Do not take KAPVAY^® if you are allergic to clonidine.

Use KAPVAY^® with caution if you have high or low blood pressure, kidney problems, or heart problems, including heart attacks or strokes. You should avoid becoming dehydrated or overheated when taking KAPVAY^®
KAPVAY^® can make you sleepy or dizzy. 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 participate in any dangerous activities until you know how KAPVAY^® will affect you
Do not stop taking KAPVAY^® without talking to your doctor. Suddenly stopping KAPVAY^® may cause withdrawal symptoms, including increased blood pressure, headache, increased heart rate, lightheadedness, tightness in your chest, and nervousness
Tell your doctor if you had a skin reaction (such as a rash) after taking clonidine in a transdermal form (skin patch). Talk to your doctor about any other medical conditions you have and all the medicines, including vitamins and herbal supplements, that you take
The most common side effects of KAPVAY^® include sleepiness, tiredness, and upper respiratory tract infections. Symptoms may include cough, runny nose, sneezing, irritability, sore throat, trouble sleeping (insomnia), nightmares, change in mood, constipation, stuffy nose, increased body temperature, dry mouth, and ear pain

THE ACTIVE INGREDIENT IN KAPVAY IS CLONIDINE:

LATEST NEWS AND FACTS ABOUT MEDICINES YOU TAKE

Home / central alpha-2 agonist / clonidine

“Clonidine is among the most commonly prescribed drugs to treat insomnia for children with ADHD... However, the American Academy of Sleep Medicine advises first trying behaviorial strategies for pediatric insomnia and using medication sparingly. Consumer Reports medical advisors urge people to avoid taking medication to treat the side effects of another drug unless that drug is essential.”

ABOVE: American Society of Health-System Pharmacists. Off-label use of clonidine: Is it really a wonder drug?; Consumer Reports, Consumers Union of US, Inc. (updated 9/2009).

The use of clonidine and methylphenidate in combination continues to be controversial. Both drugs can adversely affect an irregular heart rate or rhythm (cardiac arrhythmia) and this effect can be worsened when the drugs are combined. Four deaths of children using both drugs were reported to the FDA.

ABOVE: Cantwell D.P., Swanson J., Connor D.F. “Case study: adverse response to clonidine.” J Am Acad Child Adolesc Psychiatry 1997;36:539-44.

“Clonidine can also cause severe depression and is particularly dangerous for anyone with a history of depression.”

ABOVE: Wolfe, S.M. et al. “Worst Pills Best Pills,” Public Citizen Health Research Group, Washington DC (1988).

“Clonidine can cause severe depression and is particularly dangerous for anyone with a history of depression.” (4)

Clonidine Side Effects and Warnings

Updated August 22, 2012

Brand Names: KAPVAY, JENLOGA (extended-release tablets); CATAPRES, DIXARIT (tablets); CATAPRES-TTS (transdermal patch)
Generic Names: clonidine hydrochloride, clonidine
Categories: CENTRAL ALPHA-2 AGONIST
and ANTI-HYPERTENSIVE

How Clonidine Works

Clonidine reduces blood flow in the brain and produces dose-related sedation. (5) The drug lowers blood pressure and heart rate, thereby supressing the body's “fight or flight response” by decreasing that activity of part of the brain known as vasomotor center. Users of clonidine experience typical drowsiness. (1,2)

Used For

High blood pressure
Attention deficit disorder
Narcotic withdrawal syndrome (off-label)

Do Not Use If

You have a history of depression. Clonidine can cause severe depression and is particularly dangerous for anyone with a history of depression. (4)
You have heart disease, unless your doctor tells you it is okay. (6)
You have a problem in your heart that impacts the timing of the heartbeat or transmission of electrical impulses through the heart. (3)
You previously had an allergic reaction to clonidine. (3)

DO NOT SKIP A DOSE OR STOP SUDDENLY

Serious Risks Include ACUTE WITHDRAWAL SYMPTOMS (rebound hypertension) with abrupt discontinuation.

