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.
No drug interaction studies have been conducted with NEXICLON™ XR. The following have been reported with other oral formulations of clonidine.
Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose.
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.
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.
Experience with immediate release clonidine indicates that most adverse reactions are mild and tend to diminish with continued therapy. The most frequent (which also appear to be dose-related) are as follows:
Use in Specific Populations
Pregnancy: Pregnancy Category C. No adequate, well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Clonidine is secreted in human milk.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Elderly patients may benefit from a lower initial dose.
Renal Impairment: The initial dosage should be based on the degree of impairment. Monitor patients carefully for hypotension and bradycardia, and titrate to higher doses cautiously. Only a minimal amount of clonidine is removed during routine hemodialysis.
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.
- NEXICLON XR [prescribing information]. Athens, GA: Athena Bioscience LLC; 2021.