CloNIDine (Lexi-Drugs)

ALERT: US Boxed Warning
  Epidural use:
Pronunciation

(KLON i deen)

Brand Names: US

Catapres; Catapres-TTS-1; Catapres-TTS-2; Catapres-TTS-3; Duraclon; Kapvay

Brand Names: Canada

APO-CloNIDine; Catapres [DSC]; Dixarit [DSC]; DOM-CloNIDine; MINT-CloNIDine; TEVA-CloNIDine

Pharmacologic Category

Alpha2-Adrenergic AgonistAntihypertensive

Dosing: Adult

Note: Dosing is expressed as the salt (clonidine hydrochloride) unless otherwise noted. Formulations of clonidine (immediate release versus extended release) are not interchangeable on a mg:mg basis due to different pharmacokinetic profiles. Compounded oral suspensions may be available in multiple concentrations (up to 10-times more concentrated); precautions should be taken to verify and avoid confusion between the different concentrations; dose should be clearly presented as mcg or mg as appropriate.

Hypertension (alternative agent):

Oral: Immediate release: Initial dose: 0.1 mg twice daily; maximum dose: 2.4 mg/day; usual dose range: 0.1 to 0.8 mg/day in 2 divided doses (ACC/AHA [Whelton 2017])

Transdermal: Initial: 0.1 mg/24 hour patch applied once every 7 days and increase by 0.1 mg at 1- to 2-week intervals (dosages >0.6 mg/24 hours do not improve efficacy); usual dose range: 0.1 to 0.3 mg/24 hour patch applied once every 7 days (ACC/AHA [Whelton 2017])

Acute hypertension (urgency) (off-label use): Oral: Initial 0.1 to 0.2 mg; may be followed by additional doses of 0.1 mg every hour, if necessary, to a maximum total dose of 0.7 mg (Atkin 1992; Jaker 1989)

Off-label route of administration: Sublingual: Initial: 0.1 to 0.2 mg; followed by 0.05 to 0.1 mg every hour until blood pressure controlled or a cumulative dose of 0.7 mg is reached (Cunningham 1994; Matuschka 1999)

Clozapine-induced sialorrhea (off-label use):

Oral: Initial: 0.05 mg at bedtime; if no improvement after 2 weeks, may increase to 0.1 mg at bedtime (Praharaj 2005)

Transdermal: 0.1 to 0.2 mg/24 hour patch applied once weekly (Grabowski 1992).

Note: Additional data may be necessary to further define the role of clonidine in this condition.

Nicotine withdrawal symptoms (off-label use) (Fiore 2008):

Oral: Initial: 0.1 mg twice daily; titrate by 0.1 mg/day every 7 days if needed; dosage range used in clinical trials: 0.15 to 0.75 mg/day; duration of therapy ranged from 3 to 10 weeks in clinical trials

Transdermal: Initial: 0.1 mg/24 hour patch applied once every 7 days and increase by 0.1 mg at 1-week intervals if necessary; dosage range used in clinical trials: 0.1 to 0.2 mg/24 hour patch applied once every 7 days; duration of therapy ranged from 3 to 10 weeks in clinical trials

Opioid withdrawal (off-label use): Oral: Immediate release: Initial: 0.1 mg to 0.2 mg every 6 to 8 hours; adjust dose based on the amount needed to control withdrawal symptoms (using the Clinical Opioid Withdrawal Scale [COWS]) and effect on blood pressure (APA [Kleber 2006]; Gowing 2016; Sevarino 2017). Inpatients may receive higher initial doses if blood pressure and sedation are closely monitored (APA [Kleber 2006]; Sevarino 2017). Dosage range: 0.1 to 0.3 mg every 6 to 8 hours (maximum: 1.2 mg/day) (APA [Kleber 2006]; ASAM [Kampman 2015]). Note: Clonidine may be combined with other non-narcotic medications (eg, benzodiazepines) (APA [Kleber 2006]; ASAM [Kampman 2015]).

Tourette syndrome (off-label use): Oral: Immediate release: Initial: 0.025 to 0.05 mg once daily; gradually increase dose based on response and tolerability up to a usual dosage of 0.1 to 0.6 mg/day in 3 to 4 divided doses (Murphy 2013; Pringsheim 2012; Roessner 2011).

Vasomotor symptoms associated with menopause (off-label use; alternative agent):

Oral: 0.1 mg daily or 0.05 to 0.075 mg twice daily (AACE [Goodman 2011]; Boekhout 2011; Buijs 2009; Loibl 2007)

Transdermal: 0.1 mg/24 hour patch applied once every 7 days (Goldberg 1994; Nagamani 1987). Note: Transdermal administration may be preferred due to more stable blood levels (Stuenkel 2015).

Pain management: Epidural infusion: Reserved for cancer patients with severe intractable pain, unresponsive to other opioid analgesics: Starting dose: 30 mcg/hour; titrate as required for relief of pain or presence of side effects; experience with doses >40 mcg/hour is limited; should be considered an adjunct to opioid therapy

Conversion from oral to transdermal: Note: If transitioning from oral to transdermal therapy, overlap oral regimen for 1 to 2 days; transdermal route takes 2 to 3 days to achieve therapeutic effects. An example transition is below:

Day 1: Place Catapres-TTS 1; administer 100% of oral dose.

Day 2: Administer 50% of oral dose.

Day 3: Administer 25% of oral dose.

Day 4: Patch remains, no further oral supplement necessary.

Conversion from transdermal to oral: After transdermal patch removal, therapeutic clonidine levels persist for ~8 hours and then slowly decrease over several days. Consider starting oral clonidine no sooner than 8 hours after patch removal.

Dosing: Geriatric

Hypertension: Oral: Immediate release: Initial: 0.1 mg once daily at bedtime, increase gradually as needed.

Dosing: Renal Impairment: Adult

Oral (immediate release), transdermal, epidural: The manufacturer recommends dosage adjustment according to degree of renal impairment; however, no specific dosage adjustment provided in manufacturer’s labeling. Bradycardia, sedation, and hypotension may be more likely to occur in patients with renal failure; half-life significantly prolonged in patients with severe renal failure; consider use of lower initial doses and monitor closely.

Hemodialysis: Not dialyzable (0% to 5%); supplemental dose is not necessary. Oral antihypertensive drugs given preferentially at night may reduce the nocturnal surge of blood pressure and minimize the intradialytic hypotension that may occur when taken the morning before a dialysis session (K/DOQI 2005).

Dosing: Hepatic Impairment: Adult

No dosage adjustment provided in manufacturer’s labeling.

Dosing: Pediatric

Note: Dosing is expressed as the salt (clonidine hydrochloride) unless otherwise noted. Formulations of clonidine (immediate release vs extended release) are not interchangeable on a mg per mg basis due to different pharmacokinetic profiles. Compounded oral suspensions may be available in multiple concentrations (eg, up to a 10-times more concentrated); precautions should be taken to verify and avoid confusion between the different concentrations; dose should be clearly presented as mcg or mg as appropriate.

Attention-deficit/hyperactivity disorder (ADHD): Children ≥6 years and Adolescents:

Oral:

Immediate release: Limited data available (Pliszka 2007):

≤45 kg: Initial: 0.05 mg at bedtime; sequentially increase every 3 to 7 days in 0.05 mg/day increments given as 0.05 mg twice daily, then 3 times daily, then 4 times daily; maximum daily dose weight-dependent: Patient weight: 27 to 40.5 kg: 0.2 mg/day; patient weight: 40.5 to 45 kg; 0.3 mg/day

>45 kg: Initial: 0.1 mg at bedtime; sequentially increase every 3 to 7 days in 0.1 mg/day increments given as 0.1 mg twice daily, then 3 times daily, then 4 times daily; maximum daily dose: 0.4 mg/day

Extended release (Kapvay): Initial: 0.1 mg at bedtime; increase in 0.1 mg/day increments every 7 days until desired response; doses should be administered twice daily in the morning and at bedtime (either split equally or with the higher split dosage given at bedtime); maximum daily dose: 0.4 mg/dayNote: When discontinuing therapy, taper daily dose by ≤0.1 mg every 3 to 7 days.

