WHAT IS DEXEDRINE SPANSULE?

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

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

Dexedrine Spansule may also be used for purposes not listed in this medication guide.

Important Information
You should not use Dexedrine Spansule if you have glaucoma, overactive thyroid, severe agitation, moderate to severe high blood pressure, heart disease or coronary artery disease, or a history of drug or alcohol addiction.

Dexedrine Spansule may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use Dexedrine Spansule if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Dexedrine Spansule may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems–chest pain, feeling light-headed or short of breath; signs of psychosis–paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems–unexplained wounds on your fingers or toes.

Before taking this medicine

You should not use Dexedrine Spansule if you are allergic to any stimulant medicine, or if you have:

moderate to severe high blood pressure;
heart disease or coronary artery disease (hardened arteries);
overactive thyroid;
glaucoma;
severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or
a history of drug or alcohol addiction.
Do not use Dexedrine Spansule if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Some medicines can interact with Dexedrine Spansule and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

Uses

This medication is used to treat attention deficit hyperactivity disorder – ADHD. It works by changing the amounts of certain natural substances in the brain. Dextroamphetamine belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.

This medication is also used to treat a certain sleeping disorder (narcolepsy) to help you stay awake during the day. It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.

How to use Dextroamphetamine SULFATE

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking dextroamphetamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication with or without food as directed by your doctor, usually 1 to 3 times a day. The first dose is usually taken when you wake up in the morning. If more doses are prescribed, take them as directed by your doctor, usually 4-6 hours apart. Taking this medication late in the day may cause trouble sleeping (insomnia).

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition and response to treatment. Your doctor may adjust your dose to find the dose that is best for you. Follow your doctor’s instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

During treatment, your doctor may occasionally recommend stopping the medication for a short time to see whether there are any changes in your behavior and whether the medication is still needed.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (including severe tiredness, sleep problems, mental/mood changes such as depression) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition does not improve or if it worsens.

Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic drugs (such as amphetamine or lisdexamfetamine); 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (such as Raynaud’s disease), certain mental/mood conditions (such as severe agitation, psychosis), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychotic disorder, suicidal thoughts), heart problems (including irregular heartbeat/rhythm, coronary artery disease, heart failure, cardiomyopathy, problems with the heart structure such as valve problems), family history of heart problems (such as sudden death/irregular heartbeat/rhythm), history of stroke, high blood pressure, overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), seizures, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal or family history of uncontrolled muscle movements (such as Tourette’s syndrome).

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

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially weight loss. This medication may slow down a child’s growth. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child’s weight and height. Consult your doctor or pharmacist for more details.

Older adults may be more sensitive to the side effects of this drug, especially chest pain, trouble sleeping, or weight loss.

During pregnancy, this medication should be used only when clearly needed. 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 right away 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. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products or diet aids).

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/ “ecstasy,” St. John’s wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Dextroamphetamine is very similar to amphetamine or lisdexamfetamine. Do not use medications containing amphetamine or lisdexamfetamine while using dextroamphetamine.

This medication may interfere with certain medical/laboratory tests (including blood and urine steroid levels, brain scan for Parkinson’s disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Side Effects

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

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: signs of blood flow problems in the fingers or toes (such as coldness, numbness, pain, or skin color changes), unusual wounds on the fingers or toes, mental/mood/behavior changes (such as agitation, aggression, mood swings, depression, hallucinations, abnormal thoughts/behavior, thoughts of suicide), uncontrolled movements, muscle twitching/shaking, outbursts of words/sounds, change in sexual ability/interest, swelling ankles/feet, extreme tiredness, significant unexplained weight loss, frequent/prolonged erections (in males).

Get medical help right away if you have any very serious side effects, including: shortness of breath, chest/jaw/left arm pain, severe headache, fainting, fast/pounding/irregular heartbeat, seizures, weakness on one side of the body, slurred speech, confusion, blurred vision.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.