Vyvanse Indication and Important Safety Information
Vyvanse is indicated for the treatment of ADHD. Efficacy based on two controlled trials in children aged 6 to 12 and one controlled trial in adults.
Vyvanse is a stimulant medicine. Abuse of stimulants may lead to dependence. Misuse of stimulants may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with stimulant use.
Tell the doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform the doctor immediately if you or your child develops symptoms that suggest heart problems, such as chest pain or fainting.
Vyvanse should not be taken if you or your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine);glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.
Tell the doctor before taking Vyvanse if you or your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thoughts or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell the doctor immediately if you or your child develops any of these conditions or symptoms while taking Vyvanse.
Talk to your health care provider if your child experiences slowing of growth (height and weight). Children should have their height and weight checked periodically while taking Vyvanse. Your health care provider may stop Vyvanse treatment if a problem is found during these check-ups.
The most common side effects reported in studies of Vyvanse were upper belly pain, dry mouth, weight loss, irritability, vomiting, nausea, dizziness, trouble sleeping and decreased appetite.
Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome have been associated with use of drugs of this type. Tell the doctor if you or your child has blurred vision while taking Vyvanse.
Please see Full Prescribing Information and Medication Guide for Vyvanse
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
INTUNIV Important Safety Information
INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17. It is not known if INTUNIV is effective for use longer than 9 weeks. Your child should not change the dose or stop taking INTUNIV before you talk with the doctor.
Do not give INTUNIV to your child if your child is allergic to guanfacine or anything else in INTUNIV. Tell the doctor about all medicines, vitamins, and herbal supplements your child is taking.
Before your child takes INTUNIV, tell the doctor if your child has heart problems or a low heart rate, has fainted, has low blood pressure, has liver or kidney problems, is pregnant or plans to become pregnant, is breast-feeding or plans to breast-feed, or has any other medical conditions. Your child should not drink alcohol or take other medicines that make your child sleepy or dizzy while taking INTUNIV until you talk with the doctor.
INTUNIV may cause low blood pressure and low heart rate. The doctor may do regular checks of your child's blood pressure and heart rate. INTUNIV may also cause fainting, sleepiness, tiredness, and drowsiness. Your child should not drive or operate heavy equipment until you know how INTUNIV affects your child. Your child should avoid becoming dehydrated or overheated while taking INTUNIV.
Other commonly reported side effects in clinical studies included headache, stomach pain, nausea, dizziness, irritability, decreased appetite, dry mouth, and constipation. If your child experiences any of these or other side effects, talk with the doctor.
Please see Full Prescribing Information and FDA Approved Patient Information Leaflet.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Daytrana Important Safety Information
Daytrana is indicated for the treatment of ADHD in children aged 6 to 12 years.
Tell your doctor about any heart conditions, including structural abnormalities, your child or a family member may have. Inform your doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting.
Daytrana should not be used if the child has: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients of Daytrana; glaucoma; discontinued in the last 14 days or is taking a monoamine oxidase inhibitor (MAOI); tics, or family history or diagnosis of Tourette's syndrome.
Tell your doctor before using Daytrana if the child: is being treated for or has symptoms of depression (e.g. sadness, worthlessness, or hopelessness) or bipolar disorder; has family history of tics; has abnormal thoughts or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell your doctor immediately if the child develops any of these conditions/symptoms while using Daytrana.
In clinical studies, side effects were generally mild to moderate. The most common side effects reported with Daytrana were decreased appetite, sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, tics, and affect lability (mood swings). Aggression, new abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugs of this type. Talk to your health care provider if your child experiences slowing of growth (height and weight). Children should have their height and weight checked periodically while taking Daytrana. Your healthcare provider may stop Daytrana treatment if a problem is found during these check-ups. Tell your doctor if the child has blurred vision while using Daytrana.
Abuse of Daytrana can lead to dependence.
Daytrana should be applied daily to clean, dry skin, which is free of any cuts or irritation. Skin redness or itching is common with Daytrana. Allergic skin rash may occur.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see Full Prescribing Information and Medication Guide for Daytrana
