What is LAMICTAL?

LAMICTAL 25 MG contains LAMOTRIGINE : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02142082, held by GLAXOSMITHKLINE INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 14-Jun-2002. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is LAMICTAL used for?

LAMICTAL (lamotrigine) is indicated in adults (≥ 18 years of age) as adjunctive therapy for the management of epilepsy not satisfactorily controlled by conventional therapy; for use as monotherapy following withdrawal of concomitant antiepileptic drugs; and as adjunctive therapy for the management of the seizures associated with Lennox-Gastaut syndrome. In pediatrics (<18 years of age), LAMICTAL (lamotrigine) is indicated as adjunctive therapy for the management of the seizures associated with Lennox-Gastaut syndrome. LAMICTAL is not recommended in children weighing less than 9 kg. Safety and efficacy in patients below the age of 16 years, other than those with Lennox-Gastaut Syndrome, have not been established.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

LAMICTAL (lamotrigine) is intended for oral administration and may be taken with or without food. LAMICTAL tablets should be swallowed whole and should not be chewed or crushed. LAMICTAL Dispersible Tablets may be swallowed whole, chewed, or dispersed in water or diluted fruit juice. The scoreline on the 5-mg tablet is not intended for tablet splitting. To disperse tablets, add to a small amount of liquid (1 teaspoon, or enough to cover the medication), swirl after approximately 1 minute when completely dispersed, and consume immediately. Do not attempt to administer partial quantities of dispersed tablets. If a dose is missed, take it as soon as remembered unless the next dose is due in less than 4 hours, in which case skip the missed dose. Do not double dose. Dosage and administration instructions vary significantly based on concomitant medications (valproic acid, enzyme-inducing AEDs, or neither) and patient age (pediatric vs. adult). Initial doses and titration schedules are carefully outlined in tables (Table 1 for adults >12 years, Table 2 for pediatric patients receiving valproic acid, Table 3 for pediatric patients receiving enzyme-inducing medications). For hepatic impairment, initial, escalation, and maintenance doses should be reduced by approximately 50% for mild/moderate impairment and 75% for severe impairment. For renal impairment, caution should be exercised in dose selection.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store LAMICTAL Tablets at controlled room temperature (15°C to 30°C) in a dry place and protected from light. Cap the bottle tightly immediately after use. Keep out of reach and sight of children.

How is it supplied?

LAMICTAL Tablets (scored, shield-shaped, engraved “LAMICTAL”) are available in: 25 mg tablets (white) in bottles of 100; 100 mg tablets (peach) in bottles of 100; 150 mg tablets (cream) in bottles of 60. LAMICTAL Dispersible Tablets are available in: 2 mg tablets (white, round, engraved “LTG” over “2”) in bottles of 30; 5 mg tablets (white to off-white, elongated, and biconvex, engraved “GS CL2" on one side and "5" on the other) (initiation dose only) in bottles of 30.

Contraindications

Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.

Warnings and precautions

Serious and sometimes fatal skin rashes, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), have occurred with LAMICTAL, with higher incidence in pediatric patients and with rapid titration or concomitant valproic acid. Risk of concomitant use with valproic acid. Risk with history of rash to other antiepileptics. Nearly all cases of rash occur within 2 to 8 weeks of treatment initiation, but can occur later. All patients developing rash should be promptly evaluated and LAMICTAL withdrawn immediately unless clearly not drug-related. Multi-organ failure, in some cases fatal or irreversible, has been observed. LAMICTAL is a weak inhibitor of dihydrofolate reductase, with potential for interference with folate metabolism during long-term therapy. Abrupt discontinuation of any antiepileptic drug (AED) may provoke rebound seizures; withdrawal should be gradual over at least two weeks unless safety concerns (e.g., rash) require more rapid withdrawal. Estrogen-containing products, including oral contraceptives and HRT, can affect lamotrigine levels, requiring close clinical monitoring and dosage adjustments. Brugada-type ECG pattern and cardiac rhythm conduction abnormalities have been reported; use with caution in patients with Brugada syndrome or cardiac conduction abnormalities. Blood dyscrasias (neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, pure red cell aplasia) have been reported. Haemophagocytic lymphohistiocytosis (HLH), a life-threatening syndrome, has occurred. Aseptic meningitis has been reported. Suicidal ideation and behavior have been reported with antiepileptic drugs. Photosensitivity reactions have been reported. Asian ancestry with HLA-B*1502 allele is associated with increased risk of SJS/TEN.

What can be used instead?

Other Canadian products sharing ATC code N03AX09 LAMOTRIGINE. 29 of 48 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies LAMOTRIGINE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. LAMOTRIGINE appears in 882 registered pack listings across 13 markets, published on 10 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.