Clonidine Dosage

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Usual Adult Dose for Hypertension

Initial dose (PO): 0.1 mg orally twice a day (morning and bedtime).
Maintenance dose: 0.2 to 0.6 mg/day given in divided doses.

Initial dose (patches):Clonidine TTS-1 (0.1 mg/24 hr) applied once a week.
Maintenance dose: If after 1 to 2 weeks the desired reduction in blood pressure is not achieved, increase the dosage by adding another TTS-1 film or changing to a larger system.
An increase in dosage above 2 clonidine TTS-3 films is usually not associated with additional efficacy.

Extended-release tablets:
Initial dose: 0.17 mg orally once daily at bedtime. Further increments of 0.09 mg orally once daily may be made at weekly intervals if necessary until the desired response is achieved.
Maintenance dose: 0.17 mg to 0.52 mg orally once daily at bedtime

Extended-release oral suspension:
Initial dose: 0.17 mg (2 mL) orally once daily at bedtime. Further increments of 0.09 mg (1 mL) orally once daily may be made at weekly intervals if necessary until the desired response is achieved.
Maintenance dose: 0.17 mg to 0.52 mg orally once daily at bedtime

Usual Adult Dose for Pain

Continuous Epidural Infusion:
Initial dose: 30 mcg/hr.
May be titrated up or down depending on pain relief and occurrence of adverse events.
Maximum dose 40 mcg/hr.

Usual Adult Dose for Pheochromocytoma Diagnosis

0.3 mg orally once. Clonidine is only recommended after baseline determination of plasma catecholamines. Two baseline samples can be obtained five minutes apart from an existing IV line after the patient has remained supine for 90 minutes (a new needle stick could increase catecholamine concentrations and foul the test).

After the initial dose of clonidine, three additional hourly blood samples may be obtained for plasma catecholamine concentration measurements.

Generally, patients with hypertension and pheochromocytoma do NOT show a decrease in plasma catecholamine levels after this "suppression test", whereas hypertensive patients without pheochromocytoma do. False negative tests have been reported.

Usual Adult Dose for Hypertensive Emergency

0.2 mg orally once. Additional doses of 0.1 mg may be given as needed and tolerated every hour to control this patient's blood pressure. Be cognizant of the risk of stroke or heart attack or other problem associated with aggressive blood pressure reduction, especially in older persons. The maximum recommended total daily dose in any case of emergent hypertension is 0.8 mg.

Some clinicians report a poor antihypertensive effect of clonidine in patients with spinal injuries since this drug acts on the central nervous system to inhibit peripheral sympathetic tone, and the central and peripheral nervous systems are disrupted in these patients.

Usual Adult Dose for Alcohol Withdrawal

0.1 mg orally twice a day or TTS-1 (0.1 mg) transdermal patch once a week.

Usual Adult Dose for Anxiety

0.1 mg orally twice a day or TTS-1 (0.1 mg) transdermal patch once a week.

Usual Adult Dose for Benzodiazepine Withdrawal

0.1 mg orally twice a day or TTS-1 (0.1 mg) transdermal patch once a week.

Usual Adult Dose for Migraine Prophylaxis

0.1 mg orally twice a day or TTS-1 (0.1 mg) transdermal patch once a week.

Usual Adult Dose for Perimenopausal Symptoms

0.1 mg orally twice a day or TTS-1 (0.1 mg) transdermal patch once a week.

Usual Adult Dose for Smoking Cessation

0.1 mg orally twice a day or TTS-1 (0.1 mg) transdermal patch once a week.

Usual Adult Dose for Bipolar Disorder

0.1 mg orally twice a day or TTS-1 (0.1 mg) transdermal patch once a week.

Usual Adult Dose for Opiate Withdrawal

0.2 mg orally twice a day or TTS-2 (0.2 mg) transdermal patch once a week.

Usual Pediatric Dose for Attention Deficit Disorder

May be used alone or as an adjunct to stimulants.

Immediate release (unlabeled indication):
Children less than or equal to 45 kg:
Initial dose: 0.05 mg orally at bedtime. Increase sequentially every 3 to 7 days by 0.05 mg increments as 2 times daily, then 3 times daily, then 4 times daily.
Maximum dose: 0.2 mg/day orally for patients weighing 27 to 40.5 kg; 0.3 mg/day for patients weighing 40.5 to 45 kg.
When discontinuing therapy, taper gradually over 1 to 2 weeks.

Children greater than 45 kg:
Initial dose: 0.1 mg orally at bedtime. Increase sequentially every 3 to 7 days by 0.1 mg increments as 2 times daily, then 3 times daily, then 4 times daily
Maximum dose: 0.4 mg/day
When discontinuing therapy, taper gradually over 1 to 2 weeks.