Topical: Transdermal patch: Limited data available: Children ≥6 years and adolescents 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; apply transdermal patch and change every 5 to 7 days. Adjustment in dose of transdermal patch may be needed; there is variation in absorption and no exact equivalence or fixed ratio exist between the oral and transdermal routes (Du 2008; Hunt 1987; Hunt 1990).

Clonidine tolerance test (test of growth hormone release from the pituitary): Limited data available: Children and Adolescents: Oral: Immediate release: 0.15 mg/m2 or 5 mcg/kg as a single dose; maximum dose: 0.25 mg (250 mcg) (Lanes 1982; Richmond 2008)

Conduct disorder/oppositional-defiant disorder with or without ADHD: Limited data available; efficacy results variable (Connor 2010; Pringsheim 2015): Children ≥5 years and Adolescents: Oral: Immediate release: Initial: 0.05 mg/day; gradual titration every 3 to 7 days in 0.05 mg increments to a 2 or 3 times daily dose schedule has been used most frequently, some patients may require 4 daily doses; usual final dose range: 0.2 to 0.3 mg/day in 2 to 3 divided doses, reported overall range: 0.15 to 0.4 mg/day in divided doses; most reported experience in patients with ADHD comorbidity (Connor 2000; Hazell 2003; Kemph 1993; Palumbo 2008)

Epidural analgesia, adjunct therapy: Note: Manufacturer suggests reserving use for severe intractable pain, unresponsive to other opioid analgesics (eg, patients with cancer).

Children and Adolescents: Epidural: Continuous infusion: Initial: 0.5 mcg/kg/hour; adjust with caution, based on clinical effect; do not exceed adult doses. Do not discontinue clonidine abruptly; if needed, gradually reduce dose over 2 to 4 days to avoid withdrawal symptoms.

Hypertension:

Chronic: Limited data available:

Oral: Immediate release:

Weight-directed dosing: Children and Adolescents: Initial: 5 to 10 mcg/kg/day in divided doses every 8 to 12 hours; increase gradually as needed; usual range: 5 to 25 mcg/kg/day in divided doses every 8 to 12 hours; maximum daily dose: 0.9 mg/day (Flynn 2006; Kavey 2010; Rocchini 1984)

Fixed dosing: Children ≥12 years and Adolescents: Initial: 0.1 mg twice daily; increase gradually. In adults, titration is done by increasing by 0.1 mg/day at weekly intervals; usual maintenance dose: 0.2 to 0.6 mg/day in divided doses; maximum recommended daily dose: 2.4 mg/day (rarely required) (NHBPEP 2004; NHLBI 2012)

Topical: Transdermal patch: Limited data available: Children and Adolescents: Based on information from other indications, 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; apply transdermal patch and change every 5 to 7 days. Adjustment in dose of transdermal patch may be needed; there is variation in absorption and no exact equivalence or fixed ratio exist between the oral and transdermal routes (Galloway 2000; Hunt 1990).

Hypertensive urgency: Limited data available:

Weight-directed dosing: Children and Adolescents: Oral: Immediate release: 2 to 5 mcg/kg/dose every 6 to 8 hours. Some patients may require doses up to 10 mcg/kg/dose (AAP [Flynn 2017].

Fixed dosing: Children and Adolescents: Oral: Immediate release: 0.05 to 0.1 mg/dose; may repeat dose(s) up to a maximum total dose of 0.8 mg (NHBPEP 2004)

Neuropathic pain: Limited data available: Children and Adolescents:

Oral: Immediate release: Some centers use the following doses (Galloway 2000): Initial: 2 mcg/kg/dose every 4 to 6 hours; increase incrementally over several days; range: 2 to 4 mcg/kg/dose every 4 to 6 hours

Topical: Transdermal patch: 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; apply transdermal patch and change every 5 to 7 days. Adjustment in dose of transdermal patch may be needed; there is variation in absorption and no exact equivalence or fixed ratio exist between the oral and transdermal routes (Galloway 2000).

Sedation, critically ill patients: Limited data available: Infants, Children, and Adolescents: Oral: Immediate release: Usual reported dose: 1 to 5 mcg/kg/dose every 6 to 8 hours; maximum dose: 200 mcg/dose; reported daily dose range: 2 to 20 mcg/kg/day; Avoid abrupt discontinuation to prevent withdrawal symptoms (Arenas-López 2004; Capino 2016; Duffett 2014; Playfor 2006)

Tic disorders and Tourette syndrome: Limited data available; greater efficacy shown in patients with ADHD comorbidity (Weisman 2013): Children ≥7 years and Adolescents: Oral: Immediate release: Initial: 0.025 to 0.05 mg/day; gradual titration to a 3 to 4 times daily schedule using small increments (0.025 mg); usual daily dose: 0.1 to 0.4 mg/day in 3 to 4 divided doses (AACAP [Murphy 2013]; Pringsheim 2012; The Tourette Syndrome Study Group 2002)

Dosing: Renal Impairment: Pediatric

Children and Adolescents: Oral [extended release (Kapvay)], epidural: The manufacturer recommends dosage adjustment according to degree of renal impairment; however, there are no specific dosage adjustment provided in the labeling (has not been studied). Bradycardia, sedation, and hypotension may be more likely to occur in patients with renal failure; drug is primarily eliminated unchanged in the urine; consider using doses at the lower end of the dosage range; monitor patients closely.

Hemodialysis: Not dialyzable (0 to 5%); supplemental dose is not necessary.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Use: Labeled Indications

Attention-deficit/hyperactivity disorder (extended-release tablet): Treatment of attention-deficit/hyperactivity disorder (ADHD) (monotherapy or as adjunctive therapy)

Hypertension (immediate-release tablet and transdermal patch): Management of hypertension. Note: Not recommended for the initial treatment of hypertension (ACC/AHA [Whelton 2017]). Clonidine should be avoided for the treatment of hypertension in patients with heart failure with reduced ejection fraction (HFrEF) of ischemic origin (AHA/ACC/ASH [Rosendorff 2015]).

Pain management (epidural): Continuous epidural administration as adjunctive therapy with opioids for treatment of severe cancer pain in patients tolerant to or unresponsive to opioids alone; epidural clonidine is generally more effective for neuropathic pain and less effective (or possibly ineffective) for somatic or visceral pain.

Use: Off-Label: Adult

  Clozapine-induced sialorrheaLevel of Evidence [C]

Data from a limited number of patients studied in case reports and an open label naturalistic case series suggest that oral and transdermal clonidine may be beneficial for the treatment of clozapine-induced sialorrhea Ref. Additional data may be necessary to further define the role of clonidine in this condition.

