Vyvanse 70mg Capsules

Lisdexamfetamine is a prodrug that is converted to dextroamphetamine. Dextroamphetamine is a central nervous system (CNS) stimulant. The exact mechanism of therapeutic action in ADHD and BED is not known, but it is thought to be mediated through the release of norepinephrine and dopamine from nerve terminals in the brain, and by blocking their reuptake into the presynaptic neuron.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in vision
Abnormal or rapid heartbeat
Difficulty controlling body movements
Uncontrollable sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color (hands, feet, or other areas), which may turn pale, blue, gray, purple, or red
Numbness, pain, tingling, or cold sensation in the hands or feet
Sores or wounds on the fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating

Important Heart-Related Warnings

If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or has died suddenly, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, such as:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

Serotonin Syndrome: A Potentially Life-Threatening Condition

Taking this medication with certain other drugs can increase the risk of serotonin syndrome, a severe and potentially deadly condition. If you experience any of the following symptoms, contact your doctor right away:

Agitation
Balance problems
Confusion
Hallucinations
Fever
Abnormal or rapid heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache

Other Possible Side Effects

While many people may not experience side effects or only have mild ones, it's essential to be aware of the following potential side effects:

Anxiety
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dry mouth
Feeling jittery
Weight loss
Difficulty sleeping
Dizziness

If any of these side effects or other symptoms bother you or persist, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or visit https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ Previous instances of drug abuse or stroke
Current or recent medications, including:
+ Acetazolamide or sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as they may cause very high blood pressure)
+ Linezolid or methylene blue
* If you are breastfeeding, as you should not breastfeed while taking this medication

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine the safety of taking this medication with your existing conditions and medications. Never start, stop, or change the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug is not intended for weight loss, and if you have any questions or concerns, you should discuss them with your doctor.

When starting this medication, be cautious when driving or performing tasks that require alertness and clear vision until you understand how it affects you. Long-term or high-dose use of this medication can lead to tolerance, where the drug becomes less effective, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.

Prolonged or regular use of this medication may result in dependence, and suddenly stopping it can cause withdrawal symptoms. Before reducing the dose or discontinuing the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.

Prior to initiating treatment, you may need to undergo heart tests. If you have any questions or concerns, discuss them with your doctor. This medication can cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor.

This medication may interfere with certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug. Before using over-the-counter products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products or aids, consult your doctor.

A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can cause severe health problems, permanent damage, or even death. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin, with or without fever, red or irritated eyes, or sores in your mouth, throat, nose, or eyes.

This medication can cause changes in behavior and mood, including hallucinations, anger, and altered thinking. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Contact your doctor immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.

In some cases, this medication can affect growth in children and adolescents, and they may require regular growth checks. This medication is not approved for use in children under 6 years of age, as it can increase the risk of long-term weight loss in this age group.

If you are pregnant or plan to become pregnant, inform your doctor, as they will need to discuss the benefits and risks of using this medication during pregnancy with you.

• Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis).

• Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, tramadol, buspirone, St. John's Wort) - risk of serotonin syndrome.
• Antihypertensive agents (may reduce hypotensive effect).
• Urinary acidifying agents (e.g., ascorbic acid, ammonium chloride) - increase renal excretion of amphetamine, decreasing efficacy.
• Urinary alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease renal excretion of amphetamine, increasing efficacy and potential toxicity.
• Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines.

• Proton Pump Inhibitors (PPIs) and H2-receptor antagonists (may alter gastric pH, but less significant for lisdexamfetamine due to hydrolysis in blood).
• Antipsychotics (may antagonize stimulant effects).
• Alcohol (may alter absorption or increase adverse effects).

• Not available

• Changes in mood or behavior (e.g., agitation, aggression, anxiety, depression, mania, psychosis)
• New or worsening tics
• Chest pain, shortness of breath, syncope
• Numbness, tingling, or color changes in fingers or toes
• Unexplained weight loss or growth deceleration (in children)
• Insomnia, loss of appetite, dry mouth

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Amphetamines have been associated with adverse pregnancy outcomes, including premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.

Amphetamines are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, anorexia, poor weight gain, cardiovascular effects), advise mothers not to breastfeed during treatment with Vyvanse or to discontinue the drug, taking into account the importance of the drug to the mother.

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully. Long-term safety and efficacy in children under 6 years have not been established. Not approved for BED in pediatric patients.

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Lisdexamfetamine is a prodrug, meaning it is inactive until converted in the body to dextroamphetamine. This conversion occurs primarily in the blood, not the GI tract, which may contribute to its smoother pharmacokinetic profile and potentially lower abuse liability compared to immediate-release amphetamines.
• The duration of action is approximately 14 hours, allowing for once-daily morning dosing.
• Can be opened and mixed with soft food (yogurt) or liquid (water, orange juice) for patients who have difficulty swallowing capsules.
• Careful monitoring for cardiovascular and psychiatric adverse effects is crucial, especially at baseline and during dose titration.
• Due to its Schedule II classification, strict prescribing regulations apply.

• Other CNS Stimulants (e.g., Methylphenidate products: Concerta, Ritalin LA, Focalin XR; Amphetamine products: Adderall XR, Mydayis, Dexedrine)
• Non-stimulants for ADHD (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
• Other medications for Binge Eating Disorder (e.g., Topiramate, SSRIs)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. It is vital to read this guide carefully and review it again whenever you receive a refill of the medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.