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Generic Name
Clonidine
Brand Names
Catapres-TTS-1, Catapres-TTS-2, Catapres-TTS-3, Clonidine HCI, Clonidine Transdermal, Duraclon, Javadin, Nexiclon, ONYDA
FDA approval date: September 04, 1987
Classification: Central alpha-2 Adrenergic Agonist
Form: Patch, Injection, Tablet, Suspension, Solution
What is Catapres-TTS-1 (Clonidine)?
Catapres‑TTS ® is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.
Approved To Treat
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Brand Information
Catapres-TTS-1 (clonidine transdermal system)
1DESCRIPTION
Catapres‑TTS
1.1System Structure and Components
Catapres‑TTS
Proceeding from the visible surface towards the surface attached to the skin, there are four consecutive layers: 1) a backing layer of pigmented polyester and aluminum film; 2) a drug reservoir of clonidine, mineral oil, polyisobutylene, and colloidal silicon dioxide; 3) a microporous polypropylene membrane that controls the rate of delivery of clonidine from the system to the skin surface; 4) an adhesive formulation of clonidine, mineral oil, polyisobutylene, and colloidal silicon dioxide. Prior to use, a protective slit release liner of polyester that covers the adhesive layer is removed.
Cross Section of the System:
1.2Release Rate Concept
Catapres‑TTS
Following system application to intact skin, clonidine in the adhesive layer saturates the skin site below the system. Clonidine from the drug reservoir then begins to flow through the rate‑controlling membrane and the adhesive layer of the system into the systemic circulation via the capillaries beneath the skin. Therapeutic plasma clonidine levels are achieved 2 to 3 days after initial application of Catapres‑TTS
The 4.33, 8.67, and 13 cm
2CLINICAL 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.
2.1Pharmacokinetics
Catapres‑TTS
Following intravenous administration clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine has a total clearance of 177 mL/min and a renal clearance of 102 mL/min. The apparent volume of distribution (V
Following oral administration, about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug within 24 hours. About 50% of the absorbed dose is metabolized in the liver.
After removal of the Catapres‑TTS
3INDICATIONS AND USAGE
Catapres‑TTS
4CONTRAINDICATIONS
Catapres‑TTS
5OVERDOSAGE
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
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 LD
6DOSAGE AND ADMINISTRATION
Apply Catapres‑TTS
To initiate therapy, Catapres‑TTS
When substituting Catapres‑TTS
6.1Renal Impairment
Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.
7HOW SUPPLIED
Catapres‑TTS
8STORAGE AND HANDLING
Store at 20°C to 25°C (68°F to77°F) [see USP Controlled Room Temperature].
Manufactured by:
Grand Rapids, MI 49512
Catapres-TTS
Address medical inquiries to: (866) 380-1080
Copyright © 2021 Technomed Inc.
Revised: November 2025
222100
9PATIENT INSTRUCTIONS
Catapres-TTS
(clonidine transdermal system)
(clonidine transdermal system)
(Read the following instructions carefully before using this medication. If you have any questions, please consult with your doctor.)
General Information
Catapres‑TTS
The optional ivory, round ADHESIVE COVER should be applied directly over the SYSTEM, should the SYSTEM begins to separate from the skin. The ADHESIVE COVER ensures that the SYSTEM sticks to the skin. The Catapres-TTS
Figure 1
Skin burns have been reported at the application site in several patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI). Because the Catapres-TTS
How to Apply the Catapres-TTS® SYSTEM
1. Apply the square, tan Catapres‑TTS
Each box of Catapres‑TTS
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 Catapres‑TTS® SYSTEM. Do not place the Catapres‑TTS® SYSTEM 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. Avoid use of products that may prevent proper adhesion, such as alcohol, lotions, oils or moisturizers.
5. Select the pouch with the pink, red or dark magenta color stripe along the front side, labeled Catapres-TTS® and open it as illustrated in Figure 3. Remove the square, tan PATCH from the pouch.
Figure 3
6. Remove the clear plastic backing from the SYSTEM by gently peeling off one half of the backing at a time as shown in Figure 4. Avoid touching the sticky side of the Catapres‑TTS
Figure 4
7. Place the Catapres‑TTS
Figure 5
8. After one week, remove the old SYSTEM and discard it (refer to
What to do if your Catapres-TTS
How to Apply the ADHESIVE COVER
Note: The white, round, ADHESIVE COVER does not contain any drug and should not be used alone. The COVER should be applied directly over the Catapres‑TTS® SYSTEM only if the SYSTEM begins to separate from the skin, thereby ensuring that it sticks to the skin for seven full days.
