Onyda XR 0.1mg/ml Oral Susp 30ml

Manufacturer NEXTWAVE PHARMACEUTICALS Active Ingredient Clonidine Extended-Release Oral Suspension(KLON i deen) Pronunciation KLON-i-deen
It is used to treat attention deficit problems with hyperactivity.It may be given to your child for other reasons. Talk with the doctor.
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Drug Class
Agents for Attention Deficit Hyperactivity Disorder (ADHD)
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Pharmacologic Class
Alpha-2 Adrenergic Agonist
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Pregnancy Category
Category C
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FDA Approved
Dec 2023
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Onyda XR is an extended-release liquid medicine used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. It works by affecting certain chemicals in the brain to help improve focus, reduce hyperactivity, and control impulsive behaviors.
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How to Use This Medicine

Taking This Medication

To ensure your child takes this medication safely and effectively, follow the instructions provided by their doctor. Carefully read all the information given to you and follow the instructions closely.

This medication can be taken with or without food.
It is recommended to give this medication to your child at bedtime.
If the adapter is not already attached to the bottle, prepare the bottle according to the instructions provided or as described in the package insert.
Before using, gently shake the bottle.
When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. After each use, rinse the measuring device with water.

Continue giving this medication to your child as directed by their doctor or healthcare provider, even if they appear to be feeling well. Do not stop giving this medication to your child suddenly without first consulting their doctor, as this may increase the risk of side effects. If the medication needs to be discontinued, the doctor will provide guidance on how to gradually stop it.

Storing and Disposing of This Medication

Store the medication at room temperature in a dry place, avoiding storage in a bathroom.
* Keep the lid tightly closed.

Missing a Dose

If a dose is missed, skip the missed dose and resume the regular dosing schedule. Do not give two doses at the same time or provide extra doses.
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Lifestyle & Tips

  • Take this medicine exactly as prescribed by your doctor. Do not stop taking it suddenly, as this can cause serious side effects like a sudden increase in blood pressure.
  • Do not crush, chew, or break the extended-release suspension. It should be administered orally using the provided dosing syringe.
  • Avoid alcohol and other medications that cause drowsiness, as they can increase the sedative effects of Onyda XR.
  • Be aware of potential dizziness or drowsiness, especially when starting the medication or changing doses. Avoid driving or operating heavy machinery until you know how this medicine affects you.
  • Monitor blood pressure and heart rate regularly as advised by your doctor.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Not indicated for adult ADHD. For adult hypertension, immediate-release clonidine is typically used.

Condition-Specific Dosing:

hypertension: Not indicated for adult hypertension as an extended-release oral suspension.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial 0.05 mg orally once daily at bedtime for patients 6-17 years old. May increase by 0.05 mg/day at weekly intervals until desired response or maximum dose. Doses above 0.2 mg/day should be given in divided doses (e.g., 0.1 mg in the morning and 0.1 mg at bedtime).
Adolescent: Initial 0.05 mg orally once daily at bedtime for patients 6-17 years old. May increase by 0.05 mg/day at weekly intervals until desired response or maximum dose. Doses above 0.2 mg/day should be given in divided doses (e.g., 0.1 mg in the morning and 0.1 mg at bedtime).
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended for mild renal impairment.
Moderate: Consider dose reduction based on clinical response and tolerability. Monitor for adverse effects.
Severe: Consider dose reduction based on clinical response and tolerability. Monitor for adverse effects.
Dialysis: Clonidine is minimally removed by hemodialysis. Supplemental doses are generally not required. Monitor closely for adverse effects and adjust dose as needed.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: Use with caution. Consider lower initial doses and slower titration. Monitor for adverse effects.
Severe: Use with caution. Consider lower initial doses and slower titration. Monitor for adverse effects.

Pharmacology

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Mechanism of Action

Clonidine is an alpha-2 adrenergic agonist. It stimulates presynaptic alpha-2 adrenergic receptors in the brain, particularly in the locus coeruleus, which results in reduced 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, improving attention and reducing impulsivity/hyperactivity.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 75-95%
Tmax: Approximately 7-8 hours (extended-release oral suspension)
FoodEffect: Administration with food does not significantly alter the rate or extent of absorption.

