GLUTETHIMIDE (gloo-teth'i-mide) Doriglute Classifications: central nervous system agent; anxiolytic; sedative-hypnotic Prototype: Secobarbital Pregnancy Category: C Controlled Substance: Schedule III
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250 mg tablets
Pharmacologic actions similar to those of barbiturates. Can induce hypnosis without producing reliable analgesic, antitussive,
or anticonvulsant action. Causes less respiratory depression but greater degree of hypotension than barbiturates. Addiction
liability similar to that of barbiturates.
Significantly suppresses REM sleep; but following drug withdrawal after chronic administration, REM rebound occurs, and patient
may experience markedly increased dreaming, nightmares, insomnia.
Short-term treatment of insomnia and for sedative effect preoperatively and during first stage of labor. Not indicated for
routine sedation or persistent insomnia.
Uncontrolled pain; intermittent porphyria; severe hepatic and renal impairment; prolonged administration; lactation; children
<12 y. Safe use during pregnancy [(category C) except with caution during first stage of labor] is not established.
Older adult or debilitated patients; prostatic hypertrophy, bladder neck obstruction; pyloroduodenal obstruction, stenosing
peptic ulcer; narrow-angle glaucoma; hypotension, cardiac arrhythmias; mental depression (particularly in patients with suicidal
tendencies), history of alcoholism or drug abuse.
Insomnia Adult: PO 250500 mg h.s., may repeat prn but not <4 h before arising
Preoperative Sedation Adult: PO 500 mg the night before surgery and 500 mg1 g 1 h before anesthesia
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Oral
- Give 4 h or more before the usual time of arising to avoid residual daytime effects when administered for insomnia.
- Withdraw drug gradually, using stepwise dose reduction over a period of several days or weeks. Abrupt withdrawal following
regular use may produce nausea, vomiting, nervousness, tremors, abdominal cramps, nightmares, insomnia, tachycardia, chills,
fever, numbness of extremities, dysphagia, delirium, hallucinations, or convulsions.
Body as a Whole: Acute hypersensitivity reactions. CNS: CNS depression in fetus; paradoxic excitement, headache, vertigo. GI: Gastric irritation, nausea, drug "hangover," dry mouth. Hematologic: Blood dyscrasias. Skin: Generalized skin rash (occasionally, purpuric or urticarial), exfoliative dermatitis (rare). Other: Hiccups, blurred vision. Acute Overdosage: CNS depression (coma; depressed reflexes, including corneal reflex; dilated, fixed pupils; hypotension; hypothermia followed by hyperpyrexia;
tachycardia; respiratory depression, cyanosis, sudden apnea; decreased intestinal motility, adynamic ileus; facial twitching; intermittent spasticity; flaccid
paralysis; pulmonary and cerebral edema; renal tubular necrosis; severe infections). Chronic Ingestion: Toxic psychosis (slurred speech, impaired memory, inability to concentrate, mydriasis, dry mouth, nystagmus, ataxia, hyporeflexia,
tremors, peripheral neuropathy).
Drug: Alcohol, barbiturates, other cns depressants compound depressant effects; tricyclic antidepressants add to anticholinergic effects; decreases anticoagulant effects of oral anticoagulants.
Absorption: Erratic absorption from GI tract. Onset: 30 min. Duration: 48 h. Distribution: Widely distributed; localizes in adipose tissue, liver, kidney, brain, and bile; crosses placenta; distributed into breast
milk in small quantities. Metabolism: Metabolized in liver. Elimination: Metabolites excreted in urine. Half-Life: 1012 h.
Assessment & Drug Effects
- Inform physician of patient's response to drug. Smallest effective dosage should be used for the shortest period of time compatible
with patient's needs.
- Note: Overdosage of glutethimide is difficult to treat. Patients tend to go in and out of toxicity, possibly because of delayed
absorption of the drug.
Patient & Family Education
- Report onset of rash or any other unusual symptoms to physician. Discontinuation of drug is indicated if a rash occurs.
- Do not drive or engage in other potentially hazardous activities requiring mental alertness for 78 h after drug ingestion.
- Note: Possible adverse reactions are increased when glutethimide is combined with alcohol or other CNS depressants.
- Understand that prolonged use of moderate to high doses of glutethimide can produce tolerance and psychologic and physical
dependence.
- Do not breast feed while taking this drug.