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clonidine (Rx)Brand and Other Names:Catapres, Catapres-TTS, more...Duraclon, Jenloga, Kapvay, Nexiclon XR

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injectable solution

  • 100mcg/mL
  • 500mcg/mL

patch, extended-release

  • 0.1mg/day
  • 0.2mg/day
  • 0.3mg/day

tablet, immediate-release

  • 0.1mg
  • 0.2mg
  • 0.3mg

tablet, extended-release

  • 0.1mg
more...

Hypertension

Immediate-release tablets

  • 0.1 mg PO q12hr
  • Range: 0.1-0.2 mg/day q12hr; not to exceed 2.4 mg/day

Transdermal

  • Apply 1 patch q7Days; start with 0.1 mg; increase by 0.1 mg after q1-2Week interval; usual dose range is 0.1-0.3 mg qWeek

Cancer Pain

Epidural infusion

  • Severe pain in patients with cancer not adequately relieved by opioid analgesics alone
  • Initial: 30 mcg/hr
  • Titrate as required for pain relief or presence of side effects
  • Limited data on doses exceeding 40 mcg/hr

Acute Hypertension (Off-label)

0.1-0.2 mg PO; may follow with additional doses of 0.1 mg qhr PRN to maximum 0.6 mg total dose

EtOH Withdrawal (Off-label)

0.3-0.6 mg PO q6hr

Smoking Cessation (Off-label)

PO administration: 0.1 mg qDay; increase by 0.1 mg/day to 0.15-0.75 mg/day if required

TD administration: 100-200 mcg/day patch q7Days

Restless Legs Syndrome (Off-label)

100-300 mcg PO 2 hours befor bedtime, up to 900 mcg/day

Tourette's Syndrome (Off-label)

0.0025-0.015 mg/kg/day PO for 6 weeks to 3 months

Cyclosporine Nephrotoxicity (Off-label)

100-200 mcg/day transdermal patch; change q7Days

Menopausal Flushing (Off-label)

Apply 100 mcg/day patch; change q7Days, OR

50 mcg PO q12hr initially; may increase up to 400 mcg q12hr

Dysmenorrhea (Off-label)

PO administration: 0.025 mg q12hr for 2 weeks prior to menstruation

Opioid Withdrawal (Off-label)

PO administration: 0.1-0.3 mg q4-6hr; increase by 0.1 mg/day to 0.15-0.75 mg/day if required; do not exceed 2.4 mg/day

TD administration: 100-200 mcg/day patch q7Days; initiate 0.1-0.3 mg PO q4-6hr for first 2 days to allow for adequate drug levels

Postherpetic Neuralgia (Off-label)

PO administration: 0.1 mg q12hr

Psychosis (Off-label)

PO administration: 0.4-1.4 mg/day in divided doses

Pheochromocytoma Diagnosis (Off-label)

Clonidine suppression testing: 0.3 mg PO for 60-80 kg patient; obtain blood sample 3 hours after administration to supine patient

Dosing Considerations

Extended-release is not to be used interchangeably with immediate-release tablets

Conversion from oral to transdermal

  • Day 1: Place Catapress-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 needed

Cancer pain

  • Dilute 500 mcg/mL to 100 mcg/mL with 0.9% NaCl before administration
  • Epidural infusion considered as adjunct to intraspinal opiate therapy; epidural administration (Duraclon) is indicated in combination with opiates for the treatment of severe pain in patients with cancer not adequately relieved by opioid analgesics alone
  • More likely to be effective in patients with neuropathic pain than in those with somatic or visceral pain

Dosing Modifications

Renal Impairment

  • Impact of renal impairment not assessed
  • Initial dose should be based on amount of renal impairment
  • Monitor carefully for hypotension and bradycardia
  • Removed minimally during hemodialysis; no need to redose following dialysis

Dosage Forms & Strengths

injectable solution

  • 100mcg/mL
  • 500mcg/mL

patch

  • 0.1mg/day
  • 0.2mg/day
  • 0.3mg/day

tablet, immediate-release

  • 0.1mg
  • 0.2mg
  • 0.3mg

tablet, extended-release

  • 0.1mg
more...

Hypertension

>12 years old

  • Immediate-release tablets: 0.2 mg/day PO divided q12hr; increase qWeek; maintenance dose range, 0.2-0.6 mg/day q12hr; not to exceed 2.4 mg/day
  • Transdermal patch: 0.1 mg patch q7Day initially; may increase by weekly 0.1-mg increments after 1-2 weeks if desired blood pressure reduction not achieved; not to exceed 0.6 mg/week (ie, 2 clonidine 0.3 mg patches)

<12 years old

  • Immediate-release tablets and transdermal patch: Safety and efficacy not established

<18 years old

  • Extended-release tablets (Jenloga, Nexiclon XR): Safety and efficacy not established

ADHD

<6 years old: Not established

≥6 years old (extended-release tablets, Kapvay): 0.1 mg PO qHS initially; may adjust dose by increments of 0.1 mg/day at weekly intervals until desired response; not to exceed 0.4 mg/day

When discontinuing, taper gradually by decrements not to exceed 0.1 mg q3-7Days

Dosing considerations

  • May be given as monotherapy or as adjunctive therapy with stimulants
  • Extended-release not interchangeable with immediate-release product

Cancer Pain

Severe pain in patients with cancer not adequately relieved by opioid analgesics alone

Epidural infusion: 0.5 mcg/kg/hr initially; adjust according to clinical response  

