Prescribing Details
Description
Conva is a preparation of Lacosamide which selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing.
Uses
No Data
Indications
Conva is indicated for the treatment of-
• Partial-onset seizure in patients 1 month of age and older.
• As adjunctive therapy in the treatment of primary generalized tonic-clonic seizure in patients 4
years of age and older.
Dosage and administration
Route of administration: Conva should be taken in oral route with or without food.
Recommended dosages for partial-onset seizures (Monotherapy or Adjunctive Therapy) in patients 1 month and older and for primary generalized tonic-clonic seizures (Adjunctive Therapy) in patients 4 years of age and older*
| Age and weight | Initial dose | Dose titration | Maintenance Dose |
|---|---|---|---|
| Adults (17 years and older) | Monotherapy**: 100 mg twice daily (200 mg/day) Adjunctive Therapy: 50 mg twice daily (100 mg/day) |
Increase by 50 mg twice daily (100 mg/day) every week | Monotherapy**: 150–200 mg twice daily (300–400 mg/day) Adjunctive Therapy: 100–200 mg twice daily (200–400 mg/day) |
| Pediatric patients weighing at least 50 kg | 50 mg twice daily (100 mg/day) | Increase by 50 mg twice daily (100 mg/day) every week | Monotherapy**: 150–200 mg twice daily (300–400 mg/day) Adjunctive Therapy: 100–200 mg twice daily (200–400 mg/day) |
| Pediatric patients weighing 30 kg to less than 50 kg | 1 mg/kg twice daily (2 mg/kg/day) | Increase by 1 mg/kg twice daily (2 mg/kg/day) every week | 2–4 mg/kg twice daily (4–8 mg/kg/day) |
| Pediatric patients weighing 11 kg to less than 30 kg and 6 kg to less than 11± |
3–6 mg/kg twice daily (6–12 mg/kg/day) | ||
| Pediatric patients weighing less than 6 kg± | 3.75–7.5 mg/kg twice daily (7.5–15 mg/kg/day) |
*When not specified, the dosage is the same for monotherapy and adjunctive therapy.
**Monotherapy for partial-onset seizures only.
± Indicated only for partial-onset seizures.
Hepatic impairment
For patients with mild or moderate hepatic impairment, a reduction of 25% of the maximum dose is recommended. Conva is not recommended in patients with severe hepatic impairment.
Renal impairment
For patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end stage renal disease, a reduction of 25% of the maximum dosage is recommended. In patients on hemodialysis, following a 4 hours hemodialysis treatment, dosage supplementation of up to 50% should be considered.
Use in pregnancy & lactation
Pregnancy: There are no adequate well controlled studies of the use of Iacosamide in pregnant women.
Lactation: Lacosamide is excreted through breast milk. There is no information on the effects of lacosamide on milk production. Monitor infants exposed to lacosamide through breast milk.
Use in children and adolescents
Safety and effectiveness in children and adolescents have been described in dose and administration section.
Geriatric use
Precautions
Antiepileptic drugs (AEDs), including lacosamide, increase the risk of suicidal thoughts in patients. It may cause dizziness and ataxia in adult and pediatric patients. As with all AEDs, lacosamide should be withdrawn gradually (over a minimum of 1 week) to minimize the potential of increased seizure frequency in patients with seizure disorders. Caution should be taken in patients with phenylketonuria.
Side effects
The most common side effects are diplopia, headache, nausea and somnolence.
Contraindications
It is contraindicated in patients with known hypersensitivity to lacosamide or any other components of this product.
Drug interactions
Drug interaction with medication: For patients who are already on a single antiepileptic drug and will convert to lacosamide monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of lacosamide is achieved and has been administered for at least 3 days. A gradual withdrawal of the concomitant AED over at least 6 weeks is recommended. Dose reduction may be necessary in patients with renal or hepatic impairment who are taking strong CYP3A4 and CYP2C9 inhibitors. Caution should be taken in concomitant use with drugs that affect cardiac conduction including those that prolong PR interval.
Drug interaction with food and others: Not applicable.
Overdose
In case of overdose, dizziness, nausea and seizures may occur. Proper monitoring and general supportive measures should be initiated.
Preparation
No Data
Pharmaceutical precautions
No Data
Presentation
Conva 50 tablet: Each coated tablet contains Lacosamide BP 50 mg.
Conva 100 tablet: Each coated tablet contains Lacosamide BP 100 mg.
Package quantities
Storage
Store below 30°C in a dry place, protected from light. Keep away from the reach of children.
Packing
Conva 50 tablet: Carton of 30 tablets in blister pack.
Conva 100 tablet: Carton of 30 tablets in blister pack.
