Dexedrine

DRUG DESCRIPTION

DEXEDRINE (dextroamphetamine sulfate) is the dextro isomer of the compound d,l -amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of DEXEDRINE (dextroamphetamine) as the neutral sulfate. Structural formula:

DEXEDRINE® (dextroamphetamine sulfate) Structural Formula Illustration

SPANSULE capsules: Each SPANSULE sustained-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Each capsule, with brown cap and clear body, contains dextroamphetamine sulfate. The 5-mg capsule is imprinted 5 mg and 3512 on the brown cap and is imprinted 5 mg and SB on the clear body. The 10-mg capsule is imprinted 10 mg-3513-on the brown cap and is imprinted 10 mg-SB-on the clear body. The 15-mg capsule is imprinted 15 mg and 3514 on the brown cap and is imprinted 15 mg and SB on the clear body. A narrow bar appears above and below 15 mg and 3514. Product reformulation in 1996 has caused a minor change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C Blue No. 1 aluminum lake, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, propylene glycol, povidone, silicon dioxide, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.

What are the possible side effects of dextroamphetamine (Dexedrine, Dexedrine Spansule, Dextrostat, ProCentra)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dextroamphetamine and call your doctor at once if you have any of these serious side effects:

  • fast or pounding heartbeats;
  • feeling light-headed, fainting;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness...

Read All Potential Side Effects and See Pictures of Dexedrine »

What are the precautions when taking dextroamphetamine (Dexedrine)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic amines (e.g., epinephrine, ephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain mental/mood conditions (e.g., severe agitation, psychosis), heart/blood vessel disease (irregular heartbeat, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), moderate or severe high blood pressure (hypertension), overactive...

Read All Potential Precautions of Dexedrine »


Dexedrine Consumer (continued)

SIDE EFFECTS: Nausea, stomach upset, cramps, loss of appetite, diarrhea, dry mouth, headache, nervousness, dizziness, trouble sleeping, sweating, weight loss, irritability or restlessness may occur. If any of these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medicine because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, hallucinations, abnormal thoughts/behavior), uncontrolled movements, muscle twitching/shaking, outbursts of words/sounds, change in sexual ability/interest, swelling of the ankles/feet, extreme tiredness, significant unexplained weight loss.

Seek immediate medical attention if any of these rare but very serious side effects occur: shortness of breath, chest pain, severe headache, fast/pounding/irregular heartbeat, jaw/left arm pain, seizures, weakness on one side of the body, slurred speech, confusion, fainting, blurred vision.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic amines (e.g., epinephrine, ephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain mental/mood conditions (e.g., severe agitation, psychosis), heart/blood vessel disease (irregular heartbeat, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), moderate or severe high blood pressure (hypertension), overactive thyroid (hyperthyroidism), history of heart attack or stroke, a certain eye problem (glaucoma), personal or family history of regular use/abuse of drugs/alcohol.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: family history of sudden death/irregular heartbeat, family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts), seizures, personal or family history of uncontrolled movements or outbursts of words/sounds (e.g., due to Tourette's syndrome), mild high blood pressure (hypertension).

This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Caution is advised when using this drug in children because it may affect weight, growth rate, and final height. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child's weight and height and consult your doctor or pharmacist for more details.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who are dependent on this medication may be born too soon (premature) and have low birth weight. They may also have withdrawal symptoms. Tell your doctor immediately if you notice possible mood changes, agitation, or unusual tiredness in your newborn.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Dexedrine Patient Information Including Side Effects

Brand Names: Dexedrine, Dexedrine Spansule, Dextrostat, ProCentra

Generic Name: dextroamphetamine (Pronunciation: DEX tro am FET a meen)

  • What is dextroamphetamine (Dexedrine)?
  • What are the possible side effects of dextroamphetamine (Dexedrine)?
  • What is the most important information I should know about dextroamphetamine (Dexedrine)?
  • What should I discuss with my doctor before taking dextroamphetamine (Dexedrine)?
  • How should I take dextroamphetamine (Dexedrine)?
  • What happens if I miss a dose (Dexedrine)?
  • What happens if I overdose (Dexedrine)?
  • What should I avoid while taking dextroamphetamine (Dexedrine)?
  • What other drugs will affect dextroamphetamine (Dexedrine)?
  • Where can I get more information?

What is dextroamphetamine (Dexedrine)?

Dextroamphetamine is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Dextroamphetamine is used to treat narcolepsy and attention deficit hyperactivity disorder (ADHD).

Dextroamphetamine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of dextroamphetamine (Dexedrine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dextroamphetamine and call your doctor at once if you have any of these serious side effects:

  • fast or pounding heartbeats;
  • feeling light-headed, fainting;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure); or
  • tremor, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches).

Less serious side effects may include:

  • headache or dizziness;
  • sleep problems (insomnia);
  • dry mouth or an unpleasant taste in your mouth;
  • diarrhea, constipation;
  • loss of appetite, weight loss; or
  • loss of interest in sex, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dextroamphetamine (Dexedrine)?

Do not use dextroamphetamine if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take dextroamphetamine before the MAO inhibitor has cleared from your body.

Do not use this medication if you are allergic to dextroamphetamine, or if you have hardened arteries (arteriosclerosis), heart disease, moderate to severe high blood pressure (hypertension), overactive thyroid, glaucoma, severe anxiety or agitation, or a history of drug or alcohol addiction.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking dextroamphetamine, tell your doctor if you have any type of heart problems.

Do not give this medication to a child younger than 3 years old without the advice of a doctor.

Long-term use of dextroamphetamine can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Dextroamphetamine is a drug of abuse and may be habit-forming. Keep track of how many pills have been used from each new bottle of this medicine. You should be aware if any person in the household is using this medicine improperly or without a prescription. Using this medication improperly can cause death or serious side effects on the heart.

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