Kapvay

What is Kapvay?

• Kapvay (clonidine hydrochloride) is a centrally acting alpha2-adrenergic agonist used for the treatment of attention deficit hyperactivity disorder(ADHD).

Clonidine

Clonidine3D

What are the uses of this medicine?

• KAPVAY is a prescription medicine used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Your doctor will give 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.

How does this medicine work?

• Clonidine stimulates alpha2-adrenergic receptors in the brain.
• Clonidine is not a central nervous system stimulant.
• The mechanism of action of clonidine in ADHD is not known.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to clonidine in KAPVAY.

What drug interactions can this medicine cause?

• Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs.
• Coadministration of tricyclic antidepressants may reduce the hypotensive effect of clonidine.
• Caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers and beta-blockers) due to a potential for additive effects such as bradycardia and AV block.
• Antihypertensive drugs must be used with caution when coadministered with KAPVAY.

Is this medicine FDA approved?

• Initial U.S. Approval: 1974

How should this medicine be used?

Recommended dosage:

• Start with one 0.1 mg tablet at bedtime for one week. Increase daily dosage in increments of 0.1 mg/day at weekly intervals until the desired response is achieved.
• Take twice a day, with either an equal or higher split dosage being given at bedtime.
• Doses of KAPVAY higher than 0.4 mg/day (0.2 mg twice daily) were not evaluated in clinical trials for ADHD and are not recommended.

Administration:

• 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 are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-release tablets: 0.1 mg

This medicine is available in fallowing brand namesː

• KAPVAY

What side effects can this medication cause?

The most common side effects of this medicine include:

• sleepiness
• tiredness
• irritability
• trouble sleeping (insomnia)
• nightmare
• constipation
• dry mouth
• decreased appetite
• dizziness

KAPVAY may cause serious side effects, including:

• Low blood pressure and low heart rate
• Sleepiness
• Withdrawal symptoms

What special precautions should I follow?

• 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.
• Treatment with KAPVAY can cause dose-related decreases in blood pressure and heart rate. Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease or chronic renal failure. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Avoid concomitant use of drugs with additive effects unless clinically indicated. Advise patients to avoid becoming dehydrated or overheated.
• Somnolence and sedation were commonly reported adverse reactions in clinical studies. Consider the potential for additive sedative effects with CNS depressant drugs. Caution patients against operating heavy equipment or driving until they know how they respond to KAPVAY.
• Abrupt discontinuation of KAPVAY can cause rebound hypertension. No studies evaluating abrupt discontinuation of KAPVAY in children with ADHD have been conducted; however, to minimize the risk of rebound hypertension, gradually reduce the dose of KAPVAY in decrements of no more than 0.1 mg every 3 to 7 days.
• The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. Titrate slowly and monitor vital signs frequently.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypertension may develop early
• hypotension
• bradycardia
• respiratory depression
• hypothermia
• drowsiness
• decreased or absent reflexes
• weakness
• irritability
• miosis

• Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures.

Management of overdosage:

• Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice.

Can this medicine be used in pregnancy?

• It is not known if KAPVAY will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• There is a pregnancy registry for females who are exposed to ADHD medications, including KAPVAY, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to KAPVAY and their baby. If you or your child becomes pregnant during treatment with KAPVAY, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388.

Can this medicine be used in children?

• The safety and efficacy of KAPVAY in the treatment of ADHD have been established in pediatric patients 6 to 17 years of age.
• Safety and efficacy in pediatric patients below the age of 6 years has not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: clonidine hydrochloride
• Inactive Ingredients: sodium lauryl sulfate, lactose monohydrate, hypromellose type 2208, partially pregelatinized starch, colloidal silicon dioxide, and magnesium stearate

Who manufactures and distributes this medicine?

Mfd. for:

• Concordia Pharmaceuticals

Distributed by:

• Amdipharm Limited
• 17 Northwood House
• Dublin 9, Ireland

What should I know about storage and disposal of this medication?

• Store KAPVAY between 68°-77°F (20°-25°C).
• Keep KAPVAY in a tightly closed container.

• Dailymed label info on Kapvay
• FDA Kapvay

Kapvay Resources
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