IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
DEXTROAMPHETAMINE SUSTAINED-ACTION CAPSULE - ORAL
COMMON BRAND NAME(S): Dexedrine
WARNING: Misuse or abuse of amphetamine may result in serious (possibly fatal) heart and blood pressure problems. Amphetamine-type medications can be habit-forming and should be used cautiously by people who have mental/mood disorders or a history of alcohol/drug abuse. Such people may be more likely to increase their dose of this drug unnecessarily or take this medication too often. With prolonged use or abuse of this medication, drug dependence and abnormal behavior may occur. Withdrawal symptoms may occur after stopping the drug. Consult your doctor or pharmacist for more details. (See also How to Use section).
USES: Dextroamphetamine is used to treat attention deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, concentrate, stay focused, and stop fidgeting. This drug may also be used to treat certain sleeping disorders (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. Dextroamphetamine is a stimulant. It is thought to work by restoring the balance of certain natural chemicals (neurotransmitters) in the brain. This medication is not recommended for use in children younger than 6 years.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using dextroamphetamine and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication with or without food, usually when you first wake up in the morning or as directed by your doctor. If additional doses are prescribed, take them 4-6 hours apart. Taking this medication late in the day may cause trouble sleeping (insomnia). Swallow the capsules whole. Do not crush or chew them. Doing so may destroy the long action of the drug and may increase the risk of side effects. Use this medicine regularly exactly as your doctor prescribes in order to get the most benefit. To help you remember, take it at the same time(s) each day on the days that you take it. Dosage is based on your medical condition and response to therapy. Your doctor may adjust your dose to find the dose that is best for you. Follow your doctor's instructions carefully. If your symptoms persist or worsen, notify your doctor immediately. 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 (such as severe tiredness, mood changes (e.g., depression), and sleep problems) 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 immediately. Though it is unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit forming). Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted. If you are taking this for ADHD, your doctor may recommend "drug holidays" when the medication is stopped for a short time to observe any changes in behavior.
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.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: alpha blockers (e.g., prazosin), certain antidepressants (e.g., tricyclics such as nortriptyline/imipramine, SSRIs such as fluoxetine/paroxetine, duloxetine, venlafaxine), medication for high blood pressure (e.g., beta blockers such as atenolol/metoprolol, clonidine, guanabenz, methyldopa), antipsychotics (e.g., chlorpromazine, haloperidol), lithium, certain pain medications (e.g., meperidine, propoxyphene), sedatives (e.g., lorazepam, certain antihistamines such as diphenhydramine), certain anti-seizure drugs (e.g., ethosuximide, phenytoin, phenobarbital), medications that can raise blood pressure (e.g., norepinephrine, phenylephrine, pseudoephedrine), other stimulants (e.g., methylphenidate), certain street drugs (e.g., LSD, MDMA/ "ecstasy"), veratrum alkaloids (e.g., cevadine, veratridine). Certain foods and drugs can affect the amount of acid in your stomach/intestines or urine. This can affect how well your body absorbs and uses this medication. Tell your doctor if you take any of these products: ammonium chloride, antacids, anti-ulcer medicine (e.g., H2 blockers such as famotidine/ranitidine, proton pump inhibitors such as omeprazole/lansoprazole), ascorbic acid (vitamin C), carbonic anhydrase inhibitors (e.g., acetazolamide), fruit juices, glutamic acid, guanethidine, methenamine, reserpine, sodium acid phosphate, sodium bicarbonate, certain "water pills" (diuretics, including some thiazides). Consult your doctor or pharmacist for more details. Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products. Avoid drinking large amounts of beverages containing caffeine (e.g., coffee, tea, colas) or eating large amounts of chocolate. Caffeine can increase the side effects of this medication. This medication may affect the results of certain lab tests (blood and urine steroid levels). Tell laboratory personnel and all your doctors that you are taking this medication. Also report the use of drugs which might increase seizure risk when combined with this medication such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe mental/mood changes, seizures, severe or persistent headache, severe restlessness, fast breathing.
NOTES: Do not share this medication with others. It is against the law. This medication may raise your blood pressure. Laboratory and/or medical tests (e.g., blood pressure, heart rate, growth monitoring in children) may be performed to check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember in the morning hours. If it is late in the afternoon or near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised August 2011. Copyright(c) 2011 First Databank, Inc.