Usual Adult Dose for Anxiety

Initial dose: 15 mg orally at bedtime or in divided doses
Maintenance dose: 15 to 60 mg orally in divided doses

Comments:

• Drowsiness may develop at the start of treatment and with dosage increases.
• The usual daily dose is 30 mg/day.
• Efficacy of long-term management in patients with anxiety (e.g., greater than 4 months) has not been established.

Uses:

• Management of anxiety disorders
• Short-term relief of the symptoms of anxiety

Usual Adult Dose for Alcohol Withdrawal

Day 1: 30 mg orally, followed by 30 to 60 mg in divided doses
Day 2: 45 to 90 mg orally in divided doses
Day 3: 22.5 to 45 mg orally in divided doses
Day 4: 15 to 30 mg orally in divided doses
After Day 4: The daily dose should be reduced to 7.5 to 15 mg
Maximum dose: 90 mg/day

Comments:

• Use should be discontinued as soon as patient's condition is stable.
• Excessive reductions in the total amount of drug administered on successive days should be avoided.

Use: Symptomatic relief of acute alcohol withdrawal

Usual Adult Dose for Seizure Prophylaxis

Initial dose: 7.5 mg orally 3 times a day
Maintenance dose: May increase by no more than 7.5 mg orally every week
Maximum dose: 90 mg/day

Comments:

• To minimize drowsiness, the recommended initial dosages and dosage increments should not be exceeded.
• Continued therapeutic activity was established in patients with epilepsy during long-term studies.

Use: Adjunctive therapy in the management of partial seizures

Usual Pediatric Dose for Seizure Prophylaxis

9 to 12 years:

• Initial dose: 7.5 mg orally 2 times a day
• Maintenance dose: May increase by no more than 7.5 mg orally every week
• Maximum dose: 60 mg/day

12 years or older:

• Initial dose: 7.5 mg orally 3 times a day
• Maintenance dose: May increase by no more than 7.5 mg orally every week
• Maximum dose: 90 mg/day

Comments:

• To minimize drowsiness, the recommended initial dosages and dosage increments should not be exceeded.
• Continued therapeutic activity was established in patients with epilepsy during long-term studies.

Use: Adjunctive therapy in the management of partial seizures

Renal Dose Adjustments

Renal dysfunction: Frequent monitoring recommended.

Liver Dose Adjustments

Liver dysfunction: Frequent monitoring recommended.

Dose Adjustments

Elderly and/or debilitated patients:

• Initial doses should be decreased, and titration should be determined by the patient's response to treatment.
• Anxiety: Treatment should be initiated at a daily dose of 7.5 to 15 mg.

Precautions

US BOXED WARNINGS:
RISKS FROM CONCOMITANT USE WITH OPIOIDS:

• Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
• Reserve concomitant prescribing of these drugs for use in 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.

Safety and efficacy have not been established in patients younger than 9 years; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Data not available

Other Comments

Storage requirements:

• Protect from light and moisture.

General:

• Anxiety/tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
• Patients should be periodically reassessed for the continued need of treatment.

Monitoring:

• Hematologic: Periodic blood counts
• Hepatic: Periodic liver function tests

Psychiatric:

• Patients with a history of alcohol or drug abuse should be monitored frequently.
• Patients should be monitored for worsening and emergence of suicidal thoughts.

Patient advice:

• Patients should be cautioned accordingly since this drug may impair the mental and/or physical abilities required for the performance of operating an automobile or machinery.
• Patients and caregivers of those who are taking concomitant opioid therapy should be told to immediately report profound central nervous system or respiratory depression.
• Patients should be told to avoid drinking alcohol or taking other drugs that may cause sleepiness or dizziness while taking this drug until you talk to your healthcare provider.
• If this drug is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuation if she intends to become pregnant or is pregnant.