LEPTIC

Clonazepam USP

CNS

 
 
 
 
 


Indication

Leptic ODT is indicated for the treatment of
•    Seizure disorder
•    Panic disorder
•    Insomnia


Dosage and Administration

Indication

Patient Category

Recommended dose

Seizure Disorders

Adults

Initial dosage

Increment dosage

Maximum dosage

The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses.

Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase.

Maximum recommended daily dose is 20 mg.

Pediatric Patients

The initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.

Dosage should be increased by no more than 0.25 to 0.5 mg every third day until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weight has been reached, unless seizures are controlled or side effects preclude further increase.

0.05 mg/kg/day

Geriatric Patients

In general, elderly patients should be started on low doses of Clonazepam and observed closely.

-

20 mg/day

Panic Disorder

Adults

The initial dose for adults with panic disorder is 0.25 mg twice daily.

An increase to the target dose for most patients of 1 mg/day may be made after 3 days. The recommended dose of 1 mg/day is based on the results from a fixed dose study in which the optimal effect was seen at 1 mg/day.

20 mg/day

Pediatric Patients

There is no clinical trial experience with Clonazepam in panic disorder patients under 18 years of age

-

-

Geriatric Patients

In general, elderly patients should be started on low doses of Clonazepam and observed closely.

-

20 mg/day

Insomnia

Adults

Doses of 0.25 to 0.5 mg PO at bedtime have been suggested.

-

20 mg/day

Geriatric Adults

Doses of 0.25 to 0.5 mg PO at bedtime have been suggested for younger adults.

-

20 mg/day

Initial dosage should be low and increased gradually to a maintenance dosage that controls seizure without toxic effects. During discontinuation, the dosage should be tapered. Or as directed by the physician


Composition

Leptic 0.5: Each box contains 5x10 & 10x10 tablets in Alu-PVC/PVDC blister strips.
Leptic 1: Each box contains 3x10 & 5x10 tablets in Alu-PVC/PVDC blister strips.
Leptic 2: Each box contains 3x10 & 5x10 tablets in Alu-PVC/PVDC blister strips.
Leptic ODT 0.25: Each box contains 3x10 orally disintegrating tablets in Alu-Alu blister strips.
Leptic ODT 0.5: Each box contains 3x10 orally disintegrating tablets in Alu-Alu blister strips.