Onyda XR

Full Prescribing Information

Forms/Strengths

Age: ≥ 6 y/o
Onset: 60-90 min
Duration: 12-24 hours
Considerations: Orange flavored; Monitor for hypotension, bradycardia, and sedation. Titrate slowly.
Initial Dose: 0.1 mg orally once daily at bedtime
Titration: Increase by 0.1 mg weekly
Max Dose: 0.4 mg once daily

For patients switching from another clonidine product, discontinue that treatment, and titrate with ONYDA XR using the titration schedule

Increases synaptic dopamine and norepinephrine via presynaptic release and reuptake inhibition
Enhances focus, attention, and impulse control
Extended-release formulation with dual-phase release for rapid onset and sustained control
Unique delivery system provides consistent plasma levels throughout the day
Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort

Take once daily at bedtime to minimize daytime sedation.
Administer orally as a suspension; shake the bottle gently for at least 10 seconds before each use to ensure proper mixing.
Use the provided oral dosing dispenser for accurate measurement; do not use household spoons.
Can be taken with or without food, but maintain consistency in relation to meals to ensure stable absorption.
If a dose is missed, skip that dose and take the next dose as scheduled; do not double up.
Do not abruptly discontinue; tapering may be required to prevent rebound hypertension.

Common: Somnolence, fatigue, irritability, headache, abdominal pain, constipation, dry mouth
Serious: Hypotension, bradycardia, rebound hypertension, allergic reactions

Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
Abuse Potential: Monitor for misuse or diversion.

When to Call the Doctor:
- Severe dizziness, fainting, or low blood pressure.
- Slow or irregular heart rate.
- Excessive drowsiness or difficulty waking.
- Mood changes, depression, or unusual behavior.
- Severe headache, blurred vision, or confusion (possible hypertensive rebound if stopped abruptly).
Safety Tips:
- Monitor blood pressure and heart rate regularly.
- Avoid alcohol and sedatives, which may enhance drowsiness.
- Rise slowly from sitting or lying positions to prevent dizziness.
- Use caution when driving or operating heavy machinery due to possible sedation.
- Taper gradually when discontinuing to avoid withdrawal symptoms.
Parent Tips for Pediatric Patients:
- May cause daytime drowsiness; administering at bedtime helps minimize this effect.
- Monitor for irritability, mood swings, or behavioral changes.
- Encourage hydration and balanced nutrition to minimize side effects.
- Ensure children do not engage in high-risk activities (e.g., swimming, biking) if excessively drowsy.
- Store in child-proof packaging to prevent accidental overdose.

Contraindications:
- Hypersensitivity to clonidine or formulation components.
- Use with caution in patients with severe heart disease, bradycardia, or hypotension.
Pregnancy:
- Category C; use only if benefits outweigh risks.
- May cause neonatal withdrawal symptoms.
Lactation:
- Excreted in breast milk; use with caution due to potential effects on infant blood pressure.
Drug Interactions:
- CNS depressants (e.g., alcohol, benzodiazepines) may increase sedation.
- Beta-blockers may enhance bradycardia; caution when using together.
- Stimulants (e.g., amphetamines) may counteract ONYDA XR’s effects.
- Antihypertensive medications may lead to excessive blood pressure lowering.