Clonidine 0.1mg Tablets

Manufacturer TRUPHARMA 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
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 lower your blood pressure by relaxing blood vessels and slowing your heart rate. It can also help with certain conditions like ADHD by affecting brain signals. It's important to take it exactly as prescribed and never stop it suddenly.
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How to Use This Medicine

Taking Your Medication

To get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Do not stop taking your medication suddenly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking your medication, your doctor will instruct you on how to gradually discontinue it.

Storing and Disposing of Your Medication

To ensure the safety and effectiveness of your medication:

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

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take the missed dose as soon as you remember.
If it is 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 dose.
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Lifestyle & Tips

  • Take medication exactly as prescribed; do not skip doses or stop abruptly.
  • Avoid sudden discontinuation to prevent rebound hypertension (a dangerous increase in blood pressure).
  • Avoid alcohol and other CNS depressants (e.g., sedatives, tranquilizers) as they can increase drowsiness.
  • Be cautious when driving or operating machinery until you know how the medication affects you, due to potential dizziness or drowsiness.
  • Rise slowly from a sitting or lying position to minimize dizziness (orthostatic hypotension).
  • Manage dry mouth with sugar-free candy, gum, or artificial saliva.
  • Maintain regular follow-up appointments for blood pressure and heart rate monitoring.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 0.1 mg orally twice daily. Maintenance: 0.2-0.6 mg/day in divided doses. Max: 2.4 mg/day.
Dose Range: 0.1 - 2.4 mg

Condition-Specific Dosing:

Hypertension: Initial: 0.1 mg orally twice daily. Titrate in increments of 0.1-0.2 mg/day at weekly intervals. Maintenance: 0.2-0.6 mg/day in divided doses. Max: 2.4 mg/day.
ADHD (extended-release): Initial: 0.1 mg orally at bedtime. Titrate weekly by 0.1 mg/day. Max: 0.4 mg/day.
Opioid Withdrawal: 0.1-0.3 mg orally every 4-6 hours as needed, up to 1.2 mg/day. Titrate based on symptoms and blood pressure.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Hypertension: 5-10 mcg/kg/day orally in 3-4 divided doses, titrate weekly. Max: 0.9 mg/day or 25 mcg/kg/day. ADHD (extended-release): 6-17 years, initial 0.1 mg orally at bedtime, titrate weekly by 0.1 mg/day. Max: 0.4 mg/day.
Adolescent: Hypertension: 5-10 mcg/kg/day orally in 3-4 divided doses, titrate weekly. Max: 0.9 mg/day or 25 mcg/kg/day. ADHD (extended-release): 6-17 years, initial 0.1 mg orally at bedtime, titrate weekly by 0.1 mg/day. 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) and titrate cautiously. Monitor blood pressure and heart rate.
Severe: Reduce initial dose by 50-75% (e.g., 0.025-0.05 mg once daily) and titrate very cautiously. Monitor closely.
Dialysis: Clonidine is minimally removed by hemodialysis. Administer dose after dialysis. Monitor blood pressure closely.

Hepatic Impairment:

Mild: No specific adjustment, monitor response.
Moderate: No specific adjustment, monitor response. Use with caution.
Severe: No specific adjustment, monitor response. Use with caution, as hepatic metabolism contributes to 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 decreased peripheral vascular resistance, heart rate, and blood pressure. In ADHD, its mechanism is thought to involve modulation of noradrenergic activity in the prefrontal cortex.
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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 (range 6-24 hours, prolonged in renal impairment)
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 severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, some individuals may be at risk for life-threatening reactions. Be aware of the following symptoms that could indicate a serious side effect:
- 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, difficulty 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
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you encounter any of the following side effects or any other unusual effects that bother you or do not go away, consult your doctor:
- Dry mouth
- Constipation
- Dizziness, drowsiness, fatigue, or weakness
- Headache
- Upset stomach
These are not all the possible side effects. If you have concerns about side effects, discuss them with your doctor.

