Vimpat®
For oral administration
The daily dose is divided into 2 doses - morning and evening, regardless of the time of meal.
The recommended starting dose is 50 mg 2 times/day. After 1 week, the dose is increased to 100 mg 2 times a day. Taking into account the effectiveness and tolerability, the maintenance dose can be increased when taking tablets, it can be increased to 150 mg 2 times / day in the third week of administration, when taking syrup - by 50 mg 2 times / day every week, up to a maximum daily dose of 400 mg / day (200 mg 2 times/day) from the fourth week.
It is recommended to discontinue Vimpat® gradually, reducing the dose by 200 mg per week.
For intravenous administration
Injected intravenously for 15-60 minutes 2 times a day.
The recommended starting dose is 50 mg 2 times/day. After 1 week, the dose is increased to 100 mg 2 times a day. Taking into account the effectiveness and tolerability, the maintenance dose can be increased every week by 50 mg 2 times / day to a maximum daily dose of 400 mg (200 mg 2 times / day). It is recommended to discontinue Vimpat® gradually (reducing the dose by 200 mg per week).
The solution can be administered without additional dilution or diluted.
There is experience in using the solution for infusions for up to 5 days. You should switch to taking the drug orally as soon as possible.
Treatment with Vimpat® can be started either by taking tablets orally or by intravenously administering a solution for infusion.
If necessary, you can replace taking tablets intravenously without re-titrating the dose and vice versa. In this case, you should not change the daily dose and frequency of use (2 times/day).
When taken orally and when administered intravenously
patients with mild to moderate
renal impairment (creatinine clearance >30 ml/min)
do not require dose adjustment.
In patients with severe renal failure (creatinine clearance ≤30 ml/min),
the maximum dose is 300 mg/day.
Lacosamide is removed from plasma during hemodialysis, and within 4 hours after the procedure, AUC decreases by approximately 50%. For patients undergoing hemodialysis,
it is recommended to prescribe an additional 50% of the single dose immediately after the end of the procedure.
Treatment of patients with severe renal failure
should be carried out with caution, because clinical experience with the drug in such patients is small, and accumulation of a metabolite with no known pharmacological activity is possible. In all patients with impaired renal function, dose titration is recommended with caution.
When taken orally and when administered intravenously
For patients with
mild to moderate liver dysfunction,
no dose adjustment is required.
Dose titration in such patients should be done with caution, given that impaired liver function is often accompanied by impaired renal function. The pharmacokinetics of lacosamide in patients with severe hepatic impairment
have not been studied.
When taken orally and when administered intravenously
Elderly patients
do not require dose reduction.
Experience with lacosamide in elderly patients with epilepsy is limited. In elderly people, it is necessary to take into account the possibility of an age-related decrease in renal clearance and, as a result, an increase in the concentration of lacosamide in the blood plasma. Rules for preparing infusion solution
Before administering the drug, make sure that the solution in the bottle is transparent, colorless and does not contain foreign impurities. Otherwise, do not use this bottle.
Vimpat® solution for infusion is compatible with the following solvents: 0.9% sodium chloride solution, 5% dextrose solution, lactated Ringer's solution.
The prepared solution should be used within 24 hours after dissolution when stored in glass or polyvinyl chloride bottles at a temperature not exceeding 25°C.
Unused solution should be disposed of in accordance with existing regulations.
Side effects
Based on an analysis of the pooled results of placebo-controlled clinical trials, which included 1308 patients with partial seizures, it was found that 61.9% of patients randomized to the lacosamide group and 35.2% of patients randomized to the placebo group had at least at least 1 adverse reaction. the most common adverse reactions were dizziness, headache, nausea and diplopia. Side effects of the drug were most often minor or moderate. the occurrence of some of them was dose-dependent, and reducing the dose of the drug led to a decrease in the severity of side effects. the frequency and severity of adverse reactions from the central nervous system and gastrointestinal tract decreased after some time.
In clinical trials, the use of the drug in clinical trials was discontinued in 12.2% of cases when side effects occurred, compared to 1.6% when using placebo. The most common reason for discontinuation of lacosamide treatment was dizziness.
The use of lacosamide is accompanied by a dose-dependent prolongation of the PR interval. Adverse reactions associated with prolongation of this interval (AV block, fainting, bradycardia) are possible.
In patients with epilepsy, 1st degree AV block is observed infrequently, in 0.7; 0; 0.5 and 0% at a dose of lacosamide 200; 400; 600 mg and placebo, respectively. No II or higher degree AV block was observed in patients taking lacosamide.
Loss of consciousness occurred infrequently. However, the incidence was almost the same in patients who received lacosamide (0.1%) and in those who received placebo (0.3%).
The following are the adverse reactions identified during the analysis of the pooled results of placebo-controlled clinical trials. The frequency of adverse reactions was assessed as follows: very often (≥1/10), often (≥1/100 to 1/10), infrequently (≥1/1000 to 1/100). In each group, adverse reactions are listed in order of decreasing severity.