  Diagnosis of pheochromocytomaLevel of Evidence [B]

The clonidine suppression test for pheochromocytoma has a positive predictive value of 67% to 93% and a negative predictive value of 94% to 100% from published reports. Clonidine is generally safe when adequate precautions are taken to avoid hypotension. Additional testing (MRI, CT scan, or 24-hour urinary excretion of norepinephrine and 3,4-dihydroxyphenylglycol) is generally necessary to confirm diagnosis and locate the tumor. Interpretation of the results can vary, and the definition of a positive test will affect the sensitivity and specificity. False-negatives are possible when the tumor is moderately active or has intermittent secretory activity. More investigation into the possible causes of false-positives and false-negatives may increase the diagnostic value of the test. Access Full Off-Label Monograph

  Growth hormone stimulation testLevel of Evidence [G]

Current guidelines support the use of clonidine to assess GH secretion in potential GHD patients. Trials have demonstrated the efficacy of clonidine, and thus it remains an effective tool for the diagnosis of GHDRef.

  Opioid withdrawalLevel of Evidence [B, G]

Data from a meta-analysis of alpha2-agonists for the management of opioid withdrawal supports the use of alpha2-agonists like clonidine in decreasing the severity and duration of opioid withdrawal Ref. Additional trials may be necessary to further define the role of clonidine in this condition.

Based on the Veterans Affairs/Department of Defense (VA/DoD) guidelines for the management of substance use disorders, clonidine is a second-line option for patients with opioid use disorder when methadone and buprenorphine are contraindicated, unacceptable or unavailable, and it may be particularly useful as an adjunctive agent for symptom relief during inpatient medically supervised opioid withdrawal (VA/DoD 2015). In addition, the American Society of Addiction Medicine (ASAM) guidelines for the use of medications in the treatment of addiction involving opioid use recommends clonidine to reduce withdrawal symptoms in the management of opioid withdrawal. Clonidine is most effective at targeting the autonomic symptoms of opioid withdrawal. Hypotensive effects may limit the amount that can be used. Clonidine is often administered with other non-opioid medications targeting specific opioid withdrawal symptoms (eg, benzodiazepines, loperamide, acetaminophen/NSAIDs, ondansetron) (ASAM [Kampman 2015]).

  Tourette syndromeLevel of Evidence [B, G]

Data from a meta-analysis and small, randomized double-blind controlled trials support the use of clonidine in the treatment Tourette syndrome and chronic tic disorders (including patients with comorbid ADHD) in adults Ref. Additional trials may be necessary to further define the role of clonidine in this condition.

Based on the European Society for the Study of Tourette Syndrome and the Tourette Canada Guidelines, drug therapy, including clonidine, is effective and recommended for the management of Tourette syndrome to improve quality of life with tics that are painful or distressing, interfere with daily functioning, or cause sustained social or emotional problems. Similarly, based on the American Academy of Child and Adolescent Psychiatry practice parameter for the treatment of Children and Adolescents with Tic Disorders, drug therapy, including clonidine, is effective and recommended for the management of moderate to severe tics causing severe impairment in quality of life in chronic tic disorders, including Tourette syndrome, in young adults. Because of clonidine’s preferable side effect profile in comparison to antipsychotics, clonidine is considered a first-line option for reducing tics and ADHD symptoms in patients with Tourette syndrome and comorbid ADHD. Access Full Off-Label Monograph

  Vasomotor symptoms associated with menopauseLevel of Evidence [B, G]

In a meta-analysis of trials evaluating the treatment of vasomotor symptoms associated with menopause, the use of clonidine was effective in short term trials; however, outcomes were inconsistent Ref. Data from double blind trials supports the use of clonidine in the treatment of vasomotor symptoms (hot flashes) of premature menopause in women treated for breast cancer Ref.

Based on the American Association of Clinical Endocrinologists (AACE) Medical Guidelines for The Diagnosis and Treatment of Menopause, clonidine is an alternative agent for the management of vasomotor symptoms associated with menopause in patients with contraindications to or unable to tolerate preferred therapies. Based on the Canadian Comité de l’évolution des pratiques en oncologie (CEPO) evidenced based review, clonidine is recommended as a nonhormonal option for managing hot flashes in female breast cancer patients and survivors being treated with or without tamoxifen. Use of clonidine is limited by its adverse effect profile and the availability of other effective nonhormonal medications for hot flashes. Transdermal clonidine may be preferred over oral clonidine due to more stable blood levels RefAccess Full Off-Label Monograph

Level of Evidence Definitions
  Level of Evidence Scale
Use: Unsupported: Adult
Smoking cessation

A meta-analysis suggests clonidine may be helpful in smoking cessation; however, several controlled trials did not show statistically significant benefit. Dose-dependent adverse effects limit the use of clonidine in smoking cessation (Cahill 2013). Access Full Off-Label Monograph.

Clinical Practice Guidelines

Attention Deficit Hyperactivity Disorder:

American Academy of Child and Adolescent Psychiatry, “Attention-Deficit/Hyperactivity Disorder,” 2007

American Academy of Pediatrics, “Attention-Deficit/Hyperactivity Disorder,” 2011

National Collaborating Centre for Mental Health, “Attention Deficit Hyperactivity Disorder, NICE Guidelines,” 2009

Cancer Pain:

National Comprehensive Cancer Network® (NCCN), Clinical Practice Guidelines in Oncology™, Adult Cancer Pain

Hot Flashes:

American Association of Clinical Endocrinologists (AACE), Diagnosis and treatment of menopause, 2011

Endocrine Society (ES), Treatment of Symptoms of the Menopause, 2015

Hypertension:

“2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults,” November 2017.

“ACCF/AHA Expert Consensus Document on Hypertension in the Elderly,” 2011

AHA/ACC/CDC, “AHA/ACC/CDC Science Advisory: An Effective Approach to High Blood Pressure Control” November 2013

ASH/ISH “Clinical Practice Guidelines for the Management of Hypertension in the Community: A Statement by the American Society of Hypertension and the International Society of Hypertension,” January 2014

Eighth Joint National Committee (JNC 8), “2014 Evidence-based Guideline for the Management of High Blood Pressure in Adults,” December 2013.

K/DOQI Clinical Practice Guidelines for Cardiovascular Disease in Dialysis Patients

“National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents,” May 2005

Substance Use Disorders:

American Psychiatric Association, “Practice Guideline for the Treatment of Patients with Substance Use Disorders, 2nd edition” May 2006

American Society of Addiction Medicine (ASAM), “National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use,” 2015

VA/DoD, “VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders,” 2015

Administration: Oral

May be taken with or without food. Do not discontinue clonidine abruptly. If needed, gradually reduce dose over 2 to 4 days to avoid rebound hypertension.

Administration: Topical

Transdermal patch: Patches should be applied weekly at a consistent time to a clean, hairless area of the upper outer arm or chest. Rotate patch sites weekly. Redness under patch may be reduced if a topical corticosteroid spray is applied to the area before placement of the patch (Tom 1994). Dispose of any used or unused patches by folding adhesive ends together, replace in pouch or sealed container, and discard properly in trash away from children and pets.

Administration: Epidural

Specialized techniques are required for continuous epidural administration; administration via this route should only be performed by qualified individuals familiar with the techniques of epidural administration and patient management problems associated with this route. Familiarization of the epidural infusion device is essential. Do not discontinue clonidine abruptly; if needed, gradually reduce dose over 2-4 days to avoid withdrawal symptoms.

Administration: Pediatric

Epidural: Not for IV use. Visually inspect for particulate matter and discoloration prior to administration (whenever permitted by container and solution). Specialized techniques are required for continuous epidural administration; administration via this route should only be performed by qualified individuals familiar with the techniques of epidural administration and patient management problems associated with this route. Familiarization of the epidural infusion device is essential. Do not discontinue clonidine abruptly; if needed, gradually reduce dose over 2 to 4 days to avoid withdrawal symptoms.

