Usual Adult Dose for Seizure Prophylaxis

1.5 mg orally per day divided into 3 doses; this may be increased in increments of 0.5 mg to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase.

• Maximum dose: 20 mg/day

Comments:

• The use of multiple anticonvulsants may result in an increase of depressant adverse effects.
• Maintenance doses should be determined by patient response.
• Some loss of effect may occur during the course of treatment; dose adjustments may reestablish efficacy in some patients.

Use: Alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures

Usual Adult Dose for Panic Disorder

Initial dose: 0.25 mg orally 2 times per day
Maintenance dose: 1 mg orally per day
Maximum dose: 4 mg/day

Comments:

• An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
• The dose may be increased in increments of 0.125 mg to 0.25 mg 2 times per day every 3 days until panic disorder is controlled or until side effects make further increases undesired.
• Administration of one dose at bedtime may be desired, to reduce the inconvenience of somnolence.
• Treatment should be discontinued gradually, with a decrease of 0.125 mg 2 times per day every 3 days, until the drug is completely withdrawn.
• Efficacy was established in clinical trials with patients diagnosed with panic disorder given over 6- or 9-weeks; efficacy in long-term use (e.g., greater than 9 weeks) has not been established. Patients who require long-term use should be periodically reevaluated for usefulness.

Use: Treatment of panic disorder, with or without agoraphobia

Usual Pediatric Dose for Seizure Prophylaxis

Up to 10 years of age OR 30 kg body weight: 0.01 mg/kg/day to 0.05 mg/kg/day orally administered in 2 or 3 divided doses

• Maintenance dose: 0.1 to 0.2 mg/kg/day

10 years or older OR 30 kg and over: 1.5 mg orally per day divided into 3 doses; this may be increased in increments of 0.5 mg to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase.

• Maximum dose: 20 mg/day

Comments:

• Dosage should be increased by no more than 0.25 mg to 0.5 mg every third day until the daily maintenance dose has been reached, unless seizures are controlled or side effects preclude further increase.
• Whenever possible, the daily dose should be divided into three equal doses.
• If doses are not equally divided, the largest dose should be given before retiring.
• Maintenance doses should be determined by patient response.
• Some loss of effect may occur during the course of treatment; dose adjustments may reestablish efficacy in some patients.

Use: Alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures

Renal Dose Adjustments

Use with caution

Liver Dose Adjustments

Use with caution; frequent monitoring recommended.

Dose Adjustments

Abrupt Withdrawal: Simultaneous substitution of another anticonvulsant should be considered when gradually withdrawing this drug.

Elderly patients: Patients should be started on lower doses and observed closely.

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/symptoms of respiratory depression and sedation.

Safety and efficacy have not been established in patients with panic disorder younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Data not available

Other Comments

Administration advice:

• IV: The manufacturer product information should be consulted.
• Tablets: The tablets should be administered with water by swallowing the tablet whole.
• Orally disintegrating tablets:
• Immediately upon opening the blister, using dry hands, remove the tablet and place it in the mouth.
• Tablet disintegration occurs rapidly in saliva so it can be easily swallowed with or without water.
• Oral solution:
• Do not administer drops directly into the mouth from the bottle.
• After each administration, ensure that the dropper is secure in the neck of the bottle.
• Drops should be given with a spoon.
• This drug is compatible with water, tea or fruit juice.

Storage requirements:

• IV: Protect from light

General:

• Treatment may be useful in the treatment of patients with absence seizures (petit mal) who have failed to respond to succinimides.
• IM efficacy has not been established.
• Approximately 95% of the dose is delivered when given via non-PVC nasogastric or percutaneous endoscopic gastrostomy (PEG) tubes.

Monitoring:

• Cardiovascular: Continuous blood pressure with IV administration
• Hematologic: Periodic blood counts during long-term treatment (e.g., longer than 4 weeks)
• Hepatic: Periodic liver function tests during long-term treatment (e.g., longer than 4 weeks)
• Nervous system: Continuous electroencephalogram (EEG) with IV administration
• Respiratory: Continuous respiratory rate with IV administration

Patient advice:

• This medicine may increase the risk of suicidal thoughts and behavior. Patients should be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Patients should report any behavior of concern to their healthcare provider as soon as possible.
• This drug may cause drowsiness and dizziness and reduce alertness. Patients should not drive a car or operate dangerous machinery until they know how this drug affects them.
• Patients should avoid drinking alcohol or taking other drugs that may cause sleepiness or dizziness while taking this drug until they talk to their healthcare provider.
• Patients should be told to contact their healthcare provider before increasing/decreasing the dose or discontinuing treatment.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

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