CLONIDINE patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Clonidine (UNII: MN3L5RMN02) (Clonidine - UNII:MN3L5RMN02)

Available from:

Physicians Total Care, Inc.

INN (International Name):

Clonidine

Composition:

Clonidine 0.1 mg in 1 d

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Clonidine Transdermal Systems 0.1 mg, Clonidine Transdermal Systems 0.2 mg, and Clonidine Transdermal Systems 0.3 mg are supplied as 4 pouched systems and 4 adhesive covers per carton.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLONIDINE - CLONIDINE PATCH
Physicians Total Care, Inc.
----------
(Read the following instructions carefully before using this
medication. If you have any questions, please
consult with your doctor).
General Information
Clonidine Transdermal System is a tan colored, oval shaped adhesive
PATCH containing an active blood-
pressure-lowering medication. It is designed to deliver the drug into
the body through the skin smoothly
and consistently for one full week. Normal exposure to water, as in
showering, bathing, and swimming,
should not affect the PATCH.
Figure 1:
The optional white, oval shaped, ADHESIVE COVER should be applied
directly over the PATCH,
should the PATCH begin to separate from the skin. The ADHESIVE COVER
ensures that the PATCH
sticks to the skin. The Clonidine Transdermal System PATCH must be
replaced with a new one on a fresh
skin site if the one in use significantly loosens or falls off.
Skin burns have been reported at the patch site in several patients
wearing an aluminized transdermal
system during a magnetic resonance imaging scan (MRI). Because the
Clonidine Transdermal Patch
contains aluminum, it is recommended to remove the system before
undergoing an MRI.
How to Apply the Clonidine Transdermal System PATCH
1.
Apply the tan colored, oval shaped Clonidine Transdermal System PATCH
once a week,
preferably at a convenient time on the same day of the week (i.e.,
prior to bedtime on Tuesday of
week one; prior to bedtime on Tuesday of week two, etc.).
Figure 2:
2.
Select a hairless area such as on the upper, outer arm or upper chest.
The area chosen should be
free of cuts, abrasions, irritation, scars or calluses and should not
be shaved before applying the
Clonidine Transdermal System PATCH. Do not place the Clonidine
Transdermal System PATCH
on skin folds or under tight undergarments, since premature loosening
may occur.
3.
Wash hands with soap and water and thoroughly dry them.
4.
Clean the area chosen with soap and water. Rinse and wipe dry with a
clean, dry tissue.
5.
Select the pouch labele

Summary of Product characteristics

CLONIDINE - CLONIDINE PATCH
PHYSICIANS TOTAL CARE, INC.
----------
CLONIDINE TRANSDERMAL SYSTEM
(CLONIDINE)
CLONIDINE TRANSDERMAL SYSTEM 0.1 MG/DAY
CLONIDINE TRANSDERMAL SYSTEM 0.2 MG/DAY
CLONIDINE TRANSDERMAL SYSTEM 0.3 MG/DAY
CLONIDINE TRANSDERMAL SYSTEM
FORMULATED TO DELIVER _IN VIVO _0.1, 0.2, OR
0.3 MG CLONIDINE PER DAY, FOR ONE WEEK.
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Clonidine Transdermal System is a transdermal system (patch) 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: Clonidine Transdermal System is a
multi-laminate patch, 0.3 mm
thick, containing clonidine as the active agent. The patch surface
areas are 10.8 cm (Clonidine
Transdermal System 0.1 mg/day), 21.6 cm (Clonidine Transdermal System
0.2 mg/day), and 32.4 cm
(Clonidine Transdermal System 0.3 mg/day). The composition per unit
area is the same for all three
doses.
Proceeding from the outer printed backing layer towards the surface
applied to the skin, the system
comprises: 1) a backing layer of polyethylene/aluminum/polyester film;
2) a drug reservoir layer of
clonidine, isopropyl palmitate, and amine-compatible silicone
adhesive; 3) an ethylene vinyl acetate
(EVA) membrane that controls the rate of clonidine delivery from the
system to the skin; 4) an amine-
compatible silicone adhesive layer (ADHESIVE LAYER B); 5) an acrylate
adhesive layer (ADHESIVE
LAYER C) that attaches to the skin; and 6) a protective release liner
of siliconized polyester that is
removed prior to use.
Cross-sectional view of the Clonidine Transdermal System.
Not to scale.
2
2
2
RELEASE RATE CONCEPT: Clonidine Transdermal System is designed to
deliver clonidine through the
skin at an approximately constant rate for 7 days. Saturated clonidine
in the reservoir layer provide