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.

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.

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.

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:

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).

Vaieant Pharmaceuticals International Costa Mesa, CA 92626. Rev. July 2005. FDA rev date: 9/6/2002

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