LOXOL 25 MG 30 TAB

Indications

Approved Uses

Epilepsy (partial seizures, generalized tonic-clonic seizures, absence seizures, Lennox-Gastaut syndrome), Bipolar I disorder (maintenance treatment to delay mood episodes)

Off-Label Uses

Off-label uses with variable evidence include bipolar depression (acute), neuropathic pain, migraine prophylaxis, and certain psychiatric conditions (e.g., borderline personality disorder/PTSD) where evidence is limited; not all are guideline-endorsed.

Dosage & Administration

Dosing by Condition

Epilepsy (adjunct or monotherapy): dosing is regimen-dependent and must follow labeled titration schedules; typical adult maintenance ranges are ~100-200 mg/day with valproate, ~200-400 mg/day with enzyme inducers (without valproate), and ~225-375 mg/day for monotherapy (some patients may require up to 500 mg/day). Bipolar I maintenance (prevention of mood episodes): typical target 200 mg/day (range 100-400 mg/day depending on interacting drugs).

Initial Dose

25 mg once daily for the first 2 weeks (monotherapy or with valproate regimen)

Maintenance Dose

100-200 mg/day (monotherapy or with valproate); 200-400 mg/day (with enzyme-inducing AEDs)

Maximum Dose

Epilepsy: typical maximum 500 mg/day (depending on regimen/inducers); Bipolar disorder: typical maximum 200 mg/day (up to 400 mg/day when used with enzyme-inducing drugs and without valproate).

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

Dose Adjustment Notes

Titrate slowly to reduce rash risk; reduce lamotrigine dose when used with valproate; increase dose when used with enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, primidone, rifampin); use caution and consider lower maintenance doses in significant hepatic impairment and in significant renal impairment (especially end-stage).

How to Take

Oral tablet: swallow with water; may be taken with or without food; take at the same time each day. Do not crush/chew unless the specific product is labeled dispersible/chewable.

Side Effects

Common Side Effects

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

Side Effect Frequency

Common: headache, dizziness, drowsiness, nausea, diplopia, ataxia, rash, blurred vision, vomiting, fatigue. Serious: SJS/TEN, multiorgan hypersensitivity.

Safety & Warnings

Contraindications

Contraindicated in patients with hypersensitivity to lamotrigine or any excipients; do not re-initiate in patients who discontinued due to rash associated with prior lamotrigine treatment unless benefits clearly outweigh risks.

Warnings & Precautions

Key warnings/precautions: risk of serious rash/SJS/TEN-higher with rapid titration, high starting dose, or valproate; stop at first rash unless clearly not drug-related and do not restart after serious rash; monitor for suicidal thoughts/behavior; avoid abrupt discontinuation (taper when possible); consider interaction with estrogen-containing contraceptives (reduced lamotrigine levels); watch for hypersensitivity/DRESS, aseptic meningitis, HLH, and cardiac conduction issues in at-risk patients.

Age Restriction

Epilepsy: approved for patients ≥2 years (as adjunctive therapy; some indications include monotherapy in older children/adults depending on label). Bipolar disorder: not approved/recommended in patients <18 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions: Valproate increases lamotrigine levels (requires lower lamotrigine dosing); enzyme inducers (carbamazepine, phenytoin, phenobarbital, primidone, rifampin) decrease lamotrigine levels (may require higher dosing); estrogen-containing oral contraceptives decrease lamotrigine levels (monitor/adjust). Protease inhibitors (e.g., lopinavir/ritonavir, atazanavir/ritonavir) can decrease lamotrigine exposure; sertraline is not a consistent/major interaction (monitor clinically if combined).

Interaction Severity

MAJOR: Valproate (markedly increases lamotrigine levels and serious rash risk-requires lower lamotrigine dosing/titration). MODERATE: Enzyme inducers (carbamazepine, phenytoin, phenobarbital, primidone, rifampin) decrease lamotrigine levels; estrogen-containing contraceptives decrease lamotrigine levels and levels may rise during hormone-free interval; some protease inhibitors (e.g., lopinavir/ritonavir, atazanavir/ritonavir) can reduce lamotrigine levels. OTHER/variable: Sertraline and other agents may have minor/variable effects-monitor clinically.

Food Interaction

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

Alcohol Interaction

Avoid

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

Kidney Impairment

Use with caution in significant renal impairment; reduced maintenance doses may be effective (especially in end-stage renal disease), while initial titration is generally per standard with close monitoring.

Liver Impairment

Hepatic impairment: reduce dose ~25% in moderate (Child-Pugh B) and ~50% in severe (Child-Pugh C); greater reduction may be needed in severe impairment with ascites.

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 over at least 2 weeks if possible, unless safety requires immediate discontinuation (e.g., serious rash/SJS/TEN, hypersensitivity).

Overdose

Overdose may cause ataxia, nystagmus, dizziness, seizures, reduced consciousness/coma, and cardiac conduction abnormalities (e.g., QRS prolongation/arrhythmias); management is supportive with airway/ventilation as needed, activated charcoal if appropriate, and cardiac/neurologic monitoring-seek emergency care.

Patient Counseling

Key counseling: take exactly as prescribed with slow titration; do not stop abruptly; report any rash immediately (especially in first 2 months) and seek urgent care if rash is severe or with fever/mucosal lesions; inform providers about valproate, enzyme-inducing antiseizure meds, and hormonal contraceptives; caution with driving/alcohol until effects known; monitor for mood changes/suicidal thoughts; if therapy is interrupted for several days, contact prescriber as re-titration may be required.

Monitoring Requirements

No routine serum level monitoring is required; clinically monitor for rash (especially during early titration), CNS adverse effects, seizure control or mood symptoms, and suicidality; consider hepatic/renal function monitoring in patients with impairment or when clinically indicated.

Pharmacology

Mechanism of Action

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

Bioavailability

Approximately 98% (oral bioavailability).

Metabolism

Hepatic metabolism primarily via glucuronidation (mainly UGT1A4; also UGT2B7); minimal CYP450 involvement.

Product Information

Available Dosage Forms

For LOXOL (lamotrigine) specifically per verified API data: Tablet (immediate-release) only.

Composition per Dose

Each tablet: 25 mg lamotrigine

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Also Used For

Mood Stabilization, Bipolar Disorder Maintenance

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