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Catapres-TTS
Overview
What is Catapres-TTS?
CATAPRES‑TTS (clonidine)
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
What does Catapres-TTS look like?
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What should I talk to my health care provider before I take Catapres-TTS?
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How should I use Catapres-TTS?
Catapres‑TTS transdermal therapeutic system
is indicated in the treatment of hypertension. It may be employed
alone or concomitantly with other antihypertensive agents.
Apply CATAPRES‑TTS (clonidine) transdermal therapeutic system once every 7 days to
a hairless area of intact skin on the upper outer arm or chest. Each
new application of CATAPRES‑TTS transdermal therapeutic system should
be on a different skin site from the previous location. If the system
loosens during 7‑day wearing, the adhesive cover should be applied
directly over the system to ensure good adhesion. There have been
rare reports of the need for patch changes prior to 7 days to maintain
blood pressure control.
To initiate
therapy, CATAPRES‑TTS transdermal therapeutic system dosage should
be titrated according to individual therapeutic requirements, starting
with CATAPRES‑TTS-1. If after one or two weeks the desired reduction
in blood pressure is not achieved, increase the dosage by adding another
CATAPRES‑TTS-1 or changing to a larger system. An increase in dosage
above two CATAPRES‑TTS-3 is usually not associated with additional
efficacy.
When substituting CATAPRES‑TTS
transdermal therapeutic system for oral clonidine or for other antihypertensive
drugs, physicians should be aware that the antihypertensive effect
of CATAPRES‑TTS transdermal therapeutic system may not commence until
2‑3 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.
What interacts with Catapres-TTS?
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.
What are the warnings of Catapres-TTS?
Withdrawal
Patients should be instructed not to discontinue
therapy without consulting their physician. Sudden cessation of clonidine
treatment has, in some cases, resulted in symptoms such as nervousness,
agitation, headache, tremor, and confusion accompanied or followed
by a rapid rise in blood pressure and elevated catecholamine concentrations
in the plasma. The likelihood of such reactions to discontinuation
of clonidine therapy appears to be greater after administration of
higher doses or continuation of concomitant beta‑blocker treatment
and special caution is therefore advised in these situations. Rare
instances of hypertensive encephalopathy, cerebrovascular accidents
and death have been reported after clonidine withdrawal. When discontinuing
therapy with CATAPRES, the physician should reduce the dose gradually
over 2 to 4 days to avoid withdrawal symptomatology.
An excessive rise in blood pressure following discontinuation
of CATAPRES‑TTS transdermal therapeutic system therapy can be reversed
by administration of oral clonidine hydrochloride or by intravenous
phentolamine. If therapy is to be discontinued in patients receiving
a beta‑blocker and clonidine concurrently, the beta‑blocker should
be withdrawn several days before the gradual discontinuation of CATAPRES‑TTS
transdermal therapeutic system.
What are the precautions of Catapres-TTS?
General
In patients
who have developed localized contact sensitization to CATAPRES‑TTS (clonidine) transdermal therapeutic system continuation
of CATAPRES‑TTS transdermal therapeutic system or substitution of
oral clonidine hydrochloride therapy may be associated with development
of a generalized skin rash.
In
patients who develop an allergic reaction to CATAPRES‑TTS transdermal
therapeutic system, substitution of oral clonidine hydrochloride may
also elicit an allergic reaction (including generalized rash, urticaria,
or angioedema).
The sympatholytic
action of clonidine may worsen sinus node dysfunction and atrioventricular
(AV) block, especially in patients taking other sympatholytic drugs.
There are post-marketing reports of patients with conduction abnormalities
and/or taking other sympatholytic drugs who developed severe bradycardia
requiring IV atropine, IV isoproterenol and temporary cardiac pacing
while taking clonidine.
In hypertension
caused by pheochromocytoma, no therapeutic effect of CATAPRES‑TTS
transdermal therapeutic system can be expected.
In rare instances, loss of blood pressure control has
been reported in patients using CATAPRES‑TTS transdermal therapeutic
system according to the instructions for use.
Perioperative Use
CATAPRES‑TTS transdermal therapeutic system
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 CATAPRES‑TTS transdermal therapeutic
system 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 Catapres-TTS transdermal therapeutic
system (see ).
Defibrillation or Cardioversion
The transdermal clonidine systems should
be removed before attempting defibrillation or cardioversion because
of the potential for altered electrical conductivity which may increase
the risk of arcing, a phenomenon associated with the use of defibrillators.
