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Clonidine

(clonidine)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  • Tablets: 0.1 mg, 0.2 mg, 0.3 mg

Dosing

  • Age: ≥ 6yr
  • Onset: 30-60 min (oral)
  • Duration: 6-12 hours
  • Considerations: Monitor for bradycardia and hypotension; taper gradually over 2-4 days (or longer based on dose/duration) to avoid rebound hypertension; often dosed BID with larger dose at bedtime for ADHD
  • Initial Dose:
    • 27-40 kg: 0.05 mg nightly
    • 40+ kg: 0.1 mg nightly
  • Titration: 
    • Increase 0.05mg every 3-7 d taper gradually over 2-4 days to discontinue
  • Max Dose:
    • 27-40 kg: 0.2 mg/day 
    • 40+ kg: 0.4 mg/day

Quick Facts

  • Central alpha-2 adrenergic agonist that reduces norepinephrine release and sympathetic outflow from the locus coeruleus.
  • Improves ADHD symptoms of hyperactivity, impulsivity, and inattention, especially as adjunct to stimulants.
  • Particularly useful off-label for ADHD with tics, aggression, or sleep issues.
  • Sedation common early and dose-dependent; often improves with time or bedtime dosing.
  • Low abuse potential; not a controlled substance.
  • Risk of rebound hypertension with abrupt discontinuation.
  • Not FDA-approved for ADHD (extended-release form Kapvay is approved).

Indications

  • Hypertension (ICD-10: I10, I11.0, I11.9)

Off-Label Uses

  • ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9) – adjunct or monotherapy for hyperactivity/impulsivity.
  • Tic disorders/Tourette syndrome (ICD-10: F95.1, F95.2) – reduces tics via noradrenergic modulation.
  • Oppositional defiant disorder (ICD-10: F91.3) – decreases aggression when added to stimulants.
  • Insomnia/sleep disturbances in ADHD (ICD-10: G47.00) – promotes sleep with bedtime dosing.

How to Take

  • Take at the same time each day for consistency.
  • Can be taken with or without food.
  • Swallow whole; do not crush or chew.
  • If used for ADHD, often given twice daily, with the larger dose at bedtime to minimize drowsiness.
  • Do not suddenly stop taking; tapering may be required to prevent rebound hypertension.
  • Transdermal patches should be applied to a hairless area on the upper outer arm or chest.

Side Effects

  • Common:
    • Sedation/drowsiness (most prominent initially)
    • Dry mouth
    • Dizziness/orthostatic hypotension
    • Constipation
    • Fatigue/headache
  • Serious:
    • Bradycardia/hypotension
    • Rebound hypertension (with abrupt stop)
    • Depression, hallucinations (rare)
    • AV block (in cardiac disease)

Monitoring / Labs

  • Baseline and periodic blood pressure and heart rate (supine and standing).
  • ECG if history of cardiac disease.
  • Renal function (dose adjust in impairment).
  • Growth parameters in children (long-term use).

Education

  • When to Call the Doctor:

    • Severe dizziness, fainting, or low blood pressure.
    • Slow or irregular heart rate.
    • Signs of over-sedation, such as excessive drowsiness or difficulty waking.
    • Mood changes, hallucinations, 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.
    • Do not suddenly discontinue, as this may lead to rebound hypertension.
    • Be cautious when driving or operating machinery until individual response is known.
  • Parent Tips for Pediatric Patients:

    • May cause daytime drowsiness; consider giving the larger dose at bedtime.
    • Monitor for irritability, behavioral changes, or mood swings.
    • Encourage hydration and salt intake if dizziness occurs.
    • Ensure the child does not engage in high-risk activities (e.g., climbing, swimming unsupervised) if excessively drowsy.
    • Keep in child-proof packaging to prevent accidental overdose.

Additional Information

  • 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 if discontinuing either drug.
    • Stimulants (e.g., amphetamines) may counteract clonidine’s effects.
    • Antihypertensive medications may lead to excessive blood pressure lowering.

References

  1. Clonidine HCl Tablets Prescribing Information (DailyMed/FDA), 2023, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fe10c92-621a-4d36-b030-34098351a1e2
  2. StatPearls: Clonidine, 2024, https://www.ncbi.nlm.nih.gov/books/NBK459124/
  3. Safety and Efficacy of Clonidine in Children with ADHD (PMC), 2014, https://pmc.ncbi.nlm.nih.gov/articles/PMC3926778/
  4. AACAP Practice Parameters for ADHD (via UpToDate integration), 2022, https://www.uptodate.com/contents/attention-deficit-hyperactivity-disorder-in-children-and-adolescents-treatment-with-nonstimulant-medications