Kapvay is a prescription medicine supplied as an extended-release tablet and is used to treat 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.

Use Kapvay only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before you take Kapvay, tell your doctor if you have heart disease or severe coronary artery disease, a heart rhythm disorder, slow heartbeats, low blood pressure, a history of heart attack or stroke, kidney disease, or if you have ever had an allergic reaction to a clonidine transdermal skin patch (Catapres TTS).

Take Kapvay exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Kapvay is usually taken in the morning and at bedtime. If you take different doses of this medicine at each dosing time, it may be best to take the larger dose at bedtime.

Kapvay may be taken with or without food.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

Tell your doctor if you have a planned surgery.

You may have withdrawal symptoms if you stop using Kapvay suddenly. Ask your doctor before stopping the medicine.

Call your doctor if you are sick with vomiting. Prolonged illness can make it harder for your body to absorb clonidine, which may lead to withdrawal symptoms. This is especially important for a child taking Kapvay.

Store at room temperature away from moisture, heat, and light.

Usual Pediatric Dose for Attention Deficit Disorder:

Extended release:
6 years and older:
-Initial dose: 0.1 mg orally at bedtime
-Titration: Increase in 0.1 mg/day increments every 7 days until desired response; doses should be administered twice daily (either split equally or with the higher split dosage given at bedtime)
-Maximum dose: 0.4 mg/day in 2 divided doses

Comments:
-May be taken with or without food.
-If a dose is missed, that dose should be skipped and take the next dose as scheduled.
-Tablets should be swallowed whole, and not crushed, chewed, or broken to avoid increasing the rate of drug release.
-When discontinuing therapy, taper daily dose by no more than 0.1 mg every 3 to 7 days.

Use: For the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

You should not take Kapvay if you are allergic to clonidine.

To make sure Kapvay is safe for you, tell your doctor if you have:

• heart disease or severe coronary artery disease;

• a heart rhythm disorder, slow heartbeats;

• high or low blood pressure, or a history of fainting spells;

• a heart attack or stroke;

• pheochromocytoma (tumor of the adrenal gland);

• kidney disease; or

• if you have ever had an allergic reaction to a clonidine transdermal skin patch (Catapres TTS).

It is not known if clonidine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of clonidine on the baby.

Clonidine may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

If you are breastfeeding, tell your doctor if you notice somnolence, tiredness, rapid breathing, and poor feeding in the nursing baby.

Do not give Kapvay to a child younger than 6 years old.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include feeling cold, irritable, weak, drowsy, or light-headed, or having weak reflexes, pinpoint pupils, slow heartbeats, shallow breathing, or a seizure.

Avoid drinking alcohol. It may increase certain side effects of Kapvay.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Get emergency medical help if you have signs of an allergic reaction to Kapvay: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe chest pain, shortness of breath, irregular heartbeats;

• a very slow heart rate; or

• a light-headed feeling, like you might pass out.

Common Kapvay side effects may include:

• drowsiness, dizziness;

• feeling tired or irritable;

• dry mouth;

• constipation, loss of appetite; or

• sleep problems (insomnia), nightmares.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Kapvay with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• other heart or blood pressure medications;

• an antidepressant; or

• any other medicine that contains clonidine.

This list is not complete. Other drugs may interact with clonidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.