Clonidine

Clonidine extended-release tablets are indicated in the treatment of hypertension. Clonidine extended-release tablets may be employed alone or concomitantly with other antihypertensive agents. Clonidine extended-release tablets are a central alpha-adrenergic agonist indicated for: Treatment of hypertension ( 1 )

• The dose of clonidine extended-release tablets must be adjusted according to the patient's individual blood pressure response
• The following is a general guide to its administration
• In adults
• 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 mg to 0.52 mg once daily
• Patients with renal impairment: Up-titrate slowly Initial Dose Dosing with clonidine extended-release tablets should be initiated at 0.17 mg once daily
• Elderly patients may benefit from a lower initial dose [ see Use in Specific Populations ]
• 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 mg to 0.52 mg once daily
• Clonidine extended-release tablets were studied at doses of 0.17 to 0.52 mg once daily

0.17 mg Extended-Release Tablets (clonidine base) 0.26 mg Extended-Release Tablets (clonidine base) Extended-Release Tablets: 0.17, 0.26 mg clonidine base

• Caution patients against interruption of clonidine extended-release tablet therapy without their healthcare provider’s advice
• 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

• Clonidine extended-release tablets should not be used in patients with known hypersensitivity to clonidine [ see Warnings and Precautions ]
• Known hypersensitivity to clonidine (rash, angioedema)

No drug interaction studies have been conducted with clonidine extended-release tablets. 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. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. …

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 up-titrate 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. …

The following serious adverse reactions are discussed in detail elsewhere in the labeling: Withdrawal [ see Warnings and Precautions (5.1) ] Allergic reactions [ see Warnings and Precautions (5.2) ] There is very little experience with clonidine extended-release tablets 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 TruPharma, LLC at 1-877-541-5504 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

IN SPECIFIC POPULATIONS 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. ( 2.4 ) 8.1 Pregnancy Pregnancy Category C. …

Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma, and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.