Leptrogine Tablets: Unveiling the Power of Lamotrigine 200 mg and 25 mg Formulations
Composition:
Each double-scored tablet contains:
- Lamotrigine 200 mg.
Each chewable tablet contains:
- Lamotrigine 25 mg.
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, inhibiting voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and 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 has 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 by food. 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 of about 94% 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 (>12 years of age).
- Conversion to monotherapy in adults with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED.
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 it for more than 18 months should periodically re-evaluate the usefulness of the drug.
Dosage Administration:
For patients over 12 years of age:
When Leptrogine is added to an antiepileptic drug regimen containing valproate:
- First 2 weeks: 25 mg every other day.
- Following 2 weeks: 25 mg every day.
- Maintenance dose: 100-400 mg every day (in 1 or 2 divided doses). (To achieve maintenance, the dose should be increased by 25-50 mg/day every 1 to 2 weeks). Usual maintenance dose in patients adding Leptrogine to valproate alone: 100-200 mg daily.
When Leptrogine is added to carbamazepine, phenytoin, phenobarbital, or primidone (not valproate):
- First 2 weeks: 50 mg every day.
- Following 2 weeks: 100 mg every day in 2 divided doses.
- Maintenance dose: 300-500 mg every day (in 2 divided doses). (To achieve maintenance, the dose should be increased by 100 mg/day every 1 to 2 weeks). The recommended maintenance dose of Leptrogine as monotherapy is 500 mg/day (in 2 divided doses).
For patients 12 years of age and older: When Leptrogine is added to an antiepileptic drug regimen containing valproate:
- First 2 weeks: 0.15 mg/kg/day (in 1 or 2 divided doses).
- Following 2 weeks: 0.3 mg/kg/day (in 1 or 2 divided doses).
When Leptrogine 200 mg is added to carbamazepine, phenytoin, phenobarbital, or primidone (not valproate):
- First 2 weeks: 0.6 mg/kg/day (in 2 divided doses).
- Following 2 weeks: 1.2 mg/kg/day (in 2 divided doses).
- Maintenance dose: 5-15 mg/kg/day up to a maximum of 400 mg daily in 2 divided doses. (To achieve maintenance, the dose should be increased by 1.2 mg/kg/day every 1 to 2 weeks). Dose for children with Lennox-Gastaut syndrome is 100-300 mg every day.
Contra Indications:
Known hypersensitivity to any of the components of the product.
Precautions and 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 concomitant AEDs.
- 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 seizure 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 Breastfeeding 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 200 mg Lamotrigine.
- Box of 1, 2, or 3 strips each of 10 chewable tablets, each of 25 mg Lamotrigine.
About the Author
Dr. Ahmad Baker, PharmD
He is a senior pharmacist and health educator with extensive experience in the Middle East and North Africa region. Through his writing, Dr. Ahmad aims to empower communities by providing reliable, evidence-based health information. With expertise in clinical pharmacy and regulatory affairs, he strives to offer unique insights into healthcare and simplify complex medical concepts, making them accessible to everyone.
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