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C-IV controlled substance
Pregnancy Category D
- Antiepileptic drug
Exact mechanisms of action not understood; benzodiazepines potentiate
the effects of GABA, an inhibitory neurotransmitter.
Used alone or as adjunct in treatment of Lennox-Gastaut syndrome (petit
mal variant), akinetic and myoclonic seizures; may be useful in patients
with absence (petit mal) seizures who have not responded to succinimides;
up to 30% of patients show loss of effectiveness of drug, often within
3 mo of therapy (may respond to dosage adjustment).
Unlabeled uses: treatment of panic attacks, periodic leg movements
during sleep, hypokinetic dysarthria, acute manic episodes, multifocal
tic disorders, adjunct treatment of schizophrenia, neuralgias
Contraindicated in the presence of hypersensitivity to benzodiazepines,
psychoses, acute narrow-angle glaucoma, shock, coma, acute alcoholic intoxication
with depression of vital signs; pregnancy (increased risk of congenital
malformations, neonatal withdrawal syndrome), labor and delivery ("floppy
infant" syndrome reported), lactation (infants become lethargic and lose
Use caution in the presence of impaired liver or kidney function, debilitation.
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- CNS: Transient, mild drowsiness initially; sedation, depression,
lethargy, apathy, fatigue, lightheadedness, disorientation, anger, hostility,
episodes of mania and hypomania, restlessness, confusion, crying, delirium,
headache, slurred speech, dysarthria, stupor, rigidity, tremor, dystonia,
vertigo, euphoria, nervousness, difficulty in concentration, vivid dreams,
psychomotor retardation, extrapyramidal symptoms; mild paradoxical excitatory
reactions, during first two weeks of treatment
- GI: Constipation, diarrhea, dry mouth, salivation, nausea, anorexia,
vomiting, difficulty in swallowing, gastric disorders, hepatic dysfunction,
- CV: Bradycardia, tachycardia, cardiovascular collapse, hypertension
and hypotension, palpitations, edema
- Hematologic: Elevations of blood enzymes: LDH, alkaline phosphatase,
SGOT, SGPT; blood dyscrasias: agranulocytosis, leukopenia
- GU: Incontinence, urinary retention, changes in libido, menstrual
- EENT: Visual and auditory disturbances, diplopia, nystagmus, depressed
hearing, nasal congestion
- Dermatologic: Urticaria, pruritus, skin rash, dermatitis
- Other: Hiccups, fever, diaphoresis, paresthesias, muscular disturbances,
gynecomastia. Drug dependence with withdrawal syndrome when drug is
discontinued more common with abrupt discontinuation of higher dosage
used for longer than 4 mo.