EPITAM 100/MG/1/ML SYRUP 150/ML

Indications

Approved Uses

Adjunctive therapy for partial-onset seizures (adults and pediatric patients ≥1 month); myoclonic seizures in juvenile myoclonic epilepsy (adults and adolescents ≥12 years); and primary generalized tonic-clonic seizures in idiopathic generalized epilepsy (adults and pediatric patients ≥6 years).

Dosage & Administration

Dosing by Condition

Adults (IR): Partial-onset seizures: start 500 mg twice daily; increase by 500 mg per dose every 2 weeks as needed; max 1500 mg twice daily (3000 mg/day). Myoclonic seizures (JME, ≥12 years): start 500 mg twice daily; titrate similarly to max 1500 mg twice daily. Primary generalized tonic-clonic seizures: start 500 mg twice daily; titrate similarly to max 1500 mg twice daily. Pediatrics (partial-onset): weight/age-based dosing (e.g., ~10 mg/kg twice daily with titration up to ~30 mg/kg twice daily in many children; younger infants may start lower such as ~7 mg/kg twice daily).

Initial Dose

500 mg twice daily (adults)

Maintenance Dose

1000 mg to 3000 mg per day, administered in two divided doses.

Maximum Dose

3000 mg/day (adults)

Children's Dosage

Dosing is weight-based and varies by age and indication. Partial-onset seizures (1 to 6 months): 7 mg/kg twice daily, may increase to 21 mg/kg twice daily. (6 months to 4 years): 10 mg/kg twice daily, may increase to 25 mg/kg twice daily. (4 to 16 years): 10 mg/kg twice daily, may increase to 30 mg/kg twice daily (max 3000mg/day).

Dose Adjustment Notes

Reduce dose in renal impairment based on creatinine clearance; in severe hepatic impairment (Child-Pugh C), dose reduction is recommended because renal clearance may be reduced; avoid abrupt discontinuation-taper gradually; titrate as clinically needed (often at ~2-week intervals).

How to Prepare

No reconstitution needed (ready-to-use syrup); shake gently before each dose and measure with a calibrated oral syringe/cup.

Side Effects

Common Side Effects

Somnolence, dizziness, asthenia/fatigue, headache; behavioral/psychiatric effects (irritability, agitation, aggression, mood changes); decreased appetite; gastrointestinal upset (nausea, vomiting, diarrhea); nasopharyngitis.

Side Effect Frequency

Very common (≥10%): somnolence, headache, nasopharyngitis. Common (1-10%): decreased appetite/anorexia, dizziness, lethargy/fatigue/asthenia, irritability/nervousness, aggression/hostility, anxiety, depression, insomnia, tremor, balance disorder/vertigo, GI upset (abdominal pain, nausea, vomiting, diarrhea, dyspepsia), rash; Uncommon/rare: psychosis/hallucinations, suicidal ideation/behavior, blood dyscrasias (e.g., thrombocytopenia/leukopenia), severe cutaneous reactions (SJS/TEN/DRESS), alopecia.

Safety & Warnings

Warnings & Precautions

Monitor for behavioral/psychiatric changes and suicidality; risk of serious skin reactions and hypersensitivity; adjust dose in renal impairment and monitor renal function (especially elderly); avoid abrupt discontinuation (taper); caution with concomitant CNS depressants/alcohol.

Age Restriction

Approved from 1 month of age for oral solution/syrup (indication- and region-dependent); solid oral forms typically from ≥4 years due to swallowing/administration considerations.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Levetiracetam has no clinically significant CYP-mediated pharmacokinetic interactions with most drugs/other ASMs; clinically relevant considerations include additive CNS depression with alcohol/sedatives and specific reported interactions such as methotrexate (possible reduced clearance) and probenecid affecting the inactive metabolite (usually not clinically significant).

Interaction Severity

Clinically significant pharmacokinetic drug-drug interactions are uncommon; caution with alcohol and other CNS depressants due to additive sedation/impairment; probenecid can increase exposure to the inactive metabolite; methotrexate clearance may be reduced when co-administered (monitor).

Food Interaction

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

Special Populations

Breastfeeding

Caution

Children

Dosing is weight-based and varies by age and indication. Partial-onset seizures (1 to 6 months): 7 mg/kg twice daily, may increase to 21 mg/kg twice daily. (6 months to 4 years): 10 mg/kg twice daily, may increase to 25 mg/kg twice daily. (4 to 16 years): 10 mg/kg twice daily, may increase to 30 mg/kg twice daily (max 3000mg/day).

Elderly

Start at lower end of dosing range; monitor renal function and adjust dose based on creatinine clearance; increased risk of somnolence and behavioral changes

Kidney Impairment

CrCl 50-79 mL/min: 500-1000 mg q12h; CrCl 30-49 mL/min: 250-750 mg q12h; CrCl <30 mL/min: 250-500 mg q12h; ESRD on dialysis: 500-1000 mg q24h plus 250-500 mg supplemental post-dialysis.

Storage & Patient Advice

Storage Conditions

Do not store above 30°C; keep bottle tightly closed and store in the original container.

Preparation Instructions

No reconstitution needed (ready-to-use syrup); shake gently before each dose and measure with a calibrated oral syringe/cup.

Patient Counseling

Take exactly as prescribed (often twice daily) with or without food; measure doses with an oral syringe; do not stop abruptly (risk of increased seizures); may cause dizziness/somnolence-avoid driving/machinery until effects known; avoid/limit alcohol; report mood/behavior changes, depression, aggression, or suicidal thoughts promptly; dose adjustment/monitoring may be needed in kidney impairment.

Pharmacology

Onset of Action

Pharmacokinetic onset: peak plasma concentration ~1 hour after an oral dose; clinical seizure reduction can occur within days to 1-2 weeks after reaching an effective dose (varies by patient and titration).

Duration of Effect

Immediate-release levetiracetam has an adult elimination half-life of ~6-8 hours and is typically dosed twice daily, providing clinical coverage over ~12-hour dosing intervals.

Half-Life

Adults: ~6-8 hours; longer in the elderly and in renal impairment; children often slightly shorter (~5-7 hours).

Bioavailability

>95%.

Metabolism

Minimal hepatic metabolism; primarily enzymatic hydrolysis of the acetamide group (non-CYP) to an inactive metabolite.

Excretion

Primarily renal: ~66% excreted unchanged in urine; ~24% as an inactive metabolite; overall ~90-95% recovered in urine.

Protein Binding

<10%.

Product Information

Available Dosage Forms

Immediate-release tablets; extended-release tablets; oral solution/syrup; intravenous solution for injection/infusion.

Composition per Dose

Each 1 ml: 100 mg levetiracetam

Generic Availability

Yes

Also Used For

Adjunctive therapy for partial onset seizures, myoclonic seizures in juvenile myoclonic epilepsy, primary generalized tonic-clonic seizures.

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 15-07-2026