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LIBRIUM®
(chlordiazepoxide HCI) Capsules
Librium, the original chlordiazepoxide HCI and prototype for the benzodiazepine compounds, was synthesized and developed at Hoffmann-La Roche Inc. It is a versatile therapeutic agent of proven value for the relief of anxiety. Librium (chlordiazepoxide) is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence.
Librium (chlordiazepoxide) is available as capsules containing 5 mg, 10 mg or 25 mg chlordiazepoxide HCI. Each capsule also contains corn starch, lactose and talc. Gelatin capsule shells may contain methyl.and propyl parabens and potassium sorbater with the following dye systems: 5-mg capsules - FD&C Yellow No. 6 plus D&C Yellow No. 10 and either FD&C Blue No. 1 or FD&C Green No. 3. 10-mg capsules - D&C Yellow No. 10 and either FD&C Blue No. 1 plus FD&C Red No. 3 or FD&C Green No. 3 plus FD&C Red No. 40. 25-mg capsules- D&C Yellow No. 10 and either FD&C Green No. 3 or FD&C Blue No. 1.
Chlordiazepoxide hydrochloride is 7-chloro-2- (methylamino) -5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of chlordiazepoxide hydrochloride is as follows:
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Librium (chlordiazepoxide) is indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal" symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The effectiveness of Librium (chlordiazepoxide) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
Because of the wide range of clinical indications for Librium (chlordiazepoxide) , the optimum dosage varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects.
| ADULTS | USUAL DAILY DOSE |
| Relief of Mild and Moderate Anxiety Disorders and Symptoms of Anxiety | 5 mg or 10 mg, 3 or 4 times daily |
| Relief of Severe Anxiety Disorders and Symptoms of Anxiety | 20 mg or 25 mg, 3 or 4 times daily |
| Geriatric Patients, or in the presence of debilitating disease. | 5 mg, 2 to 4 times daily |
Preoperative Apprehension and Anxiety: On days preceding surgery, 5 to 10 mg orally, 3 or 4 times daily. If used as preoperative medication, 50 to 100 mg IM* 1 hour prior to surgery.
| PEDIATRIC PATIENTS | USUAL DAILY DOSE |
| Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required. Since clinical experience in pediatric patients under 6 years of age is limited, the use of the drug in this age group is not recommended. | 5 mg, 2 to 4 times daily (may be increased in some pediatric patients to 10 mg, 2 to 3 times daily) |
For the relief of withdrawal symptoms of acute alcoholism, the parenteral form* is usually used initially. If the drug is administered orally, the suggested initial dose is 50 to 100 mg, to be followed by repeated doses as needed until agitation is controlled up to 300 mg per day. Dosage should then be reduced to maintenance levels.
* See package insert for Injectable Librium (chlordiazepoxide HCI).
Librium (chlordiazepoxide HCI) Capsules are available in the following presentations:
