Lacosamide Tablets

​Lacosamide Tablets is indicated in patients 17 years and older with partial-onset seizures as monotherapy or adjunctive therapy.

​Lacosamide Tablets injection for intravenous use is an alternative when oral administration is temporarily not feasible.

Lacosamide Tablets is used together with other medicines to help control partial seizures (convulsions) in the treatment of epilepsy. It acts on the central nervous system (CNS) to reduce the number and severity of seizures. However, Lacosamide Tablets cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

Lacosamide Tablets is available only with your doctor's prescription.

Dosage For Lacosamide Tablets Tablet And

Oral Solution

Monotherapy

The initial recommended dose of Lacosamide Tablets is 100 mg twice daily (200 mg per day); the dose should be increased by 50 mg twice daily (100 mg per day) every week, up to a recommended maintenance dose of 150 mg twice daily to 200 mg twice daily (300 mg to 400 mg per day). Alternatively, Lacosamide Tablets may be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by 100 mg twice daily (200 mg per day); this dose regimen should be continued for one week. Based on individual response and tolerability, the dose can be increased at weekly intervals by 50 mg twice daily (100 mg per day), as needed, up to the recommended maintenance dose of 150 mg twice daily to 200 mg twice daily (300 mg to 400 mg per day). The loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions.

For patients who are already on a single antiepileptic and will convert to Lacosamide Tablets monotherapy, the therapeutic dose of 150 mg twice daily to 200 mg twice daily (300 mg to 400 mg per day) should be maintained for at least 3 days before initiating withdrawal of the concomitant antiepileptic drug. A gradual withdrawal of the concomitant antiepileptic drug over at least 6 weeks is recommended.

Adjunctive Therapy

The initial recommended dose is 50 mg twice daily (100 mg per day). Based on individual patient response and tolerability, the dose can be increased at weekly intervals by 50 mg twice daily (100 mg per day). The recommended maintenance dose is 100 mg twice daily to 200 mg twice daily (200 mg to 400 mg per day). In clinical trials, the 300 mg twice daily (600 mg per day) dose was not more effective than the 200 mg twice daily dose (400 mg per day), but was associated with a substantially higher rate of adverse reactions.

Alternatively, Lacosamide Tablets may be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice daily (200 mg per day); this maintenance dose regimen should be continued for one week. Based on individual patient response and tolerability, the dose can be increased at weekly intervals by 50 mg twice daily (100 mg per day), as needed, up to the maximum recommended maintenance dose of 200 mg twice daily (400 mg per day). The loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions.

When discontinuing Lacosamide Tablets, a gradual withdrawal over at least 1 week is recommended.

Dosage For Lacosamide Tablets Injection

Intravenous Lacosamide Tablets can be administered in the same dosing regimens described for oral dosing, including the loading dose. These dosages may be infused intravenously over a period of 15 minutes to 60 minutes.

Intravenous infusion of 30 to 60 minutes is preferable, and should be used when a 15 minute administration is not required.

Monitor closely patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease (e.g., myocardial ischemia, heart failure), as intravenous infusion of Lacosamide Tablets may cause bradycardia or AV blocks in these patients.

When switching from oral to intravenous Lacosamide Tablets, the initial total daily intravenous dosage regimen of Lacosamide Tablets should be equivalent to the dosage regimen of oral Lacosamide Tablets. The clinical study experience of intravenous Lacosamide Tablets is limited to 5 days of consecutive treatment. At the end of the intravenous treatment period, the patient may be switched to Lacosamide Tablets oral administration at the equivalent daily dosage and frequency of the intravenous administration.

Dosage Information In Patients With Renal Impairment

No dose adjustment is necessary in patients with mild to moderate renal impairment. A maximum dose of 300 mg per day Lacosamide Tablets is recommended for patients with severe renal impairment [creatinine clearance (CLCR) less than or equal to 30 mL/min] and in patients with endstage renal disease. Lacosamide Tablets is effectively removed from plasma by hemodialysis. Following a 4-hour hemodialysis treatment, dosage supplementation of up to 50% should be considered. In all renally impaired patients, the dose titration should be performed with caution. Patients with renal impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to Lacosamide Tablets. Dose reduction may be necessary in these patients.

Dosage Information In Patients With Hepatic Impairment

The dose titration should be performed with caution in patients with hepatic impairment. A maximum dose of 300 mg per day is recommended for patients with mild or moderate hepatic impairment.

Lacosamide Tablets use is not recommended in patients with severe hepatic impairment. Patients with hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to Lacosamide Tablets. Dose reduction may be necessary in these patients.

Administration Instructions

Lacosamide Tablets may be taken with or without food.

Lacosamide Tablets

Oral Solution

A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device.

Lacosamide Tablets Injection

Lacosamide Tablets injection can be administered intravenously without further dilution or may be mixed with diluents listed below. The diluted solution should not be stored for more than 4 hours at room temperature.