Reporting Side Effects
For medical advice about side effects, contact 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
  • Slow heart rate (bradycardia)
  • Chest pain or shortness of breath
  • Signs of rebound hypertension (severe headache, blurred vision, confusion, seizures) if medication is stopped suddenly
  • Allergic reaction (rash, itching, swelling, severe dizziness, trouble 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 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 interactions.

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 to take this medication in conjunction with your other medications and health issues. Never start, stop, or modify 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.

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.

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 drugs 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, discuss the benefits and risks of this medication with your doctor to ensure the best outcome for 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
  • 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. 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 (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
  • Tricyclic antidepressants (TCAs) - may antagonize the hypotensive effect of clonidine
  • MAO inhibitors - theoretical risk of hypertensive crisis (though less common than with direct sympathomimetics)
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Moderate Interactions

  • Diuretics and other antihypertensives - additive hypotensive effects
  • Vasodilators - additive hypotensive effects
  • Digitalis glycosides - increased risk of bradycardia and AV block
  • Neuroleptics (e.g., antipsychotics) - additive hypotensive and sedative effects
  • Alpha-1 blockers (e.g., prazosin) - may enhance hypotensive effect
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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.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess for bradycardia.

Timing: Prior to initiation

Renal Function (BUN, Creatinine)

Rationale: Clonidine is primarily renally eliminated; impairment requires dose adjustment.

Timing: Prior to initiation

ECG (if cardiac history)

Rationale: To assess for pre-existing conduction abnormalities.

Timing: Prior to initiation (if indicated)

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Routine Monitoring

Blood Pressure (BP)

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

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

Action Threshold: Persistent hypotension (<90/60 mmHg) or uncontrolled hypertension (>140/90 mmHg) requiring dose adjustment or alternative therapy.

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and maintenance

Target: Typically 60-100 bpm

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

Symptoms of CNS depression (drowsiness, dizziness)

Frequency: Regularly, especially during dose titration

Target: N/A

Action Threshold: Excessive or debilitating symptoms requiring dose reduction or alternative therapy.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Clonidine is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal studies; human data limited.
Second Trimester: Limited human data; continued monitoring of maternal blood pressure and fetal well-being.
Third Trimester: Limited human data; potential for neonatal withdrawal symptoms (e.g., irritability, tremors, hypertension) if used close to delivery, though rare.
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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 breastfed infants for sedation, lethargy, and poor feeding.

Infant Risk: L3 (Moderate risk). Potential for sedation, bradycardia, and hypotension in the infant. Monitor infant for adverse effects.
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Pediatric Use

Approved for hypertension in children and adolescents. Extended-release formulation (Kapvay) is approved for ADHD in children 6-17 years. Dosing is weight-based for hypertension. Close monitoring for sedation and cardiovascular effects is crucial. Abrupt discontinuation should be avoided.

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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. Increased risk of orthostatic hypotension. Monitor renal function closely as it declines with age.

Clinical Information

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Clinical Pearls

  • Clonidine should never be stopped abruptly due to the risk of severe rebound hypertension, which can be life-threatening. Taper dose gradually over 2-4 days or longer.
  • Common side effects include dry mouth, drowsiness, and dizziness. These often improve with continued use.
  • Consider administering the majority of the daily dose at bedtime to minimize daytime sedation.
  • Useful in patients with hypertension complicated by renal disease due to its renal excretion profile.
  • Can be used off-label for various conditions including opioid withdrawal, Tourette's syndrome, menopausal flushing, and restless legs syndrome.
  • Monitor for orthostatic hypotension, especially when initiating therapy or increasing dose.
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Alternative Therapies

  • For Hypertension: Thiazide diuretics (e.g., hydrochlorothiazide), ACE inhibitors (e.g., lisinopril), Angiotensin Receptor Blockers (ARBs) (e.g., losartan), Calcium Channel Blockers (e.g., amlodipine), Beta-blockers (e.g., metoprolol).
  • For ADHD: Stimulants (e.g., methylphenidate, amphetamine), other non-stimulants (e.g., atomoxetine, guanfacine).
  • For Opioid Withdrawal: Buprenorphine/naloxone, methadone.
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (0.1mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for 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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.