Oral: May be administered without regard to meals. Swallow extended release formulations whole; do not crush or chew. Kapvay should not be split. Do not discontinue clonidine abruptly; if needed, gradually reduce immediate release dose over 2 to 4 days to avoid rebound hypertension; extended release formulation (Kapvay) should be tapered in decrements of ≤0.1 mg every 3 to 7 days.

Transdermal: Patches should be applied at bedtime to a clean, hairless area of the upper arm or chest. In adults, patches are applied every 7 days, rotating patch sites weekly; in children, the patch may need to be changed more frequently (eg, every 5 days) (Galloway 2000; Hunt 1987; Hunt 1990); in adults, redness under patch may be reduced if a topical corticosteroid spray is applied to the area before placement of the patch (Tom 1994); Note: Transdermal patch is a membrane-controlled system; do not cut the patch to deliver partial doses; rate of drug delivery, reservoir contents, and adhesion may be affected if cut; if partial dose is needed, surface area of patch can be blocked proportionally using adhesive bandage (Lee 1997).

Storage/Stability

Epidural formulation: Store at 20°C to 25°C (68°F to 77°F). Preservative free; discard unused portion.

Tablets: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Extended release tablets: Store at 20°C to 25°C (68°F to 77°F). Protect from light.

Transdermal patches: Store at 25°C (77°F); excursions permitted between 15C° to 30°C (59F° and 86°F).

Preparation for Administration: Adult

Epidural formulation: Prior to administration, the 500 mcg/mL concentration must be diluted in 0.9% sodium chloride for injection (preservative-free) to a final concentration of 100 mcg/mL.

Preparation for Administration: Pediatric

Epidural formulation: Prior to administration, the 500 mcg/mL concentration must be diluted in preservative-free NS to a final concentration of 100 mcg/mL; visually inspect for particulate matter and discoloration

Compatibility

See Trissel’s IV Compatibility Database

Extemporaneously Prepared

Note: Compounded oral suspension may be available in multiple concentrations (eg, up to 10 times more concentrated); use caution to avoid confusion; verify concentration.

0.02 mg/mL (20 mcg/mL) Oral Liquid (ASHP Standard Concentration) (ASHP 2017)

0.02 mg/mL (20 mcg/mL) oral liquid may be made from tablets. Crush six 0.1 mg tablets in a glass mortar and levigate with 1 to 2 mL Simple Syrup, NF. Add additional Simple Syrup, NF and transfer to a calibrated amber bottle. Rinse the mortar and pestle with the vehicle and add quantity of vehicle sufficient to make 30 mL. Label “refrigerate.” Stable for 35 days when stored in an ambler plastic bottle and refrigerated.

Sauberan JB, Phuong P, Ilog ND, Rossi SS. Stability and osmolality of extemporaneously prepared clonidine oral liquid for neonates. Ann Pharmacother. 2016;50(3):243-244. doi: 10.1177/1060028015620625.[PubMed 26728366]

0.01 mg/mL (10 mcg/mL) Oral Suspension

0.01 mg/mL (10 mcg/mL) oral suspension may be made from tablets. Crush twenty 0.1 mg tablets in a glass mortar and reduce to a fine powder. Slowly add Ora-Blend in ~15 mL increments while mixing to form a uniform paste until approximately half of the total volume (~100 mL) is added. Transfer the suspension to a graduated cylinder. Rinse the mortar and pestle with the remaining vehicle and add quantity to fill the volume within the graduated cylinder to 200 mL. Transfer this amount to a calibrated bottle. Label “shake well.” When stored in clear plastic syringes, the suspension is stable for at least 91 days at room temperature (25°C) or refrigerated (4°C).

Ma C, Decarie D, Ensom MHH. Stability of clonidine oral suspension in oral plastic syringes. Am J Health-Syst Pharm. 2014;71:657-661.[PubMed 24688040]

0.1 mg/mL (100 mcg/mL) Oral Suspension

0.1 mg/mL (100 mcg/mL) oral suspension may be made from tablets. Crush thirty 0.2 mg tablets in a glass mortar and reduce to a fine powder. Slowly add 2 mL Purified Water USP and mix to a uniform paste. Slowly add Simple Syrup, NF in 15 mL increments; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 60 mL. Label “shake well” and “refrigerate”. Stable for 28 days when stored in amber glass bottles and refrigerated.

Levinson ML and Johnson CE. Stability of an extemporaneously compounded clonidine hydrochloride oral liquid. Am J Hosp Pharm. 1992;49(1):122-125.[PubMed 1570852]

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry mouth, constipation, fatigue, headache, nausea, loss of strength and energy, insomnia, nightmares, lack of appetite, abdominal pain, irritability, sweating a lot, vomiting, or tinnitus. Have patient report immediately to prescriber severe dizziness, passing out, bradycardia, tachycardia, abnormal heartbeat, contact lens discomfort, severe skin irritation, skin discoloration, skin redness, burning of skin, difficulty breathing, slow breathing, shallow breathing, or confusion (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  High alert medication:
  Geriatric Patients: High-Risk Medication:
  Administration issues:
  Other safety concerns:
Contraindications

Hypersensitivity to clonidine hydrochloride or any component of the formulation

Epidural administration: Injection site infection; concurrent anticoagulant therapy; bleeding diathesis; administration above the C4 dermatome

Warnings/Precautions

Concerns related to adverse effects:

• Bradycardia: May cause dose-dependent reductions in heart rate; use with caution in patients with preexisting bradycardia or those predisposed to developing bradycardia.

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Hypotension: Symptomatic hypotension may occur with use. In all patients, use epidural clonidine with caution due to the potential for severe hypotension, especially in women and those of low body weight. Most hypotensive episodes occur within the first 4 days of initiation; however, episodes may occur throughout the duration of therapy.

• Respiratory depression: Epidural administration may result in mild respiratory depression (usually associated with higher than recommended doses).

• Xerostomia: May cause significant xerostomia.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with severe coronary insufficiency, including recent MI and conduction disturbances, including sinus node dysfunction. The use of epidural clonidine frequently reduces heart rate; AV block greater than first-degree has been reported rarely. Epidural clonidine is not recommended for use in patients with severe cardiovascular disease or hemodynamic instability. May lead to cardiovascular instability (hypotension, bradycardia).

• Cerebrovascular disease: Use with caution in patients with cerebrovascular disease.

• Renal impairment: Use with caution in patients with chronic renal impairment. The hemodynamic effects may be prolonged in those with renal impairment; elimination half-life significantly prolonged (up to 41 hours) in patients with severe renal impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: Since children commonly have gastrointestinal illnesses with vomiting, they are susceptible to hypertensive episodes due to abrupt inability to take oral medication. Epidural clonidine should be reserved for pediatric cancer patients with severe intractable pain, unresponsive to other analgesics or epidural or spinal opioids.

• Surgical patients: Discontinue oral immediate-release formulations within 4 hours of surgery, then restart as soon as possible afterward.

Dosage form specific issues:

• Epidural use: [US Boxed Warning]: Must dilute concentrated epidural injectable (500 mcg/mL) solution prior to use. Epidural clonidine is not recommended for perioperative, obstetrical, or postpartum pain due to risk of hemodynamic instability. Should be administered via continuous epidural infusion device. Monitor closely for catheter-related infection such as meningitis or epidural abscess.

• Product interchangeability: Oral formulations of clonidine (immediate release versus extended release) are not interchangeable on a mg:mg basis due to different pharmacokinetic profiles.

