Conviban 50 mg 30 tablets
Marcyrl Pharmaceutical Industries
Marcyrl Pharmaceutical Industries
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.