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chloral hydrate (klor-al hye-drate) Aquachloral, Novo-Chlorhydrate, Classification Therapeutic: sedative/hypnotics Schedule IV Pregnancy Category C

= Genetic implication. = Canadian drug name. Copyright 2011 by F.A. Davis Company

PMS-Chloral Hydrate

Short-term sedative and hypnotic (effectiveness decreases after 2 wk of use). Sedation or reduction of anxiety preoperatively (anesthetic adjunct) or prior to diagnostic procedures.

Converted to trichloroethanol, which is the active drug. Has generalized CNS depressant properties. Therapeutic Effects: Sedation or induction of sleep.

Absorption: Well absorbed following oral or rectal administration. Distribution: Widely distributed. Crosses the placenta and enters breast milk in low concentrations. Metabolism and Excretion: Converted by liver to trichloroethanol, which is active. Trichloroethanol is, in turn, metabolized by the liver and kidneys to inactive compounds. Half-life: Chloral hydrateInfants: 1 hr.TrichloroethanolNeonates: 8.566 hr; Children: 10 hr; Adults: 811 hr. TIME/ACTION PROFILE (sedation) ROUTE ONSET PEAK DURATION PO
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30 min

1 hr

48 hr
1

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ROUTE ONSET PEAK DURATION Rectal 0.51 hr 1 hr 48 hr

Contraindicated in: Hypersensitivity; Severe cardiac disease; Severe renal impairment (ClCr <50 mL/min); Coma or pre-existing CNS depression; Uncontrolled severe pain; OB: Crosses placenta; chronic use during pregnancy may cause withdrawal symptoms in the neonate.; Lactation: Excreted in human milk, use by nursing mothers may cause sedation in the infant; Esophagitis, gastritis, or ulcer disease; Proctitis (rectal use); Tartrazine hypersensitivity (some rectal products); Impaired respiratory function; Sleep apnea. Use Cautiously in: Hepatic dysfunction; History of suicide attempt or substance abuse; Obstructive sleep apnea; Pedi: May cause direct hyperbilirubinemia in neonates; Geri/Pedi: Dosage reduction recommended. (CAPITALS indicate
life-threatening; underlines indicate most frequent.)

CNS: excess sedation, disorientation, dizziness, hangover, headache, incoordination, irritability, paradoxical excitation (children). Resp: respiratory depression. GI: diarrhea, nausea, vomiting, flatulence. Derm: rashes. Misc: tolerance, physical dependence, psychological dependence.

Drug-Drug: Additive CNS depression with other CNS depressants, including alcohol, antihistamines, antidepressants, sedative/hypnotics, and opioid analgesics. May potentiate warfarin. When given within 24 hr of IV furosemide, may cause diaphoresis, changes in blood pressure, and flushing. May increase metabolism and decrease effects of phenytoin. May increase toxicity of ifosfamide and cyclophoshamide.

Drug-Natural: Concomitant use of kava, valerian, skullcap, chamomile, or hops can increase CNS depression.
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PO (Adults): Hypnotic5001000 mg 1530 min before bedtime. Preoperative sedation500 mg1000 mg 30 min before surgery. Daytime sedation250 mg 3 times daily. Single dose/daily dose should not >2 g. PO (Geriatric Patients): Hypnotic250 mg 1530 min before bedtime. Rect (Adults): Sedation325 mg 3 times daily. Hypnotic5001000 mg. Single dose/daily dose should not >2 g. PO, Rect (Children> 1 month): Pre-electroencephalogram sedation 2025 mg/kg 3060 min prior. Sedation prior to dental/medical procedures5075 mg/kg 3060 min prior; may repeat within 30 min if needed; single dose should not exceed 1 g total for infants or 2 g total for children).Hypnotic50 mg/kg; maximum 2 g/day.Sedation /anxiety:2550 mg/kg/day divided q 68 hr; maximum 500 mg/dose. PO, Rect (Neonates): 25 mg/kg/dose prior to a procedure.

Capsules: 500 mg. Syrup: 500 mg/5 mL. Suppositories: 325 mg, 500 mg.

Assess mental status (orientation, mood, behavior) and potential for abuse prior to administering this medication. Prolonged use may lead to physical and psychological dependence. Limit amount of drug available to the patient. Assess sleep pattern before and periodically throughout therapy. Geri: Assess CNS effects and risk for falls. Institute fall prevention strategies. Assess level of consciousness at time of peak effect. Notify physician or other health care professional if desired sedation does not occur or if paradoxical reaction occurs. Lab Test Considerations: Interferes with tests for urinary 17-hydroxycorticosteroids and urinary catecholamines.

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(Indications) Anxiety (Indications) Risk for injury (Side Effects) Ineffective coping (Indications) Sleep deprivation (Indications) Risk for falls (Side Effects) Acute confusion (Side Effects)

High Alert: Pedi: Chloral hydrate overdosage has resulted in fatalities in children. Only accept orders written in milligrams, not volume (teaspoons) or concentration. Chloral hydrate should be administered to children only by trained staff in the health care setting. When administered to children for sedation before outpatient procedures, administer at the facility where procedure is to be performed. Repeated doses should be used with great caution in neonates, as drug and metabolites accumulate and may lead to toxicity. Continue monitoring until level of consciousness is safe for discharge. Before administering, reduce external stimuli and provide comfort measures to increase effectiveness of medication. Refer for psychotherapy if ineffective coping is basis for sleep pattern disturbance. Protect patient from injury. Place bed-side rails up. Assist with ambulation. Remove cigarettes from patients receiving hypnotic dose . PO: Capsules should be swallowed whole with a full glass of water or juice to minimize gastric irritation; do not chew. Dilute syrup in a half glass of water, juice, ginger ale, or formula to mask taste. Rect: If suppository is too soft for insertion, chill in refrigerator for 30 min or run under cold water before removing foil wrapper.

Instruct patient to take chloral hydrate exactly as directed. Missed doses should be omitted; do not double doses. If used for 2 wk or longer, abrupt withdrawal may result in CNS excitement, tremor,
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anxiety, hallucinations, and delirium. Chloral hydrate causes drowsiness and dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known. Caution patient that concurrent alcohol use may create an additive effect that results in tachycardia, vasodilation, flushing, headache, hypotension, and pronounced CNS depression. Alcohol and other CNS depressants should be avoided while taking chloral hydrate. Advise patient to discontinue use and notify health care professional if skin rash, dizziness, irritability, impaired thought processes, headache, or motor incoordination occurs. Teach sleep hygiene techniques (dark room, quiet, bedtime ritual, limit daytime napping, avoid nicotine and caffeine).

Sedation. Improvement in sleep pattern.

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