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|Amphetamines

AMPHETAMINES (Systemic)

Some commonly used brand names are:

In the U.S.—

• Adderall ³
• Adderall XR
• Desoxyn ⁴
• Desoxyn Gradumet ⁴
• Dexedrine ²
• Dexedrine Spansule ²
• DextroStat ²

In Canada—

• Dexedrine ²
• Dexedrine Spansule ²

Category

• Stimulant, central nervous system—Amphetamine; Dextroamphetamine; Methamphetamine

Description

Amphetamines (am-FET-a-meens) 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.

Amphetamines are available in the following dosage forms:

• Oral
• Amphetamine
  • Tablets (U.S.)
• Amphetamine and dextroamphetamine
  • Tablets (U.S.)
  • Extended-release capsules (U.S.)
• Dextroamphetamine
  • Extended-release capsules (U.S. and Canada)
  • Tablets (U.S. and Canada)
• Methamphetamine
  • Tablets (U.S.)
  • Extended-release tablets (U.S.)

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 amphetamines, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to amphetamine, dextroamphetamine, ephedrine, epinephrine, isoproterenol, metaproterenol, methamphetamine, norepinephrine, phenylephrine, phenylpropanolamine, pseudoephedrine, or terbutaline. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

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.

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.

Other medicines—Although certain medicines should not be used together at all, in many cases two different medicines may be used together even if an interaction might occur. In these cases, changes in dose or other precautions may be necessary. When you are taking amphetamines, it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Caffeine (e.g., NoDoz) or
• Chlophedianol (e.g., Ulone) or
• Methylphenidate (e.g., Ritalin) or
• Nabilone (e.g., Cesamet) or
• Pemoline (e.g., Cylert)—Use of these medicines may increase the CNS stimulation effects of amphetamines and cause unwanted effects such as nervousness, irritability, trouble in sleeping, and possibly convulsions (seizures)

• Appetite suppressants (diet pills) or
• Medicine for asthma or other breathing problems or
• Medicine for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays)—Use of these medicines may increase the CNS stimulation effects of amphetamines and cause unwanted effects such as nervousness, irritability, trouble in sleeping, or convulsions (seizures), as well as unwanted effects on the heart and blood vessels

• Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], carteolol [e.g., Cartrol], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Sotacor], timolol [e.g., Blocadren])—Use of amphetamines with beta-blocking agents may increase the chance of high blood pressure and heart problems

• Cocaine—Use by persons taking amphetamines may cause a severe increase in blood pressure and other unwanted effects, including nervousness, irritability, trouble in sleeping, or convulsions (seizures)

• Digitalis glycosides (heart medicine)—Amphetamines may cause additive effects, resulting in irregular heartbeat

• Meperidine—Use of meperidine by persons taking amphetamines is not recommended because the chance of serious side effects (such as high fever, convulsions, or coma) may be increased

• Monoamine oxidase (MAO) inhibitor activity—(isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking amphetamines while you are taking or within 2 weeks of taking monoamine oxidase (MAO) inhibitors may increase the chance of serious side effects such as sudden and severe high blood pressure or fever

• Thyroid hormones—The effects of either these medicines or amphetamines may be increased; unwanted effects may occur in patients with heart or blood vessel disease

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Although tricyclic antidepressants may be used with amphetamines to help make them work better, using the two medicines together may increase the chance of fast or irregular heartbeat, severe high blood pressure, or high fever

Other medical problems—The presence of other medical problems may affect the use of amphetamines. 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 of amphetamines 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 amphetamines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets 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 taking amphetamines .

• For amphetamine
• 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 amphetamine and dextroamphetamine
• 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 dextroamphetamine
• 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 methamphetamine
• 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 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—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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 as soon as possible if any of the following side effects occur:

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

Mental depression; nausea or vomiting; stomach cramps or pain; trembling; unusual tiredness or weakness

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

Revised: 11/08/2004

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