Laxovel (Tablets) Instructions for Use

Marketing Authorization Holder

Elzapharm, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

ATC Code

N03AX18 (Lacosamide)

Active Substance

Lacosamide (Rec.INN registered by WHO)

Dosage Forms

	Laxovel	Film-coated tablets 50 mg: 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 84, 90, 98, 100, 112, 126 or 140 pcs.
		Film-coated tablets 100 mg: 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 84, 90, 98, 100, 112, 126 or 140 pcs.
		Film-coated tablets 150 mg: 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 84, 90, 98, 100, 112, 126 or 140 pcs.
		Film-coated tablets 200 mg: 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 84, 90, 98, 100, 112, 126 or 140 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink in color, round, biconvex; the core on the cross-section is white, almost white, or light yellow.

Excipients: microcrystalline cellulose PH102, low-substituted hydroxypropyl cellulose, silicified microcrystalline cellulose, crospovidone, magnesium stearate, hydroxypropyl cellulose.

Film coating composition: dry mix for film coating containing polyvinyl alcohol, titanium dioxide, macrogol, talc, carmine (E120), iron oxide yellow dye (E172), or polyvinyl alcohol, titanium dioxide, macrogol 4000 (polyethylene glycol 4000, polyethylene oxide 4000), talc, carmine (E120), iron oxide yellow dye (E172).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (7) – cardboard packs.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
14 pcs. – contour cell packaging (1) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (3) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – contour cell packaging (5) – cardboard packs.
14 pcs. – contour cell packaging (6) – cardboard packs.
14 pcs. – contour cell packaging (7) – cardboard packs.
14 pcs. – contour cell packaging (8) – cardboard packs.
14 pcs. – contour cell packaging (9) – cardboard packs.
14 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Film-coated tablets from light yellow to yellow in color, round, biconvex; the core on the cross-section is white, almost white, or light yellow.

Excipients: microcrystalline cellulose PH102, low-substituted hydroxypropyl cellulose, silicified microcrystalline cellulose, crospovidone, magnesium stearate, hydroxypropyl cellulose.

Film coating composition: dry mix for film coating containing polyvinyl alcohol, titanium dioxide, macrogol, talc, iron oxide yellow dye (E172), or polyvinyl alcohol, titanium dioxide, macrogol 4000 (polyethylene glycol 4000, polyethylene oxide 4000), talc, iron oxide yellow dye (E172).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (7) – cardboard packs.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
14 pcs. – contour cell packaging (1) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (3) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – contour cell packaging (5) – cardboard packs.
14 pcs. – contour cell packaging (6) – cardboard packs.
14 pcs. – contour cell packaging (7) – cardboard packs.
14 pcs. – contour cell packaging (8) – cardboard packs.
14 pcs. – contour cell packaging (9) – cardboard packs.
14 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Film-coated tablets light orange in color, round, biconvex; the core on the cross-section is white, almost white, or light yellow.

Excipients: microcrystalline cellulose PH102, low-substituted hydroxypropyl cellulose, silicified microcrystalline cellulose, crospovidone, magnesium stearate, hydroxypropyl cellulose.

Film coating composition: dry mix for film coating containing polyvinyl alcohol, titanium dioxide, macrogol, talc, sunset yellow FCF aluminum lake dye (E110), iron oxide red dye (E172), or polyvinyl alcohol, titanium dioxide, macrogol 4000 (polyethylene glycol 4000, polyethylene oxide 4000), talc, sunset yellow FCF aluminum lake dye (E110), iron oxide red dye (E172).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (7) – cardboard packs.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
14 pcs. – contour cell packaging (1) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (3) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – contour cell packaging (5) – cardboard packs.
14 pcs. – contour cell packaging (6) – cardboard packs.
14 pcs. – contour cell packaging (7) – cardboard packs.
14 pcs. – contour cell packaging (8) – cardboard packs.
14 pcs. – contour cell packaging (9) – cardboard packs.
14 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Film-coated tablets white or almost white in color, round, biconvex; the core on the cross-section is white, almost white, or light yellow.

Excipients: microcrystalline cellulose PH102, low-substituted hydroxypropyl cellulose, silicified microcrystalline cellulose, crospovidone, magnesium stearate, hydroxypropyl cellulose.

