Clonidine 0.1mg Extended Release Tb

Manufacturer ACTAVIS Active Ingredient Clonidine Extended-Release Tablets (ADHD)(KLON i deen) Pronunciation KLON-i-deen
It is used to treat attention deficit problems with hyperactivity.It may be given to you for other reasons. Talk with the doctor.
đŸˇī¸
Drug Class
Alpha-2 Adrenergic Agonist
đŸ§Ŧ
Pharmacologic Class
Centrally Acting Alpha-2 Adrenergic Agonist
🤰
Pregnancy Category
Category C
✅
FDA Approved
Sep 2008
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Clonidine extended-release is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain to help improve focus, reduce hyperactivity, and control impulsive behaviors. It is taken once daily, usually at bedtime.
📋

How to Use This Medicine

Taking Your Medication Correctly

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

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 advise you on how to gradually discontinue it.

Swallowing Your Medication

Swallow your medication whole, without chewing, breaking, or crushing it.
If you have difficulty swallowing, discuss this with your doctor for guidance.

Storing and Disposing of Your Medication

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

What to Do If You Miss a Dose

If you miss a dose, skip it and take your next dose at the usual time.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
💡

Lifestyle & Tips

  • Take exactly as prescribed, usually once daily at bedtime. Do not crush, chew, or break the extended-release tablet.
  • Do not stop taking this medication suddenly, as it can lead to serious side effects like a sudden increase in blood pressure (rebound hypertension). Your doctor will tell you how to slowly reduce the dose if you need to stop.
  • 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.
  • Report any new or worsening side effects to your doctor, especially severe dizziness, fainting, or changes in heart rate.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 0.1 mg once daily at bedtime, titrated to effect. Typical range 0.2 mg/day to 0.4 mg/day, given as divided doses (e.g., 0.1 mg in the morning and 0.1 mg at bedtime, or 0.2 mg at bedtime).
Dose Range: 0.1 - 0.4 mg

Condition-Specific Dosing:

ADHD (adjunctive or monotherapy): Initial: 0.1 mg once daily at bedtime. Titrate in increments of 0.1 mg/day at weekly intervals until desired response or maximum tolerated dose. Doses above 0.4 mg/day have not been studied for ADHD.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For ADHD (6-17 years): Initial 0.1 mg once daily at bedtime. Titrate in increments of 0.1 mg/day at weekly intervals. Typical maintenance 0.2 mg/day to 0.4 mg/day, given as divided doses (e.g., 0.1 mg in the morning and 0.1 mg at bedtime, or 0.2 mg at bedtime).
Adolescent: For ADHD (6-17 years): Initial 0.1 mg once daily at bedtime. Titrate in increments of 0.1 mg/day at weekly intervals. Typical maintenance 0.2 mg/day to 0.4 mg/day, given as divided doses (e.g., 0.1 mg in the morning and 0.1 mg at bedtime, or 0.2 mg at bedtime).
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment for mild impairment, but monitor for increased effects.
Moderate: Consider dose reduction (e.g., 50% of usual dose) and careful titration based on clinical response and tolerability.
Severe: Significant dose reduction (e.g., 50-75% of usual dose) and careful titration required. Monitor closely for adverse effects.
Dialysis: Clonidine is minimally removed by hemodialysis. Administer after dialysis. Dose adjustment needed based on residual renal function and clinical response.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, but use with caution and monitor for increased effects.
Severe: No specific adjustment recommended, but use with caution and monitor for increased effects due to potential for altered metabolism or excretion.

Pharmacology

đŸ”Ŧ

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. For ADHD, its mechanism is not fully elucidated but is thought to involve modulation of noradrenergic activity in the prefrontal cortex, improving attention and reducing impulsivity/hyperactivity.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 100%
Tmax: 7-8 hours (for extended-release formulation)
FoodEffect: Food does not significantly affect the absorption of clonidine extended-release tablets.

Distribution:

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

Elimination:

HalfLife: 12-18 hours (for extended-release formulation)
Clearance: Not available
ExcretionRoute: Renal (40-60% as unchanged drug), Fecal (20%)
Unchanged: 40-60%
âąī¸

Pharmacodynamics

OnsetOfAction: Within 1 hour (for IR, ER is slower)
PeakEffect: Approximately 7-8 hours (for extended-release formulation)
DurationOfAction: Approximately 24 hours (for extended-release formulation)

Safety & Warnings

âš ī¸

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, difficulty 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
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- Dry mouth
- Constipation
- Dizziness, drowsiness, fatigue, or weakness
- Headache
- Upset stomach
- Difficulty sleeping
- Bad dreams
- Decreased appetite
- Stomach pain
- Irritability

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. Your doctor is available to provide medical advice about side effects.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or lightheadedness
  • Fainting (syncope)
  • Chest pain or palpitations
  • Shortness of breath
  • Unusual fatigue or weakness
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • Sudden, severe headache or blurred vision (signs of rebound hypertension if abruptly stopped)
📋

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 medications
Over-the-counter (OTC) medications
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 medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
âš ī¸

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, be cautious when driving or performing tasks 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.

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.

Avoid consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or OTC medications that may impair your reactions.

If you vomit after taking a dose of this medication, consult your doctor for guidance on what to do next.

If you have previously used a patch form of this medication and experienced skin irritation, inform your doctor. You may be more susceptible to developing 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 prone to experiencing side effects.

