Drugplain

Clonidine Transdermal System USP, 0.2 mg/day .2 mg/d

clonidine transdermal system · PATCH · TruPharma, LLC

No Recall History
Plain English

Clonidine Transdermal System USP, 0.2 mg/day is a patch containing clonidine transdermal system at .2 mg/d, taken transdermal. Manufactured by TruPharma, LLC.

Key Facts

Brand Name
Clonidine Transdermal System USP, 0.2 mg/day
Generic Name
clonidine transdermal system
NDC Code (Product)
52817-611
Manufacturer
TruPharma, LLC
Strength
.2 mg/d
Dosage Form
PATCH
Route
TRANSDERMAL
Marketing Status
Application #
NDA018891
Drug Class
Central alpha-2 Adrenergic Agonist [EPC]
Marketing Start
06/30/2023

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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.

Dosage & Administration

DOSAGE AND ADMINISTRATION Apply Clonidine Transdermal System, USP once every 7 days to a hairless area of intact skin on the upper outer arm or chest. Each new application of Clonidine Transdermal System, USP 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, Clonidine Transdermal System, USP dosage should be titrated according to individual therapeutic requirements, starting with Clonidine Transdermal System USP, 0.1 mg/day. If after one or two weeks the desired reduction in blood pressure is not achieved, increase the dosage by adding another Clonidine Transdermal System USP, 0.1 mg/day or changing to a larger system. An increase in dosage above two Clonidine Transdermal Systems USP, 0.3 mg/day is usually not associated with additional efficacy. When substituting Clonidine Transdermal System, USP for oral clonidine or for other antihypertensive drugs, physicians should be aware that the antihypertensive effect…

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 con…

Contraindications

CONTRAINDICATIONS Clonidine transdermal system 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 clonidine transdermal system Most systemic adverse effects during clonidine transdermal system therapy have been mild and have tended to diminish with continued therapy. In a 3‑month multi-clinic trial of clonidine transdermal 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 clonidine transdermal system was observed in 5 patients. Other skin reactions were localized vesiculation (7 patients), hyperpigmentation (5), edema (3), excoriation (3), burning (3), …

Frequently Asked Questions

What is Clonidine Transdermal System USP, 0.2 mg/day used for?

Clonidine Transdermal System USP, 0.2 mg/day contains clonidine transdermal system. It is a patch taken transdermal. Consult your doctor for specific uses.

Is Clonidine Transdermal System USP, 0.2 mg/day a controlled substance?

Clonidine Transdermal System USP, 0.2 mg/day is not classified as a controlled substance by the DEA.

What is the generic name for Clonidine Transdermal System USP, 0.2 mg/day?

The generic name for Clonidine Transdermal System USP, 0.2 mg/day is clonidine transdermal system. There are 10 other brand versions of clonidine transdermal system.

What is the NDC code for Clonidine Transdermal System USP, 0.2 mg/day .2 mg/d?

The NDC (National Drug Code) for Clonidine Transdermal System USP, 0.2 mg/day .2 mg/d is 52817-611, listed by TruPharma, LLC.

Product NDC

52817-611

Package NDC

52817-611-04

Other Clonidine Transdermal System USP, 0.2 mg/day Dosages

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)