Yes

Hypnotic, Miscellaneous

Dental: Sedative/hypnotic for dental procedures

Medical: Short-term sedative and hypnotic (<2 weeks), sedative/hypnotic for diagnostic procedures; sedative prior to EEG evaluations

C-IV

C

Hypersensitivity to chloral hydrate or any component; hepatic or renal impairment; gastritis or ulcers; severe cardiac disease

Use with caution in patients with porphyria; use with caution in neonates, drug may accumulate with repeated use, prolonged use in neonates associated with hyperbilirubinemia; tolerance to hypnotic effect develops, therefore, not recommended for use >2 weeks; taper dosage to avoid withdrawal with prolonged use; trichloroethanol (TCE), a metabolite of chloral hydrate, is a carcinogen in mice; there is no data in humans. Chloral hydrate is considered a second line hypnotic agent in the elderly. Recent interpretive guidelines from the Health Care Financing Administration (HCFA) discourage the use of chloral hydrate in residents of long-term care facilities.

Central nervous system: Ataxia, disorientation, sedation, excitement (paradoxical), dizziness, fever, headache, confusion, lightheadedness, nightmares, hallucinations, drowsiness, "hangover" effect

Dermatologic: Rash, urticaria

Gastrointestinal: Gastric irritation, nausea, vomiting, diarrhea, flatulence

Hematologic: Leukopenia, eosinophilia, acute intermittent porphyria

Miscellaneous: Physical and psychological dependence may occur with prolonged use of large doses

Symptoms of overdose include hypotension, respiratory depression, coma, hypothermia, cardiac arrhythmias

Treatment is supportive and symptomatic; lidocaine or propranolol may be used for ventricular dysrhythmias, while isoproterenol or atropine may be required for torsade de pointes; activated charcoal may prevent drug absorption

Chloral hydrate and ethanol (and other CNS depressants) have additive CNS depressant effects; monitor for CNS depression

Chloral hydrate's metabolite may displace warfarin from its protein binding sites resulting in an increase in the hypoprothrombinemic response to warfarin; warfarin dosages may need to be adjusted

Diaphoresis, flushing, and hypertension have occurred in patients who received I.V. furosemide within 24 hours after administration of chloral hydrate; consider using a benzodiazepine

Sensitive to light; exposure to air causes volatilization; store in light-resistant, airtight container

Central nervous system depressant effects are due to its active metabolite trichloroethanol, mechanism unknown

Peak effect: Within 0.5-1 hour

Duration: 4-8 hours

Absorption: Oral, rectal: Well absorbed

Distribution: Crosses the placenta; negligible amounts appear in breast milk

Metabolism: Rapidly to trichloroethanol (active metabolite); variable amounts metabolized in liver and kidney to trichloroacetic acid (inactive)

Half-life: Active metabolite: 8-11 hours

Elimination: Metabolites excreted in urine, small amounts excreted in feces via bile

Children:

Sedation, anxiety: Oral, rectal: 5-15 mg/kg/dose every 8 hours, maximum: 500 mg/dose

Prior to EEG: Oral, rectal: 20-25 mg/kg/dose, 30-60 minutes prior to EEG; may repeat in 30 minutes to maximum of 100 mg/kg or 2 g total

Hypnotic: Oral, rectal: 20-40 mg/kg/dose up to a maximum of 50 mg/kg/24 hours or 1 g/dose or 2 g/24 hours

Sedation, nonpainful procedure: Oral: 50-75 mg/kg/dose 30-60 minutes prior to procedure; may repeat 30 minutes after initial dose if needed, to a total maximum dose of 120 mg/kg or 1 g total

Adults: Oral, rectal:

Sedation, anxiety: 250 mg 3 times/day

Hypnotic: 500-1000 mg at bedtime or 30 minutes prior to procedure, not to exceed 2 g/24 hours

