Clonidine 0.3mg Tablets

Manufacturer UNICHEM 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
Jun 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 symptoms of opioid withdrawal.
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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 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 to make up for a missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed; do not stop taking this medication suddenly without consulting your doctor, as it can cause a dangerous increase in blood pressure (rebound hypertension).
  • 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 this medication affects you, as it can cause dizziness or drowsiness.
  • To relieve dry mouth, suck on sugar-free candy or ice chips, or use artificial saliva.
  • Rise slowly from a sitting or lying position to prevent dizziness or lightheadedness.
  • 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, titrated up to 0.2-0.6 mg/day in divided doses. 0.3 mg is a common maintenance dose.
Dose Range: 0.1 - 2.4 mg

Condition-Specific Dosing:

hypertension: Initial 0.1 mg orally twice daily; maintenance 0.2-0.6 mg/day in divided doses. Max 2.4 mg/day.
opioid_withdrawal_off_label: 0.1-0.3 mg orally every 6-8 hours, titrated based on symptoms and blood pressure. Max 1.2 mg/day.
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Pediatric Dosing

Neonatal: Not established for hypertension; limited data for specific conditions (e.g., opioid withdrawal, but requires specialized care).
Infant: Not established for hypertension; limited data for specific conditions.
Child: Not established for hypertension; for ADHD (extended-release formulation) or Tourette's, specific dosing applies. For hypertension, generally not first-line.
Adolescent: Not established for hypertension; for ADHD (extended-release formulation) or Tourette's, specific dosing applies. For hypertension, generally not first-line.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but monitor closely.
Moderate: Consider starting with a lower dose (e.g., 0.05 mg) and titrate slowly. Monitor blood pressure and heart rate closely.
Severe: Start with a lower dose (e.05 mg) and titrate very slowly. Monitor blood pressure and heart rate closely. Half-life is significantly prolonged.
Dialysis: Clonidine is minimally removed by hemodialysis. Supplemental doses are generally not needed after dialysis. Monitor blood pressure closely.

Hepatic Impairment:

Mild: No specific dose adjustment, but use with caution.
Moderate: Use with caution; consider lower initial doses and slower titration due to potential for altered metabolism.
Severe: Use with caution; consider lower initial doses and slower titration due to potential for altered 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, renal vascular resistance, heart rate, and blood pressure. It also reduces plasma renin activity and circulating catecholamine levels.
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Pharmacokinetics

Absorption:

Bioavailability: 75-95%
Tmax: 2-4 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 up to 20 hours in renal impairment)
Clearance: Not available (variable)
ExcretionRoute: Renal (40-60% unchanged), remainder as metabolites in urine and feces
Unchanged: 40-60%
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Pharmacodynamics

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

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 symptoms that bother you or persist, contact your doctor:

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. If you have questions or concerns, 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 can provide medical advice on managing side effects.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Very slow heart rate
  • Severe drowsiness or confusion
  • Sudden, severe headache, blurred vision, or chest pain (signs of rebound hypertension if stopped abruptly)
  • Swelling in hands or feet
  • Difficulty breathing
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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 issues 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 conditions. 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, get up slowly from a sitting or lying position, and be cautious 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 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, 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.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to make an informed decision about its use.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (very low blood pressure)
  • Bradycardia (very 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 blood pressure and respiration.

Drug Interactions

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Major Interactions

  • Beta-blockers (risk of rebound hypertension upon clonidine withdrawal, severe bradycardia)
  • Tricyclic antidepressants (may reduce antihypertensive effect of clonidine)
  • CNS depressants (e.g., alcohol, barbiturates, sedatives, opioids - enhanced sedation and CNS depression)
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Moderate Interactions

  • Other antihypertensives (additive hypotensive effects)
  • Diuretics (additive hypotensive effects)
  • Vasodilators (additive hypotensive effects)
  • Digoxin (may enhance bradycardia)
  • Neuromuscular blockers (may prolong effect)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and monitor for bradycardia.

Timing: Prior to initiation

Renal Function (BUN, Creatinine)

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

Timing: Prior to initiation

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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 or quarterly)

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

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

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter

Target: Typically 60-100 bpm, but individualized

Action Threshold: Symptomatic bradycardia (e.g., <50 bpm with dizziness, fatigue)

Signs/Symptoms of CNS depression (e.g., sedation, dizziness)

Frequency: Daily, especially during initiation and dose changes

Target: Minimal to no symptoms

Action Threshold: Excessive sedation or dizziness impacting daily activities

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Dry mouth
  • Sedation/Drowsiness
  • Constipation
  • Nausea
  • Fatigue
  • Headache
  • Rebound hypertension symptoms (e.g., sudden severe headache, nervousness, tremor, rapid heart rate) if abruptly discontinued

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. Studies in animals have shown adverse effects, and there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal studies; human data limited.
Second Trimester: Limited human data; monitor fetal growth and well-being if used.
Third Trimester: Limited human data; monitor for neonatal withdrawal symptoms (e.g., irritability, tremors) if used close to delivery, though this is more commonly associated with chronic opioid exposure.
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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. Potential for sedation, bradycardia, or hypotonia in the infant. Monitor closely, especially in neonates or preterm infants.
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Pediatric Use

Not a first-line agent for hypertension in children. Extended-release formulations are approved for ADHD and Tourette's syndrome. Use for hypertension in children is generally off-label and requires specialist consultation due to potential for significant sedation and cardiovascular effects. Dosing must be individualized and carefully titrated.

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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. Monitor blood pressure and heart rate closely, and assess for orthostatic hypotension and CNS depression. Renal function should be monitored, as age-related decline in renal function can prolong clonidine's half-life.

Clinical Information

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Clinical Pearls

  • **Do NOT discontinue clonidine abruptly** due to the risk of severe rebound hypertension, which can be life-threatening. Taper the dose gradually over 2-4 days or longer.
  • Common side effects include dry mouth and sedation, which often diminish with continued therapy.
  • Clonidine can cause orthostatic hypotension; advise patients to rise slowly from sitting or lying positions.
  • Often used as an add-on therapy for resistant hypertension or in specific conditions like opioid withdrawal or ADHD (extended-release).
  • Monitor blood pressure and heart rate regularly, especially during initiation and dose adjustments.
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Alternative Therapies

  • Thiazide diuretics (e.g., hydrochlorothiazide)
  • ACE inhibitors (e.g., lisinopril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan)
  • Calcium Channel Blockers (CCBs) (e.g., amlodipine)
  • Beta-blockers (e.g., metoprolol)
  • Other centrally acting alpha-2 agonists (e.g., methyldopa - less commonly used)
  • Alpha-1 blockers (e.g., prazosin)
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Cost & Coverage

Average Cost: Varies, typically $10-$30 per 30 tablets (0.3mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred generic)
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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 information about the medication taken, the amount, and the time it happened.