Amphetamine

Get emergency medical help if you have signs of an allergic reaction: 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 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.

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.

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.

Amphetamine is used in the treatment of:

• Attention Deficit Disorder with Hyperactivity
• Narcolepsy

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Amphetamine may be found in some form under the following brand names:

• Dyanavel XR

• Mydayis

Amphetamine is part of the drug class:

• Centrally acting sympathomimetics

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

Usual Adult Dose 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 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 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 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.

Amphetamine is used to treat narcolepsy (sleep disorder). It is also used to treat attention-deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Amphetamine is also used for weight reduction in obese patients.

Amphetamine works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. amphetamine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

amphetamine is available only with a doctor's prescription.

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 amphetamine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to amphetamine 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amphetamine tablets in children with obesity who are younger than 12 years of age, in children with narcolepsy who are younger than 6 years of age, and in children with ADHD who are younger than 3 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of amphetamine extended-release oral suspension and extended-release oral disintegrating tablets in children with ADHD who are younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of amphetamine tablets in geriatric patients.

Appropriate studies have not been performed on the relationship of age to the effects of amphetamine extended-release oral suspension and extended-release oral disintegrating tablets in the geriatric population. Safety and efficacy have not been established.

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 amphetamine.

Interactions with 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 amphetamine, 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 amphetamine 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.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Sibutramine
• Tranylcypromine

Using amphetamine 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.

• Abiraterone
• Acetazolamide
• Alfentanil
• Almotriptan
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Benzthiazide
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Carbamazepine
• Chlorothiazide
• Chlorpheniramine
• Cinacalcet
• Citalopram
• Clomipramine
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dextromethorphan
• Diazoxide
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Ethylmorphine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Granisetron
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxytryptophan
• Imipramine
• Ketobemidone
• Levomilnacipran
• Levorphanol
• Lithium
• Lofepramine
• Lorcaserin
• Melitracen
• Meperidine
• Methadone
• Milnacipran
• Mirabegron
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nicomorphine
• Nortriptyline
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxycodone
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Piritramide
• Polythiazide
• Protriptyline
• Quinidine
• Quinine
• Remifentanil
• Rizatriptan
• Rolapitant
• Sertraline
• Sodium Bicarbonate
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Terbinafine
• Tianeptine
• Tilidine
• Tramadol
• Trazodone
• Trichlormethiazide
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Xipamide
• Ziprasidone
• Zolmitriptan

Using amphetamine 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

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of amphetamine. Make sure you tell your doctor if you have any other medical problems, especially:

• Agitation, severe or
• Arteriosclerosis (hardening of the arteries), severe or
• Drug abuse, history of or
• Heart attack, recent or
• Heart failure or
• Heart or blood vessel disease (eg, cardiomyopathy, coronary artery disease) or
• Heart rhythm problems (eg, arrhythmia, ventricular arrhythmia) or
• Hypertension (high blood pressure), moderate to severe or
• Hyperthyroidism (overactive thyroid) or
• Stroke, history of—Should not be used in patients with these conditions.

• Bipolar disorder (manic-depressive illness), or a family history of or
• Blood vessel problems (eg, Raynaud disease) or
• Depression, or a family history of or
• Hypertension (high blood pressure), mild or
• Psychosis (mental illness), history of or
• Seizures, history of or
• Tourette syndrome, or family history of—Use with caution. May make these conditions worse.

(am FET a meen)

• Central Nervous System Stimulant

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. Overdose may also cause seizure or coma.

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).

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