Valium (Diazepam) - Indications and Dosage

INDICATIONS:

Valium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.

Valium is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome.

Oral Valium may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.

The effectiveness of Valium 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:

Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.

ADULTS:	USUAL DAILY DOSE
Management of Anxiety Disorders and Relief of Symptoms of Anxiety.	Depending upon severity of symptoms—2 mg to 10 mg, 2 to 4 times daily
Symptomatic Relief in Acute Alcohol Withdrawal.	10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
Adjunctively for Relief of Skeletal Muscle Spasm.	2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders.	2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of debilitating disease.	2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
PEDIATRIC PATIENTS:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months.	1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated

HOW SUPPLIED:

For oral administration, Valium is supplied as round, flat-faced scored tablets with V-shaped perforation and beveled edges. Valium is available as follows: 2 mg, white — bottles of 100 (NDC 0140-0004-01) and 500 (NDC 0140-0004-14); 5 mg, yellow — bottles of 100 (NDC 0140-0005-01) and 500 (NDC 0140-0005-14); 10 mg, blue — bottles of 100 (NDC 0140-0006-01) and 500 (NDC 0140-0006-14).

Engraved on tablets:

2 mg—2 VALIUM^® (front)

ROCHE (twice on scored side)   

5 mg—5 VALIUM^® (front)

ROCHE (twice on scored side)   

10 mg—10 VALIUM^® (front)

ROCHE (twice on scored side)   

Storage

Store at room temperature 59° to 86°F (15° to 30°C). Dispense in tight, light-resistant containers as defined in USP/NF.

Distributed by:

Roche Pharmaceuticals Roche Laboratories Inc.

340 Kingsland Street, Nutley, New Jersey 07110-1199

for Roche Products Inc.

26467475-0300

Printed in USA

Copyright © 1987-2000 by Roche Products Inc. All rights reserved.