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Details for: APO-AMPHETAMINE XR

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02445492APO-AMPHETAMINE XRMIXED SALTS AMPHETAMINE5 MGCAPSULE (EXTENDED RELEASE)ORAL
02445506APO-AMPHETAMINE XRMIXED SALTS AMPHETAMINE10 MGCAPSULE (EXTENDED RELEASE)ORAL
02445514APO-AMPHETAMINE XRMIXED SALTS AMPHETAMINE15 MGCAPSULE (EXTENDED RELEASE)ORAL
02445522APO-AMPHETAMINE XRMIXED SALTS AMPHETAMINE20 MGCAPSULE (EXTENDED RELEASE)ORAL
02445530APO-AMPHETAMINE XRMIXED SALTS AMPHETAMINE25 MGCAPSULE (EXTENDED RELEASE)ORAL
02445549APO-AMPHETAMINE XRMIXED SALTS AMPHETAMINE30 MGCAPSULE (EXTENDED RELEASE)ORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

APO-AMPHETAMINE XR is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children (6 to 12 years), adolescents (13 to 17 years) and adults.

APO-AMPHETAMINE XR may be a part of your/your child’s overall treatment for ADHD. The doctor may also recommend that you/your child have counseling or other therapy.

What it does

Mixed salts amphetamine, the medicinal ingredient in APOAMPHETAMINE XR, help increase attention (including the ability to follow directions and finish tasks) and decrease impulsiveness and hyperactivity in patients with ADHD. The APO-AMPHETAMINE XR capsule contains extendedrelease mini tablets which release medication to keep improving the symptoms of ADHD throughout the day and into the early evening.

When it should not be used

Do not take APO-AMPHETAMINE XR if you/your child:

  • Are allergic to amphetamines or any of the nonmedicinal ingredients in the formulation or its container (see What the nonmedicinal ingredients are)
  • Are sensitive to, allergic to or had a reaction to other stimulant medicines
  • Have advanced arteriosclerosis (hardened arteries)
  • Have symptomatic heart disease
  • Have moderate to severe high blood pressure
  • Have agitated states
  • Have glaucoma, an eye disease
  • Have hyperthyroidism (an overactive thyroid gland)
  • Have history of drug abuse
  • Are taking or have taken medications from the group called monoamine oxidase inhibitors (MAOI) within the last 14 days.
  • Are taking or have taken medications from the group called monoamine oxidase inhibitors (MAOI) within the last 14 days.

What the medicinal ingredient is

Mixed salts amphetamine: d-amphetamine saccharate, amphetamine aspartate (anhydrous), d-amphetamine sulfate and amphetamine sulfate.

What the non-medicinal ingredients are

Colloidal silicon dioxide, D&C Yellow No. 10, edible ink, FD&C Blue # 2 (5 mg, 10 mg and 15 mg capsules), FD&C Yellow No. 6, gelatin, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, iron oxide red (5 mg, 20 mg, 25 mg and 30 mg capsules), iron oxide yellow (5 mg, 20 mg, 25 mg and 30 mg capsules), stearic acid, titanium dioxide.

The black edible ink contains ammonium hydroxide, iron oxide black, propylene glycol and shellac.

What dosage form it comes in

Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg.

Warnings and precautions

Serious Warnings and Precautions

APO-AMPHETAMINE XR has a potential for abuse, misuse and dependence.
The misuse of APO-AMPHETAMINE XR may cause serious cardiovascular adverse events and sudden death.
(See also Drug Abuse and Dependence below)

The following have been reported with use of medicines used to treat ADHD such as APO-AMPHETAMINE XR:

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

Sudden death has been reported with drugs used for ADHD treatment in children/adolescents with structural heart abnormalities or other serious heart problems. Although some serious heart problems alone can carry an increased risk of sudden death, APO-AMPHETAMINE XR generally should not be used in children, adolescents or adults with known structural heart abnormalities, disease of the heart muscle, serious heart rhythm abnormalities or other serious heart disease or conditions.

