Description and Brand Names of Adderall XR – Dextroamphetamine And Amphetamine (Oral Route)
US Brand Name
- Adderall XR
Amphetamine and dextroamphetamine combination is used to treat attention-deficit hyperactivity disorder (ADHD) and narcolepsy (uncontrollable desire for sleep or sudden attacks of deep sleep). These two medicines belong to the group of medicines called central nervous system (CNS) stimulants.
Amphetamine and dextroamphetamine combination works in the treatment of ADHD to increase attention and decrease restlessness in patients who are overactive, cannot concentrate, or are easily distracted. It is used as part of a total treatment program that also includes social, educational, and psychological therapy.
This medicine is available only with a doctor’s prescription. Prescriptions cannot be refilled. A new prescription must be obtained from your doctor each time you need this medicine.
This product is available in the following dosage forms:
- Capsule, Extended Release
Before Using Adderall XR – Dextroamphetamine And Amphetamine (Oral Route)
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amphetamine and dextroamphetamine combination to treat ADHD in children. However, safety and efficacy have not been established in children younger than 6 years of age (extended-release capsules) or children younger than 3 years of age (tablets).
Appropriate studies on the relationship of age to the effects of amphetamine and dextroamphetamine combination have not been performed in the geriatric population.
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Agitation, severe or
- Anxiety, severe or
- Arteriosclerosis (hardening of the arteries), severe or
- Drug abuse, history of or
- Glaucoma or
- Heart disease, severe or
- Hypertension (high blood pressure), moderate to severe or
- Hyperthyroidism (overactive thyroid) or
- Tension, severe or – Should not be used in patients with these conditions.
- Bipolar disorder (manic-depressive illness), or a family history of or
- Depression, or a family history of or
- Heart rhythm problems (eg, arrhythmia), or a family history of or
- Hypertension (high blood pressure), mild or
- Mania, history of or
- Psychosis (mental illness), history of or
- Raynaud disease or
- Seizures, history of or
- Tachycardia (fast heart rate) or
- Tourette syndrome (tics), or a family history of – Use with caution. May make these conditions worse.
- Coronary artery disease or
- Heart disease (eg, cardiomyopathy) – Use with caution. May make side effects become worse.
Proper Use of Adderall XR – Dextroamphetamine And Amphetamine (Oral Route)
Take this medicine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you take too much, the medicine may become habit-forming (causing mental or physical dependence).
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Talk to your doctor if you have any questions.
If you think this medicine is not working properly after you have taken it for several weeks, do not increase the dose and check with your doctor.
Take the regular tablet in the morning and early afternoon. If you take the tablet in the evening, you may have trouble falling asleep at night.
If you are using the extended-release capsule:
- Swallow the capsule whole with water or other liquids. Do not crush, break, or chew it.
- Take the capsule in the morning. If you take it in the afternoon or evening, you may have trouble falling asleep at night.
- You may take the capsule with or without food.
- If you cannot swallow the capsule, carefully open it and sprinkle the small beads over a spoonful of applesauce. Swallow the mixture right away without chewing. Do not store the mixture for future use. Do not crush or chew the beads from the capsule.
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets):
- Adults, teenagers, and children 6 years of age and older – At first, 5 milligrams (mg) given one or 2 times a day. Your doctor may adjust your dose if needed.
- Children 3 to 5 years of age – At first, 2.5 mg once a day. Your doctor may adjust your dose if needed.
- Children younger than 3 years of age – Use is not recommended.
- Adults, teenagers, and children 12 years of age and older – At first, 10 milligrams (mg) per day, divided and given in 2 doses. Your doctor may adjust your dose if needed.
- Children 6 to 12 years of age – At first, 5 mg per day. Your doctor may adjust your dose if needed.
- Children younger than 6 years of age – Use and dose must be determined by your doctor.
- For ADHD:
For oral dosage form (extended-release capsules):
- Adults – 20 milligrams (mg) once a day in the morning. Your doctor may adjust your dose if needed.
- Teenagers 13 to 17 years of age – At first, 10 mg once a day in the morning. Your doctor may adjust your dose if needed.
- Children 6 to 12 years of age – At first, 10 mg once a day in the morning. Your doctor may adjust your dose if needed. However, the dose is usually not more than 30 mg per day.
- Children younger than 6 years of age – Use and dose must be determined by your doctor.
- For ADHD:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.
Do not take amphetamine and dextroamphetamine combination with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [MarplanÂ®], phenelzine [NardilÂ®], selegiline [EldeprylÂ®], tranylcypromine [ParnateÂ®]). Do not start taking this medicine during the 2 weeks after you stop a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, headaches, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter (OTC)) medicines, and especially those for appetite control, asthma, colds, cough, hay fever, allergies, or sinus problems.
This medicine may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, trouble breathing, or fainting while taking this medicine.
Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, or irritability. Also tell your doctor if you have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.
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. It may also cause blurred vision or other vision problems. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous.
If you 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 of dependence may be:
- A strong desire or need to continue taking the medicine.
- A need to increase the dose to receive the same effects.
- Withdrawal effects after stopping the medicine such as mental depression, nausea or vomiting, stomach cramps or pain, trembling, or unusual tiredness or weakness.
This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child’s height and weight.
This medicine may cause Raynaud phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Side Effects of Adderall XR – Dextroamphetamine And Amphetamine (Oral Route)
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- fast, pounding, or irregular heartbeat or pulse
- frequent urge to urinate
- lower back or side pain
- Cold or flu-like symptoms
- cough or hoarseness
- fever or chills
Incidence not known
- Blistering, peeling, or loosening of the skin
- chest pain or discomfort
- difficulty breathing
- difficulty with speaking
- difficulty with swallowing
- double vision
- inability to move the arms, legs, or facial muscles
- inability to speak
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of bladder control
- muscle spasm or jerking of all extremities
- pain or discomfort in the arms, jaw, back, or neck
- red skin lesions, often with a purple center
- red, irritated eyes
- seeing, hearing, or feeling things that are not there
- skin rash
- slow speech
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- sudden loss of consciousness
- swelling of the feet or lower legs
- tightness in the chest
- troubled breathing
- uncontrolled repeated movements (tics)
- uncontrolled vocal outbursts
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- dry mouth
- lack or loss of strength
- stomach pain
- weight loss
Incidence not known
- decreased interest in sexual intercourse
- false or unusual sense of well-being
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.