• Transdermal patch: May contain conducting metal (eg, aluminum); remove patch prior to MRI. Due to the potential for altered electrical conductivity, remove transdermal patch before cardioversion or defibrillation. Localized contact sensitization to the transdermal system has been reported; in these patients, allergic reactions (eg, generalized rash, urticaria, angioedema) have also occurred following subsequent substitution of oral therapy.

Other warnings/precautions:

• Contact lens wearers: Clonidine may cause eye dryness in patients who wear contact lenses.

• Discontinuation of therapy: Gradual withdrawal is needed (taper oral immediate release or epidural dose gradually over 2 to 4 days to avoid rebound hypertension) if drug needs to be stopped. Patients should be instructed about abrupt discontinuation (causes rapid increase in BP and symptoms of sympathetic overactivity). In patients on both a beta-blocker and clonidine where withdrawal of clonidine is necessary, withdraw the beta-blocker first and several days before clonidine withdrawal, then slowly decrease clonidine. In children and adolescents, extended release formulation (Kapvay) should be tapered in decrements of no more than 0.1 mg every 3 to 7 days. The clonidine withdrawal syndrome is more pronounced after abrupt cessation of long-term therapy than after short-term therapy (1 to 2 months). It has usually been associated with previous administration of high oral doses (>1.2 mg daily in adults) and/or continuation of beta-blocker therapy. The danger of abrupt discontinuation may be increased in patients with hypertension and/or other cardiovascular considerations. Blood pressure may increase 8 to 24 hours after last dose, but has occurred 60 hours after the last clonidine dose. Rebound hypertension has occurred with discontinuation of transdermal and epidural clonidine.

Geriatric Considerations

Because of its potential CNS adverse effects, bradycardia, and orthostatic hypotension, clonidine is not considered a drug of choice in the elderly (Beers Criteria [AGS 2015]). If the decision is made to use clonidine, adjust dose based on response and adverse reactions. In patients on the transdermal system, monitor for appropriate placement of the patch and removal of the old patch every 7 days.

Warnings: Additional Pediatric Considerations

The American Heart Association recommends that all children diagnosed with ADHD who may be candidates for medication, such as clonidine, should have a thorough cardiovascular assessment prior to initiation of therapy. These recommendations are based upon reports of serious cardiovascular adverse events (including sudden death) in patients (both children and adults) taking usual doses of stimulant medications. Most of these patients were found to have underlying structural heart disease (eg, hypertrophic obstructive cardiomyopathy). This assessment should include a combination of thorough medical history, family history, and physical examination. An ECG is not mandatory but should be considered. Note: ECG abnormalities and four cases of sudden cardiac death have been reported in children receiving clonidine with methylphenidate; reduce dose of methylphenidate by 40% when used concurrently with clonidine; consider ECG monitoring. In patients with ADHD, clonidine may cause hypotension and bradycardia; use with caution in patients with history of hypotension, heart block, bradycardia, cardiovascular disease, syncope, conditions predisposing to syncope (including orthostatic hypotension, dehydration), or receiving concomitant antihypertensive therapy. Patients should be advised to avoid becoming dehydrated or overheated. Heart rate and blood pressure should be monitored at initiation of therapy, with any dose increase, and periodically during therapy.

Pregnancy Considerations

Clonidine crosses the placenta; concentrations in the umbilical cord plasma are similar to those in the maternal serum and concentrations in the amniotic fluid may be 4 times those in the maternal serum.

The pharmacokinetics of clonidine may be altered during pregnancy due to an increase in nonrenal clearance (Buchanan 2009; Claessens 2010). Untreated chronic maternal hypertension is associated with adverse events in the fetus, infant, and mother. If treatment for chronic or acute hypertension during pregnancy is needed, other agents are preferred (ACOG 2013); use may be considered as an alternative agent for severe hypertension (Magee 2014).

[US Boxed Warning]: Epidural clonidine is not recommended for obstetrical or postpartum pain due to risk of hemodynamic instabilityHowever, in a rare obstetrical, or postpartum patient, potential benefits may outweigh the possible risks. Clonidine has been evaluated for use as an adjunctive agent for epidural labor analgesia (Kumari 2018; Landau 2002; Roelants 2015; Zhang 2015) including patients who are opioid dependent (Hoyt 2018).

Breast-Feeding Considerations

Clonidine is present in breast milk.

Studies evaluating breast milk concentrations are limited (Boutroy 1988; Bunjes 1993; Hartikainen-Sorri 1987); concentrations may be up to twice those in maternal serum. Adverse events observed in some breastfed infants also exposed in utero include apathy syndrome, hypoglycemia, hypotonia, drowsiness, feeding difficulties, and hyperexcitability (Hartikainen-Sorri 1987; Sevrez 2014). The manufacturer recommends that caution be exercised when administering clonidine to breastfeeding women. Other sources do not recommend use in breastfeeding women (Ornoy 2018) or recommend avoiding use when nursing infants born <34 weeks’ gestation or when large maternal doses are needed (Atkinson 1988).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not always defined.

Oral, Transdermal: Incidence of adverse events may be less with transdermal compared to oral due to the lower peak/trough ratio.

>10%:

Central nervous system: Drowsiness (2% to 38%), headache (1% to 29%), fatigue (4% to 16%), dizziness (2% to 16%)

Dermatologic: Transient skin rash (localized; characterized by pruritus and erythema; transdermal 15% to 50%), contact dermatitis (transdermal 8% to 34%)

Gastrointestinal: Xerostomia (≤40%), upper abdominal pain (15%)

1% to 10%:

Cardiovascular: Bradycardia (≤4%), edema (3%), localized blanching (transdermal 1%), palpitations (1%), tachycardia (≤3%), atrioventricular block, cardiac arrhythmia, cardiac failure, cerebrovascular accident, chest pain, ECG abnormality, flushing, orthostatic hypotension, prolonged Q-T Interval on ECG, Raynaud’s phenomenon, syncope

Central nervous system: Sedation (3% to 10%), irritability (5% to 9%), nightmares (4% to 9%), insomnia (≤6%), emotional disturbance (4%), lethargy (3%), nervousness (1% to 3%), depression (1%), throbbing (transdermal 1%), withdrawal syndrome (1%), aggressive behavior, agitation, anxiety, behavioral changes, delirium, delusions, hallucination (visual and auditory), malaise, numbness (localized; transdermal), paresthesia, parotid pain (oral), restlessness, vivid dream

Dermatologic: Localized vesiculation (transdermal 7%), allergic contact sensitivity (transdermal 5%), hyperpigmentation (transdermal 5%), burning sensation of skin (transdermal 3%), excoriation (transdermal 3%), macular eruption (1%), papule (transdermal 1%), alopecia, hypopigmentation (localized; transdermal), pallor, skin rash, urticaria

Endocrine & metabolic: Gynecomastia (1%), weight gain (<1%), decreased libido, hyperglycemia (transient; oral), increased thirst

Gastrointestinal: Constipation (1% to 10%), viral gastrointestinal infection (5%), anorexia (1%), abdominal pain (oral), diarrhea, gastrointestinal pseudo-obstruction (oral), nausea, parotitis (oral), sore throat, vomiting

Genitourinary: Urinary incontinence (4%), sexual disorder (3%), erectile dysfunction (2% to 3%), nocturia (1%), pollakiuria, urinary retention

Hematologic & oncologic: Thrombocytopenia (oral)

Hepatic: Abnormal hepatic function tests (mild transient abnormalities; <1%), hepatitis

Hypersensitivity: Angioedema

Neuromuscular & skeletal: Weakness (10%), tremor (1% to 4%), arthralgia (1%), myalgia (1%), leg cramps (<1%), increased creatine phosphokinase (transient; oral), limb pain

Ophthalmic: Accommodation disturbance, blurred vision, burning sensation of eyes, decreased lacrimation, dry eye syndrome, increased lacrimation

Otic: Otitis media (≤3%), otalgia

Respiratory: Asthma, dry nose, epistaxis, flu-like symptoms, nasal congestion, nasopharyngitis, respiratory tract infection, rhinorrhea

Miscellaneous: Crying (1% to 3%), fever

Epidural: Note: The following adverse events occurred more often than placebo in cancer patients with intractable pain being treated with concurrent epidural morphine.

