February 9, 2010
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Dexedrine

(dextroamphetamine sulfate)

DIN (Drug Identification Number)

01924559 DEXEDRINE 10MG SPANSULE SRC
01924567 DEXEDRINE 15MG SPANSULE SRC
01924516 DEXEDRINE 5MG TABLET

What side effects are possible with Dexedrine?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • dizziness
  • dry mouth, unpleasant taste, diarrhea, constipation, loss of appetite, nausea, or vomiting
  • erectile dysfunction (trouble getting or keeping an erection) or reduced sex drive
  • euphoria
  • irritability or mood swings
  • restlessness or trouble sleeping
  • weight loss

Check with your doctor as soon as possible if any of the following side effects occur:

  • abnormal thoughts or behaviour, hallucinations, or delusions
  • jerky body movements
  • increased blood pressure
  • palpitations (feeling your heart beat quickly or irregularly)
  • symptoms of depression (e.g., losing interest in your usual activities, feeling sad, having thoughts of suicide - see below)
  • symptoms of Tourette's syndrome (involuntary, sudden body movements or uncontrolled vocal outbursts)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • symptoms of a serious allergic reaction (e.g., hives, swelling of the face and throat, difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Dexedrine?

Be sure to inform your doctor of all your medical conditions before you begin taking a medication. Some conditions can affect how you should take this medication.

HEALTH CANADA ADVISORY

May 26, 2006

Health Canada has issued new restrictions concerning the use of medications for ADHD. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Allergy: Dextroamphetamine products contain tartrazine (FD&C Yellow No. 5), which can cause allergic-type reactions (including bronchial asthma) in susceptible individuals. People allergic to salicylates are often allergic to tartrazine.

Dependence: Amphetamines such as dextroamphetamine sulfate have been subject to extensive abuse. Tolerance, extreme psychological dependence, and severe social disability can occur with abuse of this medication. Some people have been reported to have increased their dosage to many times the recommended level.

Signs of chronic intoxication with amphetamines include:

  • severe rashes
  • extreme insomnia
  • irritability
  • hyperactivity
  • personality changes

Diabetes: Amphetamines such as dextroamphetamine may affect blood sugar levels and alter insulin requirements for people with diabetes.

Exercise: People participating in strenuous exercise or activities should consult their doctor before taking dextroamphetamine.

Heart problems: This medication can increase heart rate and blood pressure. It may also increase the risk of sudden death for people with heart problems. People with heart problems, including an irregular heartbeat, or a family history of sudden death related to heart disease should be carefully evaluated by their doctors before starting this medication, and then closely monitored if they take the medication. This medication should generally not be used by people with known structural heart abnormalities (such as abnormal size, missing or poorly functioning heart valves, or problems with blood vessels connected to the heart).

High blood pressure: Use this medication with caution even if you have only mild high blood pressure.

Long-term use: If you use this medication for a long period of time, you will need regular heart check-ups by your doctor.

Occupational hazards: This medication may disguise extreme fatigue, which can impair the ability to perform potentially hazardous activities such as driving or operating machinery.

Stopping the medication: Check with your doctor before stopping this medication.

Pregnancy: The safe use of this medication during pregnancy has not been established. Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal after birth. The use of amphetamines by women who are or may become pregnant, and especially those in the first trimester of pregnancy, requires that the potential benefit be weighed against the possible hazards.

Breast-feeding: Dextroamphetamine sulfate passes into breast milk. Women taking this medication should not breast-feed.

Children: The long-term effects of amphetamines on children have not been well established. Chronic use of amphetamines may be associated with stunted growth; therefore, children's growth should be monitored during treatment. This medication is not recommended for treating ADD in children under six years of age.

What other drugs could interact with Dexedrine?

The following medications may affect how dextroamphetamine works or increase the risk of side effects:

  • acetazolamide
  • antihistamines
  • barbiturates (e.g., phenobarbital)
  • beta-blockers (e.g., propranolol)
  • chlorpromazine
  • ethosuximide
  • guanethidine
  • haloperidol
  • hydrochlorothiazide
  • lithium
  • MAO inhibitors (e.g., phenelzine, tranylcypromine)
  • medications that treat high blood pressure
  • meperidine
  • methenamine
 
  • norepinephrine
  • phenytoin
  • propoxyphene
  • SSRI antidepressants (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline)
  • sympathomimetic medications (e.g., epinephrine, pseudoephedrine)
  • tricyclic antidepressants (e.g., amitriptyline)
  • urinary tract acidifiers (e.g., ammonium chloride) and alkalinizers (e.g., potassium citrate)
  • other medications for ADHD

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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