Diluents:

Sodium Chloride Injection 0.9% (w/v)

Dextrose Injection 5% (w/v)

Lactated Ringer's Injection

Product with particulate matter or discoloration should not be used. Any unused portion of Lacosamide Tablets injection should be discarded.

How supplied

Dosage Forms And Strengths

• 50 mg (pink), 100 mg (dark yellow), 150 mg (salmon), and 200 mg (blue) film-coated tablets
• 200 mg/20 mL injection
• 10 mg/mL oral solution

Storage And Handling

Lacosamide Tablets (Lacosamide Tablets) Tablets 50 mg are pink, oval, film-coated tablets debossed with “SP” on one side and “50” on the other. They are supplied as follows:

Bottles of 60 NDC 0131-2477-35

Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 0131-2477-60

Lacosamide Tablets (Lacosamide Tablets) Tablets 100 mg are dark yellow, oval, film-coated tablets debossed with “SP” on one side and “100” on the other. They are supplied as follows:

Bottles of 60 NDC 0131-2478-35

Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 0131-2478-60

Lacosamide Tablets (Lacosamide Tablets) Tablets 150 mg are salmon, oval, film-coated tablets debossed with “SP” on one side and “150” on the other. They are supplied as follows:

Bottles of 60 NDC 0131-2479-35

Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 0131-2479-60

Lacosamide Tablets (Lacosamide Tablets) Tablets 200 mg are blue, oval, film-coated tablets debossed with “SP” on one side and “200” on the other. They are supplied as follows:

Bottles of 60 NDC 0131-2480-35

Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 0131-2480-60

Lacosamide Tablets (Lacosamide Tablets) injection 200 mg/20 mL is a clear, colorless sterile solution supplied in 20 mL colorless single-use glass vials.

200 mg/20 mL vial in cartons of 10 vials NDC 0131-1810-67

Lacosamide Tablets (Lacosamide Tablets) oral solution 10 mg/mL is a clear, colorless to yellow or yellow-brown, strawberry-flavored liquid. It is supplied in PET bottles as follows:

200 mL bottles NDC 0131-5410-71

465 mL bottles NDC 0131-5410-70

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Do not freeze Lacosamide Tablets injection or oral solution. Discard any unused Lacosamide Tablets oral solution remaining after seven (7) weeks of first opening the bottle.

Manufactured for UCB, Inc. Smyrna, GA 30080. Revised June 2015.

See also:
What is the most important information I should know about Lacosamide Tablets?

You should not use this medication if you are allergic to Lacosamide Tablets.

Before you take Lacosamide Tablets, tell your doctor if you have kidney disease, liver disease, nerve problems caused by diabetes, or a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), heart failure, or other severe heart disorder.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Keep track of the amount of medicine used from each new bottle. Lacosamide Tablets is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Use Lacosamide Tablets solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Lacosamide Tablets solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lacosamide Tablets solution refilled.
• Take Lacosamide Tablets solution by mouth with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Taking Lacosamide Tablets solution at the same time each day will help you remember to take it.
• Continue to take Lacosamide Tablets solution even if you feel well. Do not miss any doses.
• Do not suddenly stop taking Lacosamide Tablets solution. You may have an increased risk of seizures. If you need to stop Lacosamide Tablets solution, your doctor will gradually lower your dose.
• If you miss a dose of Lacosamide Tablets solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lacosamide Tablets solution.

Lacosamide Tablets is used to prevent and control seizures. It is an anticonvulsant or antiepileptic drug. It works by reducing the spread of seizure activity in the brain.

How to use Lacosamide Tablets

Read the Medication Guide provided by your pharmacist before you start taking Lacosamide Tablets and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually twice a day with or without food.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

Dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.

Do not stop taking this medication without consulting your doctor. Seizures may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Consult your doctor or pharmacist for more details.

Though it is very unlikely to occur, this medication can result in abnormal drug-seeking behavior (addiction/habit-forming). Do not increase your dose, take it more frequently, or use it for a longer period of time than prescribed. Properly stop this medication when so directed. This will lessen the chances of becoming addicted.

Tell your doctor right away if your seizure control worsens (such as the number of seizures increases).

See also:
What other drugs will affect Lacosamide Tablets?

Lacosamide Tablets should be used with caution in patients treated with medicinal products known to be associated with PR prolongation (eg, carbamazepine, lamotrigine, pregabalin) and in patients treated with class I antiarrhythmic drugs. However, subgroup analysis did not identify an increased magnitude of PR prolongation in patients with concomitant administration of carbamazepine or lamotrigine in clinical trials.

In vitro Data: Data generally suggest that Lacosamide Tablets has a low interaction potential. In vitro studies indicate that the enzymes CYP1A2, 2B6, and 2C9 are not induced and that CYP1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2D6, and 2E1 are not inhibited by Lacosamide Tablets at plasma concentrations observed in clinical trials. An in vitro study indicated that Lacosamide Tablets is not transported by P-glycoprotein in the intestine.

In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of the O-desmethyl metabolite.

In vivo Data: Lacosamide Tablets does not inhibit or induce the enzyme CYP2C19 and CYP3A4 to a clinically relevant extent.