From the side of the central nervous system: very often - dizziness, headache; often - imbalance, impaired coordination, memory impairment, cognitive impairment, drowsiness, tremor, nystagmus.
Mental disorders: often - depression.
From the side of the organ of vision: very often - diplopia; often - blurred vision.
From the organ of hearing and vestibular apparatus: often - vertigo.
From the gastrointestinal tract: very often - nausea; often - vomiting, constipation, flatulence.
From the skin and subcutaneous tissues: often - itching.
General disorders: often - gait disturbance, asthenia, fatigue.
Injuries, poisoning and complications of procedures: often - falls, skin cracks.
Note!
Description of the drug Vimpat table. p/o 100 mg No. 14 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
special instructions
Treatment with lacosamide is sometimes accompanied by dizziness, which may lead to an increased incidence of accidental injuries and falls. Therefore, patients should be warned about the possible effects of the drug and advised to use caution.
In clinical studies, a prolongation of the P–R interval was observed during lacosamide administration. Lacosamide should be used with caution in patients with known cardiac conduction abnormalities or serious heart disease, such as a history of myocardial infarction or heart failure. The drug should be used with particular caution in the elderly, as they may have an increased risk of heart disease, or when lacosamide is used concomitantly with drugs that cause prolongation of the P-R interval.
Suicidal thinking and behavior have been observed in patients receiving antiepileptic drugs for various diseases. A meta-analysis of randomized, placebo-controlled clinical trials of anticonvulsants also demonstrated a nonsignificant increase in the risk of suicidal ideation and behavior. The mechanism of this risk is unknown, and available data do not exclude the possibility of an increased risk with lacosamide.
Thus, it is necessary to monitor the occurrence of signs of suicidal thinking and behavior in patients and prescribe appropriate treatment, if necessary. Patients and those monitoring them should be advised to consult a doctor if signs of suicidal thinking and behavior occur.
The syrup contains sodium propylhydroxybenzoate (E217) and sodium methylhydroxybenzoate (E219), which can cause allergic reactions (possibly delayed). 1 dose of the drug (200 mg of lacosamide) contains 3.7 g of sorbitol (E420), which is 9.7 kcal. Patients with the rare condition congenital fructose intolerance should not take this drug. The syrup also contains aspartame (E951), a source of phenylalanine, which may be harmful to patients with phenylketonuria. 1 dose of syrup (200 mg lacosamide) contains 1.06 mmol (or 25.2 mg) sodium. This must be taken into account when used in patients who are on a diet with limited salt intake.
1 bottle of the drug in the form of a solution for infusion contains 2.6 mmol (or 59.8 mg) sodium. This must be taken into account when used in patients who are on a diet with limited salt intake.
Use during pregnancy and lactation
Pregnancy
Risk associated with epilepsy and the use of antiepileptic drugs in general: in newborns of women with epilepsy, the incidence of birth defects is 2–3 times higher than in the general population (≈3%). Combination antiepileptic therapy in pregnant women has been associated with an increased incidence of birth defects in children, but the extent to which this is related to treatment and/or the disease itself remains unclear. Moreover, effective antiepileptic therapy should not be interrupted during pregnancy, since worsening of the disease can have serious consequences for both the mother and the fetus.
Risk associated with the use of lacosamide: There are no relevant data regarding the use of lacosamide in pregnant women. In animal studies (rats and rabbits), no teratogenic effects of the drug were revealed, but embryotoxicity was noted when the drug was administered in doses toxic to the mother's body. The possible risk for pregnant women is unknown. Lacosamide should not be used in pregnant women, unless treatment is necessary (if the benefit to the mother clearly outweighs the possible risk to the fetus). If a woman is planning a pregnancy, then it is necessary to carefully weigh the advisability of using this drug.
Lactation
There is no data on the excretion of lacosamide into breast milk. Animal studies have confirmed that lacosamide passes into milk. As a precaution, breastfeeding should be discontinued during treatment with lacosamide.
Children. It is not recommended to use the drug in children under 16 years of age.
The ability to influence reaction speed when driving vehicles and operating machinery. Vimpat may have a slight or moderate effect on the ability to drive vehicles and operate machinery. Treatment with the drug may be accompanied by the development of dizziness or blurred vision. Accordingly, patients are advised not to drive or operate complex machinery until the response to Vimpat has been assessed.
Overdose
Clinical data on lacosamide overdose are limited. after taking the drug at a dose of 1200 mg/day, clinical symptoms (dizziness and nausea) were mainly associated with the central nervous system and gastrointestinal tract and disappeared after reducing the dose. The highest dose of overdose reported during the clinical development program was the administration of 12 g of the drug concomitantly with several other antiepileptic drugs at toxic doses (the patient was in a coma; over time, his condition fully recovered without the occurrence of permanent complications).
There is no antidote for lacosamide. Treatment of overdose includes general supportive measures and, if necessary, hemodialysis.
