Management of anxiety disorders and short-term relief of symptoms of anxiety.
Management of moderate to severe anxiety (in fixed-combination with amitriptyline hydrochloride) in patients with moderate to severe depression.
Preoperative Anxiolysis
Preoperatively to relieve anxiety.
Peptic Ulcer Disease, Irritable Bowel Syndrome, and Acute Enterocolitis
Has been used in fixed combination with clidinium bromide as an adjunct in the treatment of peptic ulcer disease, functional disturbances of GI motility (e.g., irritable bowel syndrome), and acute enterocolitis. Fixed combination is classified by FDA as possibly effective for these indications.
Has limited usefulness in the treatment of peptic ulcer disease because of the advent of more effective therapies for this condition.
Therapeutic benefits achieved with the combination preparation in the management of functional disturbances of GI motility may be attributed to the anxiolytic and/or sedative properties of chlordiazepoxide.
Although the fixed combination has been used in the treatment of acute enterocolitis, antimuscarinic-containing preparations should be used with extreme caution in patients with diarrhea or ulcerative colitis.
Dosage and Administration
General
Use the smallest effective dosage (especially in geriatric and debilitated patients and in those with liver disease or low serum albumin) to avoid oversedation.
Consider the long half-life of chlordiazepoxide and its metabolites when making dosage adjustments. (See Half-life under Pharmacokinetics.)
In patients who have received prolonged (e.g., several months) therapy, avoid abrupt discontinuance, since manifestations of withdrawal can be precipitated; gradually taper dosage.
Fixed-ratio combination preparations generally should not be used as initial therapy. Administer each drug separately. If the optimum maintenance dosage corresponds to the ratio in a commercial combination preparation, a fixed-combination preparation may be used. If dosage adjustment is necessary, administer the drugs separately. Although chlordiazepoxide hydrochloride is commercially available as single-entity preparations, clidinium bromide is commercially available in the US only in fixed combination with chlordiazepoxide hydrochloride. Fixed-ratio combination preparations do not permit individual titration of dosages.
Anxiety
Periodically reassess the usefulness of the drug. Efficacy of chlordiazepoxide beyond 4 months not systematically evaluated. Administer for the shortest possible period of time; frequent dosage adjustments may be required.
Administration
Administer orally.
Has been administered parenterally†; however, a parenteral dosage form is no longer commercially available in the US.
Oral Administration
Initially, administer orally in 3 or 4 doses daily. After dosage has been stabilized, may reduce frequency to 1 or 2 doses daily.
Dosage
Available as chlordiazepoxide hydrochloride (alone and in fixed combination with clidinium bromide); dosage expressed in terms of the salt.
Also available as chlordiazepoxide (in fixed combination with amitriptyline hydrochloride); dosage expressed in terms of the base.
On the basis of molecular weight, 89 mg of chlordiazepoxide is equivalent to 100 mg of chlordiazepoxide hydrochloride; however, the manufacturer of chlordiazepoxide base (no longer commercially available in the US as a single-entity preparation) states that chlordiazepoxide and its hydrochloride salt may be used interchangeably on a mg-for-mg basis.
Pediatric Patients
Anxiety Disorders
Oral
Children ≥6 years of age: Usual dosage is 5 mg 2–4 times daily. Initial dosage should not exceed 10 mg daily. If necessary, increase dosage to 10 mg 2 or 3 times daily.
Alternatively, some clinicians have recommended a pediatric dosage of 0.5 mg/kg daily or 15 mg/m2 daily in 3 or 4 divided doses.
Adults
Alcohol Withdrawal
Oral
Initially, 50- to 100-mg dose; repeat dose until agitation is controlled.
Manufacturer states that dosage for acute alcohol withdrawal should not exceed 300 mg daily; however, some clinicians have used dosages of 600–800 mg daily to control symptoms without adverse effects.
Slowly withdraw the drug after agitation is controlled.
Anxiety and Depressive Disorders
Monotherapy
Oral
Mild to moderate anxiety: 5–10 mg 3 or 4 times daily.
Initially, chlordiazepoxide 30 or 40 mg daily (in fixed combination with amitriptyline hydrochloride 75 or 100 mg daily, respectively) in divided doses. If needed, increase dosage to chlordiazepoxide 60 mg daily (in fixed combination with amitriptyline hydrochloride 150 mg daily) in divided doses.
Alternatively, in patients who do not tolerate larger dosages, initial dosage of chlordiazepoxide 15 or 20 mg daily (in fixed combination with amitriptyline hydrochloride 37.5 or 50 mg daily, respectively) in divided doses.
For some patients, chlordiazepoxide 20 mg daily (in fixed combination with amitriptyline hydrochloride 50 mg daily) in divided doses may be adequate.
Preoperative Anxiolysis
Oral
5–10 mg 3 or 4 times daily for several days preceding surgery.
Peptic Ulcer Disease, Irritable Bowel Syndrome, and Acute Enterocolitis
Oral
Usual maintenance dosage is 5 or 10 mg (in fixed combination with clidinium bromide 2.5 or 5 mg, respectively) 3 or 4 times daily (before meals and at bedtime).
Prescribing Limits
Pediatric Patients
Anxiety Disorders
Oral
Children ≥6 years of age: Maximum initial dosage of 10 mg daily.
Adults
Alcohol Withdrawal
Oral
Maximum 300 mg daily recommended by manufacturer. Some clinicians have used higher dosages (600–800 mg daily) to control symptoms without adverse effects.
Special Populations
Hepatic Impairment
Reduce dosage; use the smallest effective dosage.
Renal Impairment
No specific dosage recommendations.
Geriatric or Debilitated Patients
Reduce initial dosage. Use the smallest effective dosage to avoid oversedation.
Anxiety and Depressive Disorders
5 mg 2–4 times daily; initial dosage should not exceed 10 mg daily.
When used in fixed combination with amitriptyline hydrochloride, select initial dosages at the lower end of the usual ranges and gradually increase dosages if needed and tolerated.
Peptic Ulcer Disease, Irritable Bowel Syndrome, and Acute Enterocolitis
Initially, 10 mg daily (given in fixed combination with clidinium bromide 5 mg daily); gradually increase dosages if needed and tolerated.
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