IPRAMAX 100 MG 60 TABS

Indications

Approved Uses

Epilepsy (partial-onset seizures, primary generalized tonic-clonic seizures), Lennox-Gastaut syndrome, Prophylaxis of migraine headache.

Dosage & Administration

Dosing by Condition

Epilepsy (adults, adjunctive therapy): start 25-50 mg/day, increase by 25-50 mg/week; usual maintenance 200-400 mg/day in 2 divided doses. Migraine prophylaxis (adults): start 25 mg nightly, increase by 25 mg/week; target 100 mg/day in 2 divided doses. (Other seizure syndromes such as Lennox-Gastaut: weight-based maintenance ~5-9 mg/kg/day.)

How to Take

Swallow tablets whole with a glass of water. Can be taken with or without food. Do not crush or chew film-coated tablets

Side Effects

Common Side Effects

Paresthesia, fatigue, dizziness, somnolence, cognitive effects (difficulty with concentration/memory/word-finding), anorexia/decreased appetite, weight loss, nausea, diarrhea; visual disturbances (e.g., diplopia) can occur.

Side Effect Frequency

Very common (>10%): paresthesia, fatigue, dizziness, somnolence, decreased appetite/anorexia, weight loss, cognitive effects (e.g., attention/memory/word-finding difficulty). Common (1-10%): nausea, diarrhea/abdominal pain, ataxia, visual disturbance (e.g., diplopia/blurred vision), mood symptoms (e.g., depression/anxiety/insomnia). Uncommon/rare but clinically important: nephrolithiasis, metabolic acidosis, oligohidrosis/hyperthermia, acute angle-closure glaucoma, suicidal ideation

Safety & Warnings

Warnings & Precautions

Monitor for suicidal ideation/behavior; check serum bicarbonate for metabolic acidosis; ensure adequate hydration to reduce kidney stone risk; counsel to seek urgent care for acute visual symptoms (angle-closure glaucoma) and discontinue if suspected; monitor for decreased sweating/hyperthermia (especially children/hot weather); caution with valproate due to hyperammonemia/encephalopathy; warn about cognitive slowing; counsel on pregnancy prevention/teratogenic risk; taper gradually to discontinue.

Age Restriction

Epilepsy: approved for patients ≥2 years (as monotherapy or adjunct depending on indication); Migraine prophylaxis: approved for patients ≥12 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: carbonic anhydrase inhibitors (e.g., acetazolamide/zonisamide) ↑ metabolic acidosis/kidney stones; valproate ↑ risk of hyperammonemia/encephalopathy (± hypothermia); enzyme inducers (carbamazepine/phenytoin) ↓ topiramate levels; topiramate (especially ≥200 mg/day) may ↓ ethinyl estradiol exposure and reduce efficacy of estrogen OCs; CNS depressants/alcohol additive CNS effects; hydrochlorothiazide may ↑ topiramate levels; metformin-caution due to additive metabolic acidosis risk.

Interaction Severity

MAJOR/clinically significant: valproate (hyperammonemia/encephalopathy ± hypothermia), estrogen-containing oral contraceptives (reduced efficacy particularly at ≥200 mg/day), additive CNS effects with alcohol/CNS depressants. MODERATE: enzyme inducers (phenytoin/carbamazepine) can lower topiramate levels; hydrochlorothiazide can increase topiramate exposure; carbonic anhydrase inhibitors (acetazolamide/zonisamide) increase metabolic acidosis/nephrolithiasis risk; metformin increases acidosis risk. MINOR/variable: digoxin, lithium (monitor if used).

Food Interaction

No clinically meaningful food restriction; may be taken with or without food.

Special Populations

Pregnancy

Category D

Breastfeeding

Caution

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually under medical supervision (typically over at least 2-4 weeks when feasible).

Overdose

Symptoms: CNS depression (drowsiness/lethargy), speech disturbance, blurred vision/diplopia, impaired mentation, seizures/convulsions, and metabolic acidosis; Management: supportive care, consider GI decontamination if early, and hemodialysis can enhance removal in severe cases; seek emergency care.

Patient Counseling

Do not stop abruptly; titrate as directed. May cause dizziness/somnolence and cognitive slowing-avoid driving until effects known. Maintain good hydration to reduce kidney stone risk; seek care for decreased sweating/overheating. Report eye pain/vision changes urgently. Avoid alcohol/CNS depressants. Discuss pregnancy prevention/teratogenic risk and possible reduced hormonal contraceptive efficacy (notably at ≥200 mg/day). Do not crush/chew film-coated tablets.

Monitoring Requirements

Monitor serum bicarbonate (metabolic acidosis), renal function, weight, and mood/suicidality; assess promptly for ocular symptoms (acute myopia/angle-closure glaucoma) and consider serum ammonia if used with valproate or if encephalopathy suspected.

Pharmacology

Mechanism of Action

Blocks voltage-dependent sodium channels, enhances GABA-A activity, antagonizes AMPA/kainate glutamate receptors, and weakly inhibits carbonic anhydrase isoenzymes (e.g., II/IV).

Onset of Action

PK: peak concentrations ~2-3 hours after an IR dose; clinical benefit: seizure control and migraine prevention typically emerge over days to weeks and may take ~4-8 weeks for full migraine prophylaxis effect due to titration.

Duration of Effect

Immediate-release topiramate has an elimination half-life ~21 hours, but is commonly dosed twice daily for seizure control; once-daily dosing may be used in some patients/indications, while extended-release products allow once-daily dosing.

Half-Life

Approximately 21 hours (range ~19-23 hours) in adults with normal renal function

Bioavailability

Oral bioavailability is high, approximately ≥80%.

Metabolism

Minimal hepatic metabolism (~20%); most is excreted unchanged in urine, and enzyme-inducing antiepileptics can increase clearance; topiramate can induce CYP3A4 and inhibit CYP2C19 (clinically relevant at higher doses)

Excretion

Primarily renal elimination; about ~70% excreted unchanged in urine.

Protein Binding

Low protein binding: ~13-17% (generally cited as ~15%)

Product Information

Available Dosage Forms

For IPRAMAX (topiramate) per verified API data: film-coated tablet (oral). In general topiramate is also available in some markets as sprinkle capsules and extended-release capsules; an oral solution is not a standard commercial dosage form.

Composition per Dose

Each film-coated tablet: 100 mg topiramate

Generic Availability

Yes

Psych Class

Anticonvulsant

Controlled Substance

No

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