clonidine transdermal system

FDA Drug Profile — Clonidine Transdermal System USP, 0.3 mg/day, Clonidine Transdermal System USP, 0.2 mg/day, Clonidine Transdermal System USP, 0.1 mg/day, Catapres-TTS-2, Catapres-TTS-1

Drug Details

Generic Name
clonidine transdermal system
Brand Names
Clonidine Transdermal System USP, 0.3 mg/day, Clonidine Transdermal System USP, 0.2 mg/day, Clonidine Transdermal System USP, 0.1 mg/day, Catapres-TTS-2, Catapres-TTS-1, Catapres-TTS-3
Application Number
NDA018891
Sponsor
TruPharma, LLC
NDC Codes
9
Dosage Forms
PATCH
Routes
TRANSDERMAL
Active Ingredients
CLONIDINE

Indications and Usage

INDICATIONS AND USAGE Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.

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 clonidine transdermal system, 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 clonidine transdermal 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is to be discontinued in patients receiving a beta‑blocker and clonidine concurrently, the beta‑blocker should be withdrawn several days before the gradual discontinuation of clonidine transdermal system.