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Leptrogine . (Tablets)

 


Composition:
Each double scored tablet contains Lamotrigine 200 mg.
Each chewable tablet contains Lamotrigine 25mg.

Properties:
Mechanism of Action:
Lamotrigine is an antiepileptic drug (AED) of the phenyltriazine class.
One proposed mechanism of action of Lamotrigine, involves an effect on sodium channels, Lamotrigine inhibits voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and consequently modulating presynaptic transmitter release of excitatory amino acids (e.g., glutamate and aspartate). The mechanism by which Lamotrigine exerts its therapeutic action in Bipolar Disorder have not been established.
Pharmacokinetics & Drug Metabolism:
Lamotrigine is rapidly and completely absorbed after oral administration with negligible first-pass metabolism (absolute bioavailability is 98%).
The bioavailability is not affected byfood.
Peak plasma concentrations occur anywhere from 1.4 to 4.8 hours following drug administration. Because Lamotrigine is not highly bound to plasma proteins, clinically significant interactions with other drugs through competition for protein binding sites are unlikely.
Lamotrigine is metabolized predominantly by glucuronic acid conjugation, and excreted mainly in the form of metabolites with a ratio ofabout94% in the urine and 2% in the feces.

Indications:
Epilepsy:
Leptrogine is indicated as adjunctive therapy for partial seizures and the generalized seizures of Lennox-Gastaut syndrome in adults and pediatric patients (>1=2 years of age).
Leptrogine is indicated for conversion to monotherapy in adults with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, orvalproate as the singleAED.
Bipolar Disorder:
Leptrogine is indicated for the maintenance treatment of Bipolar I Disorder to delay the time of occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. The physician who elects to use for more than18 months should periodically re-evaluate the usefulness of the drug.

Dosage Administration:
-When Leptrogine is added to an antiepileptic drug regimen containing valproate in patients over 12 years of age:
The first 2 weeks: 25mg every other day.
The following 2 weeks: 25mg every day.
The maintenance dose: 1 00-400mg every day (in 1 or 2 divided doses). (To achieve maintenance, the dose should be increased by 25-50mgl day every 1 t02weeks).
Usual maintenance dose in patients adding Leptrogine to valproate alone is 100-200mg daily.
- When Leptrogine is added to carbamazepine, phenytoin, phenobarbital or primidone, (not valproate) in patients over 12 years: The first 2 weeks: 50mg every day.
The following 2 weeks: 100mg every day in 2 divided doses.
The maintenance dose: 300-500mg every day (in 2 divided doses).
(To achieve maintenance, the dose should be increased by100mg/day every 1 to 2weeks)
The recommended maintenance dose of Leptrogine as monotherapy is 500mg/day (in 2 divided doses).
-When Leptrogine is added to an antiepileptic drug regimen containing valproate in patients 2.12 years of age:
The first 2 weeks: O.15mgl Kgl day (in 1 or 2 divided doses).
The following 2 weeks: O.3mgl Kg/ day (in 1 or2 divided doses).
- When Leptrogine 200mg is added to carbamazepine, phenytoin, phenobarbital or primidone, (not valproate) in patients 2-12 years:
The first 2 weeks: O.6mgl Kgl day (in 2 divided doses).
The following 2 weeks: 1.2mgl Kgl day (in 2 divided doses).
The maintenance dose: 5-15mg/ Kg/day up to a maximum of 400mg daily in 2 divided doses.
(To achieve maintenance, the dose should be increased by 1.2mg/ Kg/dayevery 1 to 2 weeks).
Dose for children with Lennox-Gastaut syndrome is 100-300mg every day.

Contra Indications:
-Known hypersensitivity to any of the components of the product.

Precautions Warnings:
-Serious rash requiring hospitalization and discontinuation of the drug, including stevens-johnson syndrome and toxic epidermal necrolysis, have occurred in association with therapy with Lamotrigine, the risk increases with pediatric patients.
-Safety and effectiveness of Lamotrigine have not been established as initial monotherapy, for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate,or for simultaneous conversion to monotherapy from 2 or more concomitantAEDs.
-Safety and effectiveness in patients below the age of 16 other than those with partial seizures and the generalized seizures of Lennox¬Gastaut syndrome have not been established.
-As with other AEDs, Leptrogine should not be abruptly discontinued, as this would lead to increasing seizures frequency, and thus the dose should be tapered over a period of at least 2 weeks. Pregnancy Category C, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Use in Nursing Mothers Breast-feeding while taking Leptrogine is not recommended.

Side Effects:
-The most commonly observed adverse reactions were: dizziness, ataxia, somnolence, headache, diplopia, blurred vision, nausea, vomiting. coordination abnormality, dyspepsia, anxiety, weight decrease, chest pain, dysmenorrhea, tremor, nystagmus, diarrhea, lymphadenopathy, pruritus, accidental injury and sinusitis.
-Serious rash that requires hospitalization and discontinuation of Leptrogine.

Packing:
Box of 1, 2 or 3 strips each of 10 double scored tablets, each of 200mg Lamotrigine.
Box Box of 1, 2 or 3 strips each of 10 chewable tablets, each of 25mg Lamotrigine.

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