MRI
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 CATAPRES-TTS
PATCH contains aluminum, it is recommended to remove the system before
undergoing an MRI.
Information for Patients
Patients should be cautioned against interruption of CATAPRES‑TTS
transdermal therapeutic system therapy without their physician’s advice.
Since patients may experience a possible
sedative effect, dizziness, or accommodation disorder with use of
clonidine, caution patients about engaging in activities such as driving
a vehicle or operating appliances or machinery. Also, inform patients
that this sedative effect may be increased by concomitant use of alcohol,
barbiturates, or other sedating drugs.
Patients who wear contact lenses should be cautioned
that treatment with CATAPRES-TTS (clonidine)
transdermal therapeutic system may cause dryness of eyes.
Patients should be instructed to consult
their physicians promptly about the possible need to remove the patch
if they observe moderate to severe localized erythema and/or vesicle
formation at the site of application or generalized skin rash.
If a patient experiences isolated, mild
localized skin irritation before completing 7 days of use, the system
may be removed and replaced with a new system applied to a fresh skin
site.
If the system should begin
to loosen from the skin after application, the patient should be instructed
to place the adhesive cover directly over the system to ensure adhesion
during its 7‑day use.
Used CATAPRES‑TTS
PATCHES contain a substantial amount of their initial drug content
which may be harmful to infants and children if accidentally applied
or ingested. THEREFORE, PATIENTS SHOULD BE CAUTIONED TO KEEP BOTH
USED AND UNUSED CATAPRES‑TTS PATCHES OUT OF THE REACH OF CHILDREN.
After use, CATAPRES‑TTS should be folded in half with the adhesive
sides together and discarded away from children’s reach.
Instructions for use, storage and disposal
of the system are provided at the end of this monograph. These instructions
are also included in each box of CATAPRES‑TTS transdermal therapeutic
system.
Drug Interactions
Clonidine may potentiate the CNS-depressive
effects of alcohol, barbiturates or other sedating drugs. If a patient
receiving clonidine is also taking tricyclic antidepressants, the
hypotensive effect of clonidine may be reduced, necessitating an increase
in the clonidine dose. If a patient receiving clonidine is also taking
neuroleptics, orthostatic regulation disturbances (e.g., orthostatic
hypotension, dizziness, fatigue) may be induced or exacerbated.
Monitor heart rate in patients receiving
clonidine concomitantly with agents known to affect sinus node function
or AV nodal conduction e.g., digitalis, calcium channel blockers,
and beta‑blockers. Sinus bradycardia resulting in hospitalization
and pacemaker insertion has been reported in association with the
use of clonidine concomitantly with diltiazem or verapamil.
Amitriptyline in combination with clonidine
enhances the manifestation of corneal lesions in rats (see ).
Toxicology
In several
studies with oral clonidine hydrochloride, a dose-dependent increase
in the incidence and severity of spontaneous retinal degeneration
was seen in albino rats treated for six months or longer. Tissue distribution
studies in dogs and monkeys showed a concentration of clonidine in
the choroid.
In view of the retinal
degeneration seen in rats, eye examinations were performed during
clinical trials in 908 patients before, and periodically after, the
start of clonidine therapy. In 353 of these 908 patients, the eye
examinations were carried out over periods of 24 months or longer.
Except for some dryness of the eyes, no drug‑related abnormal ophthalmological
findings were recorded and, according to specialized tests such as
electroretinography and macular dazzle, retinal function was unchanged.
In combination with amitriptyline, clonidine
hydrochloride administration led to the development of corneal lesions
in rats within 5 days.
Carcinogenesis, Mutagenesis,
Impairment of Fertility
Chronic dietary administration of clonidine was not carcinogenic
to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up
to 46 to 70 times the maximum recommended daily human dose as mg/kg
(9 or 6 times the MRDHD on a mg/m basis).
There was no evidence of genotoxicity in the Ames test for mutagenicity
or mouse micronucleus test for clastogenicity.
Fertility of male and female rats was unaffected by
clonidine doses as high as 150 µg/kg (approximately 3 times the MRDHD).
In a separate experiment, fertility of female rats appeared to be
affected at dose levels of 500 to 2000 µg/kg (10 to 40 times the oral
MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m basis).
