Clonidine 0.2mg/24h Weekly Patches

Manufacturer DR. REDDY'S LABORATORIES Active Ingredient Clonidine Patches(KLON i deen) Pronunciation KLON-i-deen
It is used to treat high blood pressure.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive
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Pharmacologic Class
Centrally acting alpha-2 adrenergic agonist
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Pregnancy Category
Category C
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FDA Approved
Sep 1984
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clonidine patches are used to lower high blood pressure. They work by calming down certain signals in your brain that tell your blood vessels to tighten. This helps your blood vessels relax and your heart beat slower, which lowers your blood pressure. The patch is applied to your skin once a week and slowly releases the medicine.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided and adhere to the guidelines.

Continue taking this medication as directed by your doctor or healthcare provider, even if you feel well.
Before applying a new patch, remove the old one.
Wash your hands before and after handling the patch.
Do not cut, divide, or use damaged patches.
Apply the patch to clean, dry, and healthy skin on your chest or upper arm. Rotate the site with each new patch to avoid skin irritation.
Choose a site without hair and avoid areas with irritated or damaged skin, skin folds, or skin that may be rubbed by tight clothing.
You can bathe, shower, or swim while wearing the patch.
If the patch comes loose, use the provided patch cover to secure it. Note that the patch cover does not contain any medication and should not be used alone.

Managing Skin Irritation and Patch Removal

If the skin under the patch becomes mildly irritated, you may remove the patch and apply a new one to a different area. After removing a patch, fold the sticky sides together and dispose of it in a secure location, out of reach of children and pets.

Important Safety Precautions

This medication can be harmful to children if accidentally ingested, chewed, or applied to their skin. If this occurs, seek medical help immediately.

Stopping Your Medication

Do not stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to stop taking this medication, your doctor will guide you on how to gradually discontinue its use.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from bathrooms. Keep all medications in a safe location, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal methods, and consider participating in local drug take-back programs.

Missing a Dose

If you miss a dose, apply a new patch as soon as possible after removing the old one. If it's close to the time for your next patch, apply the new one and start a new schedule. Do not apply two patches at the same time or take extra doses.
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Lifestyle & Tips

  • Apply the patch to a clean, dry, hairless area of skin on the upper arm or torso. Avoid irritated or scarred skin.
  • Press firmly for 10 seconds to ensure good adhesion.
  • Rotate application sites weekly to prevent skin irritation.
  • Do not cut the patch.
  • Wash hands thoroughly after applying or removing the patch.
  • If the patch falls off, apply a new one to a different site.
  • Do not stop using the patch suddenly without talking to your doctor, as this can cause a dangerous rise in blood pressure.
  • Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how the medication affects you, due to potential drowsiness or dizziness.
  • Limit alcohol consumption, as it can increase drowsiness.
  • Maintain a healthy diet, regular exercise, and limit sodium intake as advised by your doctor to help manage blood pressure.

Dosing & Administration

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Adult Dosing

Standard Dose: Initially 0.1 mg/24h patch applied once weekly. Dose may be increased by 0.1 mg/24h increments at 1-2 week intervals. The requested dose is 0.2 mg/24h patch applied once weekly.
Dose Range: 0.1 - 0.6 mg

Condition-Specific Dosing:

Hypertension: Initial: 0.1 mg/24h patch once weekly. Maintenance: 0.1-0.3 mg/24h patch once weekly. Max: 0.6 mg/24h (two 0.3 mg/24h patches) once weekly.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for hypertension. Limited data for ADHD (oral form more common).
Adolescent: Not established for hypertension. Limited data for ADHD (oral form more common).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but monitor blood pressure and adverse effects.
Moderate: Consider starting with a lower dose (e.g., 0.1 mg/24h patch) and titrate slowly based on response and tolerability. Monitor for increased adverse effects.
Severe: Significant dose reduction required. Start with 0.1 mg/24h patch and titrate very cautiously. Monitor closely for hypotension and bradycardia.
Dialysis: Clonidine is minimally dialyzable. Administer after dialysis. Monitor closely for hypotension.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, but use with caution and monitor for increased adverse effects due to potential for altered metabolism.
Severe: No specific adjustment recommended, but use with caution and monitor for increased adverse effects due to potential for altered metabolism.

