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Pronunciation |
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(KLOR
al HYE
drate) |
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U.S. Brand
Names |
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Aquachloral®
Supprettes® |
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Generic
Available |
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Yes |
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Canadian Brand
Names |
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Novo-Chlorhydrate; PMS-Chloral
Hydrate |
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Synonyms |
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Chloral; Hydrated Chloral; Trichloroacetaldehyde Monohydrate |
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Pharmacological Index |
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Hypnotic, Miscellaneous |
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Use |
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Dental: Sedative/hypnotic for dental procedures
Medical: Short-term sedative and hypnotic (<2 weeks), sedative/hypnotic
for diagnostic procedures; sedative prior to EEG evaluations
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Restrictions |
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C-IV |
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Pregnancy Risk
Factor |
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C |
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Contraindications |
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Hypersensitivity to chloral hydrate or any component; hepatic or renal
impairment; gastritis or ulcers; severe cardiac disease |
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Warnings/Precautions |
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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. |
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Adverse
Reactions |
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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 |
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Overdosage/Toxicology |
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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
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Drug
Interactions |
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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 |
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Stability |
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Sensitive to light; exposure to air causes volatilization; store in
light-resistant, airtight container |
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Mechanism of
Action |
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Central nervous system depressant effects are due to its active metabolite
trichloroethanol, mechanism unknown |
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Pharmacodynamics/Kinetics |
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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 |
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Usual Dosage |
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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: Clcr
<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 |
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Dietary
Considerations |
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Alcohol: Additive CNS effects, avoid use |
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Monitoring
Parameters |
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Vital signs, O2 saturation and blood pressure with doses used for
conscious sedation |
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Test
Interactions |
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False-positive urine glucose using Clinitest® method;
may interfere with fluorometric urine catecholamine and urinary
17-hydroxycorticosteroid tests |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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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. |
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Nursing
Implications |
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Gastric irritation may be minimized by diluting dose in water or other oral
liquid |
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Dosage Forms |
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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)
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References |
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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.
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