Chlordiazepoxide/Amitriptyline HCl Dosage & Rx Info

Chlordiazepoxide/amitriptyline Hcl Generic Name & Formulations

Legal Class

CIV

General Description

Chlordiazepoxide, amitriptyline HCl; 5mg/12.5mg, 10mg/25mg; tabs.

Pharmacological Class

Benzodiazepine + tricyclic.

How Supplied

Contact supplier

Manufacturer

Various generic manufacturers

Mechanism of Action

Both components of chlordiazepoxide and amitriptyline HCl tablets exert their action in the central nervous system. Extensive studies with chlordiazepoxide in many animal species suggest action in the limbic system. Recent evidence indicates that the limbic system is involved in emotional response. Taming action was observed in some species. The mechanism of action of amitriptyline in man is not known, but the drug appears to interfere with the reuptake of norepinephrine into adrenergic nerve endings. This action may prolong the sympathetic activity of biogenic amines.

Chlordiazepoxide/amitriptyline Hcl Indications

Indications

Moderate to severe depression associated with moderate to severe anxiety.

Chlordiazepoxide/amitriptyline Hcl Dosage and Administration

Adult

Individualize. Initially 3–4 tabs daily in divided doses (with largest portion taken at bedtime). 10mg/25mg tabs: may be increased to 6 tabs daily. Elderly: reduce dose.

Children

Not established.

Chlordiazepoxide/amitriptyline Hcl Contraindications

Contraindications

During or within 14 days of MAOIs. Acute post MI.

Chlordiazepoxide/amitriptyline Hcl Boxed Warnings

Boxed Warning

Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions. Suicidal thoughts and behaviors.

Chlordiazepoxide/amitriptyline Hcl Warnings/Precautions

Warnings/Precautions

Risks from concomitant use with opioids; see Interactions. Monitor closely for clinical worsening, suicidality, or unusual changes in behavior. Activation of mania/hypomania; screen patients for bipolar disorder. Discontinue several days before surgery. History of urinary retention, seizures, angle-closure glaucoma. Cardiovascular disorders. Hyperthyroidism. Renal or hepatic impairment. Monitor LFTs, CBCs during long-term therapy. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Withdraw gradually. Write Rx for smallest practical amount. Drug or alcohol abusers. Elderly. Debilitated. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: not recommended.

Chlordiazepoxide/amitriptyline Hcl Pharmacokinetics

Distribution

95% serum protein bound (amitriptyline).

Metabolism

Hepatic.

Elimination

Renal. Half-life: 24-48 hours (chlordiazepoxide); ~25 hours (amitriptyline).

Chlordiazepoxide/amitriptyline Hcl Interactions

Interactions

See Contraindications. Hyperpyretic crisis, severe convulsions, and death with MAOIs. Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Concomitant CYP2D6 inhibitors: may need to adjust dose. During or within 5 weeks of fluoxetine: not recommended. Potentiated by cimetidine, topiramate. Potentiates CNS depression with alcohol, other CNS depressants. Caution with concomitant SSRIs, ECT. May block antihypertensives (eg, guanethidine).

Chlordiazepoxide/amitriptyline Hcl Adverse Reactions

Adverse Reactions

Drowsiness, dry mouth, constipation, blurred vision, dizziness, bloating, vivid dreams, impotence, tremor, confusion, nasal congestion; rare: granulocytopenia, jaundice, hepatic dysfunction. MI, stroke, arrhythmias, sinus tachycardia, prolongation of conduction time possible with high doses, withdrawal reactions.

Chlordiazepoxide/amitriptyline Hcl Clinical Trials

See Literature

Chlordiazepoxide/amitriptyline Hcl Note

Notes

Formerly known under the brand names Limbitrol, Limbitrol DS.

Chlordiazepoxide/amitriptyline Hcl Patient Counseling