Catapres-TTS

DRUG DESCRIPTION

Catapres-TTS (clonidine) 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. It is an imidazoline derivative with the chemical name 2, 6-dichloro-N-2-imidazolidinylidenebenzenamine and has the following chemical structure:

Catapres

Catapres-TTS (clonidine)  Structural Formula Illustration

System Structure and Components

Catapres-TTS (clonidine) transdermal therapeutic system is a multi-layered film, 0.2 mm thick, containing clonidine as the active agent. The system areas are 3.5 cm? (Catapres-TTS (clonidine) -1), 7.0 cm? (Catapres-TTS (clonidine) -2) and 10.5 cm? (Catapres-TTS (clonidine) -3) and the amount of drug released is directly proportional to the area (see Release Rate Concept). The composition per unit area is the same for all three doses.

Proceeding from the visible surface towards the surface attached to the skin, there are four consecutive layers: 1) a backing layer of pigmented polyester and aluminum film; 2) a drug reservoir of clonidine, mineral oil, polyisobutylene, and colloidal silicon dioxide; 3) a microporous polypropylene membrane that controls the rate of delivery of clonidine from the system to the skin surface; 4) an adhesive formulation of clonidine, mineral oil, polyisobutylene, and colloidal silicon dioxide. Prior to use, a protective slit release liner of polyester that covers the adhesive layer is removed.

Cross Section of the System

Backing
Drug Reservoir
Control Membrane
Adhesive
Slit Release Liner

Release Rate Concept

Catapres-TTS (clonidine) transdermal therapeutic system is programmed to release clonidine at an approximately constant rate for 7 days. The energy for drug release is derived from the concentration gradient existing between a saturated solution of drug in the system and the much lower concentration prevailing in the skin. Clonidine flows in the direction of the lower concentration at a constant rate, limited by the rate-controlling membrane, so long as a saturated solution is maintained in the drug reservoir.

Following system application to intact skin, clonidine in the adhesive layer saturates the skin site below the system. Clonidine from the drug reservoir then begins to flow through the rate-controlling membrane and the adhesive layer of the system into the systemic circulation via the capillaries beneath the skin. Therapeutic plasma clonidine levels are achieved 2 to 3 days after initial application of Catapres-TTS (clonidine) transdermal therapeutic system.

The 3.5, 7.0, and 10.5 cm? systems deliver 0.1, 0.2, and 0.3 mg of clonidine per day, respectively. To ensure constant release of drug for 7 days, the total drug content of the system is higher than the total amount of drug delivered. Application of a new system to a fresh skin site at weekly intervals continuously maintains therapeutic plasma concentrations of clonidine. If the Catapres-TTS (clonidine) transdermal therapeutic system is removed and not replaced with a new system, therapeutic plasma clonidine levels will persist for about 8 hours and then decline slowly over several days. Over this time period, blood pressure returns gradually to pretreatment levels.

What are the possible side effects of clonidine transdermal (Catapres-TTS-1, Catapres-TTS-2, Catapres-TTS-3)?

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

Call your doctor at once if you have any of these serious side effects:

  • fast or pounding heartbeats;
  • a very slow heart rate (fewer than 60 beats per minute);
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • confusion, hallucinations;
  • ...

Read All Potential Side Effects and See Pictures of Catapres-TTS

What are the precautions when taking clonidine (Catapres-TTS)?

Before using clonidine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

The patch should be removed before you have certain procedures (e.g., cardioversion, defibrillation) to correct heart conduction disorders. Consult your doctor for more information.

If you are going to have an MRI test, notify testing personnel that you are using this patch. Serious burns may occur during MRI tests because of the aluminum contained in these patches. It should be removed just before the MRI test or consult your doctor for specific instructions.

Before using this medication, tell your doctor or...

