chlordiazepoxide/amitriptyline (Rx)Brand and Other Names:Limbitrol, Limbitrol DS

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

chlordiazepoxide/amitriptyline

tablet: Schedule IV

  • 5mg/12.5mg
  • 10mg/25mg
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Depression with Anxiety

1 tablet (5-10 mg chlordiazepoxide/12.5-25 mg amitriptyline) PO three/four times daily; may increase to 6 tablets if necessary; 2 tablets reported to be effective in some patients

Safety and efficacy not established

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 daily

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Interactions

Interaction Checker

chlordiazepoxide/amitriptyline and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            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)

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            Warnings

            Black Box Warnings

            Children and Antidepressants

            • In short-term studies, 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
            • This increase was not seen in patients aged >24 yr; slight decrease in suicidal thinking was seen in adults >65 yr; risks must be weighed in children and young adults against the benefits of taking antidepressants
            • 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
            • Patient’s family should communicate to the healthcare provider any abrupt changes in behavior
            • Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy
            • Not approved for pediatric patients

            Antipsychotics & Dementia

            • Patients with dementia-related psychosis that are treated with antipsychotic drugs are at an increased risk of death as shown in short-term controlled trials; deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature
            • Not approved for treatment of dementia-related psychosis

            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

            Cautions

            Caution in BPH, urinary/GI retention, increased IOP, thyroid dysfunction, open-angle glaucoma, seizure disorders, brain tumor, respiratory impairment, respiratory disease,

            Clinical worsening & suicide ideation may occur despite medication in adolescents & young adults (aged 18-24 yr)

            Write prescription for smallest effective dose

            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

            SIADH and hyponatremia reported with therapy

            Some patients may experience a large increase in amitriptyline concentration in presence of topiramate; any adjustments in amitriptyline dose should be made according to patient's clinical response and not on basis of plasma level

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: Excretion in milk unknown; not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism 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

            Absorption

            Bioavailability: Slow and erratic following IM admin (chlordiazepoxide)

            Peak serum time: 4 hr (amitriptyline)

            Peak serum time: 0.5-2 hr

            Onset of action: 1-5 min (IV, chlordiazepoxide)

            Onset of action: 6 weeks

            Duration: 15-60 min (IV, chlordiazepoxide)

            Vd: 3.3 L/kg (chlordiazepoxide)

            Metabolism

            Chlordiazepoxide: demoxepam, desmethylchlordiazepoxide, desmethyldiazepam, oxazepam

            Amiptriptyline: hepatic metabolism via CYP2C19, CYP3A4; nortriptyline is an active metabolite

            Elimination

            Half-Life

            • Chlordiazepoxide: 6.6-28 hr
            • Amitriptyline: 9-27 hr

            Excretion

            • Chlordiazepoxide: Predominately urine
            • Amitriptyline: Urine (25-50%), small amounts in bile
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
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