Lamictal Side Effects Center

SIDE EFFECTS

The following serious adverse reactions are described in more detail in the Warnings and Precautions section of the labeling:

• Serious Skin Rashes [see WARNINGS AND PRECAUTIONS]
• Hemophagocytic Lymphohistiocytosis [see WARNINGS AND PRECAUTIONS]
• Multiorgan Hypersensitivity Reactions and Organ Failure [see WARNINGS AND PRECAUTIONS]
• Cardiac Rhythm and Conduction Abnormalities [see WARNINGS AND PRECAUTIONS ]
• Blood Dyscrasias [see WARNINGS AND PRECAUTIONS]
• Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
• Aseptic Meningitis [see WARNINGS AND PRECAUTIONS]
• Withdrawal Seizures [see WARNINGS AND PRECAUTIONS]
• Status Epilepticus [see WARNINGS AND PRECAUTIONS]
• Sudden Unexplained Death in Epilepsy [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drugcannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Epilepsy

Most Common Adverse Reactions In All Clinical Trials

Adjunctive Therapy in Adults with Epilepsy: The most commonly observed(≥5% for LAMICTAL and more common on drug than placebo) adverse reactions seen in association with LAMICTAL duringadjunctive therapy in adults and not seen at an equivalent frequency among placebo-treated patients were: dizziness, ataxia,somnolence, headache, diplopia, blurred vision, nausea, vomiting, and rash. Dizziness, diplopia, ataxia, blurred vision, nausea, andvomiting were dose related. Dizziness, diplopia, ataxia, and blurred vision occurred more commonly in patients receivingcarbamazepine with LAMICTAL than in patients receiving other AEDs with LAMICTAL. Clinical data suggest a higher incidenceof rash, including serious rash, in patients receiving concomitant valproate than in patients not receiving valproate [see WARNINGS AND PRECAUTIONS].

Approximately 11% of the 3,378 adult patients who received LAMICTAL as adjunctive therapy in premarketing clinical trialsdiscontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation wererash (3.0%), dizziness (2.8%), and headache (2.5%).

In a dose-response trial in adults, the rate of discontinuation of LAMICTAL for dizziness, ataxia, diplopia, blurred vision, nausea,and vomiting was dose related.

Monotherapy In Adults With Epilepsy

The most commonly observed (≥5% for LAMICTAL and more common on drug thanplacebo) adverse reactions seen in association with the use of LAMICTAL during the monotherapy phase of the controlled trial inadults not seen at an equivalent rate in the control group were vomiting, coordination abnormality, dyspepsia, nausea, dizziness,rhinitis, anxiety, insomnia, infection, pain, weight decrease, chest pain, and dysmenorrhea. The most commonly observed (≥5% forLAMICTAL and more common on drug than placebo) adverse reactions associated with the use of LAMICTAL during theconversion to monotherapy (add-on) period, not seen at an equivalent frequency among low-dose valproate-treated patients, weredizziness, headache, nausea, asthenia, coordination abnormality, vomiting, rash, somnolence, diplopia, ataxia, accidental injury,tremor, blurred vision, insomnia, nystagmus, diarrhea, lymphadenopathy, pruritus, and sinusitis.

Approximately 10% of the 420 adult patients who received LAMICTAL as monotherapy in premarketing clinical trialsdiscontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation wererash (4.5%), headache (3.1%), and asthenia (2.4%).

Adjunctive Therapy In Pediatric Patients With Epilepsy

The most commonly observed (≥5% for LAMICTAL and more commonon drug than placebo) adverse reactions seen in association with the use of LAMICTAL as adjunctive treatment in pediatricpatients aged 2 to 16 years and not seen at an equivalent rate in the control group were infection, vomiting, rash, fever, somnolence,accidental injury, dizziness, diarrhea, abdominal pain, nausea, ataxia, tremor, asthenia, bronchitis, flu syndrome, and diplopia.

In 339 patients aged 2 to 16 years with partial-onset seizures or generalized seizures of Lennox-Gastaut syndrome, 4.2% of patientson LAMICTAL and 2.9% of patients on placebo discontinued due to adverse reactions. The most commonly reported adversereaction that led to discontinuation of LAMICTAL was rash.

