Usual Adult Dose for Anxiety

Mild to moderate anxiety: 5 or 10 mg orally 3 to 4 times a day
Severe anxiety: 20 or 25 mg orally 3 or 4 times a day

Comments:

• Doses should be individualized to provide maximum beneficial effects.
• Efficacy of long-term management in patients with anxiety (e.g., greater than 4 months) has not been established.

• Relief of mild, moderate, and severe anxiety disorders
• Management of anxiety disorders
• Short-term relief of symptoms of anxiety

Usual Adult Dose for Light Sedation

On days preceding surgery: 5 to 10 mg orally 3 to 4 times per day
If used as preoperative medication: 50 to 100 mg IM once 1 hour before surgery

Use: Preoperative apprehension and anxiety

Usual Adult Dose for Alcohol Withdrawal

50 to 100 mg orally, followed by repeated doses as needed until agitation is controlled

• Maximum dose: 300 mg orally per day

• Parenteral formulations are usually used for the relief of withdrawal symptoms of acute alcoholism.
• After agitation is controlled, the dosage should be reduced to maintenance levels.

Usual Geriatric Dose for Anxiety

5 mg orally 2 to 4 times a day

Comments:

• Initial doses should be kept to 10 mg/day or less to decrease the risk of ataxia or oversedation.
• Doses should be individualized to provide maximum beneficial effects.
• Efficacy of long-term management in patients with anxiety (e.g., greater than 4 months) has not been established.

• Relief of mild, moderate, and severe anxiety disorders
• Management of anxiety disorders
• Short-term relief of symptoms of anxiety

Usual Pediatric Dose for Anxiety

6 years and older: 5 mg orally 2 to 4 times a day

• This may be increased to 10 mg orally 2 to 3 times a day

• Doses should be individualized to provide maximum beneficial effects.
• Efficacy of long-term management in patients with anxiety (e.g., greater than 4 months) has not been established.

• Relief of mild, moderate, and severe anxiety disorders
• Management of anxiety disorders
• Short-term relief of symptoms of anxiety

Renal Dose Adjustments

Renal dysfunction: Use with caution

Liver Dose Adjustments

Liver dysfunction: Use with caution

Dose Adjustments

In the presence of debilitating disease: 5 mg orally 2 to 4 times a day

Comment: Initial doses should be kept to 10 mg/day or less to decrease the risk of ataxia or oversedation.

Uses:

• Relief of mild, moderate, and severe anxiety disorders
• Management of anxiety disorders
• Short-term relief of symptoms of anxiety

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.

Dialysis

Data not available

Other Comments

Administration advice:

• Capsules should be taken with water and not be chewed.

• Protect from light.

• Doses should be determined by patient response and clinical diagnosis.
• Anxiety/tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
• Patients should be periodically reassessed to determine the need for continued treatment, especially when they are symptom-free.
• Concomitant use with other psychotropic agents is generally not recommended; if necessary, the pharmacology of the agents should be considered prior to administration.

• General: Patients with a history of alcohol or drug abuse, or patients with a marked personality disorder should be monitored frequently.
• Hematologic: Periodic blood counts
• Hepatic: Periodic liver function tests
• Psychiatric: Signs/symptoms of dependence

• Patients should be cautioned against performing activities requiring complete mental alertness, such as operating machinery or driving a motor vehicle.
• Patients should be advised to avoid abrupt discontinuation of treatment; patients should be educated regarding the risks of tolerance, dependence, and rebound phenomena.
• 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 they talk to their 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.