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Pregnancy Category D C-IV drug
- Antianxiety drug
Exact mechanisms of action not understood; main sites of action may
be the limbic system and reticular formation; increases the effects of
gamma-aminobutyrate, an inhibitory neurotransmitter; anxiety blocking
effects occur at doses well below those necessary to cause sedation, ataxia.
Management of anxiety disorders or for short-term relief of symptoms
of anxiety; anxiety associated with depression also is responsive.
Treatment of panic attacks with or without agoraphobia
Unlabeled uses: social phobia, premenstrual syndrome, depression
Contraindicated in the presence of hypersensitivity to benzodiazepines,
psychoses, acute narrow-angle glaucoma, shock, coma, acute alcoholic intoxication
with depression of vital signs, pregnancy (crosses the placenta; increased
risk of congenital malformations, neonatal withdrawal syndrome), labor
and delivery ("floppy infant" syndrome reported when mothers were given
benzodiazepines during labor), lactation (secreted in breast milk; has
caused infants to become lethargic and lose weight).
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 2 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,
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
- Dermatologic: Urticaria, pruritus, skin rash, dermatitis
- EENT: Visual and auditory disturbances, diplopia, nystagmus, depressed
hearing, nasal congestion
- 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.