The U.S. Food and

Drug Administration approval of the non-stimulant medication Kapvay (clonidine hydrochloride) extended-release tablets, an extended-release oral formulation for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages 6-17 years. Kapvay is the only formulation of clonidine hydrochloride approved by the FDA for the treatment of ADHD, and is the first and only FDA-approved ADHD treatment indicated for use as add-on therapy to stimulant medication. Kapvay can also be used as monotherapy when treating ADHD.

 

An oral, non-stimulant, twice-daily therapy, Kapvay is a centrally acting alpha2-adrenergic receptor agonist. While the mechanism of action of alpha2 agonists in ADHD is not known, it is believed to involve the pre-frontal cortex (PFC) of the brain. Studies suggest that the PFC regulates attention and plays a critical role in impulse control, working memory and executive function.

 

Kapvay Patient Information

 

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 a prescription medicine used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Your doctor may prescribe Kapvay alone or together with certain other ADHD medicines.

• 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.

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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.

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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.

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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.