Distribution:

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

Elimination:

HalfLife: Approximately 12-16 hours (extended-release oral suspension)
Clearance: Approximately 200 mL/min
ExcretionRoute: Renal (40-60% unchanged drug), fecal (20-30%)
Unchanged: 40-60%
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours (for blood pressure lowering with immediate release; for ADHD, clinical effects may take days to weeks with titration)
PeakEffect: Approximately 7-8 hours (for extended-release formulation)
DurationOfAction: Approximately 24 hours (extended-release formulation)
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

It's essential to be aware of potential severe side effects that can occur, although rarely, when taking this medication. If your child experiences any of the following symptoms, contact their doctor or seek medical attention immediately:

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 not everyone will experience them. If your child has any of the following side effects, or if they bother your child or do not go away, contact their doctor or seek medical help:

Constipation
Dry mouth
Dizziness, sleepiness, tiredness, or weakness
Headache
Upset stomach
Trouble sleeping
Bad dreams
Decreased appetite
Stomach pain
* Irritability

This list is not exhaustive, and your child may experience other side effects. If you have questions or concerns about side effects, consult your child's doctor for medical advice.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or lightheadedness
  • Fainting spells
  • Very slow heartbeat
  • Chest pain or shortness of breath
  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • Sudden, severe headache or blurred vision (signs of rebound hypertension if stopped suddenly)
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Before Using This Medicine

Before Your Child Takes This Medication: Inform Your Doctor If:
- Your child has an allergy to this medication, any of its components, or any other medications, foods, or substances. Be sure to describe the allergic reaction and its symptoms.
- Your child is currently taking another medication that contains the same active ingredient as this drug.
- Your child is taking any of the following medications: digoxin, diltiazem, verapamil, or beta blockers such as metoprolol or propranolol.
Please note that this list does not include all possible medications or health issues that may interact with this drug.

It is crucial to inform the doctor and pharmacist about all of your child's medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. This will help ensure it is safe to administer this medication alongside your child's other medications and health conditions. Never start, stop, or adjust the dosage of any medication your child is taking without first consulting with the doctor.
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Precautions & Cautions

It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication.

Until you understand how this medication affects your child, it is crucial to have them avoid activities that require alertness, such as riding a bike, playing sports, or using potentially hazardous items like scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.

Regularly check your child's blood pressure and heart rate as directed by their doctor. To minimize the risk of dizziness or fainting, instruct your child to stand up slowly after sitting or lying down and to exercise caution when navigating stairs.

Alcohol consumption may interact with this medication, so ensure your child does not drink alcohol. If your child has high blood pressure and is taking this medication, consult with their doctor before giving them any 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, encourage your child to drink plenty of fluids to prevent dehydration. Be aware that this medication may cause dry eyes. If your child wears contact lenses and experiences dry eyes or a change in how their lenses feel, consult with their doctor.

Avoid giving your child marijuana or other forms of cannabis, as well as prescription or OTC medications that may slow their reactions. If your child vomits after taking a dose of this medication, consult with their doctor to determine the best course of action.

If your child has previously used a patch form of this medication and experienced skin irritation, inform their doctor, as they may be more likely to develop a rash on other parts of their body when using any form of this medication.

If your child is pregnant, becomes pregnant, or is breastfeeding, it is essential to discuss the benefits and risks of this medication with their doctor to ensure the best possible outcome for both your child and the baby.
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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 (irregular heartbeats)

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive, focusing on maintaining vital functions. Naloxone may be considered for respiratory depression, though its efficacy is variable.

Drug Interactions

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Major Interactions

  • CNS depressants (e.g., alcohol, barbiturates, benzodiazepines, opioids, sedating antihistamines): Increased sedation and CNS depression.
  • Beta-blockers: Risk of bradycardia, AV block, and rebound hypertension upon clonidine withdrawal (especially if beta-blocker is not tapered first).
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Moderate Interactions

  • Tricyclic antidepressants (TCAs): May antagonize the hypotensive effect of clonidine.
  • Other antihypertensives: Additive hypotensive effects.
  • Digoxin: May increase risk of bradycardia.
  • Calcium channel blockers: May increase risk of bradycardia or AV block.
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Minor Interactions

  • Diuretics: May enhance hypotensive effect.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and monitor for hypotensive effects.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and monitor for bradycardia.

