Clonidine transdermal system

What is Clonidine transdermal system?

• Clonidine transdermal system (Catapres-TTS) is a transdermal system providing continuous systemic delivery of clonidine for 7 days at an approximately constant rate.
• Clonidine is a centrally acting alpha‑agonist hypotensive agent.

Clonidine

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What are the uses of this medicine?

• Clonidine transdermal system (Catapres-TTS) is indicated in the treatment of hypertension.
• It may be employed alone or concomitantly with other antihypertensive agents.

How does this medicine work?

• Clonidine (klon' i deen) is an antihypertensive agent which acts by stimulation of the alpha 2A subtype of alpha adrenergic receptors in the brainstem, causing a reduction in the sympathic outflow of the central nervous system.
• Decreases in plasma levels of norepinephrine correlate closely with its antihypertensive effects.
• Clonidine is effective in lowering blood pressure and can be used alone or in combination with other antihypertensive medications.
• Clonidine is also used in several other conditions in which central nervous system sympathetic activity is believed to contribute including neuropathy, smoking and alcohol cessation, attention deficit disorder, vascular headache, menopausal symptoms, diabetic diarrhea, and restless leg syndrome.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to clonidine or to any other component of the therapeutic system.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• antidepressants
• beta blockers such as acebutolol (Sectral), atenolol (Tenormin, in Tenoretic), betaxolol (Kerlone), bisoprolol (Zebeta, in Ziac), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard, in Corzide), pindolol, propranolol (Inderal, Innopran XL, in Inderide), sotalol (Betapace, Sorine), and timolol (Blocadren, in Timolide)
• calcium channel blockers such as amlodipine (Norvasc, in Caduet and Lotrel), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil, in Lexxel), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan, others)
• digoxin (Digitek, Lanoxicaps, Lanoxin)
• medications for anxiety, mental illness, or seizures
• sedatives
• sleeping pills
• tranquilizers
• tricyclic antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil), maprotiline, nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil).

Is this medicine FDA approved?

• Clonidine was approved for use in the United States in 1974 and continues to be widely used with more than 11 million prescriptions being filled yearly. Current approved indications are for treatment of hypertension, but some preparations are also approved for cancer pain management and treatment of attention deficit disorder.
• Off label uses include treatment of Tourette syndrome, migraine headahces, stress and sleep disorders, and to alleviate symptoms of alcohol, nicotine or narcotic withdrawal.

How should this medicine be used?

Recommended dosage:

• Apply CATAPRES‑TTS® (clonidine) transdermal therapeutic system once every 7 days.
• There have been rare reports of the need for patch changes prior to 7 days to maintain blood pressure control.
• To initiate therapy, CATAPRES‑TTS transdermal therapeutic system dosage should be titrated according to individual therapeutic requirements, starting with CATAPRES‑TTS-1. If after one or two weeks the desired reduction in blood pressure is not achieved, increase the dosage by adding another CATAPRES‑TTS-1 or changing to a larger system. An increase in dosage above two CATAPRES‑TTS-3 is usually not associated with additional efficacy.

Administration:

• Transdermal clonidine comes as a patch to apply to the skin.
• It is usually applied to the skin every 7 days.
• Apply to a hairless area of intact skin on the upper outer arm or chest.
• Each new application of CATAPRES‑TTS transdermal therapeutic system should be on a different skin site from the previous location.
• If the system loosens during 7‑day wearing, the adhesive cover should be applied directly over the system to ensure good adhesion.
• Your doctor may start you on a low dose of clonidine patch and gradually increase your dose, not more than once every week.
• Clonidine patch controls high blood pressure but does not cure it.
• It may take 2-3 days before the full benefit of clonidine patch is seen in your blood pressure readings.
• Continue to use clonidine patch even if you feel well. Do not stop using clonidine patch without talking to your doctor.
• If you suddenly stop using clonidine patch, it can cause a rapid rise in blood pressure and symptoms such as nervousness, headache, and confusion.
• Your doctor will probably decrease your dose gradually over 2 to 4 days.