>10%:

Cardiovascular: Hypotension (45%), orthostatic hypotension (32%)

Central nervous system: Confusion (13%), dizziness (13%)

Gastrointestinal: Xerostomia (13%)

1% to 10%:

Cardiovascular: Chest pain (5%)

Central nervous system: Hallucination (5%)

Dermatologic: Diaphoresis (5%)

Gastrointestinal: Nausea and vomiting (8%)

Otic: Tinnitus (5%)

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

None known.

Drug Interactions 

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Risk D: Consider therapy modification

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]).Risk C: Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Risk X: Avoid combination

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Beta-Blockers: Alpha2-Agonists may enhance the AV-blocking effect of Beta-Blockers. Sinus node dysfunction may also be enhanced. Beta-Blockers may enhance the rebound hypertensive effect of Alpha2-Agonists. This effect can occur when the Alpha2-Agonist is abruptly withdrawn. Management: Closely monitor heart rate during treatment with a beta blocker and clonidine. Withdraw beta blockers several days before clonidine withdrawal when possible, and monitor blood pressure closely. Recommendations for other alpha2-agonists are unavailable. Exceptions: Levobunolol; Metipranolol. Risk D: Consider therapy modification

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Risk D: Consider therapy modification

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy

Bretylium: May enhance the bradycardic effect of Bradycardia-Causing Agents. Bretylium may also enhance atrioventricular (AV) blockade in patients receiving AV blocking agents. Risk C: Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromperidol: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. Risk X: Avoid combination

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants.Risk D: Consider therapy modification

Calcium Channel Blockers (Nondihydropyridine): CloNIDine may enhance the AV-blocking effect of Calcium Channel Blockers (Nondihydropyridine). Sinus node dysfunction may also be enhanced. Risk C: Monitor therapy

Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Cardiac Glycosides: CloNIDine may enhance the AV-blocking effect of Cardiac Glycosides. Sinus node dysfunction may also be enhanced. Risk C: Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Exceptions are discussed in separate monographs. Risk D: Consider therapy modification

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy

Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Risk C: Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk D: Consider therapy modification

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

EPHEDrine (Systemic): CloNIDine may enhance the therapeutic effect of EPHEDrine (Systemic). Risk C: Monitor therapy

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Risk D: Consider therapy modification

Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.Risk D: Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Risk C: Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk C: Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Macimorelin: CloNIDine may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Risk D: Consider therapy modification

Methylphenidate: May enhance the adverse/toxic effect of CloNIDine. Risk C: Monitor therapy

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Mirtazapine: May diminish the antihypertensive effect of Alpha2-Agonists. Management: Consider avoiding concurrent use. If the combination cannot be avoided, monitor for decreased effects of alpha2-agonists if mirtazapine is initiated/dose increased, or increased effects if mirtazapine is discontinued/dose decreased. Risk D: Consider therapy modification

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.Risk D: Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Risk D: Consider therapy modification

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy

Serotonin/Norepinephrine Reuptake Inhibitors: May diminish the antihypertensive effect of Alpha2-Agonists. Risk C: Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Risk D: Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Terlipressin: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Tetrahydrocannabinol and Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Tricyclic Antidepressants: May diminish the antihypertensive effect of Alpha2-Agonists. Management: Consider avoiding this combination. If used, monitor for decreased effects of the alpha2-agonist. Exercise great caution if discontinuing an alpha2-agonist in a patient receiving a TCA. Risk D: Consider therapy modification

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification

Test Interactions

Positive Coombs’ test; may lead to false-positive aldosterone/renin ratio (ARR) (Funder 2016)

Monitoring Parameters

Blood pressure, standing and sitting/supine, mental status, heart rate

ADHD: Thoroughly evaluate for cardiovascular risk. Monitor heart rate, blood pressure (when started and weaned), and consider obtaining ECG prior to initiation (Vetter 2008). Transdermal: Initial: 0.1 mg/24 hour patch applied once every 7 days and increase by 0.1 mg at 1- to 2-week intervals (dosages >0.6 mg/24 hours do not improve efficacy); usual dose range: 0.1 to 0.3 mg/24 hour patch applied once every 7 days (ACC/AHA [Whelton 2017])

Clonidine tolerance test: In addition to growth hormone concentrations, monitor blood pressure and blood glucose (Huang 2001).

Epidural: Carefully monitor infusion pump; inspect catheter tubing for obstruction or dislodgement to reduce risk of inadvertent abrupt withdrawal of infusion. Monitor closely for catheter-related infection (eg, meningitis or epidural abscess).

Hypertension: The 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults (ACC/AHA [Whelton 2017]):

Confirmed hypertension and known CVD or 10-year ASCVD risk ≥10%: Target blood pressure <130/80 mm Hg is recommended.

Confirmed hypertension without markers of increased CVD risk: Target blood pressure <130/80 mm Hg may be reasonable.

Advanced Practitioners Physical Assessment/Monitoring

Obtain blood pressure (standing and supine), heart rate, and assess mental status. Avoid concurrent drug therapy with medications known to cause bradycardia. Obtain ECG prior to start of therapy in the patient with ADHD. When transitioning to transdermal from oral route, overlap and taper oral dose with transdermal patch. Taper therapy, do not stop therapy abruptly. Consider alternative therapy in pregnant women. Monitor epidural for signs of infection or catheter blockage.

Nursing Physical Assessment/Monitoring

Check vital signs as ordered. Caution patient about rapid change in position, especially within an hour of administration; can cause dizziness. Offer patient tips on how to cope with dry mouth. Monitor epidural for signs of infection or catheter blockage. Monitor for signs/symptoms of overdose, especially in renally impaired patient. Remove transdermal patch prior to MRI exam, cardioversion, and defibrillation. Advise patients not to discontinue use abruptly.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Patch Weekly, Transdermal:

Catapres-TTS-1: 0.1 mg/24 hr (4 ea)

Catapres-TTS-2: 0.2 mg/24 hr (4 ea)

Catapres-TTS-3: 0.3 mg/24 hr (4 ea)

Generic: 0.1 mg/24 hr (1 ea, 4 ea); 0.2 mg/24 hr (1 ea, 4 ea); 0.3 mg/24 hr (1 ea, 4 ea)

Solution, Epidural, as hydrochloride:

Duraclon: 100 mcg/mL (10 mL [DSC])

Solution, Epidural, as hydrochloride [preservative free]:

Duraclon: 100 mcg/mL (10 mL)

Duraclon: 500 mcg/mL (10 mL [DSC]) [pyrogen free]

Generic: 100 mcg/mL (10 mL); 500 mcg/mL (10 mL)

Tablet, Oral, as hydrochloride:

Catapres: 0.1 mg [scored; contains brilliant blue fcf (fd&c blue #1), corn starch, fd&c yellow #6 (sunset yellow)]

Catapres: 0.2 mg, 0.3 mg [scored; contains corn starch, fd&c yellow #6 (sunset yellow)]

Generic: 0.1 mg, 0.2 mg, 0.3 mg

Tablet Extended Release 12 Hour, Oral, as hydrochloride:

