Catapres 0.1mg Tablets

Manufacturer BOEHRINGER INGELHEIM Active Ingredient Clonidine Tablets(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
Apr 1974
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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. It works by relaxing blood vessels and slowing the heart rate. It can also be used for other conditions like ADHD or to help with withdrawal symptoms.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.

Important: Do Not Stop Taking Your Medication Abruptly

Do not stop taking this medication suddenly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will advise you on how to gradually discontinue it.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store all medications in a safe location, out of the reach of children and pets.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Do not stop taking clonidine 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 needed.
  • Avoid alcohol and other medications that cause drowsiness, as clonidine can increase these effects.
  • Be cautious when driving or operating machinery until you know how clonidine affects you, as it can cause dizziness or drowsiness.
  • To relieve dry mouth, chew sugarless gum, suck on hard candy, or use saliva substitutes.
  • Maintain a healthy diet, exercise regularly, and limit sodium intake as advised by your doctor to help manage blood pressure.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 0.1 mg orally twice daily. Increase by 0.1 mg/day increments at weekly intervals.
Dose Range: 0.2 - 2.4 mg

Condition-Specific Dosing:

hypertension: Usual maintenance dose is 0.2 to 0.6 mg/day in divided doses. Doses exceeding 2.4 mg/day are generally not recommended.
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Pediatric Dosing

Neonatal: Not established for hypertension. Limited data for other indications (e.g., opioid withdrawal, ADHD).
Infant: Not established for hypertension. Limited data for other indications.
Child: Not established for hypertension. For ADHD (extended-release formulation, Kapvay): 0.05 mg at bedtime, titrate up to 0.2-0.4 mg/day in divided doses. For Tourette's syndrome: 0.05-0.3 mg/day in divided doses.
Adolescent: Not established for hypertension. For ADHD (extended-release formulation, Kapvay): 0.05 mg at bedtime, titrate up to 0.2-0.4 mg/day in divided doses.
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Dose Adjustments

Renal Impairment:

Mild: Start with lower doses and titrate slowly. Monitor blood pressure and heart rate closely.
Moderate: Start with lower doses (e.g., 0.05 mg once daily) and titrate slowly based on clinical response and tolerability. Monitor closely.
Severe: Significant dose reduction required. Start with very low doses (e.g., 0.05 mg once daily or every other day) and titrate cautiously. Monitor closely.
Dialysis: Clonidine is minimally removed by hemodialysis. Supplemental dosing after dialysis is generally not required, but careful monitoring of blood pressure is essential.

Hepatic Impairment:

Mild: No specific dose adjustment guidelines, but use with caution.
Moderate: No specific dose adjustment guidelines, but use with caution and monitor for increased effects.
Severe: No specific dose adjustment guidelines, but use with caution and monitor for increased effects due to potential for reduced 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, which results in a reduction of sympathetic outflow from the central nervous system. This leads to decreased peripheral vascular resistance, heart rate, and blood pressure.
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Pharmacokinetics

Absorption:

Bioavailability: 75-95%
Tmax: 2-4 hours
FoodEffect: Minimal effect on absorption rate or extent.

Distribution:

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

Elimination:

HalfLife: 12-16 hours (can extend to 24 hours in renal impairment)
Clearance: Not available
ExcretionRoute: Renal (40-60% unchanged), Fecal (20%)
Unchanged: 40-60%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 2-4 hours
DurationOfAction: 8-12 hours

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

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 for advice:

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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. 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
  • Very slow heart rate
  • Difficulty breathing
  • Severe drowsiness or confusion
  • Signs of rebound hypertension if stopped abruptly: severe headache, nervousness, agitation, tremor, rapid increase in blood pressure.
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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 disclose all of your medications, including prescription and over-the-counter drugs, natural products, and 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.

Remember, 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.

If you vomit after taking a dose of this medication, talk to your doctor about the best course of action. Additionally, 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.

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

It is crucial to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to both 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, somnolence, coma
  • Miosis (pinpoint pupils)
  • Hypothermia

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, focusing on maintaining vital signs. Naloxone has been used to reverse respiratory depression and CNS effects in some cases, but its efficacy is variable.

Drug Interactions

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Major Interactions

  • Beta-blockers (risk of rebound hypertension upon clonidine withdrawal)
  • Tricyclic antidepressants (may reduce hypotensive effect of clonidine)
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Moderate Interactions

  • CNS depressants (e.g., alcohol, barbiturates, sedatives, hypnotics, opioids) - additive sedative effects
  • Other antihypertensives (e.g., diuretics, vasodilators) - additive hypotensive effects
  • Digoxin (may increase risk of bradycardia)
  • Calcium channel blockers (may increase risk of bradycardia or AV block)
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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 (SCr, BUN)

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and at follow-up visits.

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

Action Threshold: Persistent BP outside target range, or symptomatic hypotension/hypertension.

Heart Rate (HR)

Frequency: Regularly, especially during dose titration.

Target: Individualized, typically >60 bpm unless otherwise indicated.

Action Threshold: Symptomatic bradycardia or HR <50 bpm.

CNS effects (drowsiness, dizziness)

Frequency: At each visit, especially during dose titration.

Target: Minimal to no impairment.

Action Threshold: Significant or debilitating drowsiness/dizziness.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Clonidine is 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: Limited human data, but animal studies show some adverse effects at high doses. Risk vs. benefit should be carefully weighed.
Second Trimester: Limited human data. Risk vs. benefit should be carefully weighed.
Third Trimester: Limited human data. Risk vs. benefit should be carefully weighed. Neonatal withdrawal symptoms (e.g., irritability, tremor, poor feeding) have been reported following maternal 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 sedation, bradycardia, or other adverse effects.

Infant Risk: L3 (Moderately safe). Potential for infant sedation, bradycardia, or hypotension. Monitor infant closely.
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Pediatric Use

Safety and efficacy for hypertension in pediatric patients have not been established. However, extended-release clonidine (Kapvay) is approved for ADHD in children and adolescents. Use in other pediatric conditions (e.g., Tourette's, opioid withdrawal) is off-label and requires careful consideration of risks vs. benefits.

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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, monitoring blood pressure and heart rate closely. Increased risk of orthostatic hypotension.

Clinical Information

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Clinical Pearls

  • Abrupt discontinuation of clonidine can lead to severe rebound hypertension, which can be life-threatening. Doses should be tapered gradually over 2-4 days.
  • Often used as an add-on therapy for resistant hypertension.
  • Can cause significant dry mouth and sedation, especially at the beginning of therapy.
  • Transdermal patch formulation (Catapres-TTS) is available for once-weekly dosing, which may improve adherence and reduce peak-trough fluctuations.
  • Also used off-label for opioid withdrawal symptoms, menopausal flushing, and certain pain syndromes.
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Alternative Therapies

  • Other centrally acting alpha-2 agonists (e.g., methyldopa)
  • Thiazide diuretics
  • ACE inhibitors
  • Angiotensin receptor blockers (ARBs)
  • Beta-blockers
  • Calcium channel blockers
  • Other vasodilators (e.g., hydralazine, minoxidil)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (0.1mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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 taken, the amount, and the time it occurred.