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Chlordiazepoxide and Amitriptyline (Chlordiazepoxide / Amitriptyline Hydrochloride) - Description and Clinical Pharmacology

 
 



DESCRIPTION

Chlordiazepoxide and amitriptyline hydrochloride tablets combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. Each film coated tablet for oral administration contains 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt) or 10 mg chlordiazepoxide and 25 mg amitriptyline as the hydrochloride salt).

Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, hydroxypropyl cellulose, isopropyl alcohol, lactose anhydrous, macrogol/PEG-400, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. In addition, the 5mg/12.5 mg tablet includes FD&C Yellow #6 and FD&C Red #40

Chlordiazepoxide is a benzodiazepine with the formula 7-chloro-2-(methyl-amino)-5-phenyl-3H-1,4 benzodiazepine 4-oxide. It is a slightly yellow crystalline material and is insoluble in water. The chemical structure is:

Amitriptyline is a dibenzocycloheptadiene derivative. The formula is 10, 11-dihydro-N,N-dimethyl-5H dibenzo[a,d]cycloheptene-Δ5γ-propylamine hydrochloride. It is a white or practically white crystalline compound that is freely soluble in water. The chemical structure is:

CLINICAL PHARMACOLOGY

Both components of chlordiazepoxide and amitriptyline hydrochloride 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.

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