Adderall XR

DRUG DESCRIPTION

ADDERALL XR (amphetamine, dextroamphetamine mixed salts) is a once daily extended-release, single-entity amphetamine product. ADDERALL XR (amphetamine, dextroamphetamine mixed salts) combines the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d,l-amphetamine aspartate monohydrate. The ADDERALL XR (amphetamine, dextroamphetamine mixed salts) capsule contains two types of drug-containing beads designed to give a double-pulsed delivery of amphetamines, which prolongs the release of amphetamine from ADDERALL XR (amphetamine, dextroamphetamine mixed salts) compared to the conventional ADDERALL (immediate-release) tablet formulation.

Each capsule contains: 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg
Dextroamphetamine Saccharate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg
Amphetamine Aspartate Monohydrate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg
Dextroamphetamine Sulfate USP 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg
Amphetamine Sulfate USP 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg
Total amphetamine base equivalence 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.6 mg 18.8mg
Inactive Ingredients and Colors

The inactive ingredients in ADDERALL XR (amphetamine, dextroamphetamine mixed salts) capsules include: 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.

What are the possible side effects of amphetamine and dextroamphetamine (Adderall, Adderall XR)?

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

Stop using amphetamine and dextroamphetamine and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeats;
  • feeling light-headed, fainting;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);...

Read All Potential Side Effects and See Pictures of Adderall XR

What are the precautions when taking amphetamine, dextroamphetamine mixed salts (Adderall XR)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to sympathomimetic drugs (e.g., epinephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain mental/mood conditions (e.g., agitation, psychosis), heart/blood vessel disease (e.g., irregular heartbeat, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), history of heart attack or stroke, moderate or severe high blood...

Read All Potential Precautions of Adderall XR


Adderall XR Consumer (continued)

SIDE EFFECTS: Loss of appetite, weight loss, dry mouth, stomach upset/pain, nausea/vomiting, dizziness, headache, diarrhea, fever, nervousness, and trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, abnormal thoughts), uncontrolled movements, continuous chewing movements/teeth grinding, outbursts of words/sounds, change in sexual ability/desire.

Seek immediate medical attention if any of these rare but very serious side effects occur: shortness of breath, chest pain, fainting, severe headache, fast/pounding/irregular heartbeat, jaw/left arm pain, seizures, weakness on one side of the body, slurred speech, confusion, swelling of the ankles/feet, extreme tiredness, blurred vision.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to sympathomimetic drugs (e.g., epinephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain mental/mood conditions (e.g., agitation, psychosis), heart/blood vessel disease (e.g., irregular heartbeat, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), history of heart attack or stroke, moderate or severe high blood pressure (hypertension), over-active thyroid (hyperthyroidism), a certain eye problem (glaucoma), personal or family history of regular use/abuse of drugs/alcohol.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of uncontrolled movements or outbursts of words/sounds (e.g., due to Tourette's syndrome), family history of sudden death/irregular heartbeat/rhythm, mild high blood pressure (hypertension), kidney disease, liver disease, family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts), seizures.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Caution is advised when using this drug in children because it may affect weight, growth rate, and final height. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child's weight and height and consult your doctor or pharmacist for more details. This drug is not recommended for use in children under 3.

This medication should be used only when clearly needed during pregnancy. Infants born to mothers dependent on this medication may have birth defects, be born too soon (premature delivery) and have low birth weight. They may also have withdrawal symptoms. Tell your doctor immediately if you notice possible mood changes, agitation, or unusual tiredness in your newborn. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Adderall XR Patient Information Including Side Effects

Brand Names: Adderall, Adderall XR

Generic Name: amphetamine and dextroamphetamine (Pronunciation: am FET a meen and DEX troe am FET a meen)

  • What is amphetamine and dextroamphetamine (Adderall XR)?
  • What are the possible side effects of amphetamine and dextroamphetamine (Adderall XR)?
  • What is the most important information I should know about amphetamine and dextroamphetamine (Adderall XR)?
  • What should I discuss with my doctor before taking amphetamine and dextroamphetamine (Adderall XR)?
  • How should I take amphetamine and dextroamphetamine (Adderall XR)?
  • What happens if I miss a dose (Adderall XR)?
  • What happens if I overdose (Adderall XR)?
  • What should I avoid while taking amphetamine and dextroamphetamine (Adderall XR)?
  • What other drugs will affect amphetamine and dextroamphetamine (Adderall XR)?
  • Where can I get more information?

What is amphetamine and dextroamphetamine (Adderall XR)?

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

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

Amphetamine and dextroamphetamine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of amphetamine and dextroamphetamine (Adderall XR)?

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

Stop using amphetamine and dextroamphetamine and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeats;
  • feeling light-headed, fainting;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
  • tremor, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches).

Less serious side effects may include:

  • headache or dizziness;
  • sleep problems (insomnia);
  • dry mouth or an unpleasant taste in your mouth;
  • diarrhea, constipation;
  • loss of appetite, weight loss; or
  • loss of interest in sex, impotence, or difficulty having an orgasm.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amphetamine and dextroamphetamine (Adderall XR)?

Do not take this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take amphetamine and dextroamphetamine before the MAO inhibitor has cleared from your body.

Do not use this medication if you are allergic to amphetamine and dextroamphetamine, or if you have hardened arteries (arteriosclerosis), heart disease, moderate to severe high blood pressure (hypertension), overactive thyroid, glaucoma, severe anxiety or agitation, or a history of drug or alcohol addiction.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking amphetamine and dextroamphetamine, tell your doctor if you have any type of heart problems.

Long-term use of amphetamine and dextroamphetamine can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Amphetamine and dextroamphetamine is a drug of abuse and may be habit-forming. Keep track of how many pills have been used from each new bottle of this medicine. You should be aware if any person in the household is using this medicine improperly or without a prescription. Using this medication improperly can cause death or serious side effects on the heart.

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