Kapvay: 0.1 mg

Generic: 0.1 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Dixarit: 0.025 mg [DSC] [contains FD&C BLUE #2 (INDIGOTINE)]

Generic: 0.025 mg

Tablet, Oral, as hydrochloride:

Catapres: 0.1 mg [DSC]

Generic: 0.1 mg, 0.2 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • C02AC01
  • N02CX02
  • S01EA04
Generic Available (US)

Yes

Pricing: US

Patch weekly (Catapres-TTS-1 Transdermal)

0.1 mg/24 hrs (per each): $78.99

Patch weekly (Catapres-TTS-2 Transdermal)

0.2 mg/24 hrs (per each): $132.99

Patch weekly (Catapres-TTS-3 Transdermal)

0.3 mg/24 hrs (per each): $184.49

Patch weekly (cloNIDine Transdermal)

0.1 mg/24 hrs (per each): $33.12 – $33.16

0.2 mg/24 hrs (per each): $55.77 – $55.83

0.3 mg/24 hrs (per each): $77.36 – $77.45

Solution (cloNIDine HCl (Analgesia) Epidural)

100 mcg/mL (per mL): $3.00 – $5.04

500 mcg/mL (per mL): $11.76 – $19.50

Solution (Duraclon Epidural)

100 mcg/mL (per mL): $5.28

Tablet, 12-hour (cloNIDine HCl ER Oral)

0.1 mg (per each): $4.50 – $7.95

Tablet, 12-hour (Kapvay Oral)

0.1 mg (per each): $8.84

Tablets (Catapres Oral)

0.1 mg (per each): $3.26

0.2 mg (per each): $4.99

0.3 mg (per each): $6.26

Tablets (cloNIDine HCl Oral)

0.1 mg (per each): $0.21 – $0.32

0.2 mg (per each): $0.32 – $0.45

0.3 mg (per each): $0.47 – $0.63

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Mechanism of Action

Stimulates alpha2-adrenoceptors in the brain stem, thus activating an inhibitory neuron, resulting in reduced sympathetic outflow from the CNS, producing a decrease in peripheral resistance, renal vascular resistance, heart rate, and blood pressure; epidural clonidine may produce pain relief at spinal presynaptic and postjunctional alpha2-adrenoceptors by preventing pain signal transmission; pain relief occurs only for the body regions innervated by the spinal segments where analgesic concentrations of clonidine exist. For the treatment of ADHD, the mechanism of action is unknown; it has been proposed that postsynaptic alpha2-agonist stimulation regulates subcortical activity in the prefrontal cortex, the area of the brain responsible for emotions, attentions, and behaviors and causes reduced hyperactivity, impulsiveness, and distractibility. Epidurally administered clonidine produces dose-dependent analgesia not antagonized by opiate antagonists. The analgesia is limited to the body regions innervated by the spinal segments where analgesic concentrations of clonidine are present. Clonidine is thought to produce analgesia at presynaptic and postjunctional alpha-2-adrenoceptors in the spinal cord by preventing pain signal transmission to the brain.

Pharmacodynamics/Kinetics

Onset of action:

Antihypertensive effect: Oral: Immediate release: 0.5 to 1 hour (maximum reduction in blood pressure: 2 to 4 hours); Transdermal: Initial application: 2 to 3 days; Transdermal: Steady state reached in ~3 days

Attention-deficit/hyperactivity disorder: Oral: Extended release (Kapvay): Onset of action: 1 to 2 weeks (AAP [Wolraich] 2011)

Absorption: Oral: Extended-release tablets (Kapvay) are not bioequivalent with immediate-release formulations; peak plasma concentrations are 50% lower compared to immediate-release formulations

Distribution: Vd: ~2.9 L/kg; highly lipid soluble; distributes readily into extravascular sites

Note: Epidurally administered clonidine readily distributes into plasma via the epidural veins and attains clinically significant systemic concentrations.

Protein binding: 20% to 40%

Metabolism: Extensively hepatic to inactive metabolites; undergoes enterohepatic recirculation

Bioavailability: Oral: Immediate release: 70% to 80%; Extended release (Kapvay): ~89% (relative to immediate-release formulation); Transdermal: ~60%

Half-life elimination:

Children: 6.13 ± 1.33 hours (Lonnqvist 1993)

Adults: Normal renal function: 12 to 16 hours; Renal impairment: ≤41 hours

Epidural administration: CSF half-life elimination: 1.3 ± 0.5 hours; plasma half-life elimination: 22 ± 15 hours

Transdermal: Half-life elimination (after patch removal): ~20 hours (due to skin depot effect; increase in plasma clonidine concentrations may occur after patch removal [MacGregor 1985])

Time to peak, plasma: Oral: Immediate release: 1 to 3 hours; Extended release (Kapvay): 7 to 8 hours

Excretion: Urine (40% to 60% as unchanged drug)

Clearance:

Oral:

Neonates: 0.16 L/kg/hour (Xie 2011)

Infants and Children ≤4 years: ~0.3 L/kg/hour (Xie 2011)

Children 5 to 10 years: ~0.26 L/kg/hour (Xie 2011)

Adults: Single dose: ~0.25 L/kg/hour; Multiple dose: ~0.4 L/kg/hour (Frisk-Holmberg 1981)

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: The half-life increases up to 41 hours in patients with severe renal impairment.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Significant xerostomia (normal salivary flow resumes upon discontinuation) and abnormal taste; Patients may experience orthostatic hypotension as they stand up after treatment; especially if lying in dental chair for extended periods of time. Use caution with sudden changes in position during and after dental treatment.

Effects on Bleeding

No information available to require special precautions

Index Terms

Clonidine HCl; Clonidine Hydrochloride

FDA Approval Date
September 03, 1974
References

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Brand Names: International

Alphapres (PH); Arkamin (IN); Aruclonin (HU); Atensina (BR); Catamed (PH); Catapin (PH); Catapres (AU, BB, BD, BF, BH, BJ, BM, BS, BZ, CI, CY, ET, GB, GH, GM, GN, GY, HK, ID, IE, IN, IQ, IR, JM, JO, JP, KE, KR, KW, LR, MA, ML, MR, MT, MU, MW, MY, NE, NG, NZ, OM, PH, PK, PR, SA, SC, SD, SG, SL, SN, SR, TN, TT, TW, TZ, UG, ZM, ZW); Catapresan (AR, AT, CH, CL, CO, CR, DE, DK, DO, EC, ES, FI, GR, GT, HN, HR, IS, IT, NI, NL, NO, PA, PE, PT, SE, SI, SV, VE); Catapresan Depot (CZ, DE); Catapresan TTS (IT); Catapress (AE); Catapressan (FR, LU, VN); Chlophazolin (BG, LV); Clonidina Larjan (AR); Clonidural (AR); Clonigen (PH); Clonipresa (EG); Clonipresan (PY); Clonipress (PH); Clonnirit (IL); Clophelin (UA); Dixarit (IE, LU, NZ); Haemiton (DE); Hylon (BD); Hypodine (TH); Iporel (PL); Isoglaucon (HU); Jenloga (BM); Kapvay (BM); Kapvay ER (KR); Melzin (PH); Menograine (ZA); Normopresan (IL); Normopresin (UY); Run Rui (CN); Terclodine (PH); Winpress (TW)

Clonidine (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(KLON i deen)

