Clonidine transdermal system .2 mg/d
Clonidine · PATCH · Actavis Pharma, Inc.
Clonidine transdermal system is a patch containing clonidine at .2 mg/d, taken transdermal. Manufactured by Actavis Pharma, Inc..
Key Facts
- Brand Name
- Clonidine transdermal system
- Generic Name
- Clonidine
- NDC Code (Product)
0591-3509- Manufacturer
- Actavis Pharma, Inc.
- Strength
- .2 mg/d
- Dosage Form
- PATCH
- Route
- TRANSDERMAL
- Marketing Status
- Application #
- ANDA090873
- Drug Class
- Central alpha-2 Adrenergic Agonist [EPC]
- Marketing Start
- 05/06/2014
Recall History
Teva Pharmaceuticals USA, Inc
CGMP Deviations: use of an unapproved raw material
Mayne Pharma Inc
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Teva Pharmaceuticals USA, Inc
CGMP Deviations: use of an unapproved raw material
Teva Pharmaceuticals USA, Inc
CGMP Deviations: use of an unapproved raw material
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 used for?
Clonidine transdermal system contains Clonidine. It is a patch taken transdermal. Consult your doctor for specific uses.
Is Clonidine transdermal system a controlled substance?
Clonidine transdermal system is not classified as a controlled substance by the DEA.
What is the generic name for Clonidine transdermal system?
The generic name for Clonidine transdermal system is Clonidine. There are 11 other brand versions of Clonidine.
What is the NDC code for Clonidine transdermal system .2 mg/d?
The NDC (National Drug Code) for Clonidine transdermal system .2 mg/d is 0591-3509, listed by Actavis Pharma, Inc..
Other Clonidine Brands
See all →- Clonidine Hydrochloride.1 mg/172162-2609
- Clonidine Hydrochloride500 ug/mL0143-9723
- clonidine hydrochloride.2 mg/146708-307
- clonidine hydrochloride.1 mg/150090-5577
- Clonidine Hydrochloride.1 mg/150090-6744
- clonidine hydrochloride.1 mg/150090-7009
- Clonidine hydrochloride.3 mg/151655-451
- Clonidine Transdermal System USP, 0.2 mg/day.2 mg/d52817-611
- Clonidine Transdermal System USP, 0.3 mg/day.3 mg/d52817-612
- Clonidine Hydrochloride.1 mg/155154-0189
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)