Pregnancy
Teratogenic Effects
Reproduction
studies performed in rabbits at doses up to approximately 3 times
the oral maximum recommended daily human dose (MRDHD) of CATAPRES (clonidine hydrochloride) produced no evidence of
a teratogenic or embryotoxic potential in rabbits. In rats, however,
doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m basis) 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 the dams were treated on gestation days 6 to
15. Increases in resorption were observed at much higher dose levels
(40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD
on a mg/mbasis) in mice and rats treated
on gestation days 1 to 14 (lowest dose employed in the study was 500
µg/kg).
No adequate well‑controlled
studies have been conducted in pregnant women. Clonidine crosses
the placental barrier (see ). 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 Catapres‑TTS (clonidine) transdermal therapeutic system is administered to a
nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients
have not been established in adequate and well-controlled trials.
What are the side effects of Catapres-TTS?
Clinical trial experience with CATAPRES-TTS
Most systemic adverse effects during Catapres-TTS transdermal
therapeutic system therapy have been mild and have tended to diminish
with continued therapy. In a 3‑month multi-clinic trial of CATAPRES-TTS
transdermal therapeutic system in 101 hypertensive patients, the systemic
adverse reactions were, dry mouth (25 patients) and drowsiness (12),
fatigue (6), headache (5), lethargy and sedation (3 each), insomnia,
dizziness, impotence/sexual dysfunction, dry throat (2 each) and constipation,
nausea, change in taste and nervousness (1 each).
In the above mentioned 3‑month controlled clinical trial,
as well as other uncontrolled clinical trials, the most frequent adverse
reactions were dermatological and are described below.
In the 3‑month trial, 51 of the 101 patients
had localized skin reactions such as erythema (26 patients) and/or
pruritus, particularly after using an adhesive cover throughout the
7‑day dosage interval. Allergic contact sensitization to CATAPRES‑TTS
transdermal therapeutic system was observed in 5 patients. Other
skin reactions were localized vesiculation (7 patients), hyperpigmentation
(5), edema (3), excoriation (3), burning (3), papules (1), throbbing
(1), blanching (1), and a generalized macular rash (1).
In additional clinical experience, contact
dermatitis resulting in treatment discontinuation was observed in
128 of 673 patients (about 19 in 100) after a mean duration of treatment
of 37 weeks. The incidence of contact dermatitis was about 34 in
100 among white women, about 18 in 100 in white men, about 14 in 100
in black women, and approximately 8 in 100 in black men. Analysis
of skin reaction data showed that the risk of having to discontinue
CATAPRES‑TTS (clonidine) transdermal therapeutic
system treatment because of contact dermatitis was greatest between
treatment weeks 6 and 26, although sensitivity may develop either
earlier or later in treatment.
In a large‑scale clinical acceptability and safety study by 451 physicians
in a total of 3539 patients, other allergic reactions were recorded
for which a causal relationship to CATAPRES‑TTS transdermal therapeutic
system was not established: maculopapular rash (10 cases); urticaria
(2 cases); and angioedema of the face (2 cases), which also affected
the tongue in one of the patients.
Marketing Experience with CATAPRES-TTS
The following adverse reactions have been identified
during post-approval use of CATAPRES-TTS transdermal therapeutic system.
Because these reactions are reported voluntarily from a population
of uncertain size, it is not always possible to estimate reliably
their frequency or establish a causal relationship to drug exposure.
Decisions to include these reactions in labeling are typically based
on one or more of the following factors: (1) seriousness of the reaction,
(2) frequency of reporting, or (3) strength of causal connection to
CATAPRES-TTS transdermal therapeutic system.
Body as a Whole:
Cardiovascular:
Central and Peripheral Nervous System/Psychiatric:
Dermatological:
Gastrointestinal:
Genitourinary:
Metabolic:
Musculoskeletal:
Ophthalmological:
Adverse Events Associated with Oral CATAPRES Therapy:
Body as a Whole:
Cardiovascular:
Central Nervous System:
Dermatological:
Gastrointestinal:
Genitourinary:
Hematologic:
Metabolic:
Musculoskeletal:
Oro-otolaryngeal:
Ophthalmological:
What should I look out for while using Catapres-TTS?
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.
What might happen if I take too much Catapres-TTS?
Hypertension may develop early and may be
followed by hypotension, bradycardia, respiratory depression, hypothermia,
drowsiness, decreased or absent reflexes, weakness, irritability and
miosis. The frequency of CNS depression may be higher in children
than adults. Large overdoses may result in reversible cardiac conduction
defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms
of overdose generally occur within 30 minutes to two hours after exposure.