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

This medicine is available in fallowing doasage form:

• As CATAPRES‑TTS-1, CATAPRES‑TTS-2, and CATAPRES-TTS-3 are supplied as 4 pouched systems and 4 adhesive covers per carton.

This medicine is available in fallowing brand namesː

• Catapres-TTS

What side effects can this medication cause?

The most common side effects of this medicine include:

• localized skin reactions such as erythema and/or pruritus
• localized vesiculation
• hyperpigmentation
• edema
• excoriation
• burning
• papules
• throbbing
• blanching
• generalized macular rash
• contact dermatitis
• maculopapular rash
• urticaria
• angioedema

The systemic adverse reactions may include:

• dry mouth and drowsiness
• fatigue
• headache
• lethargy and sedation
• insomnia
• dizziness
• impotence/sexual dysfunction
• dry throat
• constipation
• nausea
• change in taste
• nervousness

What special precautions should I follow?

• CATAPRES‑TTS transdermal therapeutic system therapy should not be interrupted during the surgical period. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required.
• The transdermal clonidine systems should be removed before attempting defibrillation or cardioversion.
• Skin burns have been reported at the patch site in several patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI). Because the CATAPRES-TTS PATCH contains aluminum, it is recommended to remove the system before undergoing an MRI.
• Patients should be cautioned against interruption of CATAPRES‑TTS transdermal therapeutic system therapy without their physician’s advice.
• Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.
• Inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.
• Patients who wear contact lenses should be cautioned that treatment with CATAPRES-TTS® (clonidine) transdermal therapeutic system may cause dryness of eyes.
• Patients should be instructed to consult their physicians promptly about the possible need to remove the patch if they observe moderate to severe localized erythema and/or vesicle formation at the site of application or generalized skin rash.
• If a patient experiences isolated, mild localized skin irritation before completing 7 days of use, the system may be removed and replaced with a new system applied to a fresh skin site.
• If the system should begin to loosen from the skin after application, the patient should be instructed to place the adhesive cover directly over the system to ensure adhesion during its 7‑day use.
• After use, CATAPRES‑TTS should be folded in half with the adhesive sides together and discarded away from children’s reach.
• As clonidine is excreted in human milk, caution should be exercised when Catapres‑TTS® (clonidine) transdermal therapeutic system is administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis.
• The frequency of CNS depression may be higher in children than adults.
• Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures.
• Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• If symptoms of poisoning occur following dermal exposure, remove all Catapres‑TTS® (clonidine) transdermal therapeutic systems.
• After their removal, the plasma clonidine levels will persist for about 8 hours, then decline slowly over a period of several days.
• There is no specific antidote for clonidine overdosage.
• Ipecac syrup‑induced vomiting and gastric lavage would not be expected to remove significant amounts of clonidine following dermal exposure.
• If the patch is ingested, whole bowel irrigation may be considered and the administration of activated charcoal and/or cathartic may be beneficial.
• Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension.
• Naloxone may be a useful adjunct for the management of clonidine‑induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension.
• Dialysis is not likely to significantly enhance the elimination of clonidine.

Can this medicine be used in pregnancy?

• No adequate well‑controlled studies have been conducted in pregnant women.
• Clonidine crosses the placental barrier.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CLONIDINE

Inactive ingredients:

• none

Who manufactures and distributes this medicine?

Distributed by:

• Boehringer Ingelheim Pharmaceuticals, Inc.
• Ridgefield, CT USA

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

• Store the CATAPRES-TTS PATCH at room temperature 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Clonidine transdermal system
• FDA Clonidine transdermal system

Clonidine transdermal system Resources
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Antihypertensive agents

• Dailymed label info on Clonidine transdermal system
• FDA Clonidine transdermal system

Clonidine transdermal system Resources
Latest articles Most recent articles Ongoing trials	Wikipedia