Generic Name: Lacosamide Tablet 50/100/200 mg and solution.
Therapeutics Category: Anticonvulsant
Pharmacological Class: Sodium channel inhibitors.
Composition: Each Film-coated tablet contains Lacosamide 50 mg/ 100 mg/ 200 mg/ 15mg/ml Solution.
Pregnancy Category: C
1. What is Lacofit?
Lacofit contains lacosamide 50/100/200 mg tablets and 15mg/ ml solution form.
2. What is it used for?
Lacosamide is indicated for
– Partial onset seizure
– Primary generalized tonic -clonic seizure
– Neuropathic pain in adults
– Refractory epilepsy in children
3. How does it works?
The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a functionalized amino acid. The precise mechanism by which lacosamide exerts its antiepileptic effect in humans remains to be fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyper excitable neuronal membranes.
4. How to take Lacosamide?
Partial Onset Seizures
Indicated as monotherapy or adjunctive therapy for partial onset seizures
• 100 mg PO/IV q12hr initially, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended dose of 150-200 mg BID (300-400 mg/day) OR
• Alternate initial loading dose schedule: 200 mg PO/IV as a single loading dose, followed 12 hr later by 100 mg PO/IV BID; THEN increase dose at weekly intervals by 50 mg BID; up to a recommended dose of 150-200 mg BID (300-400 mg/day)
• Initial: 50 mg PO/IV q12hr
Based on response and tolerability, increase dose at weekly intervals by 50 mg
Primary Generalized Tonic-Clonic Seizures
Indicated as adjunctive therapy for primary generalized tonic-clonic seizures
Initial: 50 mg PO/IV q12hr
Based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended dose of 100-200 mg BID (200-400 mg/day)
• PO/IV BID; up to a recommended dose of 100-200 mg BID (200-400 mg/day)
5. What if you miss the dose?
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
6. What to do in case of over dose?
Contact your health care professional or go to the nearest hospital emergency unit immediately.
7. What do you need to know before you take Lacofit?
Do not take Lacofit
If hypersensitivity to the active substance or to any of the excipients.
If known second- or third-degree atrioventricular (AV) block.
8. Warning and Precautions
Before taking, Lacosamide, tell your healthcare professional if you have
Suicidal ideation and behavior
Cardiac rhythm and conduction
Potential for new onset or worsening of myoclonic seizures
Potential for electro-clinical worsening in specific pediatric epilepsy syndromes
9. Lacosamide and Other Medications
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
10. Pregnancy and breast- feeding
Lacosamide should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus). If women decide to become pregnant, the use of this product should be carefully re-evaluated.
It is unknown whether lacosamide is excreted in human breast milk. A risk to the newborns/infants cannot be excluded. Animal studies have shown excretion of lacosamide in breast milk. For precautionary measures, breast-feeding should be discontinued during treatment with lacosamide.
11. Driving and using machines
Patients should be advised not to drive or to operate other potentially hazardous machinery until they are familiar with the effects of lacosamide on their ability to perform such activities.
12. What are the possible side effects?
The most frequently reported adverse reactions (≥ 10 %) with lacosamide treatment were dizziness, headache, nausea and diplopia.