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