Therapeutic Class: Combined anxiolytics &
anti-depressant drugs
Indication: Depression with Anxiety, agitation
or tension.
Dosage &
Administrations: 1 tablet (5 mg chlordiazepoxide/12.5 mg amitriptyline)
PO three/four times daily; may increase to 6 tablets if necessary.
2 tablets reported to be effective in some patients. Elderly:
Avoid; strong anticholinergic and sedative effects; may cause orthostatic
hypotension (Beers criteria) Consider alternatives; if must use, initiate with
lower initial dose; long-acting active metabolites 1 tablet (5 mg/12.5 mg) PO
three times.
Contraindications: Hypersensitivity.
Severe cardiovascular disorders, Angle clossure glaucoma,
Within 14 days of MAOIs, Any drugs or conditions that prolong QT interval,
Acute recovery post-MI.
Side Effect: Drowsiness, Dry mouth, Constipation,
Blurred vision, Dizziness, Bloating, Vivid dreams, Impotence, Tremor,
Confusion, Nasal congestion, Edema, Syncope, Ataxia, EEG abnormalities,
Menstrual irregularities, Blood dyscrasias (agranulocytosis), Hepatic
dysfunction (jaundice).
Precautions &
Warnings:
Children and Antidepressants
Antidepressants increased the risk of suicidal thinking and
behavior in children, adolescents, and young adults (age <24 yr) taking
antidepressants for major depressive disorders and other psychiatric
illnesses.Caution in BPH, urinary/GI retention, increased IOP, thyroid
dysfunction, open-angle glaucoma, seizure disorders, brain tumor, respiratory
impairment, respiratory disease. Risk of anticholinergic side-effects. May
cause orthostatic hypotension. Paradoxical reactions including hyperactive or
aggressive behavior reported. Both agents may cause sedation and impair ability
to perform tasks requiring mental alertness. Patients should be monitored
closely for changes in behavior, clinical worsening, and suicidal tendencies;
monitor during the initial 1-2 months of therapy and dosage adjustments. Not
approved for treatment of dementia-related psychosis. Lactation: Excretion in
milk unknown; not recommended.
Pregnancy Category:
Pregnancy Category-D
There is positive evidence of human fetal risk based on
adverse reaction data from investigational or marketing experience or studies
in humans, but potential benefits may warrant use of the drug in pregnant women
despite potential risks.
Mode of Action:
Chlordiazepoxide: Antianxiety agent; depresses all levels of CNS,
including limbic and reticular formation, possibly by increasing
gamma-aminobutyric acid (GABA) activity, a major inhibitory neurotransmitter. Amitriptyline:
Antidepressant; neurotransmitter (especially norepinephrine and serotonin)
reuptake inhibitor; elicits anticholinergic effects.
Interaction:
There are no known drug interactions and none well documented.
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