Dextroamphetamine-amphetamine

What is Dextroamphetamine-amphetamine?

• Dextroamphetamine-amphetamine (Adderall, Adderall XR, Mydayis) is a CNS stimulant, used for the treatment of attention deficit hyperactivity disorder (ADHD).

Dextroamphetamine-2D-skeletal

D-Amphetamine-3D-balls

What are the uses of this medicine?

Dextroamphetamine-amphetamine (Adderall, Adderall XR, Mydayis) is used as part of a treatment program to control symptoms of

• attention deficit hyperactivity disorder.
• Adderall is used to treat ADHD in adults and children 3 years of age and older.
• Adderall XR is used to treat ADHD in adults and children 6 years of age and older.
• Mydayis is used to treat ADHD in adults and children 13 years of age and older.
• Adderall is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep) in adults and children 12 years of age and older.

How does this medicine work?

• A combination of two synthetic agents with central nervous system stimulant activity.
• Both agents are non-catecholamine, sympathomimetic agents that elevate blood pressure and cause bronchodilation.
• These agents are commonly abused psychostimulant drugs that induce psychologic dependence manifested by elevated mood, increased wakefulness, concentration, physical performance and a feeling of well-being.
• Tolerance to various effects develops unequally, so that tachycardia and enhanced alertness diminish while psychotoxic effects (hallucinations and delusions) may occur.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• have heart disease or hardening of the arteries
• have moderate to severe high blood pressure
• have hyperthyroidism
• have an eye problem called glaucoma
• are very anxious, tense, or agitated
• have a history of drug abuse
• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
• is sensitive to, allergic to, or had a reaction to other stimulant medicines

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate)
• acetazolamide (Diamox)
• alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax, in Jalyn), and terazosin
• antacids and other medications for heartburn or ulcers such as cimetidine (Tagamet), esomeprazole (Nexium), omeprazole (Prilosec, in Zegerid), and pantoprazole (Protonix)
• antidepressants ('mood elevators')
• antihistamines (medications for colds and allergies)
• ascorbic acid (Vitamin C)
• beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal, Innopran)
• buspirone
• chlorpromazine
• fentanyl (Actiq, Duragesic, Subsys, others)
• guanethidine (no longer available in U.S.)
• lithium (Lithobid)
• meperidine (Demerol)
• methenamine (Hiprex, Urex)
• medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig)
• quinidine (in Nuedexta)
• reserpine
• ritonavir (Norvir, in Kaletra)
• certain medications for seizures such as ethosuximide (Zarontin), phenobarbital, and phenytoin (Dilantin, Phenytek)
• selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft)
• serotonin and norepinephrine reuptake inhibitors such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), milnacipran (Savella), and venlafaxine (Effexor)
• sodium bicarbonate(Arm and Hammer Baking Soda, Soda Mint)
• sodium phosphate
• certain thiazide diuretics ('water pills')
• tramadol (Conzip, in Ultracet)
• tricyclic antidepressants ('mood elevators') such as desipramine (Norpramin) or protriptyline (Vivactil)
• St. John's wort and tryptophan
• glutamic acid (L-glutamine)

Is this medicine FDA approved?

• Initial U.S. Approval: 2001

How should this medicine be used?

Recommended dosage:

• Pediatric patients (ages 6-17): 10 mg once daily in the morning. Maximum dose for children 6-12 years of age is 30 mg once daily.
• Adults: 20 mg once daily in the morning.
• Pediatric patients (ages 6-17) with severe renal impairment: 5 mg once daily in the morning. Maximum dose for children 6- 12 years of age with severe renal impairment is 20 mg once daily.
• Adults with severe renal impairment: 15 mg once daily in the morning.

Adderall dosage: Attention Deficit Hyperactivity Disorder:

• Not recommended for children under 3 years of age.
• In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

Narcolepsy:

• Usual dose 5 mg to 60 mg per day in divided doses, depending on the individual patient response.
• The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained.

