Diazepam

VALIUM is indicated for the: Treatment of anxiety disorders Short-term treatment of anxiety symptoms Treatment of tremor, acute agitation, hallucinosis, and impending delirium tremens or delirium tremens in acute alcohol withdrawal Adjunctive treatment of skeletal muscle spasm due to: reflex spasm to local pathology spasticity caused by upper motor neuron disorders athetosis stiff-person syndrome Adjunctive treatment of seizure disorders Limitations of Use The effectiveness of VALIUM for long-term use (greater than 4 months) has not been evaluated. VALIUM is not recommended as maintenance monotherapy for the treatment of seizure disorders.

The mechanism of action of diazepam for the listed indications is thought to involve potentiation of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter, resulting from binding at the benzodiazepine site of the GABA A receptor.

Recommended oral dosage in adults less than 65 years of age: Indication Recommended Oral Dosage Treatment of anxiety disorders 2 mg to 10 mg, two to four times daily Short-term treatment of anxiety symptoms 2 mg to 10 mg, two to four times daily Treatment of acute alcohol withdrawal See full prescribing information for complete indication 10 mg, three to four times during the first 24 hours, after 24 hours reduce to 5 mg, three to four times daily, as needed Recommended dosage is intended for most patients. Based on severity of symptoms some patients may require higher dosages. In such cases, increase dosage gradually.

VALIUM is contraindicated in patients with: Known hypersensitivity to diazepam or any of the excipients of VALIUM Acute narrow-angle glaucoma Known hypersensitivity to diazepam or any excipients of VALIUM. Acute narrow-angle glaucoma

Boxed warning: Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. Central Nervous System (CNS) Depression: Caution patients against engaging in hazardous occupations or activities requiring complete mental alertness (e.g., operating machinery or driving a motor vehicle). Avoid alcohol and use other medications that produce CNS depression with caution. Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior. Worsening of Preexisting Depression: Monitor for worsening of preexisting depression.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Risks from Concomitant Use with Opioids Abuse, Misuse, and Addiction Dependence and Withdrawal Reactions Central Nervous System Depression Suicidal Behavior and Ideation Worsening of Preexisting Depression Paradoxical Reactions Respiratory Depression and Apnea Glaucoma Neonatal Sedation and Withdrawal Syndrome The following adverse reactions associated with the use of VALIUM were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions most commonly reported were drowsiness, fatigue, muscle weakness, and ataxia.

CYP3A4 and CYP2C19 Inhibitors: Based on tolerability, consider reducing dosage of VALIUM. Avoid food or drink containing grapefruit. CYP3A4 and CYP2C19 Inducers: Based on clinical response, consider increasing dosage of VALIUM

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).