Brand Names:

• Desoxyn
• Dexedrine
• Dexedrine Spansules
• Dextrostat
• Didrex
• Vyvanse

Dosage Forms:

• Tablet
• Capsule, Extended Release
• Capsule
• Solution
• Tablet, Extended Release

Uses of This Medicine:

Amphetamines belong to the group of medicines called central nervous system (CNS) stimulants. They are used to treat attention-deficit hyperactivity disorder (ADHD). Amphetamines increase attention and decrease restlessness in patients who are overactive, unable to concentrate for very long or are easily distracted, and have unstable emotions. These medicines are used as part of a total treatment program that also includes social, educational, and psychological treatment.

Amphetamine and dextroamphetamine are also used in the treatment of narcolepsy (uncontrollable desire for sleep or sudden attacks of deep sleep).

Amphetamines should not be used for weight loss or weight control or to combat unusual tiredness or weakness or replace rest. When used for these purposes, they may be dangerous to your health.

Amphetamines may also be used for other conditions as determined by your doctor.

These medicines are 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:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

When amphetamines are used for long periods of time in children, they may cause unwanted effects on behavior and growth. Before these medicines are given to a child, you should discuss their use with your child's doctor.

Older adults

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of amphetamines in the elderly with use in other age groups.

Pregnancy

Studies have not been done in humans. However, animal studies have shown that amphetamines may increase the chance of birth defects if taken during the early months of pregnancy. Before taking this medicine, make sure your doctor knows if you are pregnant of if you may become pregnant.

In addition, overuse of amphetamines during pregnancy may increase the chances of a premature delivery and of having a baby with a low birth weight. Also, the baby may become dependent on amphetamines and experience withdrawal effects such as agitation and drowsiness.

Breast-feeding

Amphetamines pass into breast milk. Although this medicine has not been reported to cause problems in nursing babies, it is best not to breast-feed while you are taking an amphetamine. Be sure you have discussed this with your doctor.

Other medicines

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

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

Using medicines in this class 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

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Anxiety or tension (severe) or
• Drug abuse or dependence (history of) or
• Glaucoma or
• Heart or blood vessel disease or
• High blood pressure, severe or moderate or

• Mental illness (severe), especially in children, or
• Overactive thyroid This medicine should not be used if any of these conditions exist. Serious unwanted effects could occur.

• Heart abnormalities or birth defects This medicine should not be used in children or adults with this condition. Severe unwanted heart problems including death have been reported.

• Mild high blood pressure Caution should be used. May make condition worse.

• 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.

For patients taking the short-acting form of this medicine:

• Take the last dose for each day at least 6 hours before bedtime to help prevent trouble in sleeping.

For patients taking the long-acting form of this medicine:

• Take the daily dose when you wake up to help prevent trouble in sleeping.
• These capsules or tablets should be swallowed whole. Do not break, crush, or chew them before swallowing.

Amphetamines may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

Dosing

The dose medicines in this class 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 these medicines. 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 At first, 5 milligrams (mg) one to three times a day. Your doctor may increase your dose if needed.
    • Children 6 years of age and older At first, 5 mg one or two times a day. Your doctor may increase your dose if needed.
    • Children 3 to 6 years of age At first, 2.5 mg once a day. Your doctor may increase your dose if needed.
    • Children younger than 3 years of age Use is not recommended.
  • For narcolepsy:
    • Adults At first, 5 mg one to three times a day. Your doctor may increase your dose if needed.
    • Children 12 years of age and older At first, 5 mg two times a day. Your doctor may increase your dose if needed.
    • Children 6 to 12 years of age At first, 2.5 mg two times a day. Your doctor may increase your dose if needed.
    • Children younger than 6 years of age Dose must be determined by your doctor.

• For oral extended-release dosage form (capsules):
  • For attention-deficit hyperactivity disorder:
    • Adults 20 mg one time a day in the morning.
    • Children 6 years of age and older At first, 10 mg one time a day in the morning. Your doctor may increase your child's dose as needed.
    • Children less than 6 years of age Use is not recommended.
• For oral dosage form (tablets):
  • For attention-deficit hyperactivity disorder:
    • Children 6 years of age and older At first, 5 milligrams (mg) one or two times a day. Your doctor may increase your dose if needed.
    • Children 3 to 6 years of age At first, 2.5 mg once a day. Your doctor may increase your dose if needed.
    • Children younger than 3 years of age Use is not recommended.
  • For narcolepsy:
    • Adults Usually 5 to 60 mg a day, divided into two or three smaller doses.
    • Children 12 years of age and older At first, 10 mg a day. Your doctor may increase your dose if needed.
    • Children 6 to 12 years of age At first, 5 mg a day. Your doctor may increase your dose if needed.
    • Children younger than 6 years of age Dose must be determined by your doctor.

