Catapres-TTS (clonidine hydrochloride) is a transdermal centrally acting alpha-agonisthypotensive agent used to treat high blood pressure (hypertension). Catapres-TTS is available as a generic named clonidine (tablets and patches).
Catapres (clonidine hydrochloride, USP and TTS) is available in strengths of 0.1, 0.2 and 0.3 mg tablets and patches for transdermal administration (TTS form).
What Drugs, Substances, or Supplements Interact with Catapres-TTS?
Catapres-TTS may interact with other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), oral clonidine, digitalis, antidepressants, beta-blockers, heart or blood pressure medicines, medicines to treat psychiatric disorders, or other drugs to treat high blood pressure or heart problems. Tell your doctor all medications and supplements you use.
Catapres-TTS During Pregnancy or Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant during treatment with Catapres-TTS; it is unknown if Catapres-TTS transdermal is harmful to a fetus. Catapres-TTS can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding. Safety and effectiveness in pediatric patients has not been established, although some pediatric physicians have used the drug to treat hypertensive children.
Additional Information
Our Catapres (clonidine hydrochloride, USP and TTS) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Catapres-TTS Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
pounding heartbeats or fluttering in your chest;
a very slow heart rate (fewer than 60 beats per minute);
shortness of breath (even with mild exertion), swelling, rapid weight gain;
hallucinations;
fever, pale skin;
painful or difficult urination;
numbness or cold feeling in your hands or feet;
a light-headed feeling, like you might pass out; or
severe skin irritation, swelling, burning, or blistering where the patch is worn.
Common side effects may include:
headache, dizziness, drowsiness, feeling tired;
feeling nervous;
dry eyes, dry mouth;
changes in your sense of taste;
sexual problems;
nausea, constipation; or
skin discoloration or mild irritation where the patch is worn.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Clinical trial experience with CATAPRES-TTS (clonidine)
Most systemic adverse effects during Catapres-TTS (clonidine) 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 (clonidine) 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 (clonidine) 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 (clonidine) 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 (clonidine)
The following adverse reactions have been identified during post-approval use
of Catapres-TTS (clonidine) 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 (clonidine)
transdermal therapeutic system.
Body as a Whole:Fever; malaise; weakness; pallor; and withdrawal
syndrome.
Central and Peripheral Nervous System/Psychiatric:Delirium;
mental depression; hallucinations (including visual and auditory); localized
numbness; vivid dreams or nightmares; restlessness; anxiety; agitation; irritability;
other behavioral changes; and drowsiness.
Dermatological: Angioneurotic edema; localized or generalized
rash; hives; urticaria; contact dermatitis; pruritus; alopecia; and localized
hypo or hyper pigmentation.
Genitourinary: Difficult micturition; loss of libido; and decreased
sexual activity.
Metabolic:Gynecomastia or breast enlargement and weight gain.
Musculoskeletal: Muscle or joint pain; and leg cramps.
Ophthalmological:Blurred vision; burning of the eyes and dryness
of the eyes.
Adverse Events Associated with Oral Catapres Therapy
Most adverse effects are mild and tend to diminish with continued therapy.
The most frequent (which appear to be dose-related) are dry mouth, occurring
in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16
in 100; constipation and sedation, each about 10 in 100. The following less
frequent adverse experiences have also been reported in patients receiving Catapres
(clonidine hydrochloride, USP) tablets, but in many cases patients were receiving
concomitant medication and a causal relationship has not been established.
Body as a Whole: Fatigue, fever, headache, pallor, weakness,
and withdrawal syndrome. Also reported were a weakly positive Coombs' test and
increased sensitivity to alcohol.
Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic
abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree
AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud's phenomenon,
syncope, and tachycardia. Cases of sinus bradycardia and AV block have been
reported, both with and without the use of concomitant digitalis.
Central Nervous System: Agitation, anxiety, delirium, delusional
perception, hallucinations (including visual and auditory), insomnia, mental
depression, nervousness, other behavioral changes, paresthesia, restlessness,
sleep disorder, and vivid dreams or nightmares.
Dermatological: Alopecia, angioneurotic edema, hives, pruritus,
rash, and urticaria.
Gastrointestinal:Abdominal pain, anorexia, constipation, hepatitis,
malaise, mild transient abnormalities in liver function tests, nausea, parotitis,
pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain,
and vomiting.
Genitourinary: Decreased sexual activity, difficulty in micturition,
erectile dysfunction, loss of libido, nocturia, and urinary retention.
&Copy; Catapres-TTS Patient Information is supplied by Cerner Multum, Inc. and Catapres-TTS Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
