Vimpat and Alcohol/Food Interactions – Drugs.com

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There is 1 alcohol/food/lifestyle interaction with Vimpat (lacosamide).

Using lacosamide together with ethanol may increase side effects such as dizziness, drowsiness, confusion, and difficulty concentrating. Some people may also experience impairment in thinking, judgment, and motor coordination. You should avoid or limit the use of alcohol while being treated with lacosamide. Do not use more than the recommended dose of lacosamide, and avoid driving, operating machinery, or engaging in potentially hazardous activities requiring mental alertness and motor coordination until you know how the medication affects you. Talk to your doctor if you have any questions or concerns. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

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Vimpat drug interactions

There are 131 drug interactions with Vimpat (lacosamide).

Vimpat disease interactions

There are 4 disease interactions with Vimpat (lacosamide) which include:

• depression
• CVD
• hepatic impairment
• renal impairment

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• Seizures
• Epilepsy

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.

Major	Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate	Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor	Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown	No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers – Full Text View

Vimpat: instruction, price, analogues | film-coated tablets UCB Pharma

• Pharmacological properties
• Indications Wimpat
• Application Wimpat
• Contraindications
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The exact mechanism of the antiepileptic action of lacosamide has not been established. The following observations may be relevant to explain the therapeutic effect of the drug. In electrophysiological studies in vitro found that lacosamide selectively enhances the slow inactivation of voltage-gated sodium channels, which leads to stabilization of hyperexcitable neuronal membranes. In addition, lacosamide binds to the CRMP-2 phosphoprotein, which is predominantly expressed in the nervous system and is involved in the regulation of neuronal differentiation and axon growth.

Pharmacodynamics. The anticonvulsant efficacy of lacosamide has been established in various experiments on animals with partial and primary generalized convulsions and delayed development of kindling (epileptogenesis of experimental animals). In preclinical studies, lacosamide has shown synergistic or additive anticonvulsant effects in combination with levetiracetam, carbamazepine, phenytoin, valproate, lamotrigine, topiramate, or gabapentin.

There are insufficient data on the efficacy of lacosamide monotherapy.

Clinical experience

The efficacy of Vimpat as adjunctive therapy at recommended doses (200 and 400 mg/day) was established in three 12-week, multicenter, randomized, placebo-controlled clinical trials. The efficacy of 600 mg/day has also been established in controlled adjunctive therapy studies, although this dose was as effective as 400 mg/day. At the same time, patients better tolerated a lower dose, since adverse reactions from the central nervous system and gastrointestinal tract occurred when using 600 mg / day. Thus, it is not recommended to prescribe a dose of 600 mg / day. The maximum recommended dose is 400 mg/day. The aim of these studies, which involved 1308 patients with a mean history of 23 years of partial seizures, was to evaluate the efficacy and safety of lacosamide when used simultaneously with 1-3 other antiepileptic drugs in individuals with uncontrolled partial seizures, both with secondary generalization, so without it. Overall, the number of patients who experienced a 50% reduction in seizure frequency was 23; 34 and 40% with placebo, lacosamide 200 and 400 mg/day, respectively.

Pharmacokinetics. Suction. Lacosamide is rapidly and completely absorbed after oral administration. The bioavailability of lacosamide tablets is approximately 100%. After oral administration, the concentration of lacosamide in the blood plasma increases rapidly, C _max is reached after 0.5-4 hours. Tablets and syrup for oral administration are bioequivalent. Food does not affect the rate and extent of absorption.

After IV administration C _max is reached at the end of the infusion. Plasma concentration increases in proportion to the dose after oral administration (100–800 mg) and intravenous administration (50–300 mg).

Distribution. The volume of distribution is approximately 0.6 l / kg of body weight, the degree of binding to plasma proteins is <15%.

Metabolism. 95% of the dose is excreted by the kidneys unchanged (≈40% of the dose) and as metabolites (O-desmethyl metabolite <30%). The proportion of the polar fraction in the urine (probably serine derivatives) was ≈20%, but it was detected in the blood plasma only in small amounts (0-2%) in some patients. The amount of other metabolites detected in the urine is 0.5-2%.

The formation of the O-desmethyl metabolite occurs mainly under the action of CYP 2C19. Other enzymes involved in the metabolism of lacosamide have not been established. However, there were no clinically significant differences in the effect of lacosamide when comparing its pharmacokinetics with strong metabolizers (EM, with functioning CYP 2C19) and weak metabolizers (PM, with insufficient functioning of CYP 2C19).

In addition, an interaction study with omeprazole (an inhibitor of CYP 2C19) showed no clinically significant changes in plasma concentrations of lacosamide, suggesting that this pathway is not significant. No other enzymes involved in the metabolism of lacosamide have been identified. The concentration of the O-desmethyl metabolite in plasma is approximately 15% of the concentration of lacosamide. This metabolite has no pharmacological activity.

