Catapres Tts-3 Weekly Patch

Manufacturer TECHNOMED 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 treat high blood pressure. They work by affecting certain signals in your brain to relax blood vessels and slow your heart rate, which helps lower your blood pressure. The patch is applied to your skin and releases the medicine slowly over a week.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, 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.

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. Seek immediate medical help if this occurs. 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 this medication, your doctor will instruct you on how to gradually discontinue it.

Storage and Disposal

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. Consult your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.

Missed 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 use extra doses.
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Lifestyle & Tips

  • Do not stop using the patch suddenly, as this can cause a dangerous and rapid increase in blood pressure (rebound hypertension). Your doctor will tell you how to slowly reduce the dose if needed.
  • 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 and dizziness.
  • Maintain a healthy diet and exercise routine as advised by your doctor to support blood pressure control.
  • Apply the patch to a clean, dry, hairless area of the upper outer arm or chest. Rotate application sites weekly to minimize skin irritation.
  • If the patch falls off, apply a new one and continue with your original weekly schedule.
  • Wash hands thoroughly after applying or removing the patch.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 0.1 mg/24 hr patch applied once weekly. Titrate by 0.1 mg/24 hr increments at 1-2 week intervals based on therapeutic response and tolerability.
Dose Range: 0.1 - 0.3 mg

Condition-Specific Dosing:

hypertension: Apply one patch weekly to a hairless area of intact skin on the upper outer arm or chest. Doses typically range from 0.1 mg/24 hr to 0.3 mg/24 hr.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for hypertension; used off-label for ADHD or tic disorders, but specific transdermal patch dosing is highly individualized and not standardized.
Adolescent: Not established for hypertension; used off-label for ADHD or tic disorders, but specific transdermal patch dosing is highly individualized and not standardized.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; consider starting with lower doses (e.g., 0.1 mg/24 hr patch) and titrate slowly.
Moderate: Dose reduction and careful titration recommended. Monitor renal function and blood pressure closely.
Severe: Dose reduction and careful titration recommended. Monitor renal function and blood pressure closely.
Dialysis: Clonidine is minimally removed by hemodialysis. Supplemental doses generally not needed, but monitor blood pressure closely.

Hepatic Impairment:

Mild: No specific dose adjustment guidelines; use with caution.
Moderate: No specific dose adjustment guidelines; use with caution due to potential for increased sensitivity.
Severe: No specific dose adjustment guidelines; use with caution due to potential for increased sensitivity.

Pharmacology

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Mechanism of Action

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

Absorption:

Bioavailability: Designed for continuous, controlled release; plasma concentrations reach steady-state within 2-3 days.
Tmax: Steady-state plasma concentrations achieved within 2-3 days of initial application.
FoodEffect: Not applicable for transdermal administration.

Distribution:

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

Elimination:

HalfLife: 17-40 hours (effective half-life for transdermal due to continuous absorption)
Clearance: Approximately 200 mL/min
ExcretionRoute: Renal (40-60% as unchanged drug), Fecal (20%)
Unchanged: 40-60% (renal)
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Pharmacodynamics

OnsetOfAction: 2-3 days (for steady-state with transdermal patch)
PeakEffect: 2-3 days (for steady-state with transdermal patch)
DurationOfAction: 7 days (weekly patch)

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 heart rhythms, including fast, slow, or irregular heartbeat
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 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 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
  • Chest pain or shortness of breath
  • Severe skin rash, blistering, or irritation at the patch site
  • Signs of an allergic reaction (e.g., swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing)
  • Symptoms of rebound hypertension if patch is stopped abruptly (e.g., severe headache, nervousness, tremors, 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 symptoms you experienced.
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 interactions. To ensure your safety, it is crucial to discuss all of your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health conditions with your doctor and pharmacist. Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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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.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

Follow your doctor's instructions for monitoring your blood pressure and heart rate. If you have high blood pressure, consult your doctor before taking any 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 mindful of your fluid intake to prevent dehydration. Drink plenty of fluids to avoid fluid loss.

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, using marijuana or other cannabis products, or taking prescription or OTC medications that may impair your reactions, consult your doctor.

The patch form of this medication may contain metal, so it is crucial to remove it before undergoing a magnetic resonance imaging (MRI) procedure. 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 using 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 when taking this medication in any form.