Severe cases can result in a very large increase in blood pressure which requires prompt treatment to avoid complications such as organ damage.

ABOVE: Rybacki, J., et al. The Essential Guide to Prescription Drugs, HarperCollins Publishers Inc., NY (1996).

Let Your Doctor Know Before Taking This Drug If

you have or have had Serious Emotional Depression
you are taking any antidepressant
you are taking a tricyclic antidepressant
you are taking any sedative
you are taking any hypnotic drugs
you have a Circulatory Disorder of the Brain
you have Angina or Coronary Heart Disease
you have a Very Slow Heart Rate
you have Buerger's disease (hands or feet may be pale, red, or bluish and may feel cold; caused by inflammation of blood vessels)
you have Raynaud's phenomenon (cold temperatures or strong emotions cause blood vessel spasms that block blood flow to the fingers, toes, ears, and nose)
you plan to have surgery under general anesthesia in the near future

Common (Expected) Side Effects

Lowering of blood pressure (expected)
Lowering of heart rate (expected)
Drowsiness and Sedation (sleepiness) (33-35%)
Dry Nose and Mouth (40%)
Headache (19-29%)
Constipation (10%)
Upper Abdominal Pain (13-20%)
Fatigue (13-16%)
Dizziness (16%)
Irritability
Change in mood
Trouble sleeping (insomnia)
Light-headedness (caused by lowering of blood pressure)
Sore throat
Dry eyes (in patients who wear contact lenses)

Possible Adverse Effects

If any of the following develop, consult your physician promptly for guidance.

Mild Adverse Effects

Allergic Reactions: Skin rash, hives, localized swellings, itching
Headache, dizziness, fatigue, anxiety, nervousness, dryness and burning eyes
Painful parotid (salivary) gland, nausea, vomiting
Weight gain, urinary retention
Dry mouth
Urination at night
Thinning of hair (rare)

Serious Adverse Effects

Raynaud's phenomenon (cold temperatures or strong emotions cause blood vessel spasms that block blood flow to the fingers, toes, ears, and nose)
Aggravation of congestive heart failur, heart rhythm disorders, vivid dreaming, nightmares, depression, hallucinations
Sleep disorders
Corneal ulcers (rare)
Acute pancreatitis (rare)
Slow heart beat (bradycardia)

Possible Effects On Sexual Functions

Decreased libido (10%)
Impotence (8-24%)
Impaired Ejaculation (rare)
Enlargement of male breasts
Precocious puberty in females (puberty at an early age)

CAUTION

Do not stop this drug suddenly! Sudden withdrawal can cause a severe and possibly fatal reaction.
Hot weather or fever can reduce blood pressure significantly. Dose adjustments may be necessary.
Report the development of any tendency to emotional depression.

“The main problem with clonidine is that missing one or two doses can have serious effects

, including sweating, tremor, flushing, and severe high blood pressure.”

ABOVE: Wolf, S., et al. Worst Pills Best Pills, Public Citizen Health Research Group, Washington DC (1988).

Overdose Side Effects

Marked drowsiness
Weakness
Dry mouth
Slow pulse
Low blood pressure
Vomiting
Stupor progressing to coma

A review of 20-years of scientific literature on using stimulant medications, including methylphenidate drugs, to treat children with ADD and ADHD found a consensus: there is no documented long-term benefit (academic achievement or pro-social behavior) in using psychoactive drugs.

“The main problem with clonidine is that missing one or two doses can have serious effects, including sweating, tremor, flushing, and severe high blood pressure.”

ABOVE: Wolf, S., et al. Worst Pills Best Pills, Public Citizen Health Research Group, Washington DC (1988).

Additional safety precaution for ADHD patients:

Cardiovascular risks should be evaluated before starting clonidine for the treatment of ADHD. Some patients have reported changes in heart rate or rhythm.

Patients should be monitored for changes in pulse and blood pressure, and sedation while using clonidine.