Clonidine 0.1mg/24h Weekly Patch

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 patch is a medication applied to the skin once a week to help lower high blood pressure. It works by relaxing blood vessels and slowing the heart rate. It's important to apply it correctly and not stop using it suddenly.
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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 to avoid skin irritation.
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.

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 where children and pets cannot access it.

Important Safety Precautions

This medication can be harmful to children if accidentally ingested, swallowed, or applied to their skin. If this occurs, seek medical help immediately. Do not stop using this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to stop using the medication, your doctor will instruct you on how to taper off slowly.

Storing and Disposing of Your Medication

Store the 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. 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 the 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

  • Maintain a healthy diet low in sodium and saturated fats.
  • Engage in regular physical activity as advised by your doctor.
  • Limit alcohol intake.
  • Avoid smoking.
  • Manage stress effectively.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.1 mg/24h weekly patch, applied once every 7 days
Dose Range: 0.1 - 0.3 mg

Condition-Specific Dosing:

hypertension: Initial dose 0.1 mg/24h weekly. May increase by 0.1 mg/24h increments at 1-2 week intervals. Doses higher than 0.6 mg/24h weekly are generally not recommended.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for transdermal patch in hypertension; oral clonidine is used off-label for certain conditions (e.g., ADHD, Tourette's).
Adolescent: Not established for transdermal patch in hypertension; oral clonidine is used off-label for certain conditions.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor for increased adverse effects.
Moderate: Start with lower doses (e.g., 0.1 mg/24h weekly) and titrate slowly based on clinical response and tolerability.
Severe: Start with lower doses (e.g., 0.1 mg/24h weekly) and titrate slowly; consider extending dosing interval or reducing dose. Close monitoring is essential.
Dialysis: Clonidine is minimally removed by hemodialysis. Supplementation after dialysis is generally not required. Monitor blood pressure closely.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: Use with caution; monitor for increased adverse effects due to potential for altered metabolism or elimination.
Severe: Use with caution; monitor for increased adverse effects due to potential for 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 adrenergic receptors 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% (oral); transdermal system provides continuous delivery.
Tmax: 2-3 days (to reach steady-state plasma concentrations with transdermal patch)
FoodEffect: Not applicable for transdermal patch.

Distribution:

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

Elimination:

HalfLife: 12-24 hours (oral); effective half-life for transdermal system is longer due to continuous absorption from skin reservoir.
Clearance: Not readily available for transdermal, but primarily renal.
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 with transdermal patch)
PeakEffect: 2-3 days (for full therapeutic effect with transdermal patch)
DurationOfAction: 7 days (for weekly patch)

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:

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
Change in skin color

Other Possible Side Effects
While many people may not experience any side effects or only mild ones, it's essential to be aware of the following potential side effects. If you experience any of these symptoms and they bother you or persist, contact your doctor for advice:

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 fainting (orthostatic hypotension)
  • Unusual tiredness or weakness
  • Severe dry mouth that interferes with speaking or swallowing
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • Sudden increase in blood pressure, headache, or nervousness (if patch is stopped 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, 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. 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 tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.

Monitoring and Interactions
Regularly check your blood pressure and heart rate as instructed by your doctor. 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.

Precautions in Various Situations
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration.

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

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

Special Precautions
If you need to undergo an MRI, remove the patch, as it may contain metal. Inform your doctor if you will be having procedures to regulate your heart rhythm (defibrillation, cardioversion), as they should be aware 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, inform your doctor, as 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, as 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:

  • Profound hypotension (very low blood pressure)
  • Bradycardia (slow heart rate)
  • Respiratory depression (slow, shallow breathing)
  • Sedation, coma
  • Miosis (pinpoint pupils)
  • Hypothermia

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive, focusing on maintaining vital functions.

Drug Interactions

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Major Interactions

  • Beta-blockers (risk of bradycardia, AV block, and rebound hypertension upon withdrawal of either drug)
  • Tricyclic antidepressants (TCAs) (may reduce the antihypertensive effect of clonidine)
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Moderate Interactions

  • CNS depressants (e.g., alcohol, barbiturates, benzodiazepines, opioids, sedating antihistamines) (additive sedative effects)
  • Other antihypertensives (e.g., diuretics, vasodilators) (additive hypotensive effects)
  • Digitalis glycosides (risk of bradycardia, AV block)

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 (SCr, eGFR)

Rationale: To assess kidney function, as clonidine is primarily renally eliminated and dose adjustments may be needed in impairment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP)

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

Target: Individualized, typically <130/80 mmHg for most adults with hypertension.

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

Heart Rate (HR)

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

Target: Individualized, typically 60-100 bpm.

Action Threshold: Persistent bradycardia (e.g., HR <50 bpm or symptomatic bradycardia).

Patch Adhesion/Skin Reaction

Frequency: With each patch change.

Target: Intact patch, minimal skin irritation.

Action Threshold: Poor adhesion, severe erythema, rash, or blistering at application site.

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Symptom Monitoring

  • Dizziness
  • Sedation/Drowsiness
  • Dry mouth
  • Constipation
  • Fatigue
  • Orthostatic hypotension
  • Rebound hypertension (if discontinued abruptly)
  • Application site reactions (e.g., erythema, rash, pruritus)

Special Patient Groups

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Pregnancy

Clonidine is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm cannot be ruled out. Use only if clearly indicated.
Second Trimester: Potential for fetal harm cannot be ruled out. Use only if clearly indicated.
Third Trimester: Potential for fetal harm cannot be ruled out. Use only if clearly indicated. Neonatal withdrawal symptoms have been reported following maternal clonidine use near term.
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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 signs of sedation, bradycardia, or other adverse effects.

Infant Risk: Low to moderate risk. Monitor for drowsiness, lethargy, poor feeding, or bradycardia in the infant.
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Pediatric Use

Safety and efficacy of transdermal clonidine for hypertension have not been established in pediatric patients. Oral clonidine is used off-label for certain conditions in children, but transdermal use is less common.

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Geriatric Use

Use with caution in elderly patients, starting with lower doses and titrating slowly. Elderly patients may be more sensitive to the hypotensive and sedative effects of clonidine and are at increased risk for orthostatic hypotension.

Clinical Information

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Clinical Pearls

  • **Rebound Hypertension:** Abrupt discontinuation of clonidine, especially after prolonged therapy or high doses, can lead to a rapid and severe increase in blood pressure (rebound hypertension). Taper the dose gradually over 2-4 days to avoid this.
  • **Patch Application:** Apply the patch to a clean, dry, hairless area of the upper outer arm or chest. Rotate application sites weekly to minimize skin irritation. Do not cut the patch.
  • **Sedation/Dry Mouth:** These are common side effects, especially at the beginning of therapy. Patients should be cautioned about driving or operating machinery until they know how they react to the medication.
  • **Skin Reactions:** Localized skin reactions (erythema, rash, pruritus) are common with transdermal clonidine. If severe, consider switching to oral clonidine or another antihypertensive.
  • **Adherence:** Emphasize the importance of weekly patch changes and proper application for consistent blood pressure control.
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Alternative Therapies

  • Other centrally acting alpha-2 agonists (e.g., guanfacine, methyldopa)
  • Thiazide diuretics (e.g., hydrochlorothiazide)
  • ACE inhibitors (e.g., lisinopril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan)
  • Calcium Channel Blockers (CCBs) (e.g., amlodipine)
  • Beta-blockers (e.g., metoprolol)
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Cost & Coverage

Average Cost: Varies, typically $50-$200 per 4 weekly patches
Generic Available: Yes
Insurance Coverage: Tier 1 or 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 this medication, don't hesitate to discuss them with 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.