Description

What is amphetamine?

Amphetamine is a central nervous system stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Amphetamine is used to treat attention deficit hyperactivity disorder (ADHD).

The Evekeo brand of amphetamine is used to treat ADHD and also narcolepsy. Evekeo is sometimes used to treat obesity in people who have not lost weight with diets or other treatments.

Important information

Do not use amphetamine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Amphetamine may be habit-forming. Never share amphetamine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Using amphetamine improperly can cause death or serious side effects on the heart.

Before taking this medicine

Do not use amphetamine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use amphetamine if you are allergic to any stimulant medicine, or if you have:

• moderate to severe high blood pressure;
• heart disease or coronary artery disease (hardened arteries);
• overactive thyroid;
• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse);
• a history of drug or alcohol addiction

Some stimulants have caused sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

To make sure amphetamine is safe for you, tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• motor tics (muscle twitches) or Tourette’s syndrome;
• kidney disease;
• a thyroid disorder;
• seizures or epilepsy;
• an abnormal brain wave test (EEG);
• blood circulation problems in the hands or feet.

It is not known whether amphetamine will harm an unborn baby. However, taking the medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Amphetamine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Amphetamine is not approved for use by anyone younger than 6 years old.

How should I take amphetamine?

Using amphetamine improperly can cause death or serious side effects on the heart.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use amphetamine in larger or smaller amounts or for longer than recommended.

Amphetamine may be habit-forming. Never share amphetamine with another person, especially someone with a history of drug abuse or addiction.Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

You may take amphetamine with or without food. It is best to take this medicine first thing in the morning.

If your doctor changes your brand, strength, or type of stimulant medicine, your dosage needs may change. Use only the brand of amphetamine your doctor has prescribed.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

To take the orally disintegrating tablet (Adzenys XR-ODT):

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.
• Use dry hands to remove the tablet and place it in your mouth.
• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

While using this medicine, your doctor will need to check your progress at regular visits. Your heart rate, blood pressure, height and weight may also need to be checked often.

Amphetamine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Keep track of the amount of medicine used from each new bottle. Amphetamine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Throw away unused or expired amphetamine in a sealed container or bag. Ask your pharmacist where to locate a community pharmaceutical take back disposal program.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but not late in the day or you could have trouble sleeping. Skip the missed dose if it is almost evening. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amphetamine could be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, hostility, violence, panic, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Other overdose symptoms include nausea, vomiting, diarrhea, stomach pain, fainting, seizure (convulsions), or coma.

What should I avoid while taking amphetamine?

Avoid drinking alcohol while you are taking this medicine.

Avoid drinking fruit juices or taking vitamin C at the same time you take amphetamine. These can make your body absorb less of the medicine.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Amphetamine side effects

Get emergency medical help if you have signs of an allergic reaction to amphetamine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using amphetamine and call your doctor at once if you have:

• chest pain, trouble breathing, feeling like you might pass out;
• fast heartbeats, rapid breathing;
• confusion, unusual thoughts, paranoia, hallucinations (seeing or hearing things that are not real);
• new behavior problems, aggression, anger, feeling irritable;
• numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
• changes in your vision; or
• unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, and dark colored urine).

Amphetamine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common amphetamine side effects may include:

• stomach pain, nausea, vomiting, loss of appetite;
• diarrhea, constipation;
• weight loss;
• mood changes, feeling restless or nervous, sleep problems (insomnia);
• dry mouth, unusual or unpleasant taste in the mouth;
• runny nose, nosebleeds;
• increased heart rate;
• headache, dizziness;
• itching; or
• impotence, sexual problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Amphetamine dosing information

Usual Adult Dose of Amphetamine for Narcolepsy:

IMMEDIATE-RELEASE ORAL TABLET:
-Initial Dose: 10 mg orally per day in divided doses
-Maintenance Dose: Daily dose may be raised in 10 mg increments at weekly intervals until optimal response is obtained.

Comments:
-The first dose should be given on awakening; additional doses should be given at intervals of 4 to 6 hours.
-The usual dose is 5 to 60 mg per day in divided doses depending on the individual patient response.
-Reduce dosage if bothersome adverse reactions (e.g., insomnia, anorexia) appear.