Removal. Lacosamide is eliminated by renal excretion and biotransformation. After oral administration of radioactively labeled lacosamide ≈95% of radioactivity was found in urine and <0.5% in feces. T _½ is ≈13 hours. Pharmacokinetics is proportional to the dose, does not change with time and is characterized by low inter- and intra-individual variability. When applied 2 times a day, equilibrium plasma concentrations are achieved within 3 days. Cumulation is accompanied by an increase in plasma concentration by approximately 2 times.

Pharmacokinetics in special groups of patients

Pos. Clinical studies have shown that gender does not have a clinically significant effect on plasma concentrations of lacosamide.

Impaired renal function. The AUC value for lacosamide increased by approximately 30% in patients with mild to moderate renal impairment and by 60% in those with severe renal impairment and in patients with end-stage renal disease requiring hemodialysis. However, these diseases do not affect C _max .

Lacosamide is effectively eliminated from plasma during hemodialysis. After 4 hours of hemodialysis, the AUC of lacosamide is reduced by ≈50%. Therefore, after hemodialysis, it is recommended to increase the dose of the drug. The effect of the O-desmethyl metabolite is increased several times in patients with moderate to severe renal impairment. If hemodialysis was not performed in patients with end-stage renal disease, these values ​​increased continuously, as can be seen from the analyzes performed over a period of 24 hours. revealed no pharmacological activity of this metabolite.

Impaired liver function. In persons with moderate hepatic impairment (class B on the Child-Pugh scale), an increase in the concentration of lacosamide was detected (≈50% higher than AUC _norm ). The increased effect of the drug is partly due to decreased kidney function in study participants. The decrease in non-renal clearance in study patients caused a 20% increase in lacosamide AUC values. The pharmacokinetics of lacosamide in subjects with severe hepatic impairment has not been studied.

Elderly people (over 65). In studies that were conducted with the participation of women and men of advanced age and included 4 patients over the age of 75 years, the AUC level was ≈30 and ≈50% higher compared to young people, respectively. This result is partly due to underweight. This difference is 26 and 23%, respectively, with a reduced difference in body weight. An increase in the variability of the effect of the drug on the patient was also noted. This study found that the renal clearance of lacosamide was slightly reduced in the elderly.

The total dose of the drug should be reduced only in case of decreased renal function.

Vimpat is used to treat partial seizures with or without secondary generalization in patients with epilepsy over the age of 16 years as part of complex therapy.

Vimpat infusion solution is used as an alternative treatment for patients who are temporarily unable to take oral medication.

It is recommended to use the drug intravenously 2 times a day for no more than 5 days. Vimpat is used intravenously 2 times a day. The solution is injected intravenously over 15-60 minutes 2 times a day. Solution can be administered without additional dilution. If necessary, you can switch from oral to intravenous administration without dose titration and vice versa. In this case, you should not change the daily dose and frequency of use (2 times a day). Vimpat in the form of tablets and syrup is used orally 2 times a day. The recommended starting dose is 50 mg twice daily. After 1 week, the dose is increased to 100 mg 2 times a day. Based on efficacy and tolerability, the maintenance dose may be increased weekly by 50 mg twice daily to a maximum daily dose of 400 mg/day (200 mg twice daily). Tablets or syrup can be taken with or without food.

It is recommended to discontinue Wimpat gradually (by reducing the dose by 200 mg/week).

Use in patients with impaired renal function. For patients with mild to moderate renal impairment (creatinine clearance> 30 ml / min), dose adjustment is not required. In patients with severe renal insufficiency (creatinine clearance ≤30 ml / min) and terminal kidney disease, the maximum dose is 250 mg / day. Patients on hemodialysis are advised to administer up to an additional 50% of the distributed daily dose immediately at the end of the procedure. Treatment of patients with terminal kidney disease should be carried out with caution, since the clinical experience of using the drug in such patients is small and accumulation of a metabolite that does not have pharmacological activity is possible. All patients with impaired renal function are advised to carefully titrate the dose.

Use in patients with impaired liver function. Patients with mild to moderate hepatic impairment do not require dose adjustment. Dose titration in such patients should be cautious, given the possibility of concomitant renal impairment. The pharmacokinetics of lacosamide has not been studied in subjects with severe hepatic impairment.

Use in elderly patients (over 65 years). For elderly patients, there is no need to reduce the dose. Experience with the use of lacosamide in the elderly with epilepsy is limited. In elderly patients, it is necessary to take into account the possibility of an age-related decrease in renal clearance and an increase in the level of AUC.