Pregnant women, those planning to become pregnant, or breastfeeding mothers should discuss the benefits and risks of this medication with their doctor to ensure the best possible outcome for both mother and baby.
🆘

Overdose Information

Overdose Symptoms:

  • Profound sedation or coma
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Respiratory depression (slow, shallow breathing)
  • Hypothermia (low body temperature)
  • Miosis (pinpoint pupils)
  • Arrhythmias
  • Paradoxical hypertension (rare, especially in children)

What to Do:

Seek immediate medical attention or call 911. Contact a poison control center (1-800-222-1222). Management is supportive, focusing on maintaining vital signs. Naloxone may reverse respiratory depression but not other effects.

Drug Interactions

🔴

Major Interactions

  • Other CNS depressants (e.g., alcohol, barbiturates, benzodiazepines, opioids, sedating antihistamines): May potentiate sedative effects.
  • Beta-blockers: May potentiate bradycardia and AV block. Risk of rebound hypertension upon clonidine withdrawal if beta-blocker is not tapered first.
  • Calcium channel blockers (e.g., verapamil, diltiazem): May potentiate bradycardia and AV block.
  • Tricyclic antidepressants (TCAs): May antagonize the hypotensive effect of clonidine.
🟡

Moderate Interactions

  • Other antihypertensives: Additive hypotensive effects.
  • Digoxin: May potentiate bradycardia.
  • Neuroleptics (e.g., haloperidol): May potentiate hypotensive effects and increase risk of orthostatic hypotension.
  • MAO inhibitors: Theoretical risk of additive hypotensive effects.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Clonidine can cause dose-dependent decreases in BP and HR. Baseline assessment is crucial.

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

Rationale: Consider if patient has pre-existing cardiac conditions or is on other medications affecting cardiac conduction.

Timing: Prior to initiation, if indicated.

📊

Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly or every 3-6 months).

Target: Individualized, aiming for clinical improvement without excessive hypotension or bradycardia.

Action Threshold: Symptomatic hypotension, bradycardia (<50 bpm), or significant changes from baseline.

ADHD Symptom Assessment

Frequency: Regularly, especially during dose titration and periodically thereafter.

Target: Reduction in core ADHD symptoms (inattention, hyperactivity, impulsivity).

Action Threshold: Lack of efficacy or worsening of symptoms.

Sedation/Drowsiness

Frequency: Regularly, especially during dose titration.

Target: Minimal to no excessive sedation.

Action Threshold: Excessive drowsiness interfering with daily activities.

đŸ‘ī¸

Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Excessive sedation or drowsiness
  • Dry mouth
  • Constipation
  • Nausea
  • Fatigue
  • Irritability
  • Sleep disturbances (insomnia or nightmares)
  • Signs of rebound hypertension (if abruptly discontinued): headache, nervousness, tremor, rapid rise in BP.

Special Patient Groups

🤰

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 developmental toxicity observed in animal studies at doses higher than human therapeutic doses.
Second Trimester: Limited human data, but generally considered if benefits outweigh risks.
Third Trimester: Risk of neonatal withdrawal symptoms (e.g., irritability, tremor, hypertension) if used close to delivery. Monitor neonate for signs of withdrawal.
🤱

Lactation

Clonidine is excreted into human breast milk. The American Academy of Pediatrics considers clonidine compatible with breastfeeding, but caution is advised due to potential for infant sedation, bradycardia, or hypotension. Monitor breastfed infants for adverse effects.

Infant Risk: Moderate risk (L3). Potential for sedation, bradycardia, hypotension in the infant. Monitor infant for drowsiness, poor feeding, and changes in heart rate.
đŸ‘ļ

Pediatric Use

Approved for ADHD in children and adolescents aged 6-17 years. Dosing is weight-based or titrated to effect. Close monitoring for sedation, hypotension, and bradycardia is essential, especially during initiation and dose titration. Safety and efficacy in children younger than 6 years have not been established.

👴

Geriatric Use

Use with caution in elderly patients due to increased sensitivity to hypotensive and sedative effects. Start with lower doses and titrate slowly. Monitor closely for orthostatic hypotension, bradycardia, and CNS depression. Renal function should be assessed.

Clinical Information

💎

Clinical Pearls

  • Clonidine ER (Kapvay) is specifically formulated for once-daily dosing, typically at bedtime, which can help mitigate daytime sedation.
  • Abrupt discontinuation of clonidine can lead to rebound hypertension, which can be severe. Always taper the dose gradually over several days to weeks.
  • Monitor blood pressure and heart rate regularly, especially during dose titration. Orthostatic hypotension and bradycardia are common side effects.
  • Sedation is a common side effect, particularly at the beginning of therapy or with dose increases. Taking it at bedtime can help manage this.
  • Clonidine can be used as monotherapy or as an adjunct to stimulant medications for ADHD, particularly when stimulants are not tolerated or provide insufficient symptom control, or when there are comorbid conditions like tics or sleep disturbances.
  • Patients should be advised to avoid activities requiring mental alertness until they know how the medication affects them.
🔄

Alternative Therapies

  • Guanfacine Extended-Release (Intuniv) - another alpha-2 adrenergic agonist for ADHD.
  • Methylphenidate (e.g., Concerta, Ritalin LA) - stimulant for ADHD.
  • Amphetamine (e.g., Adderall XR, Vyvanse) - stimulant for ADHD.
  • Atomoxetine (Strattera) - non-stimulant for ADHD.
  • Bupropion (Wellbutrin) - atypical antidepressant, sometimes used off-label for ADHD.
💰

Cost & Coverage

Average Cost: $50 - $200+ per 30 tablets (0.1mg ER)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (may require prior authorization for brand name)
📚

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.