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  • Chloral Hydrate
    (Chloral Hydrate) - Pharmaceutical Associates

    OTHER BRAND NAMES

    Somnote (Breckenridge)

    THERAPEUTIC CLASS

    Trichloroacetaldehyde monohydrate

    DEA CLASS

    CIV

    INDICATIONS

    Short-term hypnotic (<2 weeks) in the treatment of simple insomnia and as routine sedative. To allay anxiety or produce sedation pre-operatively or prior to EEG evaluations. Alone or with paraldehyde to suppress, (Sol) prevent, and/or (Cap) reduce alcohol withdrawal syndrome. To reduce anxiety associated with withdrawal of other drugs such as narcotics or barbiturates.

    ADULT DOSAGE

    Adults: Max: 2g/day or dose. Hypnotic: Usual: 500mg-1g 15-30 min before hs. Sedative: Usual: 250mg tid pc. Alcohol Withdrawal: Usual: 500mg-1g q6h PRN. (Sol) Dilute in 1/2 glass of water, fruit juice, or ginger ale.

    PEDIATRIC DOSAGE

    Pediatrics: (Sol) Hypnotic: 50mg/kg or 1.5g/m2. Max: 1g/dose. Sedative: 8mg/kg or 250mg/m2 tid. Max: 500mg tid. Prior to EEG: 20-25mg/kg.

    HOW SUPPLIED

    Cap: 500mg; Sol: (Generic) 500mg/5mL [473mL]

    CONTRAINDICATIONS

    Marked hepatic or renal impairment.

    WARNINGS/PRECAUTIONS

    May be habit-forming. Caution with depression, suicidal tendencies, history of drug abuse. Avoid with esophagitis, gastritis or gastric/duodenal ulcers, and use of large doses in severe cardiac disease. Prolonged use may cause gastritis, skin eruptions, parenchymatous renal damage, tolerance, and physical/psychological dependence. Withdraw gradually with chronic use. May produce false-positive results for urine glucose determinations using Benedict's solution. (Cap) Anaphylaxis, angioedema, complex sleep-related behaviors may occur. May precipitate attacks of acute intermittent porphyria. May impair mental/physical abilities or produce unusual sensitivity to drug; closely monitor in elderly/debilitated.

    ADVERSE REACTIONS

    Gastric irritation (eg, N/V, diarrhea), ataxia, dizziness, cutaneous reactions (eg, scarlatiniform/erythematous rash, urticaria, angioedema, purpura, eczema, bullous lesions, erythema multiforme).

    DRUG INTERACTIONS

    Reduces effectiveness of coumarin anticoagulants. May result in transient potentiation of warfarin-induced hypoprothrombinemia. Additive CNS depression with other CNS depressants (eg, paraldehyde, barbiturates, alcohol). Use with IV furosemide may cause diaphoresis, flushes, variable BP; use alternative hypnotic (eg, benzodiazepine).

    PREGNANCY

    Category C, (Cap) not for use in nursing; (Sol) caution in nursing.

    MECHANISM OF ACTION

    Sedative/hypnotic agent; action confined to cerebral hemispheres.

    PHARMACOKINETICS

    Distribution: Found in breast milk. Metabolism: Liver. Elimination: Kidneys.

    ASSESSMENT

    Assess for renal/hepatic function, previous hypersensitivity/idiosyncratic reaction to drug, mental depression, suicidal tendencies, history of drug abuse, esophagitis, gastritis, gastric/duodenal ulcers, cardiac disease, pregnancy/nursing status, possible drug interactions, and (Cap) susceptibility to porphyria.

    MONITORING

    Monitor cardiac/renal/hepatic function, for possible development of tolerance and physical/psychological dependence, hypersensitivity reactions, and other adverse reactions.

    PATIENT COUNSELING

    Caution against performing hazardous activities requiring mental alertness or physical coordination (eg, operating machinery/driving). Caution against taking depressant drugs, including alcohol. Inform physician if pregnant, planning to become pregnant, or currently breastfeeding. Take sol in a 1/2 glass of water, fruit juice, or ginger ale. Take cap with a full glass of water/liquid.

    ADMINISTRATION/STORAGE

    Administration: Oral route. Storage: (Cap) 25°C (77°F); excursions permitted to 15-30°C (59-86°F). (Sol) 20-25°C (68-77°F). Protect from freezing and light. Keep tightly closed.