Use: Narcolepsy treatment

Usual Adult Dose of Amphetamine for Obesity:

IMMEDIATE-RELEASE ORAL TABLET:
-Initial Dose: 5 mg orally 30 to 60 minutes before each meal
-Maximum Dose: 30 mg orally per day in divided doses
-Duration of Therapy: Should not exceed a few weeks

Use: Short-term adjunct in a weight reduction regimen based on caloric restriction; for patients in whom obesity is refractory to alternative therapy (e.g., repeated diets, group programs, other drugs).

Usual Pediatric Dose of Amphetamine for Narcolepsy:

IMMEDIATE-RELEASE ORAL TABLET:
Age 6 to 11 Years:
-Initial Dose: 5 mg orally per day in divided doses
-Maintenance Dose: Daily dose may be raised in 5 mg increments at weekly intervals until optimal response is obtained.

Age 12 Years and Older:
-Initial Dose: 10 mg orally per day in divided doses
-Maintenance Dose: Daily dose may be raised in 10 mg increments at weekly intervals until optimal response is obtained.

Comments:
-The first dose should be given on awakening; additional doses should be given at intervals of 4 to 6 hours.
-The usual dose is 5 to 60 mg per day in divided doses depending on the individual patient response.
-Reduce dosage if bothersome adverse reactions (e.g., insomnia, anorexia) appear.
-Narcolepsy rarely occurs in children under 12 years of age.

Use: Narcolepsy treatment

Usual Pediatric Dose of Amphetamine for Obesity:

IMMEDIATE-RELEASE ORAL TABLET:
Age 12 Years and Older:
-Initial Dose: 5 mg orally 30 to 60 minutes before each meal
-Maximum Dose: 30 mg orally per day in divided doses
-Duration of Therapy: Should not exceed a few weeks

Use: Short-term adjunct in a weight reduction regimen based on caloric restriction; for patients in whom obesity is refractory to alternative therapy (e.g., repeated diets, group programs, other drugs).

Usual Pediatric Dose for Attention Deficit Disorder:

IMMEDIATE-RELEASE ORAL TABLETS:
Age 3 to 5 Years:
-Initial Dose: 2.5 mg orally per day
-Maintenance Dose: Daily dose may be raised in 2.5 mg increments at weekly intervals until optimal response is obtained.

Age 6 to 17 Years:
-Initial Dose: 5 mg orally 1 or 2 times a day
-Maintenance Dose: Daily dose may be raised in 5 mg increments at weekly intervals until optimal response is obtained.
-Maximum Dose: Only in rare cases will it be necessary to exceed 40 mg per day.

EXTENDED-RELEASE ORAL SUSPENSION:
Age 6 to 17 Years:
-Initial Dose: 2.5 or 5 mg orally once a day in the morning
-Maintenance Dose: Dose may be raised in increments of 2.5 to 10 mg per day every 4 to 7 days until optimal response is obtained.
-Maximum Dose: 20 mg orally per day

Comments:
-IMMEDIATE-RELEASE: The first dose should be given on awakening; 1 to 2 additional doses should be given at intervals of 4 to 6 hours.
-EXTENDED-RELEASE: When switching from other amphetamine products, this product should be titrated using the usual dosing schedule after the other amphetamine product is discontinued.
-EXTENDED-RELEASE: Substituting this product for other amphetamine products should not be done because of different amphetamine base compositions and differing pharmacokinetic profiles.
-EXTENDED-RELEASE: The bottle should be shaken before each dose, and an oral dosing syringe or other suitable measuring device should be used.

Use: As part of a total treatment program for Attention Deficit Hyperactivity Disorder (ADHD), a behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. (ADHD. It’s brand name is Adderall.)

What other drugs will affect amphetamine?

Many drugs can interact with amphetamine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• omeprazole;
• lithium, or other medicine to treat mental illness;
• reserpine, or other blood pressure medication;
• an antidepressant;
• an antacid or other stomach acid medicine (including Alka-Seltzer or baking soda);
• a blood thinner such as warfarin (Coumadin, Jantoven);
• a cold or allergy medicine that contains a decongestant such as pseudoephedrine or phenylephrine;
• a diuretic or “water pill”;
• narcotic pain medicine; or
• seizure medicine.

This list is not complete. Other drugs may interact with amphetamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.