Epileptal (lamotrigine) tablets 100 mg. №30

Description

Epileptal 100 mg. Storage
active substance: lamotrigine;

1 tablet contains lamotrigine 25 mg, 50 mg or 100 mg in terms of 100% of the substance;

Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), povidone, iron oxide yellow (E 172), magnesium stearate.

Epileptal 100 mg. Dosage form
Tablets.

Main physical and chemical properties: tablets of 25 mg and 100 mg round with a biconvex surface, pale yellow; tablets of 50 mg of round form, flat-cylindrical with a line and a facet, pale yellow color. Minor marbling and impregnation are allowed on the surface.

Pharmacotherapeutic group
Antiepileptic drugs. Lamotrigine.

ATX code N03A X09.

Pharmacological properties

Pharmacodynamics.

Lamotrigine is an anticonvulsant drug whose mechanism of action is to block potential-dependent sodium channels of presynaptic membranes of neurons in the phase of slow inactivation and inhibition of excessive release of glutamate (an amino acid that plays a significant role in the development of epileptic seizures).

Pharmacokinetics.

After oral administration, the drug is rapidly and completely absorbed from the gastrointestinal tract. The maximum concentration in blood plasma is reached in about 2.5 hours.

Lamotrigine is actively metabolized, the main metabolite is N-glucuronide. The average half-life in adult patients is 29 hours. Epileptal® has a linear pharmacological profile. It is excreted mainly as metabolites and partly unchanged, mainly in the urine. In children, the half-life is shorter than in adults.

Epileptal 100 mg. Indication
Epilepsy.

Adults and children 12 years of age and older: monotherapy and adjunctive therapy for epilepsy, including partial and generalized seizures, including tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome.

Children 2 to 12 years of age: adjunctive therapy for epilepsy, including partial and generalized seizures, including tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome.

Once seizure control has been achieved, adjuvant drugs can be discontinued and Epileptal® monotherapy continued.

Monotherapy of typical absences.

Bipolar disorders (adults).

To prevent phases of emotional disturbances in patients with bipolar disorder, mainly preventing depressive episodes.

Contraindication
Epileptal® is contraindicated in patients with known hypersensitivity to lamotrigine or to any other component of the drug.

Interaction with other medicinal products and other forms of interaction
Interaction studies were performed only in adults.

Uridine diphosphoglucuronyltransferase has been shown to be an enzyme responsible for the metabolism of lamotrigine. There is no evidence that lamotrigine can cause clinically significant stimulation or inhibition of liver oxidative enzymes involved in drug metabolism, and it is unlikely that interactions may occur between lamotrigine and drugs metabolised by cytochrome P450 enzymes. Lamotrigine may induce its own metabolism, but this effect is moderate and has no significant clinical consequences.