NEXICLON™ XR (clonidine) Extended-Release Tablets is indicated in the treatment of hypertension. NEXICLON XR may be employed alone or concomitantly with other antihypertensive agents.
IMPORTANT SAFETY CONSIDERATIONS
NEXICLON XR should not be used in patients with known hypersensitivity to clonidine (rash, angioedema, hives).
Warnings and Precautions
Patients should not discontinue therapy without consulting a physician. Dose reduction should be performed gradually over a 2- to 4-day period to avoid withdrawal symptomatology. Rare instances of hypertensive encephalopathy, cerebrovascular accidents, and death have been reported after clonidine withdrawal.
Monitor carefully and titrate slowly in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease, or chronic renal failure.
Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine.
In perioperative use, NEXICLON XR may be administered up to 28 hours prior to surgery and resumed the following day.
There is very little experience with NEXICLON XR in controlled trials. Based on this limited experience, the adverse event profile of NEXICLON XR appears similar to that of immediate release clonidine formulation. The most commonly expected adverse reactions are dry mouth, drowsiness, and dizziness.
No drug interaction studies have been conducted with NEXICLON XR; however the following have been reported with other oral formulations of clonidine:
Use in Specific Populations
Please see Full Prescribing Information for additional product information.
You are encouraged to report negative side effects of prescription drugs to Athena Bioscience, LLC at 1-833-874-2664 or to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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