Brand Names: US

Catapres; Catapres-TTS-1; Catapres-TTS-2; Catapres-TTS-3; Duraclon; Kapvay

Brand Names: Canada

Catapres; Dixarit

Warning
  • Epidural:
  • This drug is not for use to ease pain before, during, or after surgery. Most of the time, this drug is not for use while giving birth or after giving birth. Low blood pressure and slow heartbeat from this drug may cause problems in these people. Talk with the doctor.
What is this drug used for?
  • It is used to treat high blood pressure.
  • It is used to treat attention deficit problems with hyperactivity.
  • It is used to control pain when infused into the spine.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • All products:
  • If you have an allergy to clonidine or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking another drug that has the same drug in it.
  • If you are taking any of these drugs: Digoxin, diltiazem, verapamil, or a beta blocker like metoprolol or propranolol.
  • Epidural:
  • If you have bleeding problems.
  • If you have an infection where the shot will be given.
  • If you are taking a blood thinner.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
  • If you are taking this drug and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
  • Extended-release tablets:
  • Avoid alcohol or other drugs and natural products that slow your actions.
  • All other products:
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • All oral products:
  • Talk with your doctor to find out what to do if you throw up after taking a dose of this drug.
  • Skin patch:
  • The patch may have metal. Take off the patch before an MRI.
  • If you will be having certain procedures to help your heart beat normally (defibrillation cardioversion), talk with your doctor. Be sure your doctor knows you take this drug.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Fast or slow heartbeat.
  • A heartbeat that does not feel normal.
  • Change in how contact lenses feel in the eyes.
  • Skin patch:
  • Very bad skin irritation.
  • Redness.
  • Burning.
  • Change in color of skin.
  • Epidural:
  • Trouble breathing, slow breathing, or shallow breathing.
  • Feeling confused.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • All products:
  • Dry mouth.
  • Constipation.
  • Dizziness.
  • Feeling sleepy.
  • Headache.
  • Upset stomach.
  • Feeling tired or weak.
  • Extended-release tablets:
  • Trouble sleeping.
  • Bad dreams.
  • Not hungry.
  • Stomach pain.
  • Feeling irritable.
  • Skin patch:
  • Skin irritation.
  • Epidural:
  • Sweating a lot.
  • Throwing up.
  • Ringing in ears.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All oral products and skin patch:
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
  • Do not switch between different forms of this drug without first talking with the doctor.
  • All oral products:
  • Take with or without food.
  • Take this drug at the same time of day.
  • Extended-release tablets:
  • Swallow whole. Do not chew, break, or crush.
  • If you have trouble swallowing, talk with your doctor.
  • Skin patch:
  • Take off old patch first.
  • Wash your hands before and after use.
  • Put patch on clean, dry, healthy skin on the chest or upper arm. Move the site with each new patch.
  • Put patch on a site without hair.
  • Do not put on skin that is irritated or damaged. Do not put on an area with skin folds or skin that will be rubbed by tight clothes.
  • This drug comes with a patch cover to hold the patch in place if it comes loose. The patch cover does not have any drug in it. Do not use it by itself. If the patch comes loose, put the patch cover over the patch as you have been told.
  • After you take off a skin patch, be sure to fold the sticky sides of the patch to each other. Throw away used patches where children and pets cannot get to them.
  • Epidural:
  • It is given into the spine.
  • This drug will be given to you by a doctor.
What do I do if I miss a dose?
  • Extended-release tablets:
  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • All other oral products:
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Skin patch:
  • Put on a missed patch as soon as you think about it after taking off the old one.
  • If it is close to the time for your next patch, place the new patch on.
  • Start a new timetable after the patch is put back on.
  • Do not put on 2 doses at the same time or extra doses.
  • Epidural:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products and skin patch:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • All oral products:
  • Keep lid tightly closed.
  • Epidural:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Clonidine (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(KLON i deen)

Brand Names: US

Catapres; Catapres-TTS-1; Catapres-TTS-2; Catapres-TTS-3; Duraclon; Kapvay

Brand Names: Canada

Catapres; Dixarit

Warning
  • Epidural:
  • This drug is not for use to ease pain before, during, or after surgery. Most of the time, this drug is not for use while giving birth or after giving birth. Low blood pressure and slow heartbeat from this drug may cause problems in these people. Talk with the doctor.
What is this drug used for?
  • It is used to treat high blood pressure.
  • It is used to treat attention deficit problems with hyperactivity.
  • It is used to control pain when infused into the spine.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • All products:
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is taking another drug that has the same drug in it.
  • If your child is taking any of these drugs: Digoxin, diltiazem, verapamil, or a beta blocker like metoprolol or propranolol.
  • Epidural:
  • If your child has bleeding problems.
  • If your child has an infection where the shot will be given.
  • If your child is taking a blood thinner.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
  • To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child is taking this drug and has high blood pressure, talk with the doctor before giving OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Have your child be careful in hot weather or while your child is being active. Have your child drink lots of fluids to stop fluid loss.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • Extended-release tablets:
  • Avoid giving your child other drugs and natural products that may slow your child’s actions.
  • All other products:
  • Talk with the doctor before giving your child other drugs and natural products that may slow your child’s actions.
  • All oral products:
  • Talk with the doctor to find out what to do if your child throws up after taking a dose of this drug.
  • Skin patch:
  • The patch may have metal. Take off the patch before an MRI.
  • If your child will be having certain procedures to help the heart beat normally (defibrillation cardioversion), talk with your child’s doctor. Be sure the doctor knows your child takes this drug.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Fast or slow heartbeat.
  • A heartbeat that does not feel normal.
  • Change in how contact lenses feel in the eyes.
  • Skin patch:
  • Very bad skin irritation.
  • Redness.
  • Burning.
  • Change in color of skin.
  • Epidural:
  • Trouble breathing, slow breathing, or shallow breathing.
  • Feeling confused.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • All products:
  • Constipation.
  • Dry mouth.
  • Dizziness.
  • Feeling sleepy.
  • Headache.
  • Upset stomach.
  • Feeling tired or weak.
  • Extended-release tablets:
  • Trouble sleeping.
  • Bad dreams.
  • Not hungry.
  • Stomach pain.
  • Feeling irritable.
  • Skin patch:
  • Skin irritation.
  • Epidural:
  • Sweating a lot.
  • Throwing up.
  • Ringing in ears.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All oral products and skin patch:
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of side effects. If your child needs to stop this drug, you will want to slowly stop it as told by the doctor.
  • Do not switch between different forms of this drug without first talking with the doctor.
  • All oral products:
  • Give this drug with or without food.
  • Give this drug at the same time of day.
  • Extended-release tablets:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • If your child has trouble swallowing, talk with the doctor.
  • Skin patch:
  • Take off old patch first.
  • Wash your hands before and after use.
  • Put patch on clean, dry, healthy skin on the chest, back, or belly. Move the site with each new patch.
  • Put patch on a site without hair.
  • Do not put on skin that is irritated or damaged. Do not put on an area with skin folds or skin that will be rubbed by tight clothes.
  • This drug comes with a patch cover to hold the patch in place if it comes loose. The patch cover does not have any drug in it. Do not use it by itself. If the patch comes loose, put the patch cover over the patch as you have been told.
  • After you take off a skin patch, be sure to fold the sticky sides of the patch to each other. Throw away used patches where children and pets cannot get to them.
  • Epidural:
  • It is given into the spine.
  • This drug will be given to your child by a doctor.
What do I do if my child misses a dose?
  • Extended-release tablets:
  • Skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • All other oral products:
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not put on 2 doses at the same time or extra doses.
  • Skin patch:
  • Put on a missed patch as soon as you think about it after taking off the old one.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Start a new timetable after the patch is put back on.
  • Do not put on 2 doses at the same time or extra doses.
  • Epidural:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products and skin patch:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • All oral products:
  • Keep lid tightly closed.
  • Epidural:
  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.