CATAPRES- clonidine patch, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

clonidine (UNII: MN3L5RMN02) (clonidine - UNII:MN3L5RMN02)

Available from:

Rebel Distributors Corp

INN (International Name):

clonidine

Composition:

clonidine 0.1 mg in 24 h

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Catapres-TTS® (clonidine) transdermal therapeutic system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents. CATAPRES-TTS transdermal therapeutic system should not be used in patients with known hypersensitivity to clonidine or to any other component of the therapeutic system.

Product summary:

CATAPRES-TTS-1 is supplied as 4 pouched systems and 4 adhesive covers per carton. See chart below.

Authorization status:

New Drug Application

Summary of Product characteristics

CATAPRES- CLONIDINE PATCH, EXTENDED RELEASE
REBEL DISTRIBUTORS CORP
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CATAPRES-TTS -1
TRANSDERMAL THERAPEUTIC SYSTEM
PROGRAMMED DELIVERY _IN VIVO_ OF 0.1, 0.2, OR 0.3 MG CLONIDINE PER
DAY, FOR ONE WEEK.
PRESCRIBING INFORMATION
DESCRIPTION
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. It
is an imidazoline derivative with the chemical name 2,
6-dichloro-N-2-imidazolidinylidenebenzenamine
and has the following chemical structure:
CATAPRES
SYSTEM STRUCTURE AND COMPONENTS
CATAPRES-TTS 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-1), 7.0 cm
(CATAPRES-TTS-2) and 10.5 cm (CATAPRES-TTS-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:
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
®
2
2
2
prevailing in the skin. Clonidine flows in the direction of the lower