"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 "...
(clonidine hydrochloride) Extended-Release Tablets
Read the Patient Information that comes with KAPVAY before you start taking it and each time you get a refill. There may be new information. This Patient Information leaflet does not take the place of talking to your doctor about your medical condition or treatment.
What is KAPVAY?
- KAPVAY is not a central nervous system (CNS) stimulant.
- KAPVAY should be used as part of a total treatment program for ADHD that may include counseling or other therapies.
Who should not take KAPVAY?
- Do not take KAPVAY if you are allergic to clonidine in KAPVAY. See the end of this leaflet for a complete list of ingredients in KAPVAY.
What should I tell my doctor before taking KAPVAY?
Before you take KAPVAY, tell your doctor if you:
- have kidney problems
- have low or high blood pressure
- have a history of passing out (syncope)
- have heart problems, including history of heart attack
- have had a stroke or have stroke symptoms
- had a skin reaction (such as a rash) after taking clonidine in a transdermal form (skin patch)
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if KAPVAY will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. KAPVAY can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take KAPVAY.
Tell your doctor about all of the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
KAPVAY and certain other medicines may affect each other causing serious side effects. Sometimes the doses of other medicines may need to be changed while taking KAPVAY.
Especially tell your doctor if you take:
- anti-depression medicines
- heart or blood pressure medicine
- other medicines that contain clonidine
- a medicine that makes you sleepy (sedation)
Ask your doctor or pharmacist for a list of these medicines, if you are not sure if your medicine is listed above.
Know the medicines that you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.
How should I take KAPVAY?
- Take KAPVAY exactly as your doctor tells you to take it.
- Your doctor will tell you how many KAPVAY tablets to take and when to take them. Your doctor may change your dose of KAPVAY. Do not change your dose of KAPVAY without talking to your doctor.
- Do not stop taking KAPVAY without talking to your doctor.
- KAPVAY can be taken with or without food.
- KAPVAY should be taken 2 times a day (in the morning and at bedtime).
- If you miss a dose of KAPVAY, skip the missed dose. Just take the next dose at your regular time. Do not take two doses at the same time.
- Take KAPVAY tablets whole. Do not chew, crush or break KAPVAY tablets. Tell your doctor if you cannot swallow KAPVAY tablets whole. You may need a different medicine.
- If you take too much KAPVAY, call your Poison Control Center or go to the nearest hospital emergency room right away.
What should I avoid while taking KAPVAY?
- Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking KAPVAY until you talk with your doctor. KAPVAY taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
- Do not drive, operate heavy machinery or do other dangerous activities until you know how KAPVAY will affect you.
- Avoid becoming dehydrated or overheated.
Ware possible side effects of KAPVAY?
KAPVAY may cause serious side effects, including:
- Low blood pressure and low heart rate. Your doctor should check your heart rate and blood pressure before starting treatment and regularly during treatment with KAPVAY.
- Withdrawal symptoms. Suddenly stopping KAPVAY may cause withdrawal symptoms including: increased blood pressure, headache, increased heart rate, lightheadedness, tightness in your chest and nervousness.
The most common side effects of KAPVAY include:
- trouble sleeping (insomnia)
- dry mouth
- decreased appetite
Tell your doctor if you have any side effects that bother you or that does not go away.
These are not all of the possible side effects of KAPVAY. 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 KAPVAY?
- Store KAPVAY between 68°-77°F (20°-25°C).
- Keep KAPVAY in a tightly closed container.
Keep KAPVAY and all medicines out of the reach of children.
General information about the safe and effective use of KAPVAY
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use KAPVAY for a condition for which it was not prescribed.
Do not give KAPVAY to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about KAPVAY. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about KAPVAY that is written for healthcare professionals.
For more information about KAPVAY, go to www.KAPVAY.com or call 1-877-370-1142.
What are the ingredients in KAPVAY?
- Active Ingredient: clonidine hydrochloride
- Inactive Ingredients: sodium lauryl sulfate, lactose monohydrate, hypromellose type 2208, partially pregelatinized starch, colloidal silicon dioxide, and magnesium stearate
Last reviewed on RxList: 7/1/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Kapvay Information
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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