Approximately 11.5% of the 1,081 pediatric patients aged 2 to 16 years who received LAMICTAL as adjunctive therapy inpremarketing clinical trials discontinued treatment because of an adverse reaction. The adverse reactions most commonlyassociated with discontinuation were rash (4.4%), reaction aggravated (1.7%), and ataxia (0.6%).

Controlled Adjunctive Clinical Trials In Adults With Epilepsy

Table 8 lists adverse reactions that occurred in adult patients withepilepsy treated with LAMICTAL in placebo-controlled trials. In these trials, either LAMICTAL or placebo was added to thepatient's current AED therapy.

Table 8: Adverse Reactions in Pooled, Placebo-Controlled Adjunctive Trials in Adult Patients with Epilepsy^a,b

Body System/ Adverse Reaction	Percent of Patients Receiving Adjunctive LAMICTAL (n = 711)	Percent of Patients Receiving Adjunctive Placebo (n = 419)
Body as a whole
Headache	29	19
Flu syndrome	7	6
Fever	6	4
Abdominal pain	5	4
Neck pain	2	1
Reaction aggravated (seizure exacerbation)	2	1
Digestive
Nausea	19	10
Vomiting	9	4
Diarrhea	6	4
Dyspepsia	5	2
Constipation	4	3
Anorexia	2	1
Musculoskeletal
Arthralgia	2	0
Nervous
Dizziness	38	13
Ataxia	22	6
Somnolence	14	7
Incoordination	6	2
Insomnia	6	2
Tremor	4	1
Depression	4	3
Anxiety	4	3
Convulsion	3	1
Irritability	3	2
Speech disorder	3	0
Concentration disturbance	2	1
Respiratory
Rhinitis	14	9
Pharyngitis	10	9
Cough increased	8	6
Skin and appendages
Rash	10	5
Pruritus	3	2
Special senses
Diplopia	28	7
Blurred vision	16	5
Vision abnormality	3	1
Urogenital
Female patients only	(n = 365)	(n = 207)
Dysmenorrhea	7	6
Vaginitis	4	1
Amenorrhea	2	1
aAdverse reactions that occurred in at least 2% of patients treated with LAMICTAL and at a greater incidence than placebo. bPatients in these adjunctive trials were receiving 1 to 3 of the concomitant antiepileptic drugs carbamazepine, phenytoin,phenobarbital, or primidone in addition to LAMICTAL or placebo. Patients may have reported multiple adverse reactions duringthe trial or at discontinuation; thus, patients may be included in more than 1 category.

In a randomized, parallel trial comparing placebo with 300 and 500 mg/day of LAMICTAL, some of the more common drug-related adverse reactions were dose related (see Table 9).

Table 9: Dose-Related Adverse Reactions from a Randomized, Placebo-Controlled, Adjunctive Trial in Adults with Epilepsy

Adverse Reaction	Percent of Patients Experiencing Adverse Reactions
	Placebo (n = 73)	LAMICTAL 300 mg (n = 71)	LAMICTAL 500 mg (n = 72)
Ataxia	10	10	28a,b
Blurred vision	10	11	25a,b
Diplopia	8	24a	49a,b
Dizziness	27	31	54a,b
Nausea	11	18	25a
Vomiting	4	11	18a
aSignificantly greater than placebo group (P<0.05). bSignificantly greater than group receiving LAMICTAL 300 mg (P<0.05).

The overall adverse reaction profile for LAMICTAL was similar between females and males and was independent of age. Becausethe largest non-Caucasian racial subgroup was only 6% of patients exposed to LAMICTAL in placebo-controlled trials, there areinsufficient data to support a statement regarding the distribution of adverse reaction reports by race. Generally, females receivingeither LAMICTAL as adjunctive therapy or placebo were more likely to report adverse reactions than males. The only adversereaction for which the reports on LAMICTAL were >10% more frequent in females than males (without a corresponding differenceby gender on placebo) was dizziness (difference = 16.5%). There was little difference between females and males in the rates ofdiscontinuation of LAMICTAL for individual adverse reactions.