Figure 6
- Wash hands with soap and water and thoroughly dry them.
- Using a clean, dry tissue, make sure that the area around the square, tan Catapres-TTS
- Take the white, round, ADHESIVE COVER (Figure 6) from the plain white pouch and remove the paper liner backing from the COVER.
- Carefully center the round, white ADHESIVE COVER over the square, tan Catapres‑TTS
How should I store the Catapres-TTS
Store the Catapres-TTS® at room temperature 68°F to 77°F (20°C to 25°C)
Store the Catapres-TTS® at room temperature 68°F to 77°F (20°C to 25°C)
Store transdermal system in pouch until ready for use.
Instructions for Disposal
During or even after use, a SYSTEM contains active medication which may be harmful to infants and children if accidentally applied or ingested. After use, fold in half with the sticky sides together. Dispose of carefully out of reach of children.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Manufactured by:
Grand Rapids, MI 49512
Catapres-TTS
Copyright © 2021 Technomed Inc.
Revised: November 2025
222100
10PRINCIPAL DISPLAY PANEL - 0.1 mg Carton
NDC 82089-01-34
Note New Appearance
Catapres-TTS
(clonidine transdermal system)
(clonidine transdermal system)
4 Systems and 4 Adhesive Covers
Programmed delivery
per day for one week.
Rx only
For Transdermal Use Only -
See package insert for dosage information
To avoid possible burns, remove the Catapres-TTS® system before undergoing an MRI (magnetic resonance imaging) procedure.
11PRINCIPAL DISPLAY PANEL - 0.1 mg Adhesive Cover
Contents: 1 ADHESIVE COVER
WARNING
THIS DOES NOT CONTAIN
ACTIVE MEDICATION.
APPLY OVER THE PATCH,
IF NECESSARY
Suggestions for use of this adhesive
cover are in the patient information
sheet.
12PRINCIPAL DISPLAY PANEL - 0.1 mg Pouch
Note New Appearance
Catapres-TTS®-1
(clonidine transdermal system)
Programmed delivery in vivo of 0.1 mg clonidine
per day for one week.
To avoid possible burns, remove the
Catapres-TTS
undergoing an MRI (magnetic
resonance imaging) procedure.
Rx only
222102
13PRINCIPAL DISPLAY PANEL - 0.2 mg Carton
NDC 82089-
Note New Appearance
Catapres-TTS
(clonidine transdermal system)
(clonidine transdermal system)
4 Systems and 4 Adhesive Covers
Programmed delivery
per day for one week.
Rx only
For Transdermal Use Only -
See package insert for dosage information
To avoid possible burns, remove the Catapres-TTS® system before undergoing an MRI (magnetic resonance imaging) procedure.
14PRINCIPAL DISPLAY PANEL - 0.2 mg Adhesive Cover
Contents: 1 ADHESIVE COVER
WARNING
THIS DOES NOT CONTAIN
ACTIVE MEDICATION.
APPLY OVER THE PATCH,
IF NECESSARY.
Suggestions for use of this adhesive
cover are in the patient information
sheet.
15PRINCIPAL DISPLAY PANEL - 0.2 mg Pouch
Note New Appearance
Catapres-TTS®-2
(clonidine transdermal system)
Programmed delivery in vivo of 0.2 mg clonidine
per day for one week.
To avoid possible burns, remove the
Catapres-TTS
undergoing an MRI (magnetic
resonance imaging) procedure.
Rx only
222105
16PRINCIPAL DISPLAY PANEL carton - 0.3 mg
NDC 82089-
Note New Appearance
Catapres-TTS
(clonidine transdermal system)
(clonidine transdermal system)
4 Systems and 4 Adhesive Covers
Programmed delivery
per day for one week.
Rx only
For Transdermal Use Only -
See package insert for dosage information
To avoid possible burns, remove the Catapres-TTS
17PRINCIPAL DISPLAY PANEL - 0.3 mg Adhesive Cover
Contents: 1 ADHESIVE COVER
WARNING
THIS DOES NOT CONTAIN
ACTIVE MEDICATION.
APPLY OVER THE PATCH,
IF NECESSARY.
Suggestions for use of this adhesive
cover are in the patient information sheet.
18PRINCIPAL DISPLAY PANEL - 0.3 mg Pouch
Note New Appearance
Catapres-TTS
(clonidine transdermal system)
(clonidine transdermal system)
Programmed delivery in vivo of 0.3 mg clonidine
per day for one week.
To avoid possible burns, remove the
Catapres-TTS
undergoing an MRI (magnetic
resonance imaging) procedure.
Rx only
222108
