Clonidine

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

System Structure and Components Clonidine Transdermal System, USP is a multi-layered film, 0.2 mm thick, containing clonidine as the active agent. The system areas are 3.5 cm 2 (Clonidine Transdermal System USP, 0.1 mg/day), 7.0 cm 2 (Clonidine Transdermal System USP, 0.2 mg/day) and 10.5 cm 2 (Clonidine Transdermal System USP, 0.3 mg/day) and the amount of drug released is directly proportional to the area. The composition per unit area is the same for all three doses.

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.

Clonidine transdermal system should not be used in patients with known hypersensitivity to clonidine or to any other component of the transdermal system.

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.

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, fatigue, headache, 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.

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.

Store at 25°C (77°F), excursions permitted to 15°- 30°C (59°- 86°F).