Lacomax 50 Tablet

Lacomax 50 Tablet is used for: Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures

Partial Onset Seizures Indicated as monotherapy or adjunctive therapy for partial-onset seizures Monotherapy 100 mg PO twice daily initially, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO BID; up to a recommended dose of 150-200 mg BID (300-400 mg/day) OR Alternate initial loading dose schedule: 200 mg PO as a single loading dose, followed 12 hr later by 100 mg PO BID; THEN increase dose at weekly intervals by 50 mg BID; up to maintenance dose of 150-200 mg BID (300-400 mg/day) Adjunctive therapy Initial: 50 mg PO twice daily Based on response and tolerability, increase dose at weekly intervals by 50 mg PO BID; up to maintenance dose of 100-200 mg BID (200-400 mg/day) Primary Generalized Tonic-Clonic Seizures Indicated as adjunctive therapy for primary generalized tonic-clonic seizures Initial: 50 mg PO twice daily Based on response and tolerability, increase dose at weekly intervals by 50 mg PO BID; up to maintenance dose of 100-200 mg BID (200-400 mg/day)

Partial Onset Seizures Indicated as monotherapy or adjunctive therapy for partial-onset seizures <1 month: Safety and efficacy not established 1 month to 17 years, <6 kg Oral: 1 mg/kg BID (2 mg/kg/day), THEN, based on response and tolerability, increase the dose at weekly intervals by 1 mg/kg BID (2 mg/kg/day), up to 3.75-7.5 mg/kg BID (7.5-15 mg/kg/day) Alternate initial dose: No loading dose, initiate 3.75 mg/kg PO BID 1 month to 17 years, 6 to <30 kg 1 mg/kg PO BID, THEN, based on response and tolerability, increase the dose at weekly intervals by 1 mg/kg PO BID, up to the recommended 3-6 mg/kg PO BID (6-12 mg/kg/day) Alternate initial dose: 4.5 mg/kg PO loading dose, THEN, 12 hr later initiate 3 mg/kg PO BID 1 month to 17 years, 30 to <50 kg 1 mg/kg PO BID, THEN, based on response and tolerability, increase the dose at weekly intervals by 1 mg/kg PO BID, up to the recommended 2-4 mg/kg PO BID (4-8 mg/kg/day) Alternate initial dose: 4 mg/kg PO loading dose, THEN, 12 hr later initiate 2 mg/kg PO BID 1 month to 17 years, >50 kg 50 mg PO BID, THEN, based on response and tolerability, increase the dose at weekly intervals by 50 mg PO BID, up to the recommended 150-200 mg PO BID (300-400 mg/day) for monotherapy or 100-200 mg PO BID (200-400 mg/day) for adjunctive therapy Alternate initial dose: 200 mg PO loading dose, THEN, 12 hr later initiate 2 mg/kg PO BID Primary Generalized Tonic-Clonic Seizures Indicated as adjunctive therapy for primary generalized tonic-clonic seizures <4 years: Safety and efficacy not established 4-17 years, 11 to <30 kg 1 mg/kg PO BID, THEN, based on response and tolerability, increase the dose at weekly intervals by 1 mg/kg PO BID, up to the recommended 3-6 mg/kg PO BID (6-12 mg/kg/day) Alternate initial dose: 4.5 mg/kg PO loading dose, THEN, 12 hr later initiate 3 mg/kg PO BID 4-17 years, 30 to <50 kg 1 mg/kg PO BID, THEN, based on response and tolerability, increase the dose at weekly intervals by 1 mg/kg PO/IV BID, up to the recommended 2-4 mg/kg PO BID (4-8 mg/kg/day) Alternate initial dose: 4 mg/kg PO loading dose, THEN, 12 hr later initiate 2 mg/kg PO BID 4-17 years, >50 kg 50 mg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID, up to the recommended 150-200 mg PO/IV BID (300-400 mg/day) for monotherapy or 100-200 mg PO/IV BID (200-400 mg/day) for adjunctive therapy Alternate initial dose: 200 mg PO/IV loading dose, THEN, 12 hr later initiate 2 mg/kg PO/IV BID

Renal impairment In all patients with renal impairment, base dose initiation and titration on clinical response and tolerability Mild to moderate (>30 mL/min): No dose adjustnt necessary Severe (CrCl <30 mL/min) or ESRD: Reduce maximum dosage by 25% Hemodialysis: Consider supplementing with up to 50% of dose after 4-hr dialysis session Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction

Take with or without food

Lacosamide may cause dizziness and ataxia Cardiac Rhythm and Conduction Abnormalities: Obtaining ECG before beginning and after titration to steady-state maintenance is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction; closely monitor these patients Lacosamide may cause syncope Lacosamide should be gradually withdrawn to minimize the potential of increased seizure frequency Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Multi-Organ Hypersensitivity: Discontinue if no alternate etiology Monitoring Parameters Monitor patients for suicidal behavior and ideation

Pregnancy Available data from NAAED pregnancy registry, a prospective cohort study, case reports, and a case series in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy Developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy Lactation Data from published literature indicate that lacosamide is present in human milk; there are reports of increased sleepiness in breastfed infants exposed to lacosamide; there is no information on effects of lacosamide on milk production Studies in lactating rats have shown excretion of lacosamide and/or its metabolites in milk Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition Monitor infants exposed to drugs through breastmilk for excess sedation

Patients with renal or hepatic impairment who are taking strong CYP3A4 and CYP2C9 inhibitors may have a significant increase in exposure to lacosamide; dose reduction may be necessary Concomitant medications that prolong PR interval Use with caution when administered concomitantly with medications that affect cardiac conduction, including sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers, and medications that prolong the PR interval; obtain an ECG before beginning therapy, and after titrating to steady-state maintenance dose, in such patients; closely monitor if intravenous route used to administer medication Obtain an ECG before initiating and after titrated to steady-state; additionally, monitor closely if administered IV Contraindicated (0) Serious - Use Alternative (9) apalutamide fexinidazole idelalisib ivosidenib metoclopramide intranasal olopatadine intranasal tucatinib voxelotor zuranolone

Side effects of Lacosamide : >10% Dizziness (16-53%) Diplopia (6-16%) Blurred vision (2-16%) Nausea (7-17%) Vomiting (6-16%) Fatigue (7-15%) Ataxia (11-14%) Nystagmus (2-10%) 1-10% Nystagmus (2-10%) Memory impairment (1-6%) Balance disorder (1-6%) Diarrhea (3-5%) Gait disturbance (<1-4%) Asthenia (1-3%) Vertigo (1-4%) Pruritus (2-3%) Depression (2%) Frequency Not Reported Blood and lymphatic system disorders: Neutropenia, anemia Cardiac disorders: Palpitations Ear and labyrinth disorders: Tinnitus Gastrointestinal disorders: Constipation, dyspepsia, dry mouth, oral hypoaesthesia General disorders and administration site conditions: Irritability, pyrexia, feeling drunk Injury, poisoning, and procedural complications: Fall Musculoskeletal and connective tissue disorders: Muscle spasms Nervous system disorders: Paresthesia, cognitive disorder, hypesthesia, dysarthria, disturbance in attention, cerebellar syndrome Psychiatric disorders: Confusional state, mood altered, depressed mood

Antiepileptic effects unknown; may slowly inactivate voltage-gated Na channels Binds to collapsin response mediator protein-2 (CRMP-2), a phosphoprotein that is expressed mainly in the nervous system and is involved in neuronal differentiation and control of axonal outgrowth

Lacomax 50 50 mg Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Lacosamide. Lacomax 50 is availble in Bangladesh. Farmaco BD drug index information on Lacomax 50 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.