Librium (Chlordiazepoxide Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Librium 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 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.

DOSAGE AND ADMINISTRATION

Because of the wide range of clinical indications for Librium, 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 HCl).

HOW SUPPLIED

Librium (chlordiazepoxide HCl) Capsules are available in the following presentations:

5 mg hard gelatin capsules in bottles of 100 (NDC-0187-3750-10), with LIBRIUM 5 imprinted on the opaque green cap and ICN imprinted on the opaque yellow body.

10 mg hard gelatin capsules in bottles of 100 (NDC-0187-3751-10), with LIBRIUM 10 imprinted on the opaque black cap and ICN imprinted on the opaque green body.

25 mg hard gelatin capsules in bottles of 100 (NDC-0187-3758-10), with LIBRIUM 25 imprinted on the opaque green cap and ICN imprinted on the opaque white body.

Store at 25°C (77°F); excursions permitted to 15°C – 30°C (59°F – 86°F).

ICN Pharmaceuticals, Inc.

Costa Mesa, CA 92626

ICN Pharmaceuticals, Inc.

ICN Plaza
3300 Hyland Avenue
Costa Mesa, California 92626
714-545-0100

3375097EX03