Nexiclon

The dose of NEXICLON XR must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration in adults.

2.1 Initial Dose

Dosing with NEXICLON XR should be initiated at 0.17 mg once daily. Elderly patients may benefit from a lower initial dose [see Use is Specific Populations (8.4)]. Initial dose is recommended to be administered at bedtime.

2.2 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 mg to 0.52 mg once daily.

NEXICLON XR was studied at doses of 0.17 to 0.52 mg per day. Doses higher than

0.52 mg per day were not evaluated and are not recommended.

2.3 Patients Currently Using Clonidine Hydrochloride Immediate Release Tablets

The recommended dose of NEXICLON XR for patients who are currently taking clonidine hydrochloride immediate-release tablets is provide in the table below.

NEXICLON XR (clonidine) Extended-Release Tablets Equivalent Dose of Clonidine HCl Immediate-Release Tablets Initial Dose 0.17 mg once daily 0.1 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 daily 0.3 mg twice daily 2.4 Renal Impairment

Adjust dosage according to the degree of impairment. In patients with end stage kidney disease on maintenance dialysis, start at 0.09 mg per day and up-titrate slowly to minimize dose related adverse events.

Monitor patients carefully, especially for bradycardia, sedation and hypotension. Only a minimal amount of clonidine is removed during routine hemodialysis.

In patients with moderate to severe kidney impairment not undergoing dialysis, initiate clonidine at the same dose as for patients without renal impairment. Up-titrate slowly and monitor for dose-related adverse events.