NEXICLON XR® (Clonidine Extended Release) Tablet is a central alpha-adrenergic agonist indicated for:

• Treatment of hypertension (1)

• 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 (2.1).
• 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 (2.2).
• Patients with renal impairment: Uptitrate slowly (2.3).

• Known hypersensitivity to clonidine (rash, angioedema)

• 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. (5.1)
• Monitor closely and uptitrate slowly in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease, or chronic renal failure (5.2)
• Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine (5.2)
• In perioperative use, NEXICLON XR Tablet may be administered up to 28 hours prior to surgery and resumed the following day (5.3)

There is very little experience with NEXICLON XR Tablet in controlled trials.  Based on this limited experience, the adverse event profile appears similar with the immediate release clonidine formulation. The most commonly expected adverse reactions are dry mouth, drowsiness, and dizziness. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 and http://www.trispharma.com or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma Inc at 1-732-940-0358 and www.trispharma.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Sedating drugs: Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs (7)
• Tricyclic antidepressants: May reduce the hypotensive effect of clonidine, necessitating an increase in clonidine dose (7)
• Drugs known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers, beta-blockers): Additive effects such as bradycardia and AV block (7)

• Pregnancy Category C (8.1)
• Clonidine is secreted in human milk (8.2)
• Safety and effectiveness in children have not been established (8.3)
• Renal impairment: Dose may need adjustment (