing of growth (height and weight) in children   ✔  
Anxiety ✔    
New tics   ✔  
Uncomm on
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing     ✔
Trouble with vision: eyesight changes and blurred visions      
New Psychotic or Manic Symptoms:
  • Paranoia, delusions
  • Hallucination s: seeing, feeling, or hearing things that are not real
  • Mania: feeling unusually excited, overactive, or uninhibited
      
Aggressive Behavior or Hostility      
Depression:
Feeling sad, loss of interest in usual activities, hopelessness, insomnia, or sleeping too much		      
Unknown rate
Fits (seizures)      
Suicidal Behavior: Thoughts or actions about hurting or killing yourself      
Cardiomyopathy : breathlessness or swelling of the legs (signs of heart muscle disease)      
Raynaud’s Phenomenon: discoloration of the fingers and toes, pain, sensations of cold and/or numbness      

This is not a complete list of side effects. For any unexpected effects while taking DEXTROAMPHETAMINE, contact your doctor or pharmacist.

How to store

DEXTROAMPHETAMINE tablets should be stored at room temperature 15°C to 30°C in a well closed container.

Do not take your medicine after the expiry date shown on the bottle.

Keep this medicine out of the reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE:Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

For more information, please contact your doctor, pharmacist or other healthcare professional

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor AA Pharma Inc.:

1-877-998-9097

This leaflet was prepared by AA Pharma Inc.

Last revised: April 3, 2018

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