Read All Potential Precautions of Catapres-TTS


Catapres-TTS Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, drowsiness, dry mouth, unusual tiredness, or headache may occur as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

If you notice mild skin redness or itching around the patch area before finishing the full 7 days of use, remove the patch and replace it with a new one on a new skin site. These effects seem to occur more frequently in patients who use the overlay cover. If the symptoms persist or worsen into a rash, consult your doctor promptly for further instructions to see if you need to remove the patch.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/slow/irregular heartbeat, depression.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: severe or persistent rash, severe or persistent itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using clonidine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

The patch should be removed before you have certain procedures (e.g., cardioversion, defibrillation) to correct heart conduction disorders. Consult your doctor for more information.

If you are going to have an MRI test, notify testing personnel that you are using this patch. Serious burns may occur during MRI tests because of the aluminum contained in these patches. It should be removed just before the MRI test or consult your doctor for specific instructions.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, heart disease (e.g., severe coronary insufficiency, conduction disorders, recent heart attack), depression, blood circulation disorders (e.g., Raynaud's disease).

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Contact lens wearers may need to use appropriate lubricating solutions if this medication causes dry eyes.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.


Catapres-TTS Patient Information Including Side Effects

Brand Names: Catapres-TTS-1, Catapres-TTS-2, Catapres-TTS-3

Generic Name: clonidine (transdermal) (Pronunciation: KLOE ni deen )

  • What is clonidine transdermal (Catapres-TTS)?
  • What are the possible side effects of clonidine transdermal (Catapres-TTS)?
  • What is the most important information I should know about clonidine transdermal (Catapres-TTS)?
  • What should I discuss with my healthcare provider before using clonidine transdermal (Catapres-TTS)?
  • How should I use clonidine transdermal (Catapres-TTS)?
  • What happens if I miss a dose (Catapres-TTS)?
  • What happens if I overdose (Catapres-TTS)?
  • What should I avoid while using clonidine transdermal (Catapres-TTS)?
  • What other drugs will affect clonidine transdermal (Catapres-TTS)?
  • Where can I get more information?

What is clonidine transdermal (Catapres-TTS)?

Clonidine lowers blood pressure by decreasing the levels of certain chemicals in your blood. This allows your blood vessels to relax and your heart to beat more slowly and easily.

Clonidine transdermal is used to treat hypertension (high blood pressure). It is sometimes used together with other blood pressure medications.

Clonidine transdermal may also be used for other purposes not listed in this medication guide.

What are the possible side effects of clonidine transdermal (Catapres-TTS)?

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

Call your doctor at once if you have any of these serious side effects:

  • fast or pounding heartbeats;
  • a very slow heart rate (fewer than 60 beats per minute);
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • confusion, hallucinations;
  • fever, pale skin;
  • urinating less than usual or not at all;
  • numbness or cold feeling in your hands or feet;
  • feeling like you might pass out; or
  • severe skin irritation, redness, swelling, burning, or blistering where the patch is worn.

Less serious side effects may include:

  • feeling dizzy, drowsy, tired, or nervous;
  • dry mouth;
  • dry or burning eyes, blurred vision;
  • headache, muscle or joint pain;
  • nausea, vomiting, constipation, loss of appetite;
  • sleep problems (insomnia);
  • urinating more at night;
  • mild skin rash or itching;
  • decreased sex drive, impotence; or
  • skin rash, discoloration, or mild irritation where the patch is worn.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about clonidine transdermal (Catapres-TTS)?

Before using clonidine transdermal, tell your doctor if you have heart disease or severe coronary artery disease, a heart rhythm disorder, a history of heart attack or stroke, or kidney disease.

Do not stop using this medication suddenly without first talking to your doctor. Stopping this medication suddenly can cause nervousness, agitation, headache, tremors, severe high blood pressure, or life-threatening symptoms. Talk with your doctor about how to avoid withdrawal symptoms when you stop using clonidine transdermal.

Avoid drinking alcohol. It can increase some of the side effects of clonidine transdermal.

Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Clonidine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

The clonidine transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the clonidine patch before undergoing such a test.

Tell any doctor or other healthcare provider who treats you that you are using clonidine transdermal. If you need emergency heart resuscitation, your family or caregivers should tell emergency medical personnel if you are wearing a clonidine skin patch. The patch should be removed before any electrical equipment (such as a defribrillator) is used on you.

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