Pharmacology

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Mechanism of Action

Clonidine is a centrally acting alpha-2 adrenergic agonist. It stimulates alpha-2 adrenergic receptors in the brainstem, primarily in the vasomotor center. This stimulation leads to a reduction in sympathetic outflow from the central nervous system, resulting in decreased peripheral vascular resistance, heart rate, and blood pressure. It also reduces plasma renin activity and circulating catecholamine levels.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 60% (transdermal, relative to oral)
Tmax: 2-3 days (transdermal patch)
FoodEffect: Not applicable for transdermal patch.

Distribution:

Vd: 2.1 L/kg
ProteinBinding: 20-40%
CnssPenetration: Yes

Elimination:

HalfLife: 12-16 hours (systemic, after patch removal, due to continued absorption from skin depot)
Clearance: Approximately 200 mL/min
ExcretionRoute: Renal (approximately 40-60% as unchanged drug), Fecal (20%)
Unchanged: 40-60%
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Pharmacodynamics

OnsetOfAction: 2-3 days (transdermal patch)
PeakEffect: 3-5 days (transdermal patch)
DurationOfAction: 7 days (after patch application), effects may persist for up to 2 days after patch removal due to skin depot.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Abnormal heartbeat, including fast, slow, or irregular rhythms
Redness
Burning sensation
Changes in skin color

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:

Dry mouth
Constipation
Dizziness, drowsiness, fatigue, or weakness
Headache
Upset stomach
Skin irritation

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or lightheadedness, especially when standing up (orthostatic hypotension)
  • Fainting spells
  • Severe drowsiness or sedation
  • Unusual fatigue or weakness
  • Slow heartbeat
  • Severe skin irritation, rash, or allergic reaction at the patch site
  • Symptoms of high blood pressure if you stop the patch suddenly: severe headache, nervousness, agitation, tremor, rapid heart rate, sweating.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication that contains the same active ingredient as this drug.
If you are taking any of the following medications: digoxin, diltiazem, verapamil, or beta blockers like metoprolol or propranolol.

Please note that this is not an exhaustive list of all potential drug interactions or health problems that may affect your use of this medication.

To ensure your safety, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins

Additionally, share any health problems you have with your doctor. This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions.

Do not start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.

As directed by your doctor, regularly monitor your blood pressure and heart rate. If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration.

This medication may cause dry eyes. If you wear contact lenses and experience dry eyes or a change in how your lenses feel, discuss this with your doctor.

Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or OTC medications that may impair your reactions, consult your doctor.

The patch form of this medication may contain metal, so remove it before undergoing a magnetic resonance imaging (MRI) scan. If you are scheduled to undergo procedures to regulate your heart rhythm, such as defibrillation or cardioversion, inform your doctor that you are taking this medication.

If you have previously experienced skin irritation from the patch form of this medication, talk to your doctor, as you may be more likely to develop a rash on other parts of your body with any form of this medication.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (very low blood pressure)
  • Bradycardia (very slow heart rate)
  • Respiratory depression (slow, shallow breathing)
  • Sedation, somnolence, coma
  • Miosis (pinpoint pupils)
  • Hypothermia (low body temperature)
  • Arrhythmias
  • Paradoxical hypertension (rare, especially in children)

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Beta-blockers (increased risk of bradycardia, AV block, and rebound hypertension upon clonidine withdrawal)
  • Tricyclic antidepressants (TCAs) (may antagonize the hypotensive effect of clonidine)
  • CNS depressants (e.g., alcohol, barbiturates, benzodiazepines, opioids) (additive sedative effects)
  • Other antihypertensives (additive hypotensive effects)
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Moderate Interactions

  • Calcium channel blockers (additive bradycardia/hypotension)
  • Digoxin (additive bradycardia)
  • Diuretics (additive hypotensive effects)
  • Alpha-1 blockers (additive hypotensive effects)
  • Neuroleptics (e.g., haloperidol) (may increase risk of orthostatic hypotension)
  • MAO inhibitors (theoretical risk of hypertensive crisis, though less common with clonidine than other sympathomimetics)
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Minor Interactions

  • NSAIDs (may reduce hypotensive effect of clonidine)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess efficacy.

Timing: Prior to initiation.

Heart Rate (HR)

Rationale: To establish baseline and monitor for bradycardia.

Timing: Prior to initiation.

Renal Function (SCr, BUN, eGFR)

Rationale: Clonidine is primarily renally excreted; dose adjustment may be needed in renal impairment.