Dosing considerations

  • Epidural administration (Duraclon) is indicated in combination with opiates for the treatment of severe pain in patients with cancer not adequately relieved by opioid analgesics alone
  • Restrict use to pediatric patients with severe, intractable pain from malignancy that is unresponsive to epidural or spinal opiates or to other, more conventional analgesic techniques
  • More likely to be effective in patients with neuropathic pain than in those with somatic or visceral pain
  • Safety and effectiveness of epidural administration in this limited indication and clinical population have been established in patients old enough to tolerate placement and management of an epidural catheter; these conclusions are based on evidence from adequate and well-controlled studies in adults and through experience with the use of clonidine in the pediatric age group for other indications

Administration

ADHD

  • Doses 0.2 mg/day or greater should be divided BID, with either an equal or higher split dosage being given at bedtime
  • Swallow tablet whole; do not crush, chew, or split

Dosing Modifications

Renal Impairment

  • Impact of renal impairment not assessed
  • Initial dose should be based on amount of impairment
  • Monitor carefully for hypotension and bradycardia
  • Removed minimally during hemodialysis, so no need to redose following dialysis

Hypertension

Immediate-release tablets: 0.1 mg PO qHS

Dosing considerations

Not recommended as routine treatment for hypertension (Beers criteria)

Potential for orthostatic hypotension and adverse CNS effects

May cause bradycardia

Immediate release: Lower initial doses than for nongeriatric adult dosing, as well as gradual adjustments, are recommended

Extended release: May require lower initial dose than for nongeriatric adult dosing

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Interactions

Interaction Checker

clonidine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Skin reactions; patch (15-50%)

            Dry mouth (40%)

            Somnolence (19-38%)

            Headache (19-29%)

            Fatigue (13-24%)

            Drowsiness (33%)

            Dizziness (13-16%)

            Hypotension, epidural (45%)

            Postural hypotension, epidural (32%)

            Anxiety (11%)

            1-10%

            Constipation (10%)

            Sedation (10%)

            Nausea/vomiting, PO (5%)

            Malaise (3%)

            Orthostatic hypotension (3%)

            Anorexia, PO (1%)

            Abnormal LFTs (1%)

            Rash (1%)

            Weight gain, PO (1%)

            Frequency Not Defined

            Children with ADHD

            • Upper respiratory tract infection
            • Irritability
            • Throat pain
            • Nightmares
            • Insomnia
            • Emotional disorder
            • Constipation
            • Nasal congestion

            Postmarketing Reports

            Hallucinations

            AV block

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            Warnings

            Black Box Warnings

            Epidural clonidine is not recommended for obstetric postpartum or perioperative pain management because the risk of hemodynamic instability (eg, hypotension, bradycardia) may be unacceptable in this population

            Dilute product with strength of 500 mcg/mL prior to use

            Contraindications

            Hypersensitivity

            Epidural

            • Concurrent anticoagulants, bleeding diathesis
            • Presence of injection site infections
            • Administration above C4 dermatome, due to lack of adequate safety data
            • Obstetric/perioperative pain

            Cautions

            Epidural: Hemodynamically unstable patients (risk of severe hypotension)

            Do not discontinue suddenly (risk of rebound hypertension)

            Patch: May need to remove if severe erythema and/or localized vesicle formation develop at application site or generalized rash; consult physician

            Severe coronary insufficiency

            May cause xerostomia

            Recent MI

            Cerebrovascular disease

            Chronic renal failure

            Raynaud's disease

            Thromboangiitis obliterans

            History of depression (may exacerbate depression in cancer patients)

            May impair ability to perform hazardous tasks

            Remove patch before MRI (may cause burns)

            Hypotension may occur; usually responsive to IV fluids and, if necessary, appropriate parenterally administered pressor agents

            Cardiac conduction abnormalities: Sympatholytic action may worsen sinus node dysfunction and atrioventricular (AV) block, especially if coadministered with other sympatholytic drugs

            Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease or chronic renal failure; measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy; avoid concomitant use of drugs with additive effects unless clinically indicated; advise patients to avoid becoming dehydrated or overheated

            Epidural administration may result in mild respiratory depression (usually with higher than recommended dose)

            Use with caution in cerebrovascular disease

            Avoid as first line antihypertensive in the elderly due to high risk for adverse side effects

            Children may be particularly susceptible to hypertensive episodes when experiencing GI illnesses that lead to vomiting

            Discontinue oral immediate release formulations within 4 hr of surgery; restart as soon as possible following surgery

            Due to different pharmacokinetic profiles, oral formulations are not interchangeable with extended release on a mg-mg basis due to different pharmacokinetic profiles

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Distributed in breast milk; caution advised

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Central sympatholytic via stimulation of central alpha receptors; results in reduced sympathetic outflow, causing decreased PVR, HR, BP, and renal vascular resistance; produces presynaptic and postjunctional alpha-2 adrenoreceptor analgesia by preventing pain signal transmission to brain

            Postsynaptic alph2-agonist stimulation may regulate subcortical activity in the prefrontal cortex, which may regulate area of the brain responsible for attentions, emotions, and behaviors and causes reduced hyperactivity, distractibility, and impulsiveness

            Absorption

            Bioavailability: Immediate release (75-85%); extended release (89%)

            Onset: <1 hr (2-4 hr peak effect in blood pressure)

            Duration: 6-10 hr

            Peak plasma time: 1-3 hr (immediate release); 7-8 hr (extended release)

            Distribution

            Protein bound: 20-40%

            Vd: 2.9 L/kg

            Metabolism

            Liver

            Elimination

            Half-life: 12-16 hr

            Excretion: Urine (40-60%)

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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