Clonidine 0.3mg/24h Weekly Patch

Manufacturer MAYNE 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 is a medication used to lower high blood pressure. The patch form releases the medicine slowly through your skin over a week. It works by relaxing blood vessels and slowing your heart rate, which helps reduce the force of blood flowing through your arteries.
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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 follow the instructions closely. Continue using the medication as directed by your doctor or healthcare provider, even if you feel well.

Applying the Patch

1. Remove the old patch before applying a new one.
2. Wash your hands before and after handling the patch.
3. Do not cut or divide the patches, and do not use damaged patches.
4. Apply the patch to clean, dry, healthy skin on your chest or upper arm. Rotate the site with each new patch.
5. Choose a site without hair and avoid areas with irritated or damaged skin, skin folds, or skin that may be rubbed by tight clothing.

Wearing the Patch

You can bathe, shower, or swim while wearing the patch. If the patch comes loose, use the provided patch cover to hold it in place. Note that the patch cover does not contain any medication and should not be used alone.

Managing Skin Irritation

If the skin under the patch becomes mildly irritated, you may remove the patch and apply a new one to a different area.

Disposing of Used Patches

After removing a used patch, fold the sticky sides together and dispose of it in a secure location where children and pets cannot access it. This medication can be harmful to children if accidentally ingested, inhaled, or applied to the skin. If this happens, seek medical help immediately.

Stopping the Medication

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

Storing and Disposing of the Medication

Store the medication at room temperature in a dry place, away from bathrooms. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications according to the instructions provided. Do not flush medications down the toilet or pour them down the drain unless instructed to do so. Check with your pharmacist for guidance on disposing of medications, 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 is close to the time for your next patch, apply a new patch 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 your upper arm or torso. Avoid areas with cuts, rashes, or scars.
  • Change the patch once a week, at the same time each week. Choose a different skin site for each new patch to prevent irritation.
  • If the patch becomes loose, apply adhesive tape over it to keep it in place. If it falls off, replace it with a new patch and continue your weekly schedule from that day.
  • Do NOT stop using clonidine patches suddenly, as this can cause a dangerous increase in blood pressure (rebound hypertension). Your doctor will tell you how to slowly reduce the dose if you need to stop.
  • Avoid alcohol and other medications that cause drowsiness, as clonidine can increase these effects.
  • Be careful when standing up quickly, as clonidine can cause dizziness or lightheadedness (orthostatic hypotension).
  • Inform your doctor or dentist that you are using clonidine before any surgery or dental procedures.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 0.1 mg/24h patch applied once weekly. Titrate by 0.1 mg/24h increments at 1-2 week intervals. Maintenance: 0.1 to 0.3 mg/24h patch once weekly. Max: 0.6 mg/24h patch once weekly.
Dose Range: 0.1 - 0.6 mg

Condition-Specific Dosing:

Hypertension: Apply one patch once weekly to a hairless area of intact skin on the upper arm or torso. The 0.3 mg/24h patch is a higher strength, typically used after titration from lower doses or for patients requiring higher control.
ADHD (off-label): Dosing is highly individualized, typically starting at lower oral doses and titrating. Transdermal use for ADHD is less common but may be considered for adherence or side effect profiles. Consult specific guidelines for off-label use.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for hypertension. For ADHD (off-label): Dosing is highly individualized, typically starting with oral clonidine. Transdermal use is less common and requires specialist guidance.
Adolescent: Not established for hypertension. For ADHD (off-label): Dosing is highly individualized, typically starting with oral clonidine. Transdermal use is less common and requires specialist guidance.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment usually needed, but monitor response.
Moderate: Consider lower initial doses and slower titration. Monitor blood pressure and heart rate closely.
Severe: Consider lower initial doses (e.g., 0.1 mg/24h patch) and slower titration. Monitor blood pressure and heart rate closely. Significant accumulation may occur.
Dialysis: Clonidine is minimally removed by hemodialysis. Supplemental doses are generally not required. Monitor blood pressure closely.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Clonidine is a centrally acting alpha-2 adrenergic agonist. It stimulates alpha-2 adrenoceptors in the brainstem, which results in a reduction of sympathetic outflow from the central nervous system. This leads to a decrease in peripheral vascular resistance, renal vascular resistance, heart rate, and blood pressure.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 60% (transdermal, relative to oral)
Tmax: 2-3 days (for steady-state plasma concentrations after patch application)
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 (40-60% as unchanged drug), Fecal (20%)
Unchanged: 40-60%
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Pharmacodynamics

OnsetOfAction: 2-3 days (for full therapeutic effect after initial patch application)
PeakEffect: 3-5 days (for steady-state plasma concentrations)
DurationOfAction: 7 days (patch provides continuous release)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- Allergic reaction symptoms, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Severe dizziness or fainting
- Abnormal heartbeat (fast, slow, or irregular)
- Redness
- Burning sensation
- Change in skin color

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor 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 do not go away, contact your doctor for advice:
- Dry mouth
- Constipation
- Dizziness, drowsiness, tiredness, 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 fainting
  • Chest pain or shortness of breath
  • Very slow heart rate
  • Severe skin rash or irritation at the patch site that does not go away
  • Signs of allergic reaction (e.g., swelling of face/lips/tongue, difficulty breathing)
  • Sudden, severe headache, nervousness, or agitation (signs of rebound hypertension if discontinued abruptly)
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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
+ Beta blockers, such as metoprolol or propranolol
Please note that this is not an exhaustive list of all potential drug interactions.

To ensure your safety, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
as well as any health problems you may have. Your doctor and pharmacist need this information to determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

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

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.

