A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Catapres-TTS Indications, Dosage, Storage, Stability - Clonidine Patch
Catapres-TTS Indications, Dosage, Storage, Stability - Clonidine Patch
INDICATIONS
Clonidine film is indicated
in the treatment of
hypertension. It may be employed alone or concomitantly with other
antihypertensive
agents.
DOSAGE AND ADMINISTRATION
Apply clonidine film to
a hairless area of intact
skin on the upper arm or
torso, once every 7 days. Each new application of clonidine film
should be on a different skin
site from the previous
location. If the system loosens during 7-day wearing, the adhesive
overlay should be applied directly over the system
to ensure good adhesion.
To initiate therapy, clonidine film
dosage should be titrated
according to individual therapeutic
requirements, starting with clonidine film
0.1 mg. If after one or two weeks the desired reduction
in blood pressure
is not achieved, increase the dosage
by adding an additional clonidine film 0.1 mg
or changing to a larger system. An
increase in dosage above
the two clonidine film
0.3 mg is usually not associated
with additional efficacy.
When substituting clonidine film
in patients on prior antihypertensive therapy, physicians should
be aware that the antihypertensive
effect of clonidine film
may not commence until 2 to 3 days after initial
application. Therefore, gradual reduction
of prior drug dosage
is advised. Some or all previous antihypertensive
treatment may have
to be continued, particularly in patients with more severe forms
of hypertension.
Toxicology: In
several studies, oral clonidine
hydrochloride produced a dose-dependent increase in the incidence
and severity of spontaneously occurring retinal
degeneration in
albino rats treated for
six months or longer. Tissue distribution
studies in dogs and monkeys revealed that clonidine hydrochloride
was concentrated in the choroid
of the eye. In view of the
retinal degeneration
observed in rats, eye examinations
were performed in 908 patients prior to the start of clonidine hydrochloride
therapy, who were then examined periodically thereafter. In
353 of these 908 patients, examinations were performed for periods
of 24 months or longer. Except for some dryness of the eyes, no
drug-related abnormal
ophthalmologic findings were recorded and clonidine hydrochloride
did not alter retinal
function as shown by specialized tests such as the electroretinogram
and macular dazzle.
In rats, clonidine hydrochloride
in combination with amitriptyline produced corneal lesions within
5 days.
| TABLE 1 |
| Programmed Delivery |
Clonidine in vivo /day over 1 week |
Clonidine Content |
Size |
Code |
| Catapres-TTS-1 |
0.1 mg |
2.5 mg |
3.5 cm2 |
BI-31 |
| Catapres-TTS-2 |
0.2 mg |
5.0 mg |
7.0 cm2 |
BI-32 |
| Catapres-TTS-3 |
0.3 mg |
7.5 mg |
10.5 cm2 |
BI-33 |
HOW SUPPLIED
Catapres-TTS-1 (clonidine) and Catapres-TTS-2 are supplied as 4
pouched systems and 4 adhesive
overlays per carton, 3 cartons
per shipper. Catapres-TTS-3
is supplied as 4 pouched systems and 4 adhesive
overlays per carton.
See chart above.
Storage and Handling: Store below 86°F (30°C).
PRODUCT LISTING
Film, Extended Release - Topical - 0.1 mg/24 hr
|
| 4 x 3 |
Catapres-Tts-1, Boehringer Pharms
|
00597-0031-12
|
Film, Extended Release - Topical - 0.2 mg/24 hr
|
| 4 x 3 |
Catapres-Tts-2, Boehringer Pharms
|
00597-0032-12
|
Film, Extended Release - Topical - 0.3 mg/24 hr
|
| 4's |
Catapres-Tts-3, Boehringer Pharms
|
00597-0033-34
|
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