LOXOL 100/MG TAB 30/TAB

Indications

Approved Uses

Epilepsy (adjunctive therapy for partial-onset seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome), Bipolar I disorder (maintenance treatment).

Dosage & Administration

Children's Dosage

Epilepsy (2-12 years, monotherapy): Initial 0.3 mg/kg/day in 1-2 divided doses for 2 weeks, then 0.6 mg/kg/day for 2 weeks, then increase by 0.6 mg/kg every 1-2 weeks; maintenance 1-10 mg/kg/day (max 200 mg/day). Not approved for bipolar disorder in patients under 18 years. Not recommended under 2 years of age

Dose Adjustment Notes

Titrate slowly to reduce serious rash risk; reduce doses when used with valproate (inhibits lamotrigine metabolism) and increase doses when used with enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, primidone, rifampicin); adjust when starting/stopping estrogen-containing hormonal contraceptives due to reduced lamotrigine concentrations.

How to Take

Swallow the 100 mg tablet whole with water; may be taken with or without food; take consistently at the same time(s) each day. Do not chew/crush unless the specific product is a chewable/dispersible formulation (this product is a standard tablet).

Side Effects

Common Side Effects

Dizziness, headache, diplopia/blurred vision, nausea/vomiting, ataxia (lack of coordination), somnolence or insomnia, and rash.

Side Effect Frequency

Very common (>10%): headache, dizziness; common (1-10%): somnolence, insomnia, nausea, vomiting, ataxia, diplopia/blurred vision, tremor, fatigue; rash is common overall but can be very common in some datasets; rare but serious: SJS/TEN, DRESS, aseptic meningitis, HLH

Safety & Warnings

Warnings & Precautions

Key warnings/precautions: life-threatening rash (SJS/TEN)-strict titration and stop at first rash; avoid re-challenge after serious rash unless specialist-directed; HLH and DRESS/multiorgan hypersensitivity-stop if suspected; aseptic meningitis-evaluate/stop if suspected; suicidal ideation monitoring; avoid abrupt discontinuation; major interactions (valproate, enzyme inducers, estrogen OCs) require dose/monitoring; use caution/adjust in hepatic impairment and caution in significant renal impairment; consider cardiac risk in patients with conduction disorders/Brugada syndrome.

Age Restriction

Epilepsy: approved for patients ≥2 years (adjunctive therapy) and for some indications in older children; Bipolar disorder: not recommended/approved in patients <18 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: valproate markedly increases lamotrigine levels (requires lower lamotrigine dosing); enzyme inducers (carbamazepine, phenytoin, phenobarbital, primidone, rifampin) decrease lamotrigine levels; estrogen-containing oral contraceptives decrease lamotrigine levels (and levels rise during pill-free week); some protease inhibitors (e.g., lopinavir/ritonavir) can decrease lamotrigine levels.

Interaction Severity

MAJOR: Valproate (markedly increases lamotrigine exposure and rash risk-requires lower starting/maintenance doses). MODERATE: Enzyme inducers (carbamazepine, phenytoin, phenobarbital, primidone) and rifampicin (decrease lamotrigine levels-often require higher doses); estrogen-containing hormonal contraceptives (decrease lamotrigine levels-dose adjustment/monitoring needed).

Food Interaction

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

Special Populations

Breastfeeding

Caution

Children

Epilepsy (2-12 years, monotherapy): Initial 0.3 mg/kg/day in 1-2 divided doses for 2 weeks, then 0.6 mg/kg/day for 2 weeks, then increase by 0.6 mg/kg every 1-2 weeks; maintenance 1-10 mg/kg/day (max 200 mg/day). Not approved for bipolar disorder in patients under 18 years. Not recommended under 2 years of age

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered unless it is close to the next dose; do not double. If several days of doses are missed, contact the prescriber because re-titration may be needed to reduce rash risk.

Stopping the Medicine

Do not stop abruptly; taper gradually over at least 2 weeks (unless urgent safety issue such as serious rash) and consult the prescriber.

Overdose

Overdose may cause ataxia, nystagmus, CNS depression (up to coma), seizures, and cardiac conduction abnormalities (e.g., QRS prolongation/arrhythmias); management is immediate emergency care with supportive treatment, consideration of activated charcoal if early, and cardiac/neurologic monitoring (no specific antidote).

Patient Counseling

Do not stop abruptly; take exactly as titrated. Seek urgent care for any rash (especially with fever, mouth sores, facial swelling, or swollen lymph nodes). Inform clinicians about valproate, enzyme-inducing antiseizure meds, and hormonal contraceptives (starting/stopping may require dose changes). Use caution with driving/alcohol until effects are known. Store below 30°C (per SFDA).

Monitoring Requirements

Monitor closely for rash (especially during the first 2-8 weeks and after dose increases), hypersensitivity symptoms (fever, lymphadenopathy), and suicidal ideation/behavior; consider lamotrigine levels when adherence or interactions are a concern; monitor hepatic/renal function when clinically indicated (impairment) and reassess dosing when interacting drugs are added/removed.

Pharmacology

Mechanism of Action

Inhibits voltage-gated sodium channels, stabilizing neuronal membranes and reducing presynaptic release of excitatory neurotransmitters (notably glutamate; also aspartate).

Onset of Action

Hours (pharmacologic effect begins after absorption; clinical benefit requires slow titration and may take weeks).

Product Information

Available Dosage Forms

Tablet, Chewable/Dispersible Tablet, Orally Disintegrating Tablet, Extended-Release Tablet.

Composition per Dose

Each tablet: 100 mg lamotrigine

Generic Availability

Yes

Also Used For

Mood Stabilization, Bipolar Depression, Neuropathic Pain, Migraine Prevention, Treatment-Resistant Depression (augmentation)

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 15-08-2026