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DEXEDRINE ER (dextroamphetamine sulfate) is the dextro isomer of the compound d,1-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dexedrine ER is d-alpha-methylphenethylamine, and is present in all forms of DEXEDRINE ER as the neutral sulfate.
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 512 on the brown cap and is imprinted 5 mg and ap on the clear body. The 10-mg capsule is imprinted 10 mg-513-on the brown cap and is imprinted 10 mg-ap-on the clear body. The 15-mg capsule is imprinted 15 mg and 514 on the brown cap and is imprinted 15 mg and ap on the clear body. A narrow bar appears above and below 15 mg and 514. 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, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.
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 (Dextroamphetamine Overdose
If you suspect an overdose, contact a poison control center or emergency room immediately.
Missed Dose of Dextroamphetamine
If you miss a dose of dextroamphetamine, take it as soon as you remember.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.
dexedrine ER 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.
Dexedrine ER comes as a liquid, tablet, or extended-release capsule to be taken orally.
Follow your doctor’s instructions carefully when taking dexedrine ER. Don’t take more or less of the medicine than is prescribed.
The liquid is typically taken once or twice daily, with or without food.
The regular tablet is typically taken two to three times daily, with or without food.
The extended-release capsule is usually taken once a day with or without food. Don’t crush or chew these capsules.
Try to take dextroamphetamine around the same time each day at evenly spaced intervals.
Your doctor will probably start you on a low dose of this medicine and gradually increase it.
Avoid taking this medicine in the evening because it may make it more difficult for you to fall asleep or stay asleep.
However, if it’s almost time for your next dose, skip the missed dose and continue on your regular medication schedule.
Don’t take extra medicine to make up for a missed dose.
It is very important that your doctor check you or your child’s progress at regular visits to make sure that your dose is right and that the medicine is helping you. Your doctor will need to check your or your child’s blood, heart, and blood pressure for any problems or unwanted effects that may be caused by this medicine.
You should not use this medicine if you or your child are using or have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Tell your doctor about all the medicines you or your child take or plan to take, including prescription and nonprescription (over-the-counter) medicines, dietary supplements, herbal remedies, or medicines for appetite control, asthma, colds, cough, hay fever, and sinus problems.
This medicine may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, trouble breathing, or fainting while taking this medicine.
This medicine may cause some people to feel a false sense of well-being or to become dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).
Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly
If you or your child have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs that you may be dependent on dextroamphetamine are:
A strong desire or need to continue taking the medicine.
A need to increase the dose to receive the effects of the medicine.
Withdrawal effects (for example, mental depression, nausea or vomiting, stomach cramps or pain, trembling, unusual tiredness or weakness) that occur after the medicine is stopped.
This medicine may cause slow growth in children. If your child is using this medicine, the doctor will need to keep track of your child’s height and weight to make sure that your child is growing properly.
This medicine may cause a condition called Raynaud phenomenon. Check with your doctor right away if you or your child have tingling or pain in the fingers or toes when exposed to cold, paleness or a cold feeling in the fingertips and toes, or a skin color change in your fingers.
Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
If you or your child will be taking this medicine in large doses for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are taking before stopping it completely.
Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.
Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
Central Nervous System
Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics, and Tourette’s syndrome.
Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.
Impotence, changes in libido, frequent or prolonged erections.
Skin and Subcutaneous Tissue Disorders
Drug Abuse And Dependence
dexedrine ER is a Schedule II controlled substance. Amphetamines have been extensively abused. Tolerance, extreme psychological dependence and severe social disability have occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.
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