Clonidine 0.2mg 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, Centrally Acting Alpha-2 Adrenergic Agonist
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Pharmacologic Class
Alpha-2 Adrenergic Agonist
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Pregnancy Category
Category C
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FDA Approved
Aug 1974
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clonidine is a medication that works in your brain to help lower your blood pressure. It can also be used for other conditions like ADHD or to help with withdrawal symptoms. It calms down certain signals in your nervous system.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, at the same time every day. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well. Do not stop taking this medication abruptly 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, avoiding the bathroom. Keep the lid tightly closed and store all medications in a safe location, out of the reach of children and pets.

Missing 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 scheduled dose, skip the missed dose and resume your regular dosing 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.
  • Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how clonidine affects you, as it can cause drowsiness or dizziness.
  • Avoid alcohol and other CNS depressants, as they can increase drowsiness.
  • To relieve dry mouth, chew sugarless gum, suck on sugarless hard candy, or use saliva substitutes.
  • Stand up slowly from a sitting or lying position to prevent dizziness or lightheadedness.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.1 mg orally twice daily, titrated weekly
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.
adhd_off_label: Initial 0.05 mg orally at bedtime, gradually increase to 0.1-0.4 mg/day in divided doses.
opioid_withdrawal_off_label: 0.1-0.3 mg orally every 6-8 hours as needed, based on symptoms. Max 1.2 mg/day.
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Pediatric Dosing

Neonatal: Not established (limited data for specific conditions like NAS)
Infant: Not established (limited data for specific conditions like NAS)
Child: Dosing for ADHD (off-label): Initial 0.05 mg orally at bedtime, gradually increase to 0.05-0.4 mg/day in 2-4 divided doses. Max 0.4 mg/day.
Adolescent: Dosing for ADHD (off-label): Initial 0.05 mg orally at bedtime, gradually increase to 0.05-0.4 mg/day in 2-4 divided doses. Max 0.4 mg/day.
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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 twice daily), titrate slowly based on response and tolerability. Monitor for increased sedation and bradycardia.
Severe: Reduce initial dose by 50-75% (e.g., 0.05 mg once daily or every other day), titrate very slowly. Monitor closely for adverse effects.
Dialysis: Clonidine is minimally removed by hemodialysis. Administer dose after dialysis. Follow severe renal impairment guidelines.

Hepatic Impairment:

Mild: No specific adjustment, monitor response.
Moderate: Use with caution; consider lower initial doses and slower titration due to potential for altered metabolism and elimination.
Severe: Use with caution; consider lower initial doses and slower titration. Monitor closely for adverse 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, primarily in the vasomotor center. This stimulation reduces sympathetic outflow from the central nervous system, leading to decreased peripheral vascular resistance, renal vascular resistance, heart rate, and blood pressure. It also reduces plasma renin activity and aldosterone secretion.
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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 40 hours in renal impairment)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (40-60% unchanged drug), Fecal (20% as metabolites)
Unchanged: 40-60%
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Pharmacodynamics

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

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

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 do not go away, 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 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
  • Chest pain
  • Shortness of breath
  • Swelling in hands or feet
  • 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
+ Beta blockers, such as metoprolol or propranolol
Please note that this is not an exhaustive list of all potential drug interactions.

To ensure your safety, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
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 drugs and health conditions. Never 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.

Regularly monitor your blood pressure and heart rate as directed by your doctor. 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.

You may experience dry eyes while taking this medication. If you wear contact lenses and notice 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 or older, use this medication with caution, as you may be more susceptible to side effects.

It is crucial to discuss your pregnancy status or plans with your doctor, as well as any breastfeeding, to weigh the benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Profound sedation
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Hypothermia (low body temperature)
  • Miosis (pinpoint pupils)
  • Respiratory depression
  • Apnea (cessation of breathing)
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including maintaining airway, breathing, and circulation. Naloxone may reverse respiratory depression in some cases, but is not a primary antidote for clonidine toxicity itself. Atropine for bradycardia, vasopressors for hypotension.

