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DESCRIPTION
Valium (diazepam) is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin- 2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75.
Valium is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, pregelatinized starch and calcium stearate with the following dyes: 5-mg tablets contain FD&C Yellow No. 6 and D&C Yellow No. 10; 10-mg tablets contain FD&C Blue No. 1. Valium 2-mg tablets contain no dye.

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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.

HOW SUPPLIED
For oral administration, Valium is supplied as round, flat-faced scored tablets with V-shaped perforation and beveled edges: 10 mg, blue – bottles of 100 (NDC 0140-0006-01) and 500 (NDC 0140-0006-14).

Engraved on tablets:
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.

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