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Drugs reference index «lisdexamfetamine dimesylate»

lisdexamfetamine dimesylate (Oral route)

lis-dex-am-FET-a-meen dye-MES-i-late

Oral routeCapsule

Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.

Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events .

Amphetamines have a high potential for abuse, and administration for prolonged periods of time may lead to drug dependence and must be avoided. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events .

Commonly used brand name(s):

In the U.S.

  • Vyvanse

Available Dosage Forms:

  • Capsule

Therapeutic Class: CNS Stimulant

Chemical Class: Lisdexamfetamine

Uses For lisdexamfetamine dimesylate

Lisdexamfetamine dimesylate belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 to 12 years of age and in adults .

Lisdexamfetamine dimesylate increases attention and decreases restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. lisdexamfetamine dimesylate is used as part of a total treatment program that also includes social, educational, and psychological treatment .

lisdexamfetamine dimesylate is available only with your doctor's prescription .

Before Using lisdexamfetamine dimesylate

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For lisdexamfetamine dimesylate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lisdexamfetamine dimesylate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of lisdexamfetamine dimesylate in children 6 to 12 years of age. Safety and efficacy have not been established inchildren younger than 6 years of age and in teenagers .

Geriatric

Adequate and well-controlled studies have not been done in the geriatric population .

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using lisdexamfetamine dimesylate with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Clorgyline
  • Iproniazid
  • Isocarboxazid
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Selegiline
  • Toloxatone
  • Tranylcypromine

Using lisdexamfetamine dimesylate with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Furazolidone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of lisdexamfetamine dimesylate. Make sure you tell your doctor if you have any other medical problems, especially:

  • Agitation, severe or
  • Anxiety, severe or
  • Blood vessel problems or
  • Glaucoma or
  • Heart disease or failure or
  • High blood pressure, moderate to severe or
  • Hyperthyroidism (overactive thyroid) or
  • Tension, severe—Should not be used in patients with these conditions .
  • Depression, severe or
  • Heart rhythm problems (e.g., fast heartbeat) or
  • High blood pressure, mild or
  • Motor tics (repeated muscle movements) or
  • Psychosis (mental illness) or
  • Seizures, history of or
  • Tourette's syndrome, or family history of—May make these conditions worse .
  • Drug abuse and dependence, history of—Dependence may be more likely to develop .

Proper Use of lisdexamfetamine dimesylate

lisdexamfetamine dimesylate may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions .

lisdexamfetamine dimesylate should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one .

lisdexamfetamine dimesylate may be taken with or without food .

It is best to take lisdexamfetamine dimesylate in the morning. Taking lisdexamfetamine dimesylate in the afternoon or evening could make it harder for you to fall asleep .

The capsule should be swallowed whole, and not crushed, divided, or chewed. If you or your child are not able to swallow the capsule whole, carefully open the capsule and pour the medicine into a glass of water. Stir this mixture well and swallow it right away. The drug mixture can not be stored for future use .

Dosing

The dose of lisdexamfetamine dimesylate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of lisdexamfetamine dimesylate. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For attention deficit hyperactivity disorder (ADHD):
    • For oral dosage form (capsules):
      • Adults and children 6 to 12 years of age—30 milligrams (mg) once a day in the morning. If needed, your doctor may increase the dose once a week by 10 mg or 20 mg a day until symptoms improve or a maximum dose of 70 mg is reached.
      • Children younger than 6 years of age and teenagers—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of lisdexamfetamine dimesylate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using lisdexamfetamine dimesylate

It is very important that your doctor check your progress at regular visits and make sure that your dose is right and that the medicine is helping you. Your doctor will need to check your blood, heart, and blood pressure for any problems or unwanted effects that may be caused by lisdexamfetamine dimesylate .

You should not use lisdexamfetamine dimesylate if you have used a drug for depression called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, in the past 14 days .

Tell your doctor about all the medicines you take or plan to take, including prescription and nonprescription (over-the-counter) medicines, dietary supplements, herbal remedies, or medicines for appetite control, asthma, colds, cough, hay fever, and sinus problems .

lisdexamfetamine dimesylate may cause blurred vision or make you drowsy or dizzy. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert or not able to see well .

Lisdexamfetamine dimesylate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, shortness of breath, or fainting while taking lisdexamfetamine dimesylate .

Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

lisdexamfetamine dimesylate may cause slow growth. If your child is using lisdexamfetamine dimesylate, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly .

lisdexamfetamine dimesylate Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Uncontrolled vocal outbursts and/or tics (uncontrolled repeated body movements)

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Abdominal cramps
  • blurred vision
  • change in consciousness
  • confusion
  • dark-colored urine
  • diarrhea
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • fainting
  • fast breathing
  • fast, slow, or irregular heartbeat
  • feeling sad or empty
  • lack of appetite
  • loss of consciousness
  • loss of interest or pleasure
  • mood or mental changes
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nervousness
  • overactive reflexes
  • physical attempt to injure yourself
  • panic states
  • pounding in the ears
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shakiness in legs, arms, hands, or feet
  • sweating
  • trembling or shaking of hands or feet
  • trouble concentrating
  • unusual tiredness or weakness
  • violent actions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Decreased appetite
  • headache
  • irritability
  • nausea
  • sleeplessness
  • trouble sleeping
  • unable to sleep
  • upper abdominal pain
  • vomiting
  • weight decreased
Less common
  • Crying
  • depersonalization
  • depression
  • dizziness
  • dry mouth
  • dysphoria
  • euphoria
  • fever
  • paranoia
  • quick to react or overreact emotionally
  • rapidly changing moods
  • rash
  • sleepiness or unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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