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Uses
NEXICLON XR is indicated in the treatment of hypertension. NEXICLON XR Tablet may be employed alone or concomitantly with other antihypertensive agents.
History
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Other Information
NEXICLON XR (clonidine) Extended-Release Tablets are available for oral administration in two dose strengths: 0.17 mg and 0.26 mg. The 0.17 mg and 0.26 mg tablets are equivalent to 0.2 mg and 0.3 mg of immediate-release clonidine hydrochloride, respectively.
Clonidine hydrochloride, a centrally active alpha-adrenergic agonist, is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2.6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:
[IC]
C9H9Cl2N3·HCl Mol. Wt. 266.56
Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol.
The inactive ingredients are: crospovidone, dental-type silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl acetate, povidone, sodium polystyrene sulfonate, triacetin. The 0.17 mg tablet also contains hypromellose 2910, polyethylene glycol, and titanium dioxide. The 0.26 mg tablet also contains D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, fractionated coconut oil, maltodextrin, polydextrose, talc, and titanium dioxide.
Sources
Nexiclon Manufacturers
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Tris Pharma, Inc.
Nexiclon | Tris Pharma, Inc.
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 DoseDosing 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 DoseFurther 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 TabletsThe 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 ImpairmentAdjust 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.
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