Extended release (Kapva {R}):
Children greater than or equal to 6 years:
Initial dose: 0.1 mg orally at bedtime. Increase in 0.1 mg/day increments every 7 days until desired response. Doses should be administered twice daily (either split equally or with the higher split dosage given at bedtime).
Maximum dose: 0.4 mg/day orally
Note: Maintenance treatment for greater than 5 weeks has not been evaluated.
When discontinuing therapy, taper daily dose by less than or equal to 0.1 mg every 3 to 7 days.
Transdermal: Children may be switched to the transdermal delivery system after oral therapy is titrated to an optimal and stable dose; a transdermal dose approximately equivalent to the total oral daily dose may be used.

The dose of clonidine extended-release tablets, administered either as monotherapy or as adjunctive therapy to a psychostimulant, should be individualized according to the therapeutic needs and response of the patient. Dosing should be initiated with one 0.1 mg tablet at bedtime, and the daily dosage should be adjusted in increments of 0.1 mg/day at weekly intervals until the desired response is achieved. Doses should be taken twice a day, with either an equal or higher split dosage being given at bedtime.

Renal Dose Adjustments

Doses should be titrated up slowly in patients with renal dysfunction.

CrCl less than 10 mL/min: The dose should be reduced by 50% to 75% of the normal initial dose.

For extended-release tablets and oral suspension: 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 titrate up slowly to minimize dose related adverse events.

Liver Dose Adjustments

Data not available

Dose Adjustments

Elderly patients may benefit from a lower initial dose.

Dosing adjustments of 0.1 mg/day, may be made at weekly intervals if necessary until the desired response is achieved.

When switching from immediate-release to extended-release tablets:
Initial dose: Substitute 0.17 mg extended-release orally once daily for 0.1 mg immediate-release orally twice daily
Maintenance dose titration increments: Substitute 0.09 mg extended-release orally once daily for 0.05 mg immediate-release orally twice daily
Maintenance doses: Substitute 0.17 mg extended-release orally once daily for 0.1 mg immediate-release orally twice daily, or 0.34 mg extended-release orally once daily for 0.2 mg immediate-release orally twice daily, or 0.52 mg extended-release orally once daily for 0.3 mg immediate-release orally twice daily.

When switching from immediate-release tablets to extended-release oral suspension:
Initial dose: Substitute 0.17 mg (2 mL) extended-release orally once daily for 0.1 mg immediate-release orally twice daily
Maintenance dose titration increments: Substitute 0.09 mg (1 mL) extended-release orally once daily for 0.05 mg immediate-release orally twice daily
Maintenance doses: Substitute 0.17 mg (2 mL) extended-release orally once daily for 0.1 mg immediate-release orally twice daily, or 0.34 mg (4 mL) extended-release orally once daily for 0.2 mg immediate-release orally twice daily, or 0.52 mg (6 mL) extended-release orally once daily for 0.3 mg immediate-release orally twice daily.

Precautions

When substituting clonidine topical film for oral clonidine or for other antihypertensive drugs, the antihypertensive effect of clonidine topical film may not commence until 2 to 3 days after initial application. Therefore, gradual reduction of prior drug dosage is advised. Some or all previous antihypertensive treatment may have to be continued, particularly in patients with more severe forms of hypertension.

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.

Patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease, or chronic renal failure should have their dosage titrated up slowly.

In perioperative use, clonidine extended-release tablets and suspension may be administered up to 28 hours prior to surgery and resumed the following day.

Clonidine extended-release tablet formulation is dosed twice a day, the same as the immediate-release clonidine formulation, but it is not to be used interchangeably with the immediate-release formulation.

Clonidine extended-release tablets must be swallowed whole and never crushed, cut or chewed.

Clonidine extended-release tablets may be taken with or without food.

Due to the lack of controlled clinical trial data and differing pharmacokinetic profiles, substitution clonidine extended-release tablets for other clonidine products on a mg-per-mg basis is not recommended.

Elderly patients may benefit from a lower initial dose of clonidine.

Safety and effectiveness of clonidine immediate-release, patches, extended-release tablets, and extended-release suspension have not been established in pediatric patients (less than 18 years of age). Safety and effectiveness of clonidine extended-release tablets have not been studied in children with ADHD less than 6 years old.

Dialysis

Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.

Other Comments

Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. In addition, administration at bedtime may minimize the risk of morning-associated cardiovascular events (i.e., stroke, transient ischemic attacks, myocardial infarction, or sudden cardiac death). Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.

Apply clonidine topical film once every 7 days to a hairless area of intact skin on the upper outer arm or chest. Each new application of should be on a different skin site from the previous location. If the system loosens during 7-day wearing, the adhesive overlay should be applied directly over the system to ensure good adhesion. There have been rare reports of the need for patch changes prior to 7 days to maintain blood pressure control.

The effectiveness of clonidine extended-release tablets for longer-term use (more than 5 weeks) has not been systematically evaluated in controlled trials. Therefore the physician electing to use clonidine extended-release tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

When discontinuing clonidine extended-release tablets, the total daily dose should be tapered in decrements of no more than 0.1 mg every 3 to 7 days.

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