Catapres 0.2mg 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, centrally acting
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Pharmacologic Class
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 by relaxing blood vessels and slowing the heart rate. It works by affecting certain signals in your brain. 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 to you 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 instruct 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.
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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 help with dry mouth, chew sugarless gum, suck on hard candy, or use saliva substitutes.
  • Stand up slowly from a sitting or lying position to avoid dizziness or lightheadedness (orthostatic hypotension).
  • Maintain a healthy diet and exercise routine as advised by your doctor to help manage blood pressure.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.1 mg orally twice daily, increasing by 0.1 mg/day at weekly intervals until desired response is achieved.
Dose Range: 0.1 - 2.4 mg

Condition-Specific Dosing:

hypertension: Initial 0.1 mg BID; usual maintenance 0.2-0.6 mg/day in divided doses; max 2.4 mg/day.
adhd: Typically 0.05-0.3 mg/day in divided doses (off-label).
opioid_withdrawal: 0.1-0.3 mg every 6-8 hours (off-label, titrated to symptoms).
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Pediatric Dosing

Neonatal: Not established (limited data for specific conditions like NAS).
Infant: Not established (limited data for specific conditions).
Child: Not FDA approved for hypertension. For ADHD (off-label): 0.05 mg at bedtime, titrate up to 0.05-0.4 mg/day in 2-4 divided doses. For Tourette's (off-label): 0.05 mg at bedtime, titrate up to 0.15-0.3 mg/day in 2-3 divided doses.
Adolescent: Similar to child dosing for off-label uses; for hypertension, consider adult dosing with caution.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor response.
Moderate: Reduce initial dose by 50% (e.g., 0.05 mg BID), titrate cautiously. For CrCl < 30 mL/min, consider 50% reduction.
Severe: Reduce initial dose by 50% (e.g., 0.05 mg BID), titrate cautiously. For CrCl < 30 mL/min, consider 50% reduction.
Dialysis: Clonidine is minimally removed by hemodialysis. Supplemental dose after dialysis is generally not required, but monitor BP closely.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: Use with caution; monitor for increased sedative and hypotensive effects.
Severe: Use with caution; monitor for increased sedative and hypotensive effects.

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 reduces sympathetic outflow from the central nervous system. This leads to a decrease in peripheral vascular resistance, renal vascular resistance, heart rate, and blood pressure. It also inhibits the release of norepinephrine.
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Pharmacokinetics

Absorption:

Bioavailability: 75-95%
Tmax: 1-3 hours (oral)
FoodEffect: Minimal effect on absorption rate or extent.

Distribution:

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

Elimination:

HalfLife: 6-20 hours (prolonged in renal impairment, up to 40 hours)
Clearance: Approximately 200 mL/min (total body clearance)
ExcretionRoute: Renal (40-60% unchanged), Fecal (20%)
Unchanged: 40-60%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (oral)
PeakEffect: 2-4 hours (oral)
DurationOfAction: 6-10 hours (oral)

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, or 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
While not everyone experiences side effects, it's essential to be aware of the potential ones. If you encounter any of the following or any other side effects that bother you or do not go away, contact your doctor for advice:
- Dry mouth
- Constipation
- Dizziness, drowsiness, tiredness, or weakness
- Headache
- Upset stomach

Reporting Side Effects
This list does not include all possible 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
  • 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, severe headache or blurred vision (signs of rebound hypertension if 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.

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.

Follow your doctor's instructions for monitoring 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.

Be cautious in hot weather or during physical activity, 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, 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.

If you are pregnant, plan to become pregnant, or are 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 (slow heart rate)
  • Respiratory depression (slow or 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. Treatment is supportive, focusing on maintaining vital signs. Naloxone has been used to reverse some effects in children.

Drug Interactions

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Major Interactions

  • Beta-blockers (risk of rebound hypertension upon clonidine withdrawal, or exaggerated bradycardia/hypotension)
  • Tricyclic antidepressants (TCAs) (may antagonize the hypotensive effect of clonidine)
  • CNS depressants (e.g., alcohol, barbiturates, sedatives, hypnotics, opioids) (additive sedative effects)
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Moderate Interactions

  • Other antihypertensives (additive hypotensive effects)
  • Diuretics (additive hypotensive effects)
  • Alpha-blockers (additive hypotensive effects)
  • Digitalis glycosides (risk of bradycardia or AV block)
  • Neuroleptics (may increase risk of orthostatic hypotension)

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 (e.g., CrCl, BUN, Creatinine)

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

Timing: Prior to initiation, especially in elderly or those with suspected renal issues.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly/quarterly).

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 and periodically thereafter.

Target: Typically 60-100 bpm, unless otherwise indicated.

Action Threshold: Persistent bradycardia (<50 bpm) or symptomatic bradycardia.

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

Frequency: At each visit, especially during initial therapy.

Target: N/A

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

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Drowsiness/Sedation
  • Dry mouth
  • Constipation
  • Fatigue
  • Nausea
  • Headache
  • Orthostatic hypotension
  • Rebound hypertension (if 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 data; potential for fetal harm cannot be ruled out.
Second Trimester: Limited data; potential for fetal harm cannot be ruled out.
Third Trimester: Limited data; potential for fetal harm cannot be ruled out. Neonatal withdrawal symptoms (e.g., jitteriness, irritability) 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, lethargy, and bradycardia.

Infant Risk: Low to moderate risk. Potential for sedation, bradycardia, and hypotension in the infant. Monitor closely.
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Pediatric Use

Not FDA approved for hypertension in children. Used off-label for ADHD and Tourette's syndrome. Dosing must be carefully titrated based on weight and response. Children may be more sensitive to sedative effects.

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Geriatric Use

Start with lower doses and titrate slowly due to increased sensitivity to hypotensive and sedative effects, and potential for impaired renal function. Increased risk of orthostatic hypotension.

Clinical Information

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Clinical Pearls

  • Crucial to educate patients about the risk of rebound hypertension if clonidine is abruptly discontinued. Emphasize slow tapering over 2-4 days.
  • Common side effects include dry mouth, drowsiness, and dizziness, which often diminish with continued therapy.
  • Can be used off-label for various conditions including ADHD, Tourette's syndrome, opioid/alcohol withdrawal, and menopausal flushing.
  • The transdermal patch formulation (Catapres-TTS) offers once-weekly dosing and may reduce some oral side effects, but can cause skin reactions.
  • Monitor blood pressure and heart rate closely, especially during initiation and dose adjustments.
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Alternative Therapies

  • Other antihypertensives (e.g., Thiazide diuretics, ACE inhibitors, ARBs, Calcium Channel Blockers, Beta-blockers)
  • For ADHD: Stimulants (methylphenidate, amphetamines), other non-stimulants (atomoxetine, guanfacine)
  • For opioid withdrawal: Buprenorphine/naloxone, methadone
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (0.2mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 happened.