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Clonidine hydrochloride

CLONIDINE HYDROCHLORIDE

Manufacturer: Ajanta Pharma USA Inc.

Score: 141.0

Quick Summary

Clonidine hydrochloride extended-release tablets are a centrally acting alpha 2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. The drug is not a central nervous system stimulant and its mechanism of action in ADHD is not known. Clonidine hydrochloride extended-release tablets are available in 0.1 mg strength and should be swallowed whole, without crushing, chewing, or breaking. The dose should be initiated at 0.1 mg at bedtime and increased in increments of 0.1 mg/day at weekly intervals until the desired response is achieved, with a maximum dose of 0.4 mg/day.

Key Clinical Findings and Indications

  • Clonidine hydrochloride extended-release tablets are indicated for the treatment of ADHD as monotherapy and as adjunctive therapy to stimulant medications.
  • The drug is not a central nervous system stimulant.
  • Clonidine hydrochloride extended-release tablets stimulate alpha 2-adrenergic receptors in the brain, reducing sympathetic outflow from the central nervous system and decreasing peripheral resistance, renal vascular resistance, heart rate, and blood pressure.

Important Safety Information

Warning

Clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of hypersensitivity reaction to clonidine.

Contraindications

  • History of hypersensitivity reaction to clonidine

Adverse Reactions

  • Somnolence
  • Fatigue
  • Irritability
  • Nightmare
  • Insomnia
  • Constipation
  • Dry mouth

Dosing Recommendations

General Guidance

Dose adjustments may be necessary when concomitantly administered with other medications, such as tricyclic antidepressants, antihypertensive drugs, and CNS depressants.

ADHD

Adult Dose

Initiate at 0.1 mg at bedtime, increase in increments of 0.1 mg/day at weekly intervals

Pediatric Dose

Initiate at 0.1 mg at bedtime, increase in increments of 0.1 mg/day at weekly intervals

Special Population Considerations

Pregnancy

  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including clonidine hydrochloride extended-release tablets, during pregnancy.

Nursing Mothers

  • Clonidine hydrochloride extended-release tablets may impair fertility in females and males of reproductive potential.

Pediatric Use

  • The safety and efficacy of clonidine hydrochloride extended-release tablets in the treatment of ADHD have been established in pediatric patients 6 to 17 years of age.

Geriatric Use

  • No specific information available

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