"The US Food and Drug Administration (FDA) has approved the amphetamine Dyanavel XR (Tris Pharma Inc), a once-daily extended-release oral liquid, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years "...
(guanfacine) Extended-Release Tablets
Read the Patient Information that comes with INTUNIV® before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
What is INTUNIV® ?
INTUNIV® is not a central nervous system (CNS) stimulant.
It is not known if INTUNIV® is safe and effective in children younger than 6 years of age.
Who should not take INTUNIV® ?
Do not take INTUNIV® if you are allergic to guanfacine or any of the ingredients in INTUNIV. See the end of this leaflet for a complete list of ingredients in INTUNIV.
What should I tell my doctor before taking INTUNIV® ?
Before you take INTUNIV®, tell your doctor if you:
- have heart problems or a low heart rate
- have fainted
- have low or high blood pressure
- have liver or kidney problems
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if INTUNIV® will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if INTUNIV® passes into your breast milk. Talk to your doctor about the best way to feed your baby while taking INTUNIV®.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
INTUNIV® may affect the way other medicines work, and other medicines may affect how INTUNIV® works.
Especially tell your doctor if you take:
- medicines that can affect enzyme metabolism
- high blood pressure medicine
Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How should I take INTUNIV® ?
- Take INTUNIV® exactly as your doctor tells you.
- Your doctor may change your dose. Do not change your dose of INTUNIV® without talking to your doctor.
- Do not stop taking INTUNIV® without talking to your doctor.
- Try not to miss your dose of INTUNIV®. If you miss a dose of INTUNIV®, take the next dose at your regular time. If you miss 2 or more doses, talk to your doctor, as you may need to restart INTUNIV® with a lower dose.
- Do not take a double dose to make up for a missed dose.
- INTUNIV® should be taken 1 time a day in the morning or in the evening, either alone or in combination with an ADHD stimulant medicine that your doctor may prescribe. Your doctor will tell you when to take INTUNIV® and when to take your ADHD stimulant medication.
- INTUNIV® should be swallowed whole with a small amount of water, milk, or other liquid.
- Do not crush, chew, or break INTUNIV®. Tell your doctor if you cannot swallow INTUNIV® whole.
- Do not take INTUNIV® with a high-fat meal.
- Your doctor will check your blood pressure and heart rate while you take INTUNIV®.
- If you take too much INTUNIV®, call your local Poison Control Center at 1-800-222-1222 or go to the nearest emergency room right away.
What should I avoid while taking INTUNIV® ?
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how INTUNIV® affects you. INTUNIV® can slow your thinking and motor skills.
- Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking INTUNIV® until you talk with your doctor. INTUNIV® taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
- Do not become dehydrated or overheated. This may increase your chance of having low blood pressure or fainting while taking INTUNIV.
What are the possible side effects of INTUNIV® ?
INTUNIV® may cause serious side effects including:
- low blood pressure
- low heart rate
- withdrawal symptoms of increased heart rate and high blood pressure after suddenly stopping INTUNIV® (which may be accompanied by headaches, feeling confused, nervousness, agitation, and tremors).
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of INTUNIV® include:
- trouble sleeping
- low blood pressure
- stomach pain
- dry mouth
- slow heart rate
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of INTUNIV®. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store INTUNIV® ?
- Store INTUNIV® between 68°F to 77°F (20°C to 25°C)
Keep INTUNIV® and all medicines out of the reach of children.
General Information about the safe and effective use INTUNIV®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use INTUNIV® for a condition for which it was not prescribed. Do not give INTUNIV® to other people, even if they have the same symptoms that you have. It may harm them.
This leaflet summarizes the most important information about INTUNIV®. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about INTUNIV® that is written for health professionals.
For more information, go to www.INTUNIV.com or call 1-800-828-2088.
What are the ingredients in INTUNIV® ?
Active ingredient: guanfacine hydrochloride
Inactive ingredients : hypromellose, methacrylic acid copolymer, lactose, povidone, crospovidone, microcrystalline cellulose, fumaric acid, and glycerol behenate. In addition, the 3 mg and 4 mg tablets also contain green pigment blend PB-1763.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 7/18/2016
This monograph has been modified to include the generic and brand name in many instances.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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