Lanistor tablets are indicated for:
Epilepsy. Adults and children from 12 years of age: monotherapy and adjunctive therapy in epilepsy, in particular partial and generalized seizures, including tonic-clonic seizures, as well as seizures associated with Lennox-Gastaut syndrome. Children from 2 to 12 years of age: adjunctive therapy in epilepsy, in particular partial and generalized seizures, including tonic-clonic seizures, as well as seizures associated with Lennox-Gastaut syndrome. Bipolar disorder (adults). For the prevention of phases of emotional disturbances in patients with bipolar disorder, mainly by preventing depressive episodes.
Composition
Active ingredient: lamotrigine;
Each tablet contains lamotrigine 25 mg, 50 mg, 100 mg;
Excipients: lactose, microcrystalline cellulose, sodium starch (type A), povidone, magnesium stearate.
Contraindication
The drug is contraindicated in patients with known hypersensitivity to lamotrigine or any other component of the drug.
Method of application
Tablets should be swallowed whole, without chewing or breaking.
If the calculated dose of lamotrigine (e.g. for the treatment of children with epilepsy or patients with impaired liver function) is not a multiple of whole tablets, the dose used should correspond to the nearest smaller number of whole tablets.
If the estimated dose of lamotrigine is less than 25 mg, lamotrigine preparations with the possibility of such a dosage should be used.
Application features
Pregnant women
The drug can be prescribed during pregnancy only if the expected benefit to the mother outweighs the possible risk to the fetus.
Children
There is insufficient information on the use of the drug for the treatment of children under 2 years of age with epilepsy, therefore the drug is not recommended for this age group.
Drivers
Contraindicated until individual reaction to the drug is determined.
Overdose
There have been reports of cases of acute overdose (doses 10-20 times the maximum therapeutic dose), including fatalities. Symptoms of overdose included ataxia, nystagmus, impaired consciousness, grand mal seizures and coma. Also, prolonged QRS interval on the electrocardiogram (intraventricular conduction delay) was observed in patients with overdose.
In case of overdose, the patient should be hospitalized for appropriate supportive therapy. Therapy should be aimed at reducing absorption (activated charcoal), further therapy should be symptomatic. There is no experience with the use of hemodialysis as a treatment for overdose.
Side effects
Blood and lymphatic system disorders: haematological abnormalities (including neutropenia, leukopenia, anaemia, thrombocytopenia, pancytopenia, aplastic anaemia and agranulocytosis). Immune system disorders: hypersensitivity syndrome (including symptoms such as fever, lymphadenopathy, facial oedema, blood and liver function abnormalities, disseminated intravascular coagulation and multiple organ failure). Psychiatric disorders: aggression, irritability. Nervous system disorders: headache, somnolence, insomnia, dizziness, tremor. Visual disorders: diplopia, halos. Gastrointestinal disorders: nausea, vomiting, diarrhoea, dry mouth. Skin and subcutaneous tissue disorders: skin rash, alopecia. Musculoskeletal and connective tissue disorders: arthralgia.
Interaction
Interaction studies have only been conducted in adults.
In a study of 10 male volunteers, rifampicin increased the clearance and decreased the half-life of lamotrigine due to induction of hepatic enzymes responsible for glucuronidation. Patients receiving concomitant rifampicin therapy should follow the treatment regimen recommended for lamotrigine and appropriate inducers of glucuronidation.
In healthy volunteers, lopinavir/ritonavir approximately halved the plasma concentration of lamotrigine by inducing glucuronidation. Patients already taking lopinavir/ritonavir should be treated with the same regimen recommended for lamotrigine and glucuronidation inducers.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 2 years.