Film coating composition: dry mix for film coating containing polyvinyl alcohol, titanium dioxide, macrogol, talc, or polyvinyl alcohol, titanium dioxide, macrogol 4000 (polyethylene glycol 4000, polyethylene oxide 4000), talc, titanium dioxide.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (7) – cardboard packs.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
14 pcs. – contour cell packaging (1) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (3) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – contour cell packaging (5) – cardboard packs.
14 pcs. – contour cell packaging (6) – cardboard packs.
14 pcs. – contour cell packaging (7) – cardboard packs.
14 pcs. – contour cell packaging (8) – cardboard packs.
14 pcs. – contour cell packaging (9) – cardboard packs.
14 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Anticonvulsant drug

Pharmacotherapeutic Group

Antiepileptic drugs; other antiepileptic drugs

Pharmacological Action

Antiepileptic drug. In electrophysiological studies, Lacosamide has been shown to selectively enhance the slow inactivation of voltage-gated sodium channels, which leads to a reduction in the hyperexcitability of neuronal membranes.

Moreover, Lacosamide has the potential to interact with the collapsin response mediator protein-2 (CRMP-2), a phosphoprotein that is expressed mainly in the nervous system and is involved in neuronal differentiation processes and the control of axonal growth.

Pharmacokinetics

After oral administration, Lacosamide is rapidly and completely absorbed from the gastrointestinal tract. T_max is approximately 0.5-4 hours. After intravenous administration, C_max is reached at the end of the infusion. V_d is about 0.6 L/kg. Plasma protein binding is less than 15%.

It is metabolized in the liver with the participation of the CYP2C19 isoenzyme to form a pharmacologically inactive O-desmethyl metabolite. An interaction study with omeprazole (a CYP2C19 inhibitor) showed no clinically significant changes in the plasma concentration of lacosamide, so the significance of this metabolic pathway is minimal.

T_1/2 is about 13 hours. It is excreted in the urine unchanged (about 40%), as the O-desmethyl metabolite (less than 30%) and other metabolites; less than 0.5% is found in feces.

Indications

As adjunctive therapy for the treatment of partial-onset epileptic seizures with or without secondary generalization in patients with epilepsy aged 16 years and older.

ICD codes

Dosage Regimen

Administer Laxovel orally twice daily, with or without food.

Initiate therapy at a starting dose of 50 mg twice daily (100 mg total daily dose).

Increase the dose based on individual patient response and tolerability to achieve effective seizure control.

Titrate the dose at weekly intervals by increasing the twice-daily dose by 50 mg increments.

The recommended maintenance dose is 100 mg to 200 mg twice daily (200 mg to 400 mg total daily dose).

Do not exceed the maximum recommended daily dose of 400 mg (200 mg twice daily).

Monitor patients for adverse reactions, such as dizziness and coordination disturbances, particularly during dose titration.

Exercise caution in patients with known cardiac conduction problems or severe cardiac disease.

Discontinue Laxovel therapy gradually over a minimum of one week to minimize the potential for increased seizure frequency.

For patients with severe renal impairment (CrCl ≤30 mL/min) or end-stage renal disease, a maximum dose of 300 mg daily is recommended.

In patients with mild to moderate hepatic impairment, do not exceed a maximum daily dose of 300 mg.

Avoid use in patients with severe hepatic impairment due to lack of data.

Swallow tablets whole with a glass of water; do not chew or crush.

Adverse Reactions

From the central and peripheral nervous system: dizziness, headache, impaired coordination, drowsiness, tremor, nystagmus, memory impairment, cognitive disorders, depression, hypoesthesia, dysarthria, impaired concentration.

From the digestive system: nausea, vomiting, constipation, flatulence, dyspepsia, dry mouth.

From the cardiovascular system: PR interval prolongation, AV block, syncope, bradycardia.

From the sensory organs: labyrinthine vertigo, diplopia, blurred vision, tinnitus.

Other: asthenia, gait disturbance, weakness, skin abrasions, increased trauma, skin itching, muscle spasms.

Contraindications

Second- and third-degree AV block, hypersensitivity to lacosamide.

Use in Pregnancy and Lactation

The use of lacosamide during pregnancy is not recommended, except in cases of extreme necessity, when the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

If it is necessary to use lacosamide during lactation, the issue of discontinuing breastfeeding should be considered.

Special Precautions

When using antiepileptic drugs, including Lacosamide, the risk of suicidal attempts and suicidal behavior increases, regardless of the indications for which the drug is used.

Effect on ability to drive vehicles and operate machinery

During the treatment period, patients should avoid driving vehicles and engaging in other potentially hazardous activities, as Lacosamide may cause dizziness and diplopia.

Drug Interactions

Lacosamide should be used with caution in patients receiving drugs that can cause PR interval prolongation (including carbamazepine, lamotrigine, pregabalin) and in patients receiving class I antiarrhythmic drugs.

With simultaneous use with inducers of liver microsomal enzymes (carbamazepine, phenytoin, phenobarbital in various doses), a 25% decrease in the AUC of lacosamide was noted.

With simultaneous use of lacosamide with 1-3 antiepileptic drugs in patients, impaired liver function tests (increased activity of liver transaminases) were observed.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.