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, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe drowsiness or sedation
  • Confusion
  • Weakness
  • Slow heart rate (bradycardia)
  • Very low blood pressure (hypotension)
  • Shallow breathing or respiratory depression
  • Pinpoint pupils (miosis)
  • Hypothermia (low body temperature)
  • Coma

What to Do:

Seek immediate medical attention or call Poison Control (1-800-222-1222). Treatment is supportive, focusing on maintaining vital signs and airway. Naloxone may reverse respiratory depression in some cases, but its efficacy is variable.

Drug Interactions

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Major Interactions

  • Beta-blockers (e.g., propranolol, metoprolol): Increased risk of severe bradycardia, AV block, and rebound hypertension upon clonidine withdrawal.
  • CNS Depressants (e.g., alcohol, barbiturates, benzodiazepines, opioids): Additive sedative effects.
  • Tricyclic Antidepressants (TCAs): May antagonize the hypotensive effect of clonidine.
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Moderate Interactions

  • Other Antihypertensives (e.g., diuretics, vasodilators, alpha-blockers): Additive hypotensive effects.
  • Digoxin, Calcium Channel Blockers: Increased risk of bradycardia or AV block.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To establish baseline cardiovascular status and assess the need for treatment.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine)

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Weekly initially 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 BP above target, symptomatic hypotension, or significant bradycardia.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Sedation
  • Dry mouth
  • Constipation
  • Rebound hypertension (if patch removed abruptly)
  • Skin reactions at application site (e.g., rash, itching, redness)

Special Patient Groups

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Pregnancy

Category C. Clonidine crosses the placenta. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Close monitoring of the mother and fetus is recommended.

Trimester-Specific Risks:

First Trimester: Limited human data; generally avoided if possible due to potential for fetal harm, though no clear pattern of malformations has been established.
Second Trimester: May be considered for severe hypertension if benefits outweigh risks; monitor fetal growth and well-being.
Third Trimester: May be associated with neonatal withdrawal symptoms (e.g., irritability, tremors, feeding difficulties) if used close to delivery. Monitor neonate for signs of withdrawal.
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Lactation

L3 (Moderately safe). Clonidine is excreted into breast milk. Monitor breastfed infant for potential adverse effects.

Infant Risk: Potential for sedation, bradycardia, and hypotension in the infant. Observe infant for unusual drowsiness, poor feeding, or changes in heart rate.
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Pediatric Use

Not FDA-approved for the treatment of hypertension in children. It is used off-label for conditions such as ADHD, tic disorders (e.g., Tourette's syndrome), and certain pain conditions. Dosing in pediatric patients requires specialist supervision and careful titration.

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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. Increased risk of orthostatic hypotension and falls in this population.

Clinical Information

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Clinical Pearls

  • **Rebound Hypertension:** Abrupt discontinuation of clonidine, especially after prolonged use or high doses, can lead to a rapid and severe increase in blood pressure, nervousness, agitation, and headache. Always taper the dose gradually over 2-4 days under medical supervision.
  • **Patch Application:** Proper application technique is crucial. Instruct patients to apply the patch to a clean, dry, hairless area of the upper outer arm or chest and to rotate application sites weekly to minimize skin irritation. Avoid areas that are rubbed by clothing.
  • **Sedation and Dry Mouth:** These are common side effects, particularly at the beginning of therapy. Patients should be advised to avoid activities requiring mental alertness (e.g., driving) until they know how they react to the medication.
  • **Adherence:** The weekly transdermal patch can improve patient adherence compared to multiple daily oral doses.
  • **Off-label Uses:** Clonidine is commonly used off-label for various conditions including ADHD, tic disorders (e.g., Tourette's syndrome), opioid withdrawal symptoms, and menopausal hot flashes.
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Alternative Therapies

  • Other Antihypertensives (e.g., Thiazide diuretics, ACE inhibitors, Angiotensin Receptor Blockers (ARBs), Calcium Channel Blockers, Beta-blockers).
  • Other Alpha-2 Agonists (e.g., Guanfacine - oral, extended-release formulations for ADHD).
  • For ADHD/Tic Disorders (off-label uses): Stimulants (e.g., methylphenidate, amphetamines), Atomoxetine, Guanfacine (oral).
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Cost & Coverage

Generic Available: Yes
Insurance Coverage: Often Tier 1 or Tier 2 for generic formulations; Tier 3 for brand-name.
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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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.