Controlled Monotherapy Trial In Adults With Partial-Onset Seizures

Table 10 lists adverse reactions that occurred in patients withepilepsy treated with monotherapy with LAMICTAL in a double-blind trial following discontinuation of either concomitantcarbamazepine or phenytoin not seen at an equivalent frequency in the control group.

Table 10: Adverse Reactions in a Controlled Monotherapy Trial in Adult Patients with Partial-Onset Seizures^a,b

Body System/ Adverse Reaction	Percent of Patients Receiving LAMICTALc as Monotherapy (n = 43)	Percent of Patients Receiving Low-Dose Valproated Monotherapy (n = 44)
Body as a whole
Pain	5	0
Infection	5	2
Chest pain	5	2
Digestive
Vomiting	9	0
Dyspepsia	7	2
Nausea	7	2
Metabolic and nutritional
Weight decrease	5	2
Nervous
Coordination abnormality	7	0
Dizziness	7	0
Anxiety	5	0
Insomnia	5	2
Respiratory
Rhinitis	7	2
Urogenital (female patients only)	(n = 21)	(n = 28)
Dysmenorrhea	5	0
aAdverse reactions that occurred in at least 5% of patients treated with LAMICTAL and at a greater incidence than valproate-treated patients. bPatients in this trial were converted to LAMICTAL or valproate monotherapy from adjunctive therapy with carbamazepine orphenytoin. Patients may have reported multiple adverse reactions during the trial; thus, patients may be included in more than 1category. cUp to 500 mg/day. d1,000 mg/day.

Adverse reactions that occurred with a frequency of <5% and >2% of patients receiving LAMICTAL and numerically morefrequent than placebo were:

Body as a Whole: Asthenia, fever.

Digestive: Anorexia, dry mouth, rectal hemorrhage, peptic ulcer.

Metabolic and Nutritional: Peripheral edema.

Nervous System: Amnesia, ataxia, depression, hypesthesia, libido increase, decreased reflexes, increased reflexes, nystagmus,irritability, suicidal ideation.

Respiratory: Epistaxis, bronchitis, dyspnea.

Skin and Appendages: Contact dermatitis, dry skin, sweating.

Special Senses: Vision abnormality.

Incidence In Controlled Adjunctive Trials In Pediatric Patients With Epilepsy

Table 11 lists adverse reactions that occurred in 339pediatric patients with partial-onset seizures or generalized seizures of Lennox-Gastaut syndrome who received LAMICTAL up to15 mg/kg/day or a maximum of 750 mg/day.

Table 11: Adverse Reactions in Pooled, Placebo-Controlled, Adjunctive Trials in Pediatric Patients with Epilepsy^a

Body System/ Adverse Reaction	Percent of Patients Receiving LAMICTAL (n = 168)	Percent of Patients Receiving Placebo (n = 171)
Body as a whole
Infection	20	17
Fever	15	14
Accidental injury	14	12
Abdominal pain	10	5
Asthenia	8	4
Flu syndrome	7	6
Pain	5	4
Facial edema	2	1
Photosensitivity	2	0
Cardiovascular
Hemorrhage	2	1
Digestive
Vomiting	20	16
Diarrhea	11	9
Nausea	10	2
Constipation	4	2
Dyspepsia	2	1
Hemic and lymphatic
Lymphadenopathy	2	1
Metabolic and nutritional
Edema	2	0
Nervous system
Somnolence	17	15
Dizziness	14	4
Ataxia	11	3
Tremor	10	1
Emotional lability	4	2
Gait abnormality	4	2
Thinking abnormality	3	2
Convulsions	2	1
Nervousness	2	1
Vertigo	2	1
Respiratory
Pharyngitis	14	11
Bronchitis	7	5
Increased cough	7	6
Sinusitis	2	1
Bronchospasm	2	1
Skin
Rash	14	12
Eczema	2	1
Pruritus	2	1
Special senses
Diplopia	5	1
Blurred vision	4	1
Visual abnormality	2	0
Urogenital Male and female patients
Urinary tract infection	3	0
aAdverse reactions that occurred in at least 2% of patients treated with LAMICTAL and at a greater incidence than placebo.

Bