CATAPRES-TTS-1- clonidine transdermal system patch CATAPRES-TTS-2- clonidine transdermal system patch CATAPRES-TTS-3- clonidin

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLONIDINE (UNII: MN3L5RMN02) (CLONIDINE - UNII:MN3L5RMN02)

Available from:

Technomed Inc.

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Catapres‑TTS® -1, Catapres‑TTS® -2, and Catapres-TTS® -3 are supplied as 4 pouched systems and 4 adhesive covers per carton. See chart below. Clonidine Content

Authorization status:

New Drug Application

Summary of Product characteristics

CATAPRES-TTS-1- CLONIDINE TRANSDERMAL SYSTEM PATCH
CATAPRES-TTS-2- CLONIDINE TRANSDERMAL SYSTEM PATCH
CATAPRES-TTS-3- CLONIDINE TRANSDERMAL SYSTEM PATCH
TECHNOMED INC.
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CATAPRES-TTS
(CLONIDINE TRANSDERMAL SYSTEM)
CATAPRES-TTS -1
CATAPRES-TTS -2
CATAPRES-TTS -3
PROGRAMMED DELIVERY _IN VIVO_ OF 0.1, 0.2, OR 0.3 MG CLONIDINE PER
DAY, FOR ONE
WEEK.
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Catapres‑TTS (clonidine transdermal system) 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 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.
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Cross Section of the System:
RELEASE RATE CONCEPT
Catapres‑TTS (clonidine transdermal system) is programmed to release
clonidine at an
approximately constant rate for 7 days. The energy for drug release is
derived from the