NEXICLON XR provides the antihypertensive clinical benefits of immediate-release clonidine in a convenient once-daily, extended-release tablet1.

NEXICLON XR was studied in an open-label crossover, force titration, partially randomized trial in patients with mild and moderate essential hypertension who were on two or fewer antihypertensive medications. The trial was designed to compare steady-state exposures between the NEXICLON XR and clonidine immediate-release tablets. There were up- and down-titration phases. There was no washout period between phases or treatments.1

Following single doses of NEXICLON XR 0.17 mg, clonidine means (S.D.) peak plasma concentrations of 0.49 (+/- 0.09) ng/mL occurred at 7.8 (+/- 1.7) hours. The plasma half-life of clonidine was 13.7 (+/- 3.0) hours. There was no effect of food on the pharmacokinetic parameters.1

Graph of single dose mean concentration over time

In the multi-dose study, mild to moderate hypertensive patients were randomized to ER and BID IR clonidine formulations. The following plot shows the sitting blood pressure values for each treatment group at Day 22.

Graph of blood pressure values

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.