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Catapres-TTS (clonidine) -1
Catapres-TTS (clonidine) -2
Catapres-TTS (clonidine) -3
Transdermal Therapeutic System
Programmed delivery in vivo of 0.1, 0.2, or 0.3 mg clonidine per day, for one week.
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:
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 cm² (Catapres-TTS (clonidine) -1), 7.0 cm² (Catapres-TTS (clonidine) -2) and 10.5 cm² (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
|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 cm² 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 a serious side effect such as:
- 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...
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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, heart rhythm problems (such as slow/irregular heartbeat, second- or third-degree atrioventricular block).
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. Avoid alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including...
Last reviewed on RxList: 5/28/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Catapres-TTS Information
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Report Problems to the Food and Drug Administration
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