Tell your doctor if you or your child has 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 APOAMPHETAMINE XR. Your doctor may wish to check you or your child’s blood pressure and heart rate regularly during treatment with APO-AMPHETAMINE 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 APO-AMPHETAMINE XR.

2. Mental (Psychiatric) problems:

  • New or worse thoughts or feelings related to suicide (thinking about or feeling like killing yourself) and suicide actions (suicide attempt, completed suicide)
  • New or worse bipolar illness, characterized by extreme mood swings, with periods of mania (unusually excited, over-active or un-inhibited) alternating with periods of depression (feelings of sadness, worthlessness or hopelessness)
  • New or worse aggressive behavior or hostility
  • New psychosis (such as hearing voices, believing things that are not true, are suspicious) or new mania (unusually excited, over-active or uninhibited)

These new or worse mental problems may be more likely to occur if you/your child have mental disorders that you may or may not know about. Tell your doctor about any mental problems you or your child have, or about any personal or family history of suicide, bipolar illness, or depression.

A small number of patients taking ADHD drugs may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of suicide, self-harm or harm to others. Those suicidal thoughts or behaviors may occur at any time during treatment, particularly at the start or during dose changes, and also after stopping APO-AMPHETAMINE XR. Should this happen to you, or to those in your care if you are a caregiver or guardian, talk to your doctor immediately. Close observation by a doctor is necessary in this situation.

Call your doctor right away if you or your child has any new or worsening mental symptoms while taking APOAMPHETAMINE XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

BEFORE you/your child uses APO-AMPHETAMINE XR, talk to your doctor, nurse, or pharmacist if you/your child:

  • have heart disease or a heart condition, structural heart abnormalities or high blood pressure
  • have a family history of sudden death or death related to heart problems
  • participate in strenuous exercise or activities
  • take other drugs for ADHD
  • have mental problems or a family history of mental problems including psychosis, mania, bipolar illness, depression or suicide.
  • have motion 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 motion tics, verbal tics, or Tourette’s syndrome
  • have a history of seizures (convulsions, epilepsy) or have had an abnormal brain wave test (EEG)
  • are pregnant or plan to become pregnant. Taking APO-AMPHETAMINE XR during pregnancy can cause harm to your baby. If APO-AMPHETAMINE XR is required during pregnancy, the risk to the unborn baby should be weighed against the benefits for the mother. Your doctor can discuss these issues with you
  • have symptoms of Raynaud’s phenomenon (fingers and toes feeling numb, tingling and changing colour when cold) or thromboangitis obliterans (causes pain in hands and feet)
  • have any kidney related problems as your doctor may reduce the dose.

Drug Abuse and Dependence
Amphetamines have the potential for abuse and misuse. Abuse of amphetamines can lead to dependence and possibly serious heart problems and death. Substance abuse may be less likely in patients with ADHD if they are treated with medication. APO-AMPHETAMINE XR should only be given under close medical supervision to patients whose condition has been properly diagnosed (see Serious Warnings and Precautions above).

Growth in Children
Other stimulants have been reported to temporarily slow growth in children, however there is not sufficient evidence to determine if mixed salts amphetamine extended-release capsules in children may cause slower growth (slowed weight gain and/or height). The doctor will be carefully watching your / your child’s height and weight. If you / your child is not growing or gaining weight as the doctor expects, the doctor may stop APOAMPHETAMINE XR treatment.

Interactions with this medication

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you/your child takes, including drugs prescribed by other doctors, vitamins, minerals, natural or herbal supplements, or alternative medicines.

The following may interact with APO-AMPHETAMINE XR:

  • medicines used to treat depression including monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs)
  • 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 reduce or increase blood pressure
  • cold and allergy medicines
  • antipsychotic medicines (e.g., chlorpromazine, haloperidol)
  • lithium
  • methenamine therapy
  • narcotic pain medicines (e.g., meperidine)
  • seizure medicines (e.g., ethosuximide, phenobarbital, phenytoin)
  • antacids, APO-AMPHETAMINE XR may interact with a class of medications that reduce the acid produced in the stomach called Proton Pump Inhibitors, commonly known as PPI (e.g., omeprazole). Therefore, do not take antacids at the same time as APO-AMPHETAMINE XR.