Timing: Prior to initiation.

Liver Function Tests (ALT, AST, ALP, Bilirubin)

Rationale: To assess baseline hepatic function, though hepatic impairment generally does not require dose adjustment.

Timing: Prior to initiation (optional, if clinically indicated).

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Routine Monitoring

Blood Pressure (BP)

Frequency: Weekly during titration, then periodically (e.g., monthly or as clinically indicated) once stable.

Target: Individualized, typically <130/80 mmHg for most hypertensive patients.

Action Threshold: Persistent hypotension (e.g., SBP <90 mmHg or symptomatic), or inadequate BP control.

Heart Rate (HR)

Frequency: Weekly during titration, then periodically (e.g., monthly or as clinically indicated) once stable.

Target: Individualized, typically >60 bpm.

Action Threshold: Bradycardia (<50-60 bpm or symptomatic).

Adverse Effects (e.g., dry mouth, drowsiness, dizziness, application site reactions)

Frequency: At each visit, especially during titration.

Target: Minimal to none.

Action Threshold: Severe or intolerable side effects requiring dose adjustment or discontinuation.

Patch Adherence and Application Site

Frequency: At each visit.

Target: Proper application, no significant irritation.

Action Threshold: Poor adherence, severe skin irritation, rash, or allergic reaction.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Dry mouth
  • Drowsiness
  • Sedation
  • Fatigue
  • Constipation
  • Nausea
  • Headache
  • Application site reactions (redness, itching, rash)
  • Symptoms of rebound hypertension upon withdrawal (nervousness, agitation, headache, tremor, rapid rise in BP)

Special Patient Groups

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Pregnancy

Clonidine is classified as Pregnancy Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Abrupt discontinuation during pregnancy can be dangerous.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal data; human data limited.
Second Trimester: Potential for fetal harm based on animal data; human data limited.
Third Trimester: Potential for fetal harm based on animal data; human data limited. Risk of rebound hypertension in mother if discontinued abruptly.
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Lactation

Clonidine is excreted into breast milk. The American Academy of Pediatrics considers clonidine to be compatible with breastfeeding, but caution is advised. Monitor the infant for sedation, bradycardia, or other adverse effects.

Infant Risk: L3 (Moderately Safe) - Monitor infant for sedation, bradycardia, and poor feeding. Consider alternative if infant is premature or has underlying conditions.
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Pediatric Use

Safety and efficacy of clonidine patches for hypertension in pediatric patients have not been established. Oral clonidine is used off-label for ADHD and tic disorders in children, but transdermal formulation is less common for these indications in this population.

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Geriatric Use

Elderly patients may be more sensitive to the hypotensive and sedative effects of clonidine. Start with lower doses and titrate slowly. Monitor closely for orthostatic hypotension, bradycardia, and CNS depression. Renal function should be assessed, as age-related decline in renal function may necessitate dose adjustment.

Clinical Information

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Clinical Pearls

  • Transdermal clonidine offers once-weekly dosing, which can improve adherence compared to oral formulations.
  • It has a slower onset and offset of action compared to oral clonidine, which may reduce the severity of rebound hypertension if a dose is missed, but abrupt discontinuation should still be avoided.
  • Patients should be educated on proper patch application and rotation to minimize skin irritation.
  • The patch should be removed before MRI procedures due to the aluminum backing, which can cause skin burns.
  • Clonidine can cause significant dry mouth and drowsiness, especially at the beginning of therapy or with dose increases.
  • Always taper clonidine slowly over 2-4 days (or longer) when discontinuing to prevent rebound hypertension, even with the patch formulation.
  • Consider the transdermal patch for patients who have difficulty swallowing pills or prefer a less frequent dosing schedule.
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Alternative Therapies

  • Other centrally acting alpha-2 agonists (e.g., guanfacine - oral)
  • Thiazide diuretics (e.g., hydrochlorothiazide)
  • ACE inhibitors (e.g., lisinopril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan)
  • Beta-blockers (e.g., metoprolol)
  • Calcium channel blockers (e.g., amlodipine)
  • Other classes of antihypertensives depending on patient comorbidities and specific indications.
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Cost & Coverage

Average Cost: Varies widely by pharmacy and specific patch strength/quantity. For 0.2mg/24h weekly patches (4 patches/month), expect a range of $50-$200+ without insurance. per 4 patches
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.