chlordiazepoxide 25 mg capsule

Uses

Anxiety Disorders, Preoperative Anxiolysis, and Alcohol Withdrawal

Chlordiazepoxide shares the actions of other benzodiazepines and is used for the management of anxiety disorders or for short-term relief of symptoms of anxiety, preoperatively to relieve anxiety and tension, and for the management of agitation associated with acute alcohol withdrawal. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of chlordiazepoxide for long-term use (i.e., for longer than 4 months) has not been established, and the need for continued therapy with the drug should be periodically reassessed.

Chlordiazepoxide hydrochloride, as the fixed-combination with amitriptyline, also has been used in the management of depression associated with severe anxiety.

Peptic Ulcer Disease, Irritable Bowel Syndrome, Acute Enterocolitis

Chlordiazepoxide hydrochloride, as the fixed-combination with clidinium bromide, has been used as an adjunct in the treatment of peptic ulcer disease and in the treatment of functional disturbances of GI motility such as irritable bowel syndrome and acute enterocolitis.

Dosage and Administration

Administration

Chlordiazepoxide and its hydrochloride salt are usually administered orally in 3 or 4 doses daily. After dosage has been stabilized, most clinicians believe that the drug may be administered in 1 or 2 doses daily. Although chlordiazepoxide hydrochloride also has been administered parenterally†, a parenteral dosage form of the drug is no longer commercially available in the US.

Dosage

On the basis of molecular weight, 89 mg of chlordiazepoxide is equivalent to 100 mg of chlordiazepoxide hydrochloride; however, the manufacturer of chlordiazepoxide base claims that chlordiazepoxide and its hydrochloride salt may be used interchangeably on a milligram-for-milligram basis.

Dosage must be individualized, and the smallest effective dosage should be used (especially in geriatric or debilitated patients and in those with liver disease or low serum albumin) to avoid oversedation.

Since chlordiazepoxide and its metabolites have long elimination half-lives, time to reach steady-state plasma concentrations should be considered when dosage adjustments are made.

Commercially available preparations containing chlordiazepoxide or its hydrochloride salt in fixed combination with an anticholinergic (clidinium) or an antidepressant (amitriptyline) generally should not be used as initial therapy in patients who require both drugs. Dosage should first be adjusted by administering each drug separately. If it is determined that the optimum maintenance dosage corresponds to the ratio in a commercial combination preparation, such a product may be used. When dosage adjustment is necessary, the drugs should be administered separately.

In patients who have received prolonged (e.g., for several months) chlordiazepoxide hydrochloride therapy, abrupt discontinuance of the drug should be avoided since manifestations of withdrawal can be precipitated; if the drug is to be discontinued in such patients, it is recommended that dosage be gradually tapered.

Adult Dosage

Anxiety Disorders

For the management of mild to moderate anxiety, the usual adult oral dosage of chlordiazepoxide hydrochloride is 5-10 mg 3 or 4 times daily. For severe anxiety, 20-25 mg may be given orally 3 or 4 times daily.

Preoperative Anxiolysis

To relieve anxiety and tension preoperatively in adults, the manufacturer recommends that 5-10 mg of chlordiazepoxide hydrochloride be given orally 3 or 4 times daily for several days preceding surgery.

Acute Alcohol Withdrawal

For the management of agitation associated with acute alcohol withdrawal, the initial oral dose is 50-100 mg; doses are repeated until agitation is controlled.

The manufacturers state that in acute alcohol withdrawal, oral dosage should not exceed 300 mg daily; however, some clinicians have used chlordiazepoxide hydrochloride dosages of 600-800 mg daily to control symptoms without adverse effects. After agitation is controlled, the drug should be withdrawn slowly.

Peptic Ulcer Disease, Irritable Bowel Syndrome, Acute Enterocolitis

When chlordiazepoxide hydrochloride is used in fixed combination with clidinium bromide, the usual adult maintenance dosage of chlordiazepoxide hydrochloride is 5 or 10 mg given orally 3 or 4 times daily, administered before meals and at bedtime.

Pediatric Dosage

Because of the unpredictable response of children to CNS drugs, chlordiazepoxide therapy should be initiated with the lowest dosage and increased as required.

Anxiety Disorders, Preoperative Anxiolysis, and Alcohol Withdrawal

The usual oral dosage of chlordiazepoxide hydrochloride in children older than 6 years of age is 5 mg 2-4 times daily; the initial dosage should not exceed 10 mg daily. If necessary, dosage for children may be increased to 10 mg 2 or 3 times daily. Alternatively, some clinicians have recommended a pediatric oral dosage of 0.5 mg/kg daily or 15 mg/m daily, given in 3 or 4 divided doses.

Dosage in Geriatric or Debilitated Patients

Geriatric or debilitated patients may receive 5 mg of chlordiazepoxide hydrochloride orally 2-4 times daily; the initial dose should not exceed 10 mg daily. When chlordiazepoxide hydrochloride is used in fixed combination with clidinium bromide, the recommended initial geriatric dosage of chlordiazepoxide hydrochloride is 10 mg daily, which may be increased gradually as needed and tolerated. (See Cautions: Geriatric Precautions.)

Cautions

Precautions

Chlordiazepoxide shares the toxic potentials of the benzodiazepines, and the usual precautions of benzodiazepine administration should be observed. The precautions and contraindications associated with antimuscarinics or tricyclic antidepressants also should be considered when commercially available preparations containing chlordiazepoxide or its hydrochloride salt in fixed combination with clidinium or amitriptyline are used.

Pediatric Precautions

Safety and efficacy of orally administered chlordiazepoxide or chlordiazepoxide hydrochloride in children younger than 6 years of age have not been established.

Safety and efficacy of the fixed-combination preparation containing chlordiazepoxide hydrochloride and clidinium bromide in pediatric patients have not been established.

Geriatric Precautions

Although safety and efficacy of chlordiazepoxide in geriatric patients have not been studied specifically to date, one manufacturer states that geriatric adults may be especially prone to adverse effects such as drowsiness, ataxia, and confusion when receiving chlordiazepoxide hydrochloride in fixed combination with clidinium bromide. These adverse effects usually can be prevented by proper dosage adjustment. Therefore, it is recommended that the initial dosage of this combination in geriatric patients be selected carefully and gradually increased if needed and tolerated. However, these adverse effects occasionally have been observed in geriatric patients receiving the lower range of the usual dosage of this combination.