Conviban 50 mg 30 tablets

Conviban 50 mg 30 tablets

Composition:
One tablet contains:
Topiramate 50 mg.
Full list of excipients:
Lactose monohydrate (13.75 mg per tablet), Microcrystalline cellulose PH101, Copovidone VA64, Croscarmellose sodium, Pregelatinized starch, Magnesium stearate, Ethanol, HPMC, Titanium dioxide, Talc, PEG-6000, Sunset Yellow.
Description:
An antiepileptic medicinal product (AED) used for monotherapy or adjunctive treatment of partial and generalized seizures, including Lennox-Gastaut syndrome.
In adults, it is also indicated for migraine prophylaxis (not for acute treatment).
Indications:
Monotherapy (adults, adolescents, children >6 years):
- Partial seizures with or without secondary generalisation
- Primary generalized tonic-clonic seizures.
Adjunctive therapy (children ≥2 y, adolescents, adults):
- Partial onset seizures with or without secondary generalisation
- Primary generalized tonic-clonic seizures
- Seizures associated with Lennox-Gastaut syndrome.
Adults:
- Prophylaxis of migraine headache after evaluation of alternatives.
Dosage and Method of Administration:
General principles:
- Start with a low dose and titrate gradually.
- Dose adjustments should be guided by clinical response.
- Plasma level monitoring is not required.
- Tablets must be swallowed whole and must not be broken.
- May be taken with or without food.
Monotherapy for Epilepsy:
Adults:
- Initiation: 25 mg nightly for 1 week.
- Titration: Increase by 25-50 mg/day every 1-2 weeks.
- Target dose: 100-200 mg/day, divided twice daily.
- Maximum dose: 500 mg/day (up to 1000 mg/day tolerated in refractory cases).
Children ≥6 years:
- Initiation: 0.5-1 mg/kg nightly for 1 week.
- Titration: Increase by 0.5-1 mg/kg/day every 1-2 weeks (in 2 divided doses).
- Target dose: Approximately 100 mg/day (~2 mg/kg/day).
Adjunctive Therapy for Epilepsy:
Adults:
- Initiation: 25-50 mg nightly for 1 week.
- Titration: Increase by 25-50 mg/day every 1-2 weeks.
- Effective dose range: 200-400 mg/day, divided doses.
- Some patients may use once-daily dosing.
Children ≥2 years:
- Recommended total dose: 5-9 mg/kg/day, divided twice daily.
- Initiation: 25 mg nightly (or 1-3 mg/kg/day).
- Titration: Increase by 1-3 mg/kg/day every 1-2 weeks.
- Doses up to 30 mg/kg/day have been studied and tolerated.
Migraine Prophylaxis (Adults):
- Recommended total daily dose: 100 mg/day, in 2 divided doses.
- Initiation: 25 mg nightly for 1 week.
- Titration: Increase by 25 mg/day weekly.
- Some patients benefit from 50 mg/day.
- Doses up to 200 mg/day were used, but adverse effects increase with higher doses.
Contraindications:
- Hypersensitivity to topiramate or any excipients
- Migraine prophylaxis during pregnancy
- Migraine prophylaxis in women of childbearing potential without highly effective contraception.
Precautions:
- Risk of increased seizure frequency when adjusting therapy.
- Ensure adequate hydration (risk of nephrolithiasis, heat-related adverse reactions, oligohidrosis).
- Mood disturbances and depression; monitor for suicidal ideation.
- Risk of metabolic acidosis; monitor bicarbonate levels if symptomatic.
- Acute myopia and secondary angle-closure glaucoma; urgent discontinuation if suspected.
- Visual field defects; usually reversible after stopping treatment.
- Weight loss may occur; consider dietary supplementation.
- Hyperammonemia ± encephalopathy, especially with valproic acid.
- Use in pregnancy carries increased risk of congenital malformations; crosses placenta.
- Contains lactose; contraindicated in rare hereditary disorders of carbohydrate metabolism.
Side Effects:
Very common: Anorexia, paraesthesia, somnolence, dizziness, fatigue, weight decreased.
Common:
- Depression, insomnia, mood changes, irritability, cognitive impairment, speech disturbances
- Blurred vision, diplopia
- Nausea, diarrhoea
- Decreased appetite
Uncommon/Rare/Not known:
- Suicidal ideation, hallucinations, agitation
- Oligohidrosis, hyperthermia
- Kidney stones
- Metabolic acidosis
- Visual field defects
- Stevens–Johnson syndrome, toxic epidermal necrolysis
- Hepatic failure
- Cardiac arrhythmias.
Pregnancy and Breastfeeding:
Pregnancy:
Contraindicated for migraine prophylaxis.
Increased risk of congenital malformations (oral clefts, hypospadias, growth restriction).
Use only if benefit outweighs risks.
Breastfeeding:
Topiramate is extensively excreted in human milk.
Reported infant effects: diarrhoea, irritability, somnolence, poor weight gain.
Decision required: discontinue breastfeeding or discontinue therapy.
Storage Conditions:
Store below 30°C.
Store in a cool, dry place, protected from direct sunlight.
Keep out of reach of children.
Packaging:
A carton box containing 3 blisters 10 tablets each and leaflet.