Lacosamide Tablets did not affect the AUC of midazolam (metabolized by CYP3A4, Lacosamide Tablets given 200 mg b.i.d.) but C_max of midazolam was slightly increased (30%). Lacosamide Tablets did not affect the pharmacokinetics of omeprazole (metabolised by CYP2C19 and 3A4, Lacosamide Tablets given 300 mg b.i.d.).

The CYP2C19 inhibitor omeprazole (40 mg q.d.) did not give rise to a clinically significant change in Lacosamide Tablets exposure. Thus, moderate inhibitors of CYP2C19 are unlikely to affect systemic Lacosamide Tablets exposure to a clinically relevant extent.

Caution is recommended in concomitant treatment with strong inhibitors of CYP2C9 (eg, fluconazole) and CYP3A4 (eg, itraconazole, ketoconazole, ritonavir, clarithromycin), which may lead to increased systemic exposure of Lacosamide Tablets. Such interactions have not been established in vivo but are possible based on in vitro data.

Strong enzyme inducers such as rifampicin or St. John's wort (Hypericum perforatum) may moderately reduce the systemic exposure of Lacosamide Tablets. Therefore, starting or ending treatment with these enzyme inducers should be done with caution.

Antiepileptic Drugs: In interaction trials, Lacosamide Tablets did not significantly affect the plasma concentrations of carbamazepine and valproic acid. Lacosamide Tablets plasma concentrations were not affected by carbamazepine and by valproic acid. A population pharmacokinetic analysis estimated that concomitant treatment with other antiepileptic drugs known to be enzyme inducers (carbamazepine, phenytoin, phenobarbital, in various doses) decreased the overall systemic exposure of Lacosamide Tablets by 25%.

Oral Contraceptives:

Others: Interaction trials showed that Lacosamide Tablets had no effect on the pharmacokinetics of digoxin. There was no clinically relevant interaction between Lacosamide Tablets and metformin.

No data on the interaction of Lacosamide Tablets with alcohol are available.

Lacosamide Tablets has a low protein-binding of less than 15%. Therefore, clinically relevant interactions with other drugs through competition for protein-binding sites are considered unlikely.

Incompatibilities: Tablet: Not applicable.

Solution for Infusion: Lacosamide Tablets must not be mixed with other medicinal products except those mentioned in Cautions for Usage.

See also:
What are the possible side effects of Lacosamide Tablets?

Based on the analysis of pooled placebo-controlled clinical trials in 1,308 patients with partial-onset seizures, a total of 61.9% of patients randomized to Lacosamide Tablets and 35.2% of patients randomized to placebo reported at least 1 adverse reaction. The most frequently reported adverse reactions with Lacosamide Tablets treatment were dizziness, headache, nausea and diplopia. They were usually mild to moderate in intensity. Some were dose-related and could be alleviated by reducing the dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reactions usually decreased over time.

Over all controlled studies, the discontinuation rate due to adverse reactions was 12.2% for patients randomized to Lacosamide Tablets and 1.6% for patients randomized to placebo. The most common adverse reaction resulting in discontinuation of Lacosamide Tablets therapy was dizziness.

Incidence of CNS adverse reactions eg, dizziness may be higher after a loading dose.

The table shows the frequencies of adverse reactions which have been reported in pooled placebo-controlled clinical trials (with an incidence rate ≥1% in the Lacosamide Tablets group and which are >1% more than placebo) and post-marketing experience. The frequencies are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

In clinical trials in epilepsy patients, the incidence rate of reported first degree AV block is uncommon, 0.7%, 0%, 0.5% and 0% for Lacosamide Tablets 200 mg, 400 mg, 600 mg or placebo, respectively. No second or higher degree AV block was seen Lacosamide Tablets treated patients.

The incidence rate for syncope is uncommon and did not differ between Lacosamide Tablets-treated epilepsy patients (0.1%) and placebo-treated epilepsy patients (0.3%).

Atrial fibrillation or flutter were not reported in short-term clinical trials; however both have been reported in open-label epilepsy trials and in post-marketing experience.

Laboratory Abnormalities: Abnormalities in liver function tests have been observed in controlled trials with Lacosamide Tablets in adult patients with partial-onset seizures who were taking 1-3 concomitant antiepileptic drugs. Elevations of ALT to ≥3 x upper limit of normal (ULN) occurred in 0.7% (7/935) of Lacosamide Tablets patients and 0% (0/356) of placebo patients.

Multiorgan Hypersensitivity Reactions:

Lacosamide Tablets is a functionalized amino acid that has activity in the maximal electroshock seizure test, and is indicated for the adjunctive treatment of partial-onset seizures and diabetic neuropathic pain. Recent studies indicate that Lacosamide Tablets only affects those neurons which are depolarized or active for long periods of time, typical of neurons at the focus of an epileptic seizure, as opposed to other antiepileptic drugs such as carbamazepine or lamotrigine which slow the recovery from inactivation and reduce the ability of neurons to fire action potentials.