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 Warnings, Precautions, Pregnancy, Nursing, Abuse - Clonidine Patch
Catapres-TTS Warnings, Precautions, Pregnancy, Nursing, Abuse - Clonidine Patch
WARNINGS
No information provided.
PRECAUTIONS
General: In
patients who have developed localized
contact sensitization to clonidine film, substitution
of oral clonidine hydrochloride
therapy may be associated with development
of a generalized skin rash.
In patients who develop an allergic
reaction to clonidine
film that extends beyond
the local patch
site (such as generalized
skin rash, urticaria, or
angioedema) oral clonidine
hydrochloride
substitution may
elicit a similar reaction.
As with all antihypertensive
therapy, clonidine film
should be used with caution in patients with severe coronary insufficiency,
recent myocardial infarction, cerebrovascular
disease, or chronic
renal failure.
Transdermal clonidine systems should be removed before attempting
defibrillation or cardioversion
because of the potential
for altered electrical conductivity which may enhance the possibility
of arcing, a phenomenon
associated with the use of defibrillators.
Withdrawal: Patients should be instructed not to
discontinue therapy without consulting their physician. Sudden cessation
of clonidine treatment has resulted in subjective
symptoms such as nervousness, agitation and headache, accompanied
or followed by a rapid rise in blood
pressure and elevated catecholamine
concentrations in the plasma, but such occurrences have usually
been associated with previous administration
of high oral doses (exceeding 1.2 mg/day) and/or with continuation
of concomitant beta-blocker
therapy. Rare instances of hypertensive
encephalopathy and death
have been reported.
An excessive rise in blood
pressure following
clonidine film discontinuance
can be reversed by administration
of oral clonidine or by
intravenous phentolamine.
If therapy is to be discontinued in patients receiving beta-blockers
and clonidine concurrently, beta-blockers should be discontinued
several days before cessation of clonidine film
administration.
Perioperative Use: As
with oral clonidine therapy,
clonidine film therapy should not be interrupted during the surgical
period. Blood pressure should be carefully monitored during surgery
and additional measures to control
blood pressure
should be available if required. Physicians considering starting
clonidine film therapy
during the perioperative
period must be aware
that therapeutic
plasma clonidine levels
are not achieved until 2 to 3 days after initial
application of clonidine film
(see DOSAGE AND ADMINISTRATION.)
Information for the Patient: Patients who engage
in potentially hazardous activities, such as operating machinery
or driving, should be advised of a potential
sedative effect
of clonidine. Patients should be cautioned against interruption
of clonidine film therapy
without a physician's advice. Patients should be advised that if
the system begins to
loosen from the skin after
application, the adhesive
overlay should be applied directly over the system
to ensure good adhesion
over its 7-day lifetime. Instructions for using the system
are provided. Patients who develop moderate or severe erythema
and/or localized vesicle
formation at the site
of application, or a generalized skin
rash, should consult their physician
promptly about the possible need
to remove the patch.
Carcinogenesis, Mutagenesis, and Impairment of Fertility:
In a 132-week (fixed concentration) dietary administration
study in rats, clonidine HCl administered at 32 to 46 times the
oral maximum
recommended daily human
dose (MRDHD) was unassociated
with evidence of carcinogenic
potential. Results from the Ames test
with clonidine hydrochloride
reveled no evidence
of mutagenesis. Fertility of male
or female rats was unaffected
by clonidine doses as high as 150 mcg/kg or about 3 times the oral
MRDHD. Fertility of female
rats did, however, appear to be affected (in another experiment)
at the dose levels of 500
to 2000 mcg/kg or 10 to 40 times the oral
MRDHD.
Pregnancy, Teratogenic Effects, Pregnancy Category C:
Reproduction studies performed in rabbits at doses up to approximately
3 times the oral maximum
recommended daily human
dose (MRDHD) of Catapres
(clonidine HCl) have revealed no evidence
of teratogenic or
embryotoxic potential in rabbits. In
rats, however, doses as low as 1/3 the MRDHD of clonidine were associated
with increased resorptions in a study in which dams were treated
continuously from 2 months prior to mating. Increased resorptions
were not associated with treatment
at the same or at higher dose levels (up to 3 times the oral
MRDHD) when dams were treated days 6-15 of gestation. Increased
resorptions were observed at much higher levels (40 times the MRDHD)
in rats and mice treated days 1-14 of gestation
(lowest dose employed in the study was 500 mcg/kg). There are, however,
no adequate and well- controlled studies in pregnant
women. Because animal
reproduction studies are not always predictive of human
response, this drug should
be used during pregnancy only if clearly needed.
Nursing Mothers: As
clonidine is excreted in human
milk, caution should be exercised when clonidine film
is administered to a nursing woman.
Pediatric Use: Safety and effectiveness
in children below the age
of twelve have not been established.
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