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VYVANSE (lisdexamfetamine dimesylate), a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diaminoN-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O•(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).
Information for VYVANSE Capsules
VYVANSE capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine).
Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells 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.
Information for VYVANSE Chewable Tablets
VYVANSE chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine).
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, sucralos
Tell your doctor and pharmacist about any drugs you’re taking.
This includes prescription and over-the-counter (OTC) medications, vitamins and other dietary supplements (nutritional shakes, protein powders, etc.), herbal remedies, and any illegal and recreational drugs.
Don’t take Vyvanse if you are taking monoamine oxidase inhibitors (MAOIs) or have taken them within 14 days.
MAOIs include Nardil (phenelzine), Parnate (tranylcypromine), and Marplan (isocarboxazid).
Ask your doctor if it’s safe to take VYVANSE INTERACTIONS if you are also taking:
Diet drugs, such as benzphetamine (Didrex), phendimetrazine (Brontril, Brontril PDM), and phentermine (Adipex-P)
Selegeline (Eldepryl, Emsam, Zelapar)
There are many drugs that interact with Vyvanse.
These include drugs that make the urine more acidic than normal, such as vitamin C, or alkaline, such as sodium bicarbonate.
Vyvanse and Alcohol
Both alcohol and VYVANSE can cause dizziness, changes in mood, and dry mouth.
Drinking while taking Vyvanse could make all of these side effects worse, so don’t drink while taking it.
Vyvanse and Grapefruit Juice
The liver breaks down Vyvanse and grapefruit juice differently, so grapefruit and the juice don’t appear to affect Vyvanse.
DOSAGE AND ADMINISTRATION
Prior to treating children, adolescents, and adults with CNS stimulants, including VYVANSE, assess for the presence of cardiac disease (e.g., a careful history, family history of sudden death or ventricular arrhythmia, and physical exam)
To reduce the abuse of CNS stimulants including VYVANSE, assess the risk of abuse, prior to prescribing. After prescribing, keep careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for VYVANSE use
General Instructions For Use
Take VYVANSE by mouth in the morning with or without food; avoid afternoon doses because of the potential for insomnia. VYVANSE may be administered in one of the following ways:
Information For VYVANSE Capsules:
Swallow VYVANSE capsules whole, or Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. If the contents of the capsule include any compacted owder, a spoon may be used to break apart the powder. The contents should be mixed until completely dispersed. Consume the entire mixture immediately. It should not be stored. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed.
Information For VYVANSE Chewable Tablets:
VYVANSE chewable tablets must be chewed thoroughly before swallowing.
VYVANSE capsules can be substituted with VYVANSE chewable tablets on a unit per unit/ mg per mg basis (for example, 30 mg capsules for 30 mg chewable tablet)
Do not take anything less than one capsule or chewable tablet per day. A single dose should not be divided.
Dosage For Treatment Of ADHD
The recommended starting dose is 30 mg once daily in the morning in patients ages 6 and above. Dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals up to maximum dose of 70 mg/day
Dosage For Treatment Of Moderate To Severe BED In Adults
The recommended starting dose is 30 mg/day to be titrated in increments of 20 mg at approximately weekly intervals to achieve the recommended target dose of 50 to 70 mg/day. The maximum dose is 70 mg/day [see Clinical Studies]. Discontinue VYVANSE if binge eating does not improve.
Dosage In Patients With Renal Impairment
In patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m2), the maximum dose should not exceed 50 mg/day. In patients with end stage renal disease (ESRD, GFR < 15 mL/min/1.73 m2), the maximum recommended dose is 30 mg/day [see Use In Specific Populations].
Dosage Modifications Due To Drug Interactions
Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust VYVANSE dosage accordingly
Store Vyvanse in a secure place out of the reach of children, and at room temperature. Do not share your Vyvanse prescription with anyone, even another person with ADHD. Sharing prescription medication is illegal, and can cause harm.
You should not take Vyvanse if you are allergic to any of the ingredients in Vyavanse, or if you have taken a monoamine oxidase inhibitor (MAOI) within 14 days.
If you’re thinking of becoming pregnant, discuss the use of Vyvanse with your doctor. It is not known if it can cause fetal harm. Vyvanse is passed through breastmilk, so it is recommended that mothers do not nurse while taking it.
The safety of Vyvanse for children under age six has not been established.
Nausea, vomiting, constipation, stomach/abdominal pain, loss of appetite, dry mouth, headache, nervousness, dizziness, trouble sleeping, sweating, weight loss, irritability, and restlessness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist 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.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if you have any serious side effects, including: blurred vision, fast/pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, depression, hallucinations, abnormal thoughts/behavior, suicidal thoughts/attempts), uncontrolled movements, muscle twitching/shaking, signs of blood flow problems in the fingers or toes (such as coldness, numbness, pain, or skin color changes), unusual wounds on the fingers or toes, outbursts of words/sounds, change in sexual ability/interest, swelling ankles/feet, extreme tiredness, rapid/unexplained weight loss, frequent/prolonged erections (in males).
Get medical help right away if you have any very serious side effects, including: shortness of breath, fainting, chest/jaw/left arm pain, seizures, weakness on one side of the body, slurred speech, confusion, sudden vision changes.
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take .Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.
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