【藥品訊息】 可律靜內服液劑 仿單

Procedural sedation: Sedative/hypnotic for surgeries and diagnostic procedures; sedative prior to EEG evaluations
Note: The manufacturer labeling includes indications for pain control; alcohol, opioid or barbiturate withdrawal; and short-term treatment of insomnia; however, chloral hydrate is no longer recommended to be used this way (Schutte-Rodin 2008; VA/DoD 2015).

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

Onset of action: 15 to 30 minutes
Duration: 1 to 2 hours
Absorption: Oral: Well absorbed
Protein binding: Trichloroethanol: 35% to 40%; trichloroacetic acid: ?94% (may compete with bilirubin for albumin binding sites)
Metabolism: Rapidly metabolized in the liver by alcohol dehydrogenase to trichloroethanol (active metabolite); trichloroethanol undergoes glucuronidation in the liver; variable amounts hepatically and renally to trichloroacetic acid (inactive)

Half-life elimination:
Chloral hydrate:
Preterm infants (postmenstrual age [PMA] 31 to 37 weeks): 1.01 ± 0.97 hours
Term infants (PMA 38 to 42 weeks): 3.01 ± 5.81 hours
Children and Adolescents <14 years: 9.68 ± 7.73 hours

Active metabolite (trichloroethanol) (Mayers 1991):
Preterm infants (PMA 31 to 37 weeks): 39.82 ± 14.27 hours
Term infants (PMA 38 to 42 weeks): 27.8 ± 21.32 hours
Children and Adolescents <14 years: 9.67 ± 1.72 hours
Adults: 8 to 12 hours (Fuhrman 2011)
Trichloroacetic acid: Adults: 67 hours (Furhman 2011)

Excretion: Urine (as metabolites); feces (small amounts)

Hypersensitivity to chloral hydrate or any component of the formulation; marked hepatic or renal impairment

Animal reproduction studies have not been conducted. Chloral hydrate crosses the placenta, and long-term use may lead to withdrawal symptoms in the neonate.

Chloral hydrate is excreted in breast milk; use by breast-feeding women may cause sedation in the infant.

Cardiovascular: Atrial arrhythmia, depression of myocardial contractility, hypotension, shortening of refractory periods, torsades de pointes, ventricular arrhythmia.
Central nervous system: Abnormal gait, ataxia, confusion, delirium, dizziness, drowsiness, drug dependence (physical and psychological; with prolonged use or large doses), hallucinations, hangover effect, malaise, nightmares, paradoxical excitation, somnambulism, vertigo
Dermatologic: Skin rash (including erythema, eczematoid dermatitis, urticaria, scarlatiniform exanthems)
Endocrine & metabolic: Acute porphyria, ketonuria
Gastrointestinal: Diarrhea, flatulence, gastric irritation, nausea, vomiting
Hematologic & oncologic: Acute porphyria, eosinophilia, leukopenia
Ophthalmic: Allergic conjunctivitis, blepharoptosis, keratoconjunctivitis
Otic: Increased middle ear pressure (infants and children)
Respiratory: Airway obstruction (young children), laryngeal edema (children)
Miscellaneous: Drug tolerance

Procedural sedation: Oral: 500 to 1,000 mg 30 minutes prior to procedure

Sedation, mechanically-ventilated patients: Very limited data available: Infants, Children, and Adolescents: Oral: Initial: 8 to 25 mg/kg/dose every 6 to 8 hours; titrate to effect based on patient response up to 50 mg/kg/dose every 6 hours; maximum dose: 1,000 mg/dose (AHFS 1993; Parkinson 1997). Dosing based on randomized control trial of 44 patients (age range: 1 day to 15 years) that compared continuous infusion midazolam (n=20) to promethazine plus chloral hydrate (n=23) at dose of 25 mg/kg/dose every 6 hours for sedation in ventilated patients. If sedation unsatisfactory, doses could be increased up to 50 mg/kg/dose every 6 hours. The total number of satisfactory sedation assessments was significantly higher in the chloral hydrate/promethazine group (61%) compared to the midazolam group (48%) (Parkinson 1997).

Sedation, procedural (eg, echocardiogram or EEG): Limited data available: Infants and Children (best results in children <3 years): Oral: 25 to 100 mg/kg/dose 30 minutes prior to procedure; maximum dose 1,000 mg/dose; may repeat after 30 minutes with 25 to 50 mg/kg/dose if necessary. Maximum total dose: 100 mg/kg/procedure or 2,000 mg/procedure (Heistein 2006; Krauss 2006; Napoli 1996; Wheeler 2001). Note: Although dosing may be used in adolescent patients, use in these patients is not common; older children and adolescent patients may not require sedation for echocardiogram and other agents used for EEG.

There are no dosage adjustments provided in the manufacturer's labeling. Use is contraindicated in patients with marked renal impairment.
Dialysis: Dialyzable

There are no dosage adjustments provided in the manufacturer's labeling. Use is contraindicated in patients with marked hepatic impairment.

(1)請密封儲存於 25℃以下，毋須冰存並避免陽光直射。
(2)開封後之保存期限為 30 天，儲存溫度為 25℃，未使用完應丟棄。