Use in children. Vimpat is not recommended for use in children and adolescents under 16 years of age because the safety and efficacy of the drug in these age groups have not been studied.

hypersensitivity to the active substance, peanuts, soy or other excipients. Atrioventricular block II or III degree.

based on an analysis of the pooled results of placebo-controlled clinical trials in which 1308 patients with partial seizures participated, it was found that 61.9% of patients randomized to the lacosamide group and 35. 2% of patients randomized to the placebo group experienced 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 moderately pronounced. 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 CNS and gastrointestinal tract decreased after some time.

The use of the drug in clinical studies with the occurrence of side effects was discontinued in 12.2% of cases compared with 1.6% when using placebo. The most common reason for discontinuing treatment with lacosamide was dizziness.

The use of lacosamide is associated with a dose-dependent prolongation of the interval PR . Possible adverse reactions associated with the lengthening of this interval (AV blockade, syncope, bradycardia).

In patients with epilepsy, AV blockade of the first degree is noted infrequently, in 0. 7; 0; 0.5 and 0% at a dose of lacosamide 200; 400; 600 mg and placebo, respectively. In patients treated with lacosamide, AV block II or the highest degree was not observed.

Loss of consciousness occurred infrequently. At the same time, the incidence is 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.

On the part of the organ of vision: very often – diplopia; often blurred vision.

On the part of the organ of hearing and vestibular apparatus: often – vertigo.

From the gastrointestinal tract: very often – nausea; often – vomiting, constipation, flatulence.

From the side of the skin and subcutaneous tissues: often – itching.

General disorders: often – gait disturbance, asthenia, fatigue.

Injury, poisoning and procedural complications: often – falls, skin cracks.

treatment with lacosamide is sometimes accompanied by dizziness, which can 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 exercise caution.

Prolongation of the P–R interval has been observed in clinical studies with lacosamide. Lacosamide should be used with caution in patients with known cardiac conduction disorders or serious heart disease such as myocardial infarction or a history of heart failure. The drug is used with extreme 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 interval P–R .

Suicidal ideation and behavior has been noted in patients receiving antiepileptic drugs for various diseases. A meta-analysis of randomized placebo-controlled clinical trials of anticonvulsants also showed a slight increase in the risk of suicidal ideation and behavior. The mechanism of this risk is unknown, and the available data do not exclude the possibility of an increased risk with the use of lacosamide.

Patients should therefore be monitored for signs of suicidal ideation and behavior and appropriate treatment instituted if necessary. Patients and caregivers should be advised to seek medical attention if signs of suicidal ideation and behavior occur.

Syrup contains sodium propylhydroxybenzoate (E217) and sodium methylhydroxybenzoate (E219), which may 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 of congenital fructose intolerance should not take this drug. The syrup also contains aspartame (E951) – a source of phenylalanine, which can be harmful to patients with phenylketonuria. 1 dose of syrup (200 mg of lacosamide) contains 1.06 mmol (or 25.2 mg) of sodium. This should be taken into account when used in patients who are on a salt-restricted diet.

1 bottle of the drug in the form of a solution for infusion contains 2.6 mmol (or 59.8 mg) sodium. This should be taken into account when used in patients who are on a salt-restricted diet.

Use during pregnancy and lactation

Pregnancy

Risk associated with epilepsy and use of antiepileptic drugs in general: in newborns in women with epilepsy, the incidence of birth defects is 2-3 times higher than in the general population (≈3%). Combined antiepileptic therapy in pregnant women was accompanied by an increase in the incidence of congenital malformations in children, but it remains unclear to what extent this is associated with treatment and / or the disease itself. Moreover, during pregnancy, effective antiepileptic therapy should not be interrupted, since worsening of the disease can have serious consequences for both the mother and the fetus.

Risk associated with the use of lacosamide: no relevant data on the use of lacosamide in pregnant women. In animal studies (rats and rabbits), no teratogenic effects of the drug were detected, but embryotoxicity was noted when the drug was administered in doses toxic to the mother’s body. The possible risk to 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 appropriateness of using this drug.

Breast-feeding

No data on excretion of lacosamide in breast milk. Animal studies have confirmed that lacosamide passes into milk. As a precaution, breast-feeding should be discontinued during treatment with lacosamide.

Children. Not recommended for use in children under 16 years of age.

The ability to influence the reaction rate when driving vehicles and working with mechanisms. Vimpat may slightly or moderately affect the ability to drive and use machines. 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 response to Wimpat has been evaluated.

Lacosamide should be used with caution in combination with drugs that cause prolongation of the PR interval (eg carbamazepine, lamotrigine, pregabalin) and class I antiarrhythmic drugs. However, in clinical studies, no additional prolongation of the PR interval was noted in patients who simultaneously took lacosamide in combination with carbamazepine or lamotrigine.

