Clonidine Transdermal System
Generic Name: clonidine transdermal system
Brand Names:
Clonidine Transdermal System Usp, 0.1 Mg/day, Clonidine Transdermal System Usp, 0.2 Mg/day, Clonidine Transdermal System Usp, 0.3 Mg/day
DESCRIPTION Clonidine Transdermal System, USP provides continuous systemic delivery of clonidine for 7 days at an approximately constant rate. Clonidine is a centrally acting alpha‑agonist hypotensive agent. It is an imidazoline derivative with the chemical name 2,6‑dichloro‑N‑2‑imidazolidinylidenebenzenamine and has the following chemical structure: System Structure and Components Clonidine Transdermal System, USP is a multi-layered film, 0.2 mm thick, containing clonidine as the active agent.
Overview
DESCRIPTION Clonidine Transdermal System, USP provides continuous systemic delivery of clonidine for 7 days at an approximately constant rate. Clonidine is a centrally acting alpha‑agonist hypotensive agent. It is an imidazoline derivative with the chemical name 2,6‑dichloro‑N‑2‑imidazolidinylidenebenzenamine and has the following chemical structure: System Structure and Components Clonidine Transdermal System, USP is a multi-layered film, 0.2 mm thick, containing clonidine as the active agent.
Uses
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
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.
Side Effects
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.
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.
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. CONTRAINDICATIONS Clonidine transdermal system should not be used in patients with known hypersensitivity to clonidine or to any other component of the transdermal system.
Pregnancy
Pregnancy Teratogenic Effects Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating.
Storage
STORAGE AND HANDLING Store at 25°C (77°F); excursions permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature]. Distributed by: TruPharma LLC, Tampa FL 33609, USA Address medical inquiries to: (877) 541-5504 Revised: March 2023 222078
Frequently Asked Questions
What is Clonidine Transdermal System used for?▼
INDICATIONS AND USAGE Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.
What are the side effects of Clonidine Transdermal System?▼
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.
Can I take Clonidine Transdermal System during pregnancy?▼
Pregnancy Teratogenic Effects Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating.
What are the important warnings for Clonidine Transdermal System?▼
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. CONTRAINDICATIONS Clonidine transdermal system should not be used in patients with known hypersensitivity to clonidine or to any other component of the transdermal system.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.