Dosing adjustment/comments in renal impairment: Cl_cr <50 mL/minute: Avoid use

Hemodialysis: Dialyzable (50% to 100%); supplemental dose is not necessary

Dosing adjustment/comments in hepatic impairment: Avoid use in patients with severe hepatic impairment

Alcohol: Additive CNS effects, avoid use

Vital signs, O₂ saturation and blood pressure with doses used for conscious sedation

False-positive urine glucose using Clinitest® method; may interfere with fluorometric urine catecholamine and urinary 17-hydroxycorticosteroid tests

No information available to require special precautions

No effects or complications reported

Use exactly as directed (do not increase dose or frequency or discontinue without consulting prescriber); may cause physical and/or psychological dependence. While using this medication, do not use alcohol and other prescription or OTC medications (especially, pain medications, sedatives, antihistamines, or hypnotics) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience drowsiness, dizziness, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, unpleasant taste (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); diarrhea (buttermilk, boiled milk, yogurt may help). Report skin rash or irritation, CNS changes (confusion, depression, increased sedation, excitation, headache, insomnia, or nightmares), unresolved gastrointestinal distress, chest pain or palpitations, or ineffectiveness of medication. Pregnancy precautions: Inform prescriber if you are or intend to be pregnant.

Gastric irritation may be minimized by diluting dose in water or other oral liquid

Suppository, rectal: 324 mg, 500 mg, 648 mg

Syrup: 250 mg/5 mL (10 mL); 500 mg/5 mL (5 mL, 10 mL, 480 mL)

American Academy of Pediatrics, Committee on Drugs and Committee on Environmental Health, "Use of Chloral Hydrate for Sedation in Children," Pediatrics, 1993, 92(3):471-3.

Buck ML, "Chloral Hydrate Use During Infancy," Neonatal Pharmacology Quarterly, 1992, 1(1):31-7.

Buur T, Larsson R, and Norlander B, "Pharmacokinetics of Chloral Hydrate Poisoning Treated With Hemodialysis and Hemoperfusion," Acta Med Scand, 1988, 223(3):269-74.

Donovan KL and Fisher DJ, "Reversal of Chloral Hydrate Overdose With Flumazenil," Br Med J (Clin Res Ed), 1989, 298(6682):1253.

Kauffman RE, "Chloral Hydrate - Is It a Carcinogenic Hazard?," Pediatr Alert, 1991, 16(6) 21-22.

Laptook AR and Rosenfeld CR, "Chloral Hydrate Toxicity in a Preterm Infant," Pediatr Pharmacol New York, 1984, 4(3):161-5.

Mayers DJ, Hindmarsh KW, Gorecki DK, et al, "Sedative/Hypnotic Effects of Chloral Hydrate in the Neonate: Trichloroethanol or Parent Drug?" Dev Pharmacol Ther, 1992, 19(2-3):141-6.

Mayers DJ, Hindmarsh KW, Sankaran K, et al, "Chloral Hydrate Disposition Following Single-Dose Administration to Critically Ill Neonates and Children," Dev Pharmacol Ther, 1991, 16(2):71-7.

Meyer E, Van Bocxlaer JF, Lambert WE, et al, "Determination of Chloral Hydrate and Metabolites in a Fatal Intoxication," J Anal Toxicol, 1995, 19(2):124-6.

Salmon AG, Kizer KW, Zeise L, et al, "Potential Carcinogenicity of Chloral Hydrate - A Review," J Toxicol Clin Toxicol, 1995, 33(2):115-21.

Seger D and Schwartz G, "Chloral Hydrate: A Dangerous Sedative for Overdose Patients?" Pediatr Emerg Care, 1994, 10(6):349-50.

Steinberg AD, "Should Chloral Hydrate be Banned?" Pediatrics, 1993, 92(3)442-6.

Zeltzer LK, Altman A, Cohen D, et al, "American Academy of Pediatrics Report of the Subcommittee on the Management of Pain Associated With Procedures in Children With Cancer," Pediatrics, 1990, 86(5 Pt 2):826-31.