Administration:

• The combination of dextroamphetamine and amphetamine comes as an immediate-relase tablet (Adderall) and as an extended-release (long-acting) capsule (Adderall XR, Mydayis) to take by mouth.
• The immediate-release tablet (Adderall) is usually taken 2 to 3 times daily, 4 to 6 hours apart, with or without food.
• The extended-release capsule (Adderall XR) is usually taken upon awakening with or without food.
• The extended-release capsule (Mydayis) is usually taken upon awakening and must be taken consistently either with or without food.
• Dextroamphetamine and amphetamine combination should not be taken in the late afternoon or evening because it may cause difficulty falling asleep or staying asleep.
• Swallow the extended-release capsules whole; do not chew or crush them.
• If you are unable to swallow the extended-release capsule, you may open the capsule and sprinkle the entire contents on a teaspoonful of applesauce.
• Swallow this mixture right away without chewing.
• Do not store the applesauce and medication mixture for future use, and do not divide the contents of one capsule into more than one dose.
• Your doctor will probably start you on a low dose of dextroamphetamine and amphetamine and increase your dose gradually, not more often than once every week.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• Asan immediate-relase tablet and as an extended-release (long-acting) capsule

This medicine is available in fallowing brand namesː

• Adderall, Adderall XR, Mydayis

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• decreased appetite
• stomach ache
• nervousness
• trouble sleeping
• mood swings
• weight loss
• dizziness
• dry mouth
• fast heart beat

Other serious side effects include:

• slowing of growth (height and weight) in children
• seizures, mainly in patients with a history of seizures
• eyesight changes or blurred vision
• serotonin syndrome

What special precautions should I follow?

• Sudden death has been reported with usual doses of CNS stimulants in children and adolescents with structural cardiac abnormalities or other serious heart problems; sudden death, stroke, and myocardial infarction have been reported in adults taking CNS stimulants at usual doses. Stimulant drugs should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems.
• Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases. Monitor blood pressure and pulse at appropriate intervals. Use with caution in patients for whom blood pressure increases may be problematic.
• Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder. Stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis. Evaluate for bipolar disorder prior to stimulant use. Monitor for aggressive behavior.
• Monitor growth in children during treatment with stimulants. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted.
• stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in the absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures.
• Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
• Serotonin syndrome, a potentially life-threatening reaction, may occur. Increased risk when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during overdosage situations. If it occurs, discontinue MAS-ER Capsules and initiate supportive treatment.
• Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
• Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Evaluate for tics and Tourette's syndrome prior to stimulant administration.
• Because of the potential for serious adverse reactions in nursing infants, advise patients that breastfeeding is not recommended during treatment with Dextroamphetamine-amphetamine.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• restlessness
• tremor
• hyperreflexia
• rapid respiration
• confusion
• assaultiveness
• hallucinations
• panic states
• hyperpyrexia
• rhabdomyolysis
• Fatigue and depression
• Serotonin syndrome
• arrhythmias, hypertension or hypotension and circulatory collapse
• nausea, vomiting, diarrhea and abdominal cramps
• convulsions
• coma

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• d-Amphetamine is not dialyzable.
• The prolonged release of mixed amphetamine salts from capsules should be considered when treating patients with overdose.

Can this medicine be used in pregnancy?

• Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers taking amphetamines during pregnancy.

Can this medicine be used in children?

• Adderall is used to treat ADHD in adults and children 3 years of age and older.
• Adderall XR is used to treat ADHD in adults and children 6 years of age and older.
• Mydayis is used to treat ADHD in adults and children 13 years of age and older.
• Growth should be monitored during treatment with stimulants and pediatric patients aged 6 to 17 years who are not growing or gaining weight as expected may need to have their treatment interrupted.

What are the active and inactive ingredients in this medicine?

• Active Ingredients: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
• Inactive Ingredients: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, sugar spheres, talc, and triethyl citrate. Gelatin capsules contain edible inks, kosher gelatin, and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #2. The 20 mg, 25 mg, and 30 mg capsules also contain red iron oxide and yellow iron oxide

Who manufactures and distributes this medicine?

Distributed by:

• Prasco Laboratories
• Mason, OH

What should I know about storage and disposal of this medication?

• Store Capsules in a safe place at room temperature, 59 to 86° F (15 to 30° C).

• Dailymed label info on Dextroamphetamine-amphetamine
• FDA Dextroamphetamine-amphetamine

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