Drug Interactions

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Major Interactions

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

  • Other Antihypertensives (e.g., diuretics, ACE inhibitors, ARBs, calcium channel blockers): Additive hypotensive effects.
  • Digoxin: Increased risk of bradycardia.
  • Alpha-1 Blockers (e.g., prazosin): May enhance hypotensive effect.
  • Neuroleptics (e.g., haloperidol): May increase risk of orthostatic hypotension.
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Minor Interactions

  • NSAIDs (e.g., ibuprofen, naproxen): May reduce the antihypertensive effect of clonidine (less significant than with other antihypertensives).

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

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

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and monitor for bradycardia.

Timing: Prior to initiation

Renal Function (SCr, BUN)

Rationale: Clonidine is primarily renally excreted; dose adjustment may be needed in renal impairment.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: Consider in patients with pre-existing cardiac conditions or those on other bradycardia-inducing drugs.

Timing: Prior to initiation (if indicated)

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Routine Monitoring

Blood Pressure (BP)

Frequency: Daily initially, then weekly during titration, then periodically (e.g., monthly) once stable.

Target: Individualized, typically <130/80 mmHg for hypertension.

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

Heart Rate (HR)

Frequency: Daily initially, then weekly during titration, then periodically (e.g., monthly) once stable.

Target: Typically >60 bpm (unless clinically indicated lower).

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

Signs/Symptoms of CNS Depression (sedation, dizziness)

Frequency: Daily, especially during initiation and dose changes.

Target: Not applicable

Action Threshold: Excessive sedation or dizziness impacting daily activities.

Dry Mouth

Frequency: Daily, especially during initiation and dose changes.

Target: Not applicable

Action Threshold: Severe dry mouth impacting quality of life.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Sedation/Drowsiness
  • Dry mouth
  • Constipation
  • Nausea
  • Fatigue
  • Headache
  • Insomnia
  • Nervousness
  • 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. It crosses the placenta.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided if possible due to potential for fetal harm, though no clear pattern of major malformations has been established.
Second Trimester: May be used if clinically indicated for severe hypertension, with careful monitoring of fetal growth and well-being.
Third Trimester: Use with caution. Neonatal withdrawal symptoms (e.g., irritability, tremors, hypertension) have been reported following maternal use near term. Monitor neonate for signs of withdrawal or adverse effects.
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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, and poor feeding.

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

Not FDA approved for hypertension in children, but commonly used off-label for ADHD, Tourette's syndrome, and opioid withdrawal. Dosing must be carefully individualized and titrated slowly due to potential for significant sedation and hypotension. Close monitoring is essential.

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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 more slowly. Monitor closely for orthostatic hypotension, bradycardia, and CNS depression.

Clinical Information

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Clinical Pearls

  • **Rebound Hypertension:** Abrupt discontinuation of clonidine can lead to a rapid and severe increase in blood pressure, potentially life-threatening. Always taper the dose gradually over 2-4 days or longer.
  • **Sedation and Dry Mouth:** These are very common side effects, especially at the beginning of therapy. Patients should be counseled on managing dry mouth and avoiding activities requiring alertness until they know how they react.
  • **Orthostatic Hypotension:** Advise patients to rise slowly from sitting or lying positions to minimize dizziness.
  • **Combination Therapy:** Often used in combination with diuretics or other antihypertensives for better blood pressure control.
  • **Off-label Uses:** Widely used off-label for ADHD, Tourette's syndrome, menopausal flushing, and opioid/alcohol withdrawal due to its central alpha-2 agonism.
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Alternative Therapies

  • Other Antihypertensives (e.g., Thiazide diuretics, ACE inhibitors, Angiotensin Receptor Blockers (ARBs), Calcium Channel Blockers, Beta-blockers)
  • For ADHD: Stimulants (e.g., methylphenidate, amphetamine), Atomoxetine, Guanfacine (another alpha-2 agonist)
  • For Opioid Withdrawal: Buprenorphine/naloxone, Methadone
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (0.2mg)
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 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 check with your pharmacist for more information. 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.