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INDICATIONS
Diazepam Tablets USP are 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, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Diazepam 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 diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
The effectiveness of diazepam 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.
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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.
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| Adults: | Usual Daily Dose |
| Management of Anxiety Disorders and relief of Symptoms of Anxiety. | Depending on 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 2 ½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated |
| Children: | |
| Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months. | 1 mg to 2 ½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated |
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HOW SUPPLIED
Diazepam Tablets USP 2 mg are scored, round, white tablets imprinted DAN 5621 and 2 supplied in bottles of 100, 500 and 1000.
Diazepam Tablets USP 5 mg are scored, round, yellow tablets imprinted DAN 5619 and 5 supplied in bottles of 100, 500 and 1000.
Diazepam Tablets USP 10 mg are scored, round, blue tablets imprinted DAN 5620 and 10 supplied in bottles of 100, 500 and 1000.
Dispense in tight, light-resistant container with child-resistant closure.
Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]
Watson Laboratories, Inc.
Corona, CA 92880 USA
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