Vyvanse

DRUG DESCRIPTION

Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3OĽ(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:

Vyvanse« (lisdexamfetamine dimesylate)  Structural Formula Illustration

Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Vyvanse capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells (imprinted with NRP104) contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Green #3, and FD&C Red #40. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.

What are the possible side effects of lisdexamfetamine (Vyvanse)?

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 lisdexamfetamine and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeats;
  • decreased blood pressure (feeling light-headed, fainting);
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath,...

Read All Potential Side Effects and See Pictures of Vyvanse

What are the precautions when taking lisdexamfetamine dimesylate (Vyvanse)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic amines (e.g., dextroamphetamine); 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., severe agitation, psychosis), heart/blood vessel disease (e.g., irregular heartbeat, coronary artery disease, angina, heart failure, cardiomyopathy), history of heart attack/stroke, problems with heart structure (e.g., valve problems), moderate or severe high blood...

Read All Potential Precautions of Vyvanse


Vyvanse Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, stomach/abdominal pain, loss of appetite, dry mouth, headache, nervousness, dizziness, trouble sleeping, sweating, weight loss, irritability, or restlessness may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medicine 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: blurred vision, fast/pounding/irregular heartbeat, mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, hallucinations, abnormal thoughts/behavior), uncontrolled movements, muscle twitching/shaking, outbursts of words/sounds, change in sexual ability/interest, swelling ankles/feet, extreme tiredness, rapid/unexplained weight loss.

Seek immediate medical attention if any of these rare but very serious side effects occur: shortness of breath, fainting, chest/jaw/left arm pain, seizures, weakness on one side of the body, slurred speech, confusion, sudden vision changes.

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 other sympathomimetic amines (e.g., dextroamphetamine); 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., severe agitation, psychosis), heart/blood vessel disease (e.g., irregular heartbeat, coronary artery disease, angina, heart failure, cardiomyopathy), history of heart attack/stroke, problems with heart structure (e.g., valve problems), moderate or severe high blood pressure (hypertension), overactive 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: family history of sudden death or irregular heartbeat, family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts), seizures, personal or family history of uncontrolled movements or outbursts of words/sounds (e.g., due to Tourette's syndrome), mild high blood pressure (hypertension), liver disease.

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 height. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child's weight and height. Consult your doctor or pharmacist for more details.

During pregnancy, this medication should be used only if clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who are dependent on this medication may be born too soon (premature) 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.

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


Vyvanse Patient Information Including Side Effects

Brand Names: Vyvanse

Generic Name: lisdexamfetamine (Pronunciation: lis dex am FET a meen)

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

What is lisdexamfetamine (Vyvanse)?

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

Lisdexamfetamine is used to treat attention deficit hyperactivity disorder (ADHD) in adults and in children who are 6 to 12 years old.

Lisdexamfetamine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of lisdexamfetamine (Vyvanse)?

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 lisdexamfetamine and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeats;
  • decreased blood pressure (feeling light-headed, fainting);
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
  • tremor, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches).

Less serious side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite, weight loss;
  • blurred vision;
  • skin rash;
  • feeling irritable;
  • sleep problems (insomnia); or
  • dry mouth or an unpleasant taste in your mouth.

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.

What is the most important information I should know about lisdexamfetamine (Vyvanse)?

Do not use lisdexamfetamine 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 lisdexamfetamine before the MAO inhibitor has cleared from your body.

Do not use this medication if you are allergic to lisdexamfetamine, 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 lisdexamfetamine, tell your doctor if you have any type of heart problems.

Lisdexamfetamine may be habit-forming and should be used only by the person it was prescribed for. Lisdexamfetamine should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Using this medication improperly can cause death or serious side effects on the heart.

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