As little as 0.1 mg of clonidine has produced signs of toxicity in
children.
If symptoms of poisoning
occur following dermal exposure, remove all Catapres‑TTS (clonidine) transdermal therapeutic systems. After
their removal, the plasma clonidine levels will persist for about
8 hours, then decline slowly over a period of several days. Rare
cases of CATAPRES‑TTS poisoning due to accidental or deliberate mouthing
or ingestion of the patch have been reported, many of them involving
children.
There is no specific
antidote for clonidine overdosage. Ipecac syrup‑induced vomiting
and gastric lavage would not be expected to remove significant amounts
of clonidine following dermal exposure. If the patch is ingested,
whole bowel irrigation may be considered and the administration of
activated charcoal and/or cathartic may be beneficial. Supportive
care may include atropine sulfate for bradycardia, intravenous fluids
and/or vasopressor agents for hypotension and vasodilators for hypertension.
Naloxone may be a useful adjunct for the management of clonidine‑induced
respiratory depression, hypotension and/or coma; blood pressure should
be monitored since the administration of naloxone has occasionally
resulted in paradoxical hypertension. Dialysis is not likely to significantly
enhance the elimination of clonidine.
The largest overdose reported to date, involved a 28‑year
old male who ingested 100 mg of clonidine hydrochloride powder. This
patient developed hypertension followed by hypotension, bradycardia,
apnea, hallucinations, semicoma, and premature ventricular contractions.
The patient fully recovered after intensive treatment. Plasma clonidine
levels were 60 ng/mL after 1 hour, 190 ng/mL after 1.5 hours, 370 ng/mL
after 2 hours, and 120 ng/mL after 5.5 and 6.5 hours. In mice and
rats, the oral LDof clonidine is 206 and
465 mg/kg, respectively.
How should I store and handle Catapres-TTS?
Storage and HandlingStore in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not leave PEGASYS out of the refrigerator for more than 24 hours. Do not freeze or shake. Protect from light. Vials, prefilled syringes and autoinjectors are for single use only. Discard any unused portion remaining in the vial, prefilled syringe.Storage and HandlingStore in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not leave PEGASYS out of the refrigerator for more than 24 hours. Do not freeze or shake. Protect from light. Vials, prefilled syringes and autoinjectors are for single use only. Discard any unused portion remaining in the vial, prefilled syringe.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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Clonidine stimulates alpha‑adrenoreceptors in the brain stem. This
action results in reduced sympathetic outflow from the central nervous
system and in decreases in peripheral resistance, renal vascular resistance,
heart rate, and blood pressure. Renal blood flow and glomerular filtration
rate remain essentially unchanged. Normal postural reflexes are intact;
therefore, orthostatic symptoms are mild and infrequent.
Acute studies with clonidine hydrochloride
in humans have demonstrated a moderate reduction (15% to 20%) of cardiac
output in the supine position with no change in the peripheral resistance;
at a 45° tilt there is a smaller reduction in cardiac output and a
decrease of peripheral resistance.
During long‑term therapy, cardiac output tends to return to control
values, while peripheral resistance remains decreased. Slowing of
the pulse rate has been observed in most patients given clonidine,
but the drug does not alter normal hemodynamic responses to exercise.
Tolerance to the antihypertensive effect
may develop in some patients, necessitating a reevaluation of therapy.
Other studies in patients have provided evidence
of a reduction in plasma renin activity and in the excretion of aldosterone
and catecholamines. The exact relationship of these pharmacologic
actions to the antihypertensive effect of clonidine has not been fully
elucidated.
Clonidine acutely stimulates
the release of growth hormone in children as well as adults but does
not produce a chronic elevation of growth hormone with long‑term use.
Non-Clinical Toxicology
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.Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated.
Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction e.g., digitalis, calcium channel blockers, and beta‑blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.
Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see ).
In patients who have developed localized contact sensitization to CATAPRES‑TTS (clonidine) transdermal therapeutic system continuation of CATAPRES‑TTS transdermal therapeutic system or substitution of oral clonidine hydrochloride therapy may be associated with development of a generalized skin rash.
In patients who develop an allergic reaction to CATAPRES‑TTS transdermal therapeutic system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema).
The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine.
In hypertension caused by pheochromocytoma, no therapeutic effect of CATAPRES‑TTS transdermal therapeutic system can be expected.
In rare instances, loss of blood pressure control has been reported in patients using CATAPRES‑TTS transdermal therapeutic system according to the instructions for use.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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