• For oral extended-release capsule dosage form:
  • For attention-deficit hyperactivity disorder:
    • Adults 5 to 60 milligrams (mg) a day.
    • Children 6 years of age and older At first, 5 mg one or two times a day. Your doctor may increase your dose if needed.
    • Children 3 to 6 years of age At first, 2.5 mg a day. Your doctor may increase your dose if needed.
    • Children younger than 3 years of age Use is not recommended.
  • For narcolepsy:
    • Adults 5 to 60 mg a day.
    • Children 12 years of age and older At first, 10 mg a day. Your doctor may increase your dose if needed.
    • Children 6 to 12 years of age At first, 5 mg a day. Your doctor may increase your dose if needed.
    • Children 3 to 6 years of age Dose must be determined by your doctor.
    • Children younger than 3 years of age Use is not recommended.
• For oral tablet dosage form:
  • For attention-deficit hyperactivity disorder:
    • Adults 5 to 60 mg a day.
    • Children 6 years of age and older At first, 5 mg one or two times a day. Your doctor may increase your dose if needed.
    • Children 3 to 6 years of age At first, 2.5 mg a day. Your doctor may increase your dose if needed.
    • Children younger than 3 years of age Use is not recommended.
  • For narcolepsy:
    • Adults 5 to 60 mg a day.
    • Children 12 years of age and older At first, 10 mg a day. Your doctor may increase your dose if needed.
    • Children 6 to 12 years of age At first, 5 mg a day. Your doctor may increase your dose if needed.
    • Children younger than 6 years of age Dose must be determined by your doctor.

• For oral tablet dosage form:
  • For attention-deficit hyperactivity disorder:
    • Children 6 years of age and older At first, 5 milligrams (mg) one or two times a day. Your doctor may increase your dose if needed.
    • Children younger than 6 years of age Use is not recommended.
• For oral extended-release tablet dosage form:
  • For attention-deficit hyperactivity disorder:
    • Children 6 years of age and older 20 to 25 mg a day.
    • Children younger than 6 years of age Use is not recommended.

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.

If you miss a dose of this medicine and your dosing schedule is:

• One dose a day Take the missed dose as soon as possible, but not later than stated above, to prevent trouble in sleeping. However, if you do not remember the missed dose until the next day, skip it and go back to your regular dosing schedule. Do not double doses.

• Two or three doses a day If you remember within an hour or so of the missed dose, take the dose right away. However, if you do not remember until later, skip it and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

Your doctor should check your progress at regular visits to make sure that this medicine does not cause 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 amphetamines within 14 days of taking an MAO inhibitor.

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.

Amphetamines may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SOF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.
• If you have a severe reaction from the sun, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of the metyrapone test may be affected by this medicine.

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.

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

Anxiety

crying

depersonalization

dry mouth

dysphoria

euphoria

fast, pounding, or irregular heartbeat or pulse

hyperventilation

irritability

mental depression

nervousness

paranoia

quick to react or overreact emotionally

rapidly changing moods

restlessness

shaking

shortness of breath

trouble sleeping

Less common

Chills

cold flu-like symptoms

cough or hoarseness

difficult or labored breathing

lower back or side pain

painful or difficult urination

tightness in chest

wheezing

Rare

Chest pain

fever, unusually high

skin rash or hives

uncontrolled movements of head, neck, arms, and legs

With long-term use or high doses

Difficulty in breathing

dizziness or feeling faint

mood or mental changes

pounding heartbeat

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:

More common

False sense of well-being

irritability

nervousness

restlessness

trouble in sleeping

After these stimulant effects have worn off, drowsiness, trembling, unusual tiredness or weakness, or mental depression may occur.

Less common

Accidental injury

bladder pain

bloody or cloudy urine

blurred vision

changes in sexual desire or decreased sexual ability

constipation

cramps

diarrhea

difficult, burning, or painful urination

difficulty in speaking

dizziness or lightheadedness

dryness of mouth or unpleasant taste

fast or pounding heartbeat

frequent urge to urinate

headache

heavy bleeding with menstrual period

inability to have or keep an erection

increased sensitivity of skin to sunlight

increased sweating

itching, redness or other discoloration of skin

loss of appetite

lower back or side pain

nausea or vomiting

pain

severe sunburn

sleepiness or unusual drowsiness

tooth disorder

twitching

weight loss

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Mental depression

nausea or vomiting

stomach cramps or pain

unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.