Expiration date: 12/2025
Release Form: Film-coated tablets
Composition
One tablet contains 50, 100, 150 or 200 mg Lacosamide
Other ingredients: MCC giproloza low substituted, prosolv HD 90 (ICC and silica colloidal anhydrous), crospovidone, magnesium stearate, giproloza.
Packaging
14 or 56 pcs.
pharmachologic effect
Vimpat - antiepileptic drug. The exact mechanism of antiepileptic action Lacosamide not installed. Lacosamide selectively enhances slow inactivation of voltage-dependent sodium channels, resulting in stabilization of membranes hyperexcitable neurons. Furthermore, Lacosamide binds SKMR-2 phosphoprotein that is expressed predominantly in the nervous system and is involved in regulating neuronal differentiation and neurite outgrowth. It has been shown that the increased delays Lacosamide seizure development. Lacosamide has a synergistic or additive anticonvulsant effects in combination with levetiracetam, carbamazepine, phenytoin, valproate, lamotrigine, topiramate or gabapentin.
testimony
In the complex treatment of partial seizures, accompanied or not by secondary generalization in patients with epilepsy aged 16 years and older.
Contraindications
Hypersensitivity to any one Vimpat components. Atrioventricular block II or III degree. Age up to 16 years. Pregnancy and lactation. With caution in patients with severe renal insufficiency.
Dosing and Administration
Vimpat is taken orally. The daily dose is divided into 2 doses - in the morning and evening, regardless of mealtime. The recommended starting dose is 50 mg 2 times a day. After 1 week, the dose was increased to 100 mg 2 times a day. Given the efficacy and tolerability of the maintenance dose may be increased to 150 mg 2 times a day on the third week and to receive the maximum daily dose of 400 mg / day (200 mg, 2 times a day) with the fourth week. Cancelling Vimpat is recommended to gradually reducing the dose of 200 mg per week.
Side effects
When treating Lacosamide most common adverse reactions were dizziness, headache, nausea and diplopia. As a rule, they were mild or moderate in intensity. Intensity of some adverse reactions was dependent on the dose and decreased after the reduction. The frequency and severity of adverse reactions from the central nervous system and the digestive system usually decreases over time.
Application Lacosamide accompanied by a dose-dependent prolongation of the interval PR, whereby the possible development of such medical conditions as AV-block, bradycardia, and syncope.
Adverse reactions marked with more than 1% of patients in clinical studies are listed below. Determining the incidence of side reactions often (?1 / 10), often (of ?1 / 100 <1 ,, = 10 "" = 1 "" = 1000 "" 100 = "" br = "">, the part central nervous system: very often - dizziness, headache, often - depression, irritability, impaired balance, coordination of movements, memory impairment, attention deficits, cognitive disorders, hypoesthesia, lethargy, confusion, tremor, nystagmus, dysarthria.
From the senses: very often - diplopia, often - blurred vision, vertigo, tinnitus.
From the digestive system: very often - nausea, frequent - vomiting, constipation, flatulence, dyspepsia, dry mouth.
Dermatological reactions: often - itching.
From the musculoskeletal system: often - muscle cramps.
Other: often - gait disturbance, asthenia, fatigue, falls, and increased risk of injury (due to violations of motor coordination and dizziness).
special instructions
Lacosamide treatment may be accompanied by dizziness, potentially leading to serious injury or falls. Therefore, patients with caution. Clinical trials data anticonvulsants showed a small increased risk of suicidal thoughts or suicidal behavior. The mechanism of increased risk is not clear, the existing data do not deny the existence of such a risk when taking Lacosamide. Those caring for patients should be warned of the risks and the need to consult a specialist in case of suicidal behavior. Patients receiving treatment Lacosamide should be monitored carefully, and be aware of the need to consult a specialist in case of suicidal thoughts. Given the possibility of prolongation of the PR interval on the background of therapy with Vimpat, patients are recommended periodic monitoring of ECG.
Drug interactions
The research results indicate a low probability of interaction with other drugs Lacosamide. Lacosamide should be used cautiously in combination with drugs that cause elongation RK interval (eg, carbamazepine, lamotrigine, pregabalin) and antiarrhythmic drugs of class I. However, in clinical trials, there were no additional RK interval elongation in patients who took Lacosamide simultaneously in combination with carbamazepine or lamotrigine.
Lacosamide is a substrate of cytochrome P450 (SUR2S19). Strong enzyme inducers such as rifampicin or St John's wort (Hypericum perforatum), may cause a moderate decrease in the systemic concentration Lacosamide. In this regard, the appointment of such drugs or their removal should be careful.
Overdose
Symptoms: after taking the drug at a dose of 1200 mg / cut - mostly dizziness and nausea, which disappeared after dose reduction. During the clinical trials it was recorded a one-time admission Lacosamide at a dose of 12 g, which was adopted in conjunction with toxic doses of other anti-epileptic drugs. The patient fell into a coma, but then fully recovered without consequences.
Treatment: There is no antidote Lacosamide, symptomatic therapy, hemodialysis may be used if necessary.
Storage conditions
Store at temperatures not above 25 ° C.
