NEXICLON™ XR (clonidine) Extended-Release Tablets are available for oral administration in 0.17 mg tablets, which is equivalent to 0.2 mg of immediate-release clonidine hydrochloride. Tablets are scored and may be split for more precise dose titration.

Dosing Guidelines1

Initial Dose
0.17 mg once daily

Elderly patients may benefit from a lower initial dose.
Initial dose is recommended to be administered at bedtime.

Maintenance Dose
Further increments of 0.09 mg once daily may be made at weekly intervals if necessary until the desired response is achieved. The therapeutic doses most commonly employed have ranged from 0.17 to 0.52 mg once daily.

Doses higher than 0.52 were not evaluated and are not recommended.

NEXICLON XR is supplied as clonidine base and contains the same active moiety (clonidine) that is found in clonidine hydrochloride immediate-release tablets. The recommended dose of NEXICLON XR for patients who are currently taking clonidine hydrochloride immediate-release tablets is provided in the table below. The dose of NEXICLON XR must be adjusted according to the patient’s individual blood pressure response. Dose adjustments may be made at weekly intervals until the desired response is achieved.

 NEXICLON XR (clonidine)
Extended-Release Tablets
Equivalent dose of Clonidine HCl
Immediate-Release Tablets
Initial Dose 0.17 mg once daily0.1 mg twice daily
Maintenance Dose Titration Increments 0.09 mg once daily 0.05 mg twice daily
Common Doses Used for Blood Pressure Effect

0.17 mg once daily 0.1 mg twice daily
0.34 mg once daily 0.2 mg twice daily
0.52 mg once daily0.3 mg twice daily

Patient Counseling Information
Caution patients against interruption of NEXICLON XR therapy without your advice. When discontinuing therapy with NEXICLON XR, reduce the dose gradually over 2 to 4 days to avoid withdrawal symptoms.

Advise patients who engage in potentially hazardous activities, such as operating machinery or driving, of a possible sedative effect of clonidine. The sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.

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.