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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (C's) » Clonidine Patch



DESCRIPTION

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 and is an antihypertensive agent. It is an imidazoline derivative whose chemical name is 2,6-dichloro-N-2-imidazolidinylidenebenzenamine.

System Structure and Components: Catapres-TTS is a multilayered film, 0.2 mm thick, containing clonidine as the active agent. System area is 3.5, 7.0, or 10.5 cm2 and the amount of drug released is directly proportional to area. (See Release Rate Concept). The composition per unit area of all three dosages is identical.

Proceeding from the visible surface towards the surface attached to the skin, are four layers 1) a backing layer of pigmented polyester 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 peel strip of polyester that covers layer 4 is removed.

Cross Section of the System - Backing; Drug Reservoir; Control Membrane; Adhesive; Protective Peel Strip

Release Rate Concept: Clonidine film is programmed to release clonidine at an approximately constant rate for 7 days. The energy source for drug release derives 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 sites below the system. Clonidine from the drug reservoir then begins to wflow 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 clonidine film.

The 3.5, 7.0, and 10.5 cm2 systems respectively deliver 0.1, 0.2, and 0.3 mg clonidine per day. To ensure constant release of drug over 7 days, the total drug content of the system is greater 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 clonidine film is removed and not replaced with a new system, therapeutic plasma clonidine levels will persist for about 8 hours and than decline slowly over several days. Over this time period, blood plasma returns gradually to pretreatment levels. If the patient experiences localized skin irritation before completing 7 days of use, the system may be removed and replaced with a new one applied on a fresh skin site.

CATEGORIES, BRAND NAMES

CATEGORIES: Hypertension, essential; Pregnancy Category C; FDA Approved 1984 Oct; Orphan Drugs

FDA Drug Classes: Antihypertensives

BRAND NAMES:

BRAND NAMES: Arkamin; Barclyd; Capril; Caprysin; Catapres; Catapres-TTS; Catapres TTS; Catapresan; Catapresan 100; Catapresan Depot; Catapresan TTS; Catapressan; Clonidine; Daipres; Dixarit; Haemiton; Normopresan; Paracefan; Sulmidine; Taitecin
(Foreign Brand names outside U.S. in italics)

FOREIGN BRAND AVAILABILITY:
Arkamin (India)
Barclyd (France)
Capril (Thailand)
Caprysin (Finland)
Catapres (Australia; Bahamas; Bahrain; Barbados; Belize; Benin; Bermuda; Burkina-Faso; Canada; Curacao; Cyprus; Egypt; England; Ethiopia; Gambia; Ghana; Guinea; Guyana; Hong-Kong; India; Indonesia; Iran; Iraq; Israel; Ivory-Coast; Jamaica; Japan; Jordan; Kenya; Korea; Kuwait; Liberia; Malawi; Mali; Mauritania; Mauritius; Morocco; Netherland-Antilles; New-Zealand; Niger; Nigeria; Oman; Philippines; Qatar; Saudi-Arabia; Senegal; Seychelles; Sierra-Leone; South-Africa; Sudan; Surinam; Taiwan; Tanzania; Thailand; Trinidad; Tunia; Uganda; United-Arab-Emirates; Zambia; Zimbabwe)
Catapres TTS (New-Zealand)
Catapresan (Austria; Belgium; Colombia; Costa-Rica; Denmark; Dominican-Republic; Ecuador; El-Salvador; Finland; Germany; Greece; Guatemala; Honduras; Italy; Netherlands; Nicaragua; Norway; Panama; Peru; Portugal; Spain; Sweden)
Catapresan 100 (Mexico)
Catapresan Depot (Czech-Republic; Germany; Switzerland)
Catapresan TTS (Italy)
Catapressan (Argentina; France)
Clonidine (Thailand)
Daipres (Japan)
Dixarit (Malaysia)
Haemiton (Bahrain; Cyprus; Egypt; Germany; Iran; Iraq; Israel; Jordan; Kuwait; Lebanon; Libya; Oman; Qatar; Republic-Of-Yemen; Saudi-Arabia; Syria; United-Arab-Emirates)
Normopresan (Israel)
Paracefan (Belgium)
Sulmidine (Japan)
Taitecin (Japan)





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