Generic Name

Triclofos Sodium

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Classification

FDA Approved Indications

• Sedation for medical procedures in children

Mechanism of Action

Converted in the body to chloral hydrate, which acts centrally as a sedative by increasing the activity of GABA-A receptors, leading to sedative and hypnotic effects.

Dosage and Administration

Adult: Typically not used in adults; pediatric dosing is standard.

Pediatric: Orally, 50-80 mg/kg at bedtime as a single dose or divided doses. Duration of treatment should be limited.

Geriatric: Use cautiously; lower doses may be necessary due to increased sensitivity.

Renal Impairment: Use with caution; dosage adjustments may be required.

Hepatic Impairment: Use with caution; monitor for prolonged sedation.

Pharmacokinetics

Absorption: Well absorbed orally.

Distribution: Distributed widely in body tissues, crosses blood-brain barrier.

Metabolism: Converted to chloral hydrate, then broken down to inactive metabolites.

Excretion: Excreted primarily in urine.

Half Life: Chloral hydrate has a half-life of approximately 8 hours, but this may be prolonged in cases of impaired hepatic or renal function.

Contraindications

• Hypersensitivity to chloral hydrate or Triclofos.
• Acute porphyria.

Precautions

• Use with caution in hepatic or renal impairment, in patients with history of respiratory depression, or in children with compromised health status. Use cautiously in patients with sleep apnea, epilepsy, or in those taking other CNS depressants. It is not recommended during pregnancy or breastfeeding.

Adverse Reactions - Common

• Gastrointestinal upset (nausea, vomiting) (Rare)
• Drowsiness, dizziness (Common)
• Skin rash (Rare)

Adverse Reactions - Serious

• Respiratory depression (Rare)
• Allergic reactions including angioedema, anaphylaxis (Rare)
• Cardiac arrhythmias (Rare)

Drug-Drug Interactions

• Other CNS depressants (alcohol, sedatives, opioids) can increase sedation and respiratory depression.
• MAO inhibitors may enhance effects.
• Anticonvulsants may have altered effects.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Do not operate machinery or drive after administration.
• Avoid alcohol and other CNS depressants.
• Report any allergic reactions or excessive drowsiness.
• Use as directed, and do not increase dose without medical advice.

Special Considerations

Black Box Warnings:

• Potential for respiratory depression, especially in children and when combined with other CNS depressants.

Genetic Factors: No widely recognized genetic variations affecting drug response.

Lab Test Interference: May interfere with sleep studies and some laboratory tests involving sedation or respiratory function.

Overdose Management

Signs/Symptoms: Severe CNS depression, respiratory depression, hypotension, possible coma.

Treatment: Supportive care, airway management, mechanical ventilation if necessary, activated charcoal if ingestion is recent, and supportive measures. Hemodialysis is not typically effective.

Storage and Handling

Storage: Store in a tightly closed container at room temperature, away from moisture and light.

Stability: Stable under recommended storage conditions for the period specified by the manufacturer.