Drugplain

Catapres-TTS-2 .2 mg/d

clonidine transdermal system · PATCH · Technomed Inc.

1 Recall on Record
Plain English

Catapres-TTS-2 is a prescription patch containing clonidine transdermal system at .2 mg/d, taken transdermal. Manufactured by Technomed Inc..

Key Facts

Brand Name
Catapres-TTS-2
Generic Name
clonidine transdermal system
NDC Code (Product)
82089-102
Manufacturer
Technomed Inc.
Strength
.2 mg/d
Dosage Form
PATCH
Route
TRANSDERMAL
Marketing Status
HUMAN PRESCRIPTION DRUG
Application #
NDA018891
Drug Class
Adrenergic alpha2-Agonists [MoA]; Central alpha-2 Adrenergic Agonist [EPC]
Marketing Start
03/01/2022

Recall History

1 Recall on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

application site pruritus337 reports
application site erythema295 reports
drug ineffective262 reports
blood pressure increased249 reports
application site rash195 reports
product adhesion issue148 reports
hypertension140 reports
application site irritation119 reports
headache93 reports
blood pressure inadequately controlled83 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Catapres‑TTS ® is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.

Dosage & Administration

DOSAGE AND ADMINISTRATION Apply Catapres‑TTS ® (clonidine transdermal 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 ® 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 ® 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 ® for oral clonidine or for other antihypertensive drugs, physicians should be aware that the antihypertensive effect of Catapres‑TTS ® may not commence until 2‑3 days after initial application. Therefore, gradual reduction of prior drug dosage

Warnings

WARNINGS 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 ® 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

Contraindications

CONTRAINDICATIONS Catapres‑TTS ® should not be used in patients with known hypersensitivity to clonidine or to any other component of the transdermal system.

Drug Interactions

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 ).

Adverse Reactions

ADVERSE REACTIONS Clinical trial experience with Catapres-TTS ® Most systemic adverse effects during Catapres-TTS ® therapy have been mild and have tended to diminish with continued therapy. In a 3‑month multi-clinic trial of Catapres-TTS ® 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 ® 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 general

Frequently Asked Questions

What is Catapres-TTS-2 used for?

Catapres-TTS-2 contains clonidine transdermal system. It is a patch taken transdermal. Consult your doctor for specific uses.

Is Catapres-TTS-2 a controlled substance?

Catapres-TTS-2 is not classified as a controlled substance by the DEA.

What is the generic name for Catapres-TTS-2?

The generic name for Catapres-TTS-2 is clonidine transdermal system. There are 10 other brand versions of clonidine transdermal system.

What is the NDC code for Catapres-TTS-2 .2 mg/d?

The NDC (National Drug Code) for Catapres-TTS-2 .2 mg/d is 82089-102, listed by Technomed Inc..