The results of studies indicate a low reliability of the interaction of lacosamide with other drugs. Research in vitro have shown that lacosamide does not induce CYP 1A2, 2B6 and 2C9 enzymes and does not inhibit CYP 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2D6 and 2E1 at plasma concentrations used in clinical studies. In vitro studies have shown that lacosamide is not transported by P-glycoprotein in the gut. In in vivo Lacosamide does not inhibit or induce the CYP 2C19 enzyme.

In vitro data from indicate that lacosamide may be a weak inhibitor and inducer of CYP 3A4. The clinical significance of this effect is unknown. When studying the interaction with carbamazepine, there were no signs of a pronounced inhibitory effect of lacosamide at therapeutic doses on metabolism, which is catalyzed by CYP 3A4.

Potent enzyme inducers such as rifampicin or St. John’s wort (Hypericum perforatum) may cause a moderate decrease in the systemic concentration of lacosamide. In this regard, when prescribing such drugs or canceling them, care must be taken.

Antiepileptic drugs

Lacosamide did not cause significant changes in plasma concentrations of carbamazepine and valproic acid. In turn, carbamazepine and valproic acid did not affect plasma levels of lacosamide. According to a population pharmacokinetic analysis, concomitant therapy with other antiepileptic drugs that induce enzymes (carbamazepine, phenytoin, phenobarbital at various doses) reduced the total systemic exposure of lacosamide by 25%.

Oral contraceptives

There were no signs of a significant interaction between lacosamide and the oral contraceptives ethinyl estradiol and levonorgestrel. Lacosamide did not affect progesterone concentrations.

Others

Lacosamide did not affect the pharmacokinetics of digoxin. No clinically significant interaction between lacosamide and metformin has been identified. Omeprazole at a dose of 40 mg 1 time per day increased the AUC of lacosamide by 19%. This effect is probably not of clinical significance. When taken as a single dose, lacosamide did not affect the pharmacokinetics of omeprazole. There are no data on the interaction of lacosamide with alcohol. The degree of binding of lacosamide to plasma proteins is <15%. In this regard, clinically significant interactions with other drugs that bind to proteins are unlikely.

Incompatible. Vimpat infusion solution, when mixed with the following solvents, has been found to be physically compatible and chemically stable for at least 24 hours when stored in glass or PVC containers at temperatures not exceeding 25°C.

Solvents:

• sodium chloride 9 mg/ml (0.9%), injection solution;
• glucose 50 mg/ml (5%), injection solution;
• Ringer’s lactate injection.

From a microbiological point of view, the drug should be used immediately. If not used immediately, storage times and conditions are the responsibility of the user and generally cannot exceed 24 hours at 2-8°C unless reconstitution is carried out under controlled and approved aseptic conditions.

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 dose reduction. The highest dose of overdose reported during the clinical development program was 12 g of the drug at the same time as several other antiepileptic drugs at toxic doses (the patient was in a coma; over time, his condition fully recovered without persistent complications).

There is no antidote for lacosamide. Treatment of overdose includes general supportive measures and, if necessary, hemodialysis.

in a dry, dark place at a temperature not exceeding 30 °C, infusion solution – at a temperature not exceeding 25 °C. After the first opening of the vial, use the syrup within 4 weeks.

Alcohol and medicines – Alkoinfo.ee

If a person does not recognize the problem himself, it is difficult to send him for treatment. There are certain criteria for referral to compulsory treatment.

Psychiatric Care Act, § 11. Involuntary and Unavoidable Psychiatric Care, states that
will (hereinafter referred to as compulsory treatment). ) only if the following circumstances occur together:
1) the person has a severe mental disorder that limits his ability to understand or control his behavior;
2) by not being treated in a hospital, a person endangers the life, health or safety of himself or others due to a mental disorder;
3) other psychiatric care is not enough.

In case of delirium, an ambulance can be called. A person is admitted to the hospital if he is dangerous, and even then he can be kept there for 48 hours without a court order. Just because a person drinks, one cannot treat him against his will. Unfortunately, this is the bitter truth. Often, simply spending some time sober in a hospital is not enough to treat an alcohol use disorder (dependence). It is a lifelong condition that requires long-term treatment, sometimes even years, before a person can remain sober. Even if your family member sobers up, it takes willpower to stay sober. Here we come to a person’s own intrinsic motivation, which is the basis for maintaining sobriety in the future. You can do your best, but if the family member does not take responsibility and sees the need to change their drinking, the help provided will only be temporary and will not produce the desired result.
To increase motivation and understand the seriousness of the problem, you can talk to a family member who drinks about how you and others feel about his drinking and how it affects you. This should be done in a calm tone, avoiding accusations, nit-picking, threats and moralizing. You must speak when a family member is sober. Try to choose a time and place where you can talk calmly and have enough time. If he notices the attack, he may tell you that this is not a problem for him, or he may act aggressively and make excuses. Unfortunately, you cannot force a member of your family to go to treatment. However, you can try to motivate him.