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PHENOBARBITAL SODIUM Luminal Sodium Classifications: CENTRAL NERVOUS SYSTEM AGENT; ANTICONVULSANT; SEDATIVE-HYPNOTIC; BARBITURATE

Anticonvulsant Adult: PO 100–300 mg/d IV/IM 200–600 mg up to 20 mg/kg Child: PO/IV 3–8 mg/kg or 125 mg/m2/d Neonate: PO/IV 3–4 mg/kg/d (max: 5 mg/kg/d) Status Epilepticus Adult/Child: IV 15–18 mg/kg in single or divided doses (max: 20 mg/kg) Neonate: IV 15–20 mg/kg in single or divided doses Sedative Adult: PO 30–120 mg/d IV/IM 100–200 mg/d Child: PO 6 mg/kg/d or 180 mg/m2 in 3 divided doses IV/IM 16–100 mg/d (1–3 mg/kg)

Long-acting barbiturate. Sedative and hypnotic effects of barbiturates appear to be due primarily to interference with impulse transmission of cerebral cortex by inhibition of reticular activating system. CNS depression may range from mild sedation to coma, depending on dosage, route of administration, degree of nervous system excitability, and drug tolerance. Initially, barbiturates suppress REM sleep, but with chronic therapy REM sleep returns to normal.

Long-term management of tonic-clonic (grand mal) seizures and partial seizures; status epilepticus, eclampsia, febrile convulsions in young children. Also used as a sedative in anxiety or tension states; in pediatrics as preoperative and postoperative sedation and to treat pylorospasm in infants.

Body as a Whole: Myalgia, neuralgia, CNS depression, coma, and death. CNS: Somnolence, nightmares, insomnia, "hangover," headache, anxiety, thinking abnormalities, dizziness, nystagmus, irritability, paradoxic excitement and exacerbation of hyperkinetic behavior (in children); confusion or depression or marked excitement (older adult or debilitated patients); ataxia. CV: Bradycardia, syncope, hypotension. GI: Nausea, vomiting, constipation, diarrhea, epigastric pain, liver damage. Hematologic: Megaloblastic anemia, agranulocytosis, thrombocytopenia. Metabolic: Hypocalcemia, osteomalacia, rickets. Musculoskeletal: Folic acid deficiency, vitamin D deficiency. Respiratory: Respiratory depression. Skin: Mild maculopapular, morbilliform rash; erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis (rare). .

Sensitivity to barbiturates; manifest hepatic or familial history of porphyria; severe respiratory or kidney disease; history of previous addiction to sedative hypnotics; uncontrolled pain; pregnancy (particularly early pregnancy) (category D), lactation; sustained release formulation for children <12 y of age.

Assessment & Drug Effects

Observe patients receiving large doses closely for at least 30 min to ensure that sedation is not excessive. • Keep patient under constant observation when drug is administered IV, and record vital signs at least every hour or more often if indicated. • Lab tests: Obtain liver function and hematology tests and determinations of serum folate and vitamin D levels during prolonged therapy. • Monitor serum drug levels. Serum concentrations >50 mcg/mL may cause coma. Therapeutic serum concentrations of 15–40 mcg/mL produce anticonvulsant activity in most patients. These values are usually attained after 2 or 3 wk of therapy with a dose of 100–200 mg/d. • Expect barbiturates to produce restlessness when given to patients in pain because these drugs do not have analgesic action. • Be prepared for paradoxical responses and report promptly in older adult or debilitated patient and children (i.e., irritability, marked excitement [inappropriate tearfulness and aggression in children], depression, and confusion).

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