While on APO-AMPHETAMINE XR, do not start taking a new medicine or herbal remedy before checking with the doctor

Proper use of this medication

APO-AMPHETAMINE XR should be taken by mouth, oncea-day early in the morning.

Capsules may be swallowed whole with water or milk. Capsules may be opened and all the mini tablets inside sprinkled on applesauce and taken immediately; do not store for later use. Do not crush or chew the capsule or mini tablets before swallowing.

APO-AMPHETAMINE XR can be taken with or without meals.

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

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

As with all medicines, never share APO-AMPHETAMINE XR with anyone else and take only the number of APOAMPHETAMINE XR capsules prescribed by your / your child’s doctor.

Usual Dose

Children (6 to 12 years of age): The usual starting dose is 10 mg once a day in the morning. The dose may be adjusted up to a maximum dose of 30 mg/day.

Adolescents (13 to 17 years of age) and Adults (18 years of age and over): The usual starting dose is 10 mg once a day in the morning. The dose may be adjusted up to the usual maximum dose of 20 mg/day. In some cases a maximum daily dose of 30 mg/day may be used.

Overdose

If you think you/your child has taken too much APOAMPHETAMINE XR, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you/your child forget to take your/his or her dose in the morning, wait until the next morning and carry on with the next dose at the usual time. Do not double dose.

Afternoon doses should be avoided because of the longacting nature of the drug, including the potential for insomnia.

Side effects and what to do about them

Side effects may include:

  • decrease or loss of appetite
  • stomach ache
  • difficulty falling asleep
  • mood swings
  • weight loss
  • dry mouth
  • headache
  • dizziness
  • nervousness, anxiety, irritability
  • vomiting, nausea, diarrhea

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and get immediate medical help
Common
Heart palpitations or fast heart beat (see Warnings and Precautions)    
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing    
New ticks    
Depression: feeling sad, loss of interest in usual activities, hopelessness, insomnia or sleeping too much    
Uncommon
Aggressive Behavior, Anger or Hostility    
High Blood Pressure: headaches, dizziness, lightheadedness, ringing in the ears, fainting    
Trouble with vision: eyesight changes or blurred vision    
Unknown
Heart attack: severe, crushing chest pain that can radiate into the arm and/or jaw, palpitations, shortness of breath, nausea, vomiting, sweating

(see Warnings and Precautions)
   
New Psychotic or Manic Symptoms: Paranoia, delusions

-Hallucinations: Seeing, feeling or hearing things that are not real,

-Mania: feeling unusually excited, over-active, or uninhibited

(see Warnings and Precautions)
   
Suicidal Behavior:

Thoughts or actions about hurting or killing yourself

(see Warnings and Precautions)
   
Fits (seizures)    
Condition Resembling Raynaud’s Phenomenon: discoloration of the hands and feet, pain, sensations of cold and/or numbness    
Stroke: weakness, trouble speaking, vision problems, headache, dizziness    
Serious Skin Conditions (Steven’s Johnson Syndrome, Toxic Epidermal Necrolysis): Swelling of the skin or serious skin rash seen as severe blisters of the skin and mucous membranes    

This is not a complete list of side effects. For any unexpected effects while taking APO-AMPHETAMINE XR, contact your doctor, nurse or pharmacist.

How to store

Keep out of the reach and sight of children.
Store at controlled room temperature 15°C -30°C.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. 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 DISpedia, Apotex's Drug Information Service at:

1-800-667-4708

This leaflet can also be found at: http://www.apotex.ca/products.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last Revised: February 19, 2019

Program does not provide medical advice.

Date modified: