Topmate 25mg Tablet 1 Strip

✔️ Side Effects

Common:
Nausea, abdominal pain, dyspepsia, diarrhea, dry mouth, weight loss, paraesthesia, hypoaesthesia, fatigue, headache, dizziness, speech disorder, insomnia, impaired memory and concentration, depression, anxiety, and visual disturbances.

Less Common:
Suicidal ideation, metabolic acidosis, alopecia, taste disturbances, and reduced sweating in children.

Rare:
Leucopenia, thrombocytopenia, and serious skin reactions.

✔️ Dosage & Administration

Epilepsy: Monotherapy

Adults and children over 16 years:

• Start with 25 mg nightly for 1 week.
• Increase dosage at 1- or 2-week intervals by 25-50 mg/day, divided into two doses.
• The initial target dose is 100 mg/day, with a maximum recommended dose of 400 mg/day.

Children aged 6–16 years:

• Begin with 0.5–1 mg/kg nightly during the first week.
• Increase dosage by 0.5–1 mg/kg/day at 1- or 2-week intervals, divided into two doses.
• The target dose is 3–6 mg/kg/day, though higher doses up to 16 mg/kg/day have been occasionally used.

Epilepsy: Adjunctive Therapy

Adults and children over 16 years:

• The minimum effective dose is 200 mg/day.
• Typical dose range: 200–400 mg/day, divided into two doses.
• Some patients may need up to 800 mg/day (maximum recommended).

Children aged 2–16 years:

• Recommended dose: 5–9 mg/kg/day, divided into two doses.
• Start with 25 mg nightly for the first week.
• Increase dosage by 1–3 mg/kg/day at 1- or 2-week intervals to achieve optimal response.
• Doses up to 30 mg/kg/day have been studied and were generally well tolerated.

Migraine Prophylaxis

Adults and children over 16 years:

• Start with 25 mg nightly for 1 week.
• Increase dosage by 25 mg/day at 1-week intervals.
• The recommended daily dose is 100 mg/day, divided into two doses.
• Some patients may benefit from a lower dose of 50 mg/day.

Children under 16 years:

• Topiramate has not been studied for migraine prophylaxis in this age group.

✔️ Interaction

• Antiepileptic Drugs (AEDs):
  Topmate generally does not affect the plasma concentrations of phenytoin, carbamazepine, valproic acid, phenobarbital, or primidone. However, in some cases, it may increase phenytoin plasma concentrations.
• CNS Depressants:
  Use with caution alongside alcohol or other CNS depressants due to additive sedative effects.
• Oral Contraceptives:
  Topmate increases the clearance of the estrogenic component of combined oral contraceptives, potentially reducing contraceptive efficacy. Use alternatives with at least 50 μg of estrogen or non-hormonal contraceptives.
• Lithium:
  Lithium pharmacokinetics may be affected at high doses of Topmate (up to 600 mg/day). Monitoring lithium levels is recommended.
• Hydrochlorothiazide (HCTZ):
  Co-administration may result in significant decreases in serum potassium.
• Metformin:
  Topmate reduces metformin clearance; clinical implications are unclear. Monitor diabetic control when either drug is added or withdrawn.
• Pioglitazone/Glibenclamide:
  Monitor diabetic control when combined with Topmate.
• Other Agents:
  The use of Topmate with nephrolithiasis-inducing agents increases the risk of kidney stones.
• Valproic Acid:
  Concomitant use can cause hyperammonemia (with or without encephalopathy).

✔️ Contraindications

• Hypersensitivity to any component of Topmate.

✔️ Overdose Effects

• Symptoms: Severe metabolic acidosis.
• Management:
  • Recent ingestion: Gastric lavage or induced emesis.
  • Activated charcoal can adsorb Topmate.
  • Hemodialysis effectively removes the drug.
  • Supportive measures and hydration are recommended.

✔️ Pregnancy & Lactation

• Avoid use during pregnancy unless the benefit outweighs the risks.
• Avoid use during breastfeeding.

✔️ Precautions & Warnings

• Gradual withdrawal is recommended to avoid seizure rebound.
• Patients may experience drowsiness, visual disturbances, or blurred vision.
• Caution against driving or operating machinery if affected.

✔️ Storage Conditions

• Store below 30°C, protected from light and moisture.
• Keep out of reach of children.