Timing: Prior to initiation

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)

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly during titration and periodically thereafter (e.g., weekly during titration, then every 3-6 months or as clinically indicated)

Target: Age-appropriate normal BP

Action Threshold: Symptomatic hypotension or significant drop from baseline

Heart Rate (HR)

Frequency: Regularly during titration and periodically thereafter (e.g., weekly during titration, then every 3-6 months or as clinically indicated)

Target: Age-appropriate normal HR

Action Threshold: Symptomatic bradycardia or significant drop from baseline

ADHD Symptoms

Frequency: Regularly during titration and periodically thereafter

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

Action Threshold: Lack of efficacy or worsening symptoms

Sedation/Drowsiness

Frequency: Regularly, especially during initial therapy and dose adjustments

Target: Minimal to no excessive sedation

Action Threshold: Excessive drowsiness interfering with daily activities

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Excessive sedation or drowsiness
  • Dry mouth
  • Constipation
  • Nausea
  • Headache
  • Irritability (especially during withdrawal)
  • 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. Use during pregnancy 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.
Second Trimester: Limited human data, but generally avoided unless clearly needed.
Third Trimester: Risk of neonatal withdrawal symptoms (e.g., irritability, tremors, hypertension) if used close to delivery.
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Lactation

Clonidine is excreted into human breast milk. The American Academy of Pediatrics considers clonidine to be a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor infants for sedation, bradycardia, and hypotension. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: L3 (Moderately Safe - Limited controlled studies show no adverse effects, or only minor non-serious adverse effects. Risk of adverse effects is possible. Monitor infant for sedation, bradycardia, and hypotension.)
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Pediatric Use

Onyda XR is specifically approved for the treatment of ADHD in pediatric patients aged 6-17 years. Safety and effectiveness in pediatric patients younger than 6 years have not been established. Careful titration and monitoring of vital signs are crucial.

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Geriatric Use

Clonidine is generally not indicated for ADHD in geriatric patients. For other indications, geriatric patients may be more sensitive to the hypotensive and sedative effects of clonidine. Lower initial doses and slower titration are recommended. Monitor closely for adverse effects, particularly orthostatic hypotension and bradycardia.

Clinical Information

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Clinical Pearls

  • Onyda XR is an extended-release formulation designed for once-daily dosing, typically at bedtime, to minimize daytime sedation and provide sustained ADHD symptom control.
  • Abrupt discontinuation of clonidine can lead to rebound hypertension, especially with higher doses or prolonged use. Taper the dose gradually over 2-4 days to avoid this effect.
  • Patients should be advised to avoid activities requiring mental alertness (e.g., driving, operating machinery) until they know how the medication affects them, due to potential for sedation.
  • Monitor blood pressure and heart rate at baseline and periodically during treatment, especially during dose titration.
  • This formulation is an oral suspension and should be measured with an accurate dosing device, not a household spoon. Do not mix with other liquids or foods.
  • Consider potential for additive CNS depression when co-prescribing with other sedating medications or alcohol.
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Alternative Therapies

  • Other alpha-2 adrenergic agonists (e.g., Guanfacine extended-release - Intuniv)
  • Stimulants (e.g., methylphenidate, amphetamines)
  • Non-stimulants (e.g., atomoxetine, viloxazine)
  • Behavioral therapy for ADHD
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Cost & Coverage

Average Cost: Varies, typically $200-$400 per 30ml bottle (0.1mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand)
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General Drug Facts

If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safe and effective treatment, never share your child's medication with others, and do not administer someone else's medication to your child. Some medications may include an additional patient information leaflet; if you have questions or concerns about this medication, consult with your child's doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek urgent medical attention. When reporting the incident, be prepared to provide detailed information, including the substance taken, the quantity, and the time it occurred.