Monitoring and Interactions
Follow your doctor's instructions for monitoring your blood pressure and heart rate. If you have high blood pressure, consult your doctor before taking 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.

Precautions in Hot Weather and with Physical Activity
Be careful in hot weather or when engaging in physical activity, and drink plenty of fluids to prevent dehydration.

Eye Care
Dry eyes may occur with this medication. If you wear contact lenses and experience dry eyes or a change in how your lenses feel, consult your doctor.

Interactions with Other Substances
Discuss with your doctor before using alcohol, marijuana or other forms of cannabis, or prescription or OTC medications that may slow your reactions.

Special Precautions
The patch 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 (defibrillation, cardioversion), inform your doctor that you are taking this medication.

Skin Irritation and Allergic Reactions
If you have used a patch form of this medication and experienced skin irritation, consult your doctor. You may be more likely to develop a rash on other parts of your body with any form of this medication.

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

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to discuss the benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe drowsiness or coma
  • Pinpoint pupils
  • Slow heart rate (bradycardia)
  • Low blood pressure (hypotension)
  • Respiratory depression (slow, shallow breathing)
  • Hypothermia (low body temperature)
  • Arrhythmias (irregular heartbeats)

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)
  • Calcium channel blockers (increased risk of bradycardia and hypotension)
  • CNS depressants (e.g., alcohol, barbiturates, benzodiazepines, opioids, sedatives, hypnotics) - additive sedative effects
  • Tricyclic antidepressants (TCAs) - may antagonize the hypotensive effect of clonidine
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Moderate Interactions

  • Diuretics (additive hypotensive effect)
  • Other antihypertensives (additive hypotensive effect)
  • Digitalis glycosides (increased risk of bradycardia and AV block)
  • Neuroleptics (e.g., haloperidol) - may increase risk of orthostatic hypotension
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Minor Interactions

  • NSAIDs (may reduce antihypertensive effect)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation of therapy.

Heart Rate (HR)

Rationale: To establish baseline and monitor for bradycardia.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine)

Rationale: Clonidine is primarily renally excreted; impairment may require dose adjustment.

Timing: Prior to initiation of therapy.

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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 adults.

Action Threshold: Persistent BP above target, or symptomatic hypotension.

Heart Rate (HR)

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

Target: Typically 60-100 bpm, unless otherwise specified by clinician.

Action Threshold: Persistent bradycardia (<60 bpm) or symptomatic bradycardia.

Adverse Effects (e.g., dry mouth, drowsiness, dizziness, constipation, skin reactions)

Frequency: At each visit, especially during titration.

Target: N/A

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

Patch Adhesion/Skin Integrity

Frequency: At each patch change.

Target: N/A

Action Threshold: Poor adhesion, significant skin irritation, rash, or allergic reaction.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Drowsiness
  • Dry mouth
  • Constipation
  • Fatigue
  • Headache
  • Nausea
  • Skin irritation/rash at patch site
  • Symptoms of rebound hypertension (e.g., nervousness, agitation, headache, tremor, rapid rise in BP) if patch is abruptly discontinued.

Special Patient Groups

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Pregnancy

Category C. Clonidine crosses the placenta. Use only if the potential benefit justifies the potential risk to the fetus. Neonatal withdrawal symptoms (e.g., jitteriness, irritability, poor feeding) have been reported following maternal clonidine use during pregnancy, especially if discontinued abruptly.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly necessary.
Second Trimester: May be used if benefits outweigh risks, with close monitoring.
Third Trimester: Increased risk of neonatal withdrawal symptoms if used close to delivery or discontinued abruptly.
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Lactation

Clonidine is excreted into breast milk. The American Academy of Pediatrics considers clonidine to be of 'unknown effect on nursing infant but may be of concern'. Monitor breastfed infants for sedation, bradycardia, and hypotension. Use with caution.

Infant Risk: L3 (Moderately safe; possible adverse effects, but controlled studies are lacking or adverse effects are minor and reversible).
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Pediatric Use

Safety and efficacy for hypertension in pediatric patients have not been established. Transdermal clonidine is used off-label for ADHD in some pediatric populations, but dosing and monitoring require specialist guidance. Due to potential for significant adverse effects (e.g., sedation, bradycardia, hypotension), careful titration and monitoring are essential.

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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.

Clinical Information

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Clinical Pearls

  • The clonidine transdermal patch is designed for once-weekly application, providing continuous drug delivery and potentially improving adherence compared to multiple daily oral doses.
  • Abrupt discontinuation of clonidine (oral or transdermal) can lead to severe rebound hypertension, which can be life-threatening. Taper the dose gradually over 2-4 days or longer if possible.
  • Skin reactions (e.g., erythema, pruritus, burning) at the patch application site are common. Rotate application sites weekly to minimize irritation.
  • The patch contains an aluminum layer; patients should be advised to remove the patch before MRI procedures to prevent skin burns.
  • Sedation and dry mouth are common side effects, especially at the beginning of therapy or with dose increases. These often diminish with continued use.
  • Patients should be educated on proper patch application and removal techniques, and what to do if a patch falls off.
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Alternative Therapies

  • Other centrally acting alpha-2 agonists (e.g., guanfacine - primarily for ADHD, less common for hypertension)
  • Thiazide diuretics (e.g., hydrochlorothiazide)
  • ACE inhibitors (e.g., lisinopril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan)
  • 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 insurance plan, typically $50-$200+ per 4 patches (1 month supply)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic), Tier 3 or higher (for brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. 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 details about the medication taken, the amount, and the time it occurred.