Contraindications

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.

Drug Interactions

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.

Adverse Events

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:

Dry Mouth~40%
Drowsiness~33%
Dizziness~16%
Constipation~10%
Sedation~10%

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.

References:

  1. NEXICLON XR [prescribing information]. Athens, GA: Athena Bioscience LLC; 2021.

Important Safety Information

INDICATION

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

Contraindications

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.

Adverse Reactions

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.

Drug Interactions

No drug interaction studies have been conducted with NEXICLON XR; however 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.
  • Tricyclic antidepressants may reduce the hypotensive effect of clonidine, necessitating an increase in clonidine dose.
  • Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.

Use in Specific Populations

  • Pregnancy Category C. Clonidine is secreted in human milk.
  • Safety and effectiveness in pediatric patients have not been established.
  • Dose may need adjustment in patients with renal impairment.
  • Elderly patients may benefit from a lower initial dose.

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.