Allina Health

Brand Names:

• Adderall
• Adderall XR

Dosage Forms:

• Tablet
• Capsule, Extended Release

Warnings:

Amphetamines have a high potential for abuse, and administration for prolonged periods of time may lead to drug dependence and must be avoided. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events .

Classifications:

Therapeutic—

CNS Stimulant

Chemical—

Amphetamine

Uses of This Medicine:

Amphetamine and dextroamphetamine combination belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention-deficit hyperactivity disorder (ADHD) and narcolepsy (uncontrollable desire for sleep or sudden attacks of deep sleep) .

Amphetamine and dextroamphetamine combination increases attention and decreases restlessness in patients who are overactive, cannot concentrate for very long or are easily distracted, and have unstable emotions. It is also used as part of a total treatment program that also includes social, educational, and psychological treatment .

Amphetamine and dextroamphetamine combination may also be used for other conditions as determined by your doctor .

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 or your child needs this medicine .

Before Using This Medicine:

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:

Allergies—

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of amphetamine and dextroamphetamine combination in children with attention-deficit hyperactivity disorder below 3 years of age. Safety and efficacy have not been established .

Older adults—

Appropriate studies on the relationship of age to the effects of amphetamine and dextroamphetamine combination have not been performed in the geriatric population .

Pregnancy—

Breast-feeding—

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.

Other medicines—

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.

• Clorgyline
• Furazolidone
• Iproniazid
• Isocarboxazid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Selegiline
• Sibutramine
• Toloxatone
• Tranylcypromine

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.

• Chlorpromazine
• Citalopram
• Furazolidone
• Venlafaxine

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.

• Guanethidine

Other interactions—

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, anxiety, or tension or
• Arteriosclerosis (hardening of the arteries), severe or
• Drug abuse or dependence, history of or
• Glaucoma or
• Heart disease or
• High blood pressure, moderate to severe or
• Overactive thyroid—This medicine should not be used in patients with these conditions .

• Heart problems or defects or
• High blood pressure, mild or
• Mental illness (e.g., aggressive behavior, hostility, psychosis, mania, family history of suicide, bipolar illness, depression) or
• Seizures, history of or
• Thyroid problems—Use with caution. Serious side effects may occur .

• Tourette's syndrome, history of or other tics—Children and their families should be checked by their doctor for this condition before taking this medicine .

Proper Use of This Medicine:

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 too much is taken, it may become habit-forming (causing mental or physical dependence) .

If you think this medicine is not working properly after you have taken it for several weeks, do not increase the dose. Instead, check with your doctor .

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions .

Swallow the extended-release capsule whole with water or other liquids. If you cannot swallow the extended-release capsule, you may open it and sprinkle the medicine into a small amount of applesauce. Stir this mixture well and swallow it right away without chewing. Do not store this mixture for future use. Do not crush or chew the medicine inside the capsule .

You may take the extended-release capsule with or without food .

Dosing—

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):
  • For attention-deficit hyperactivity disorder:
    • Adults and children 6 years of age and older—At first, 5 milligrams (mg) one to two times a day. Your doctor may increase your dose if needed.
    • Children 3 to 5 years of age—At first, 2.5 mg daily. Your doctor may increase your dose if needed.
    • Children younger than 3 years of age—Use is not recommended .
  • For narcolepsy:
    • Adults, teenagers, and children 12 years of age and older—At first, 10 mg daily. Your doctor may adjust your dose if needed.
    • Children 6 to 12 years of age—At first, 5 mg daily. Your doctor may increase your dose if needed.
    • Children younger than 6 years of age—Dose must be determined by your doctor .

• For oral dosage form (extended-release capsules):
  • For attention-deficit hyperactivity disorder:
    • Adults—20 milligrams (mg) once a day in the morning.
    • Children and teenagers 6 to 17 years of age—At first, 10 milligrams (mg) once a day in the morning. Your doctor may adjust your dose if needed.
    • Children younger than 6 years of age—Dose must be determined by your doctor .

Missed dose—

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.

Storage—

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

If you 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 to reduce gradually the amount you are taking before stopping completely .

Do not take this medicine within 14 days of taking an MAO inhibitor such as Eldepryl®, Marplan®, Nardil®, or Parnate®.

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 if you are dizzy or are not alert.

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 to have your eyes checked by an ophthalmologist (eye doctor) .

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 on amphetamines 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) occurring after the medicine is stopped .

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 to make sure that your child is growing properly .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .

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 This Medicine:

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:

More common

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

Less common

Cold flu-like symptoms

cough or hoarseness

fever or chills

Incidence not known

Blistering, peeling, loosening of skin

chest pain or discomfort

confusion

convulsions

diarrhea

difficulty breathing

difficulty in speaking

difficulty swallowing

dizziness

double vision

faintness

hallucinations (seeing, hearing, or feeling things that are not there)

headache

inability to move arms, legs, or facial muscles

inability to speak

itching

joint or muscle pain

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of bladder control

muscle spasm or jerking of all extremities

nausea

pain or discomfort in arms, jaw, back, or neck

red irritated eyes

red skin lesions, often with a purple center

severe mental changes

shortness of breath

skin rash

slow speech

sore throat

sores, ulcers, or white spots in mouth or on lips

sudden loss of consciousness

sweating

swelling of feet or lower legs

tightness in chest

troubled breathing

uncontrolled vocal outbursts and/or tics (uncontrolled repeated body movements)

unusual tiredness or weakness

vomiting

wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

dark-colored urine

discouragement

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

muscle cramps or spasms

muscle pain or stiffness

nervousness

overactive reflexes

physical attempt to injure

restlessness

stomach cramps

trembling or shaking of legs, arms, hands, or feet

trouble concentrating

trouble sleeping

violent actions

panic state

pounding in the ears

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:

More common

Anxiety

dry mouth

lack or loss of strength

sleeplessness

stomach pain

unable to sleep

weight loss

Incidence not known

Constipation

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 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.