Catapres 0.3mg 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 primarily used to lower high blood pressure. It works by calming down certain signals in your brain that tell your blood vessels to tighten, which helps them relax and lowers your blood pressure. 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 one.
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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 your 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 fainting.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.1 mg orally twice daily (BID)
Dose Range: 0.1 - 2.4 mg

Condition-Specific Dosing:

hypertension: Initial: 0.1 mg BID; gradually increase by 0.1-0.2 mg/day at weekly intervals. Usual maintenance: 0.2-0.6 mg/day in divided doses. Max: 2.4 mg/day.
ADHD (extended-release): Initial: 0.1 mg at bedtime; titrate weekly by 0.1 mg/day in divided doses (morning and bedtime). Max: 0.4 mg/day.
opioidWithdrawal (off-label): 0.1-0.3 mg every 4-6 hours as needed for symptoms. Max: 1.2 mg/day.
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Pediatric Dosing

Neonatal: Not established (limited data, used for neonatal abstinence syndrome with caution)
Infant: Not established (limited data, used for neonatal abstinence syndrome with caution)
Child: Hypertension (off-label): 5-10 mcg/kg/day divided BID-TID; titrate weekly. Max: 0.8 mg/day or 25 mcg/kg/day. ADHD (extended-release): 0.05 mg at bedtime, titrate weekly by 0.05 mg/day. Max: 0.4 mg/day.
Adolescent: Similar to adult dosing for off-label uses (e.g., ADHD, tics), but with careful titration.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor response.
Moderate: Consider lower initial doses (e.g., 0.05 mg/day) and slower titration. Monitor blood pressure and heart rate closely.
Severe: Significant dose reduction required. Initial: 0.05 mg/day. Titrate cautiously based on response and tolerability. Monitor closely.
Dialysis: Clonidine is minimally dialyzable. Administer dose after dialysis on dialysis days. Monitor for exaggerated hypotensive response.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: No specific adjustment, but monitor for increased adverse effects due to potential altered metabolism/elimination.
Severe: No specific adjustment, but monitor for increased adverse effects due to potential altered metabolism/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 75-95%
Tmax: 1-3 hours
FoodEffect: Food does not significantly affect the rate or extent of absorption.

Distribution:

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

Elimination:

HalfLife: 12-16 hours (can be prolonged in renal impairment up to 40 hours)
Clearance: Not available
ExcretionRoute: Renal (40-60% as unchanged drug), 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 immediately or seek emergency medical attention, 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 heart rhythms, including fast, slow, or irregular heartbeat

Other Possible Side Effects
While many people taking this medication may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects. If any of these symptoms 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. Your doctor is available to provide medical advice about side effects.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or lightheadedness
  • Fainting
  • Chest pain or shortness of breath
  • Very slow heart rate
  • Signs of an 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 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 drug interactions or health concerns that may affect your use of this medication.

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. This will help determine whether it is safe for you to take this medication in conjunction with your other medications and health issues. Never start, stop, or adjust the dosage 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 cause drowsiness, 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 drowsiness or coma
  • Pinpoint pupils
  • Severe hypotension (very low blood pressure)
  • Bradycardia (very slow heart rate)
  • Respiratory depression (slow, shallow breathing)
  • Hypothermia (low body temperature)
  • Arrhythmias

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.

Drug Interactions

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Major Interactions

  • Beta-blockers (increased risk of bradycardia, AV block, and rebound hypertension upon clonidine withdrawal)
  • CNS depressants (e.g., alcohol, barbiturates, benzodiazepines, opioids, sedating antihistamines) - additive sedative effects.
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Moderate Interactions

  • Tricyclic antidepressants (TCAs) - may antagonize the hypotensive effect of clonidine.
  • Other antihypertensives - additive hypotensive effects.
  • Digoxin - increased risk of bradycardia.
  • Neuroleptics (e.g., haloperidol) - may increase risk of orthostatic hypotension.
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Minor Interactions

  • NSAIDs - may reduce the antihypertensive effect of clonidine.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing for hypertension.

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

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

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Routine Monitoring

Blood Pressure (BP)

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

Target: Individualized based on treatment goals (e.g., <130/80 mmHg for most adults with hypertension).

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

Heart Rate (HR)

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

Target: Typically 60-100 bpm, unless otherwise specified for patient's condition.

Action Threshold: Persistent bradycardia (<50-60 bpm) or symptomatic bradycardia.

Adverse Effects (e.g., dry mouth, sedation, dizziness)

Frequency: At each visit, or as needed based on patient report.

Target: Minimal to tolerable.

Action Threshold: Intolerable side effects requiring dose adjustment or discontinuation.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Drowsiness/Sedation
  • Dry mouth
  • Constipation
  • Fatigue
  • Nausea
  • Headache
  • Rebound hypertension (if abruptly discontinued)

Special Patient Groups

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Pregnancy

Clonidine is classified as Pregnancy Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal data; human data limited.
Second Trimester: Potential for fetal harm based on animal data; human data limited.
Third Trimester: Potential for fetal harm based on animal data; human data limited. May cause neonatal withdrawal symptoms if used close to delivery.
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Lactation

Clonidine is excreted into breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding, but caution is advised. Monitor the infant for sedation, bradycardia, or hypotension.

Infant Risk: Low to moderate risk (L3). Monitor for drowsiness, poor feeding, and bradycardia in the infant.
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Pediatric Use

Use in pediatric hypertension is off-label and requires careful titration and monitoring due to varying responses and potential for adverse effects. Extended-release formulations are approved for ADHD in children 6 years and older. Not recommended for routine use in children under 6 years for hypertension.

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Geriatric Use

Elderly patients may be more sensitive to the hypotensive and sedative effects of clonidine. Lower initial doses and slower titration are recommended. Increased risk of orthostatic hypotension and falls.

Clinical Information

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Clinical Pearls

  • Abrupt discontinuation of clonidine can lead to severe rebound hypertension, sometimes exceeding pre-treatment levels. Taper dose gradually over 2-4 days or longer.
  • Common side effects include dry mouth, drowsiness, and dizziness, which often diminish with continued therapy.
  • Clonidine can cause orthostatic hypotension; advise patients to rise slowly from sitting or lying positions.
  • Used off-label for various conditions including opioid withdrawal, restless legs syndrome, hot flashes, and certain pain syndromes.
  • The transdermal patch formulation (Catapres-TTS) offers continuous delivery and may reduce peak-and-trough effects and improve adherence for some patients.
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Alternative Therapies

  • Other antihypertensives (e.g., ACE inhibitors, ARBs, calcium channel blockers, diuretics, beta-blockers)
  • For ADHD: Stimulants (e.g., methylphenidate, amphetamines), other non-stimulants (e.g., atomoxetine, guanfacine)
  • For opioid withdrawal: Buprenorphine/naloxone, methadone, lofexidine
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 0.3mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 reporting the incident, be prepared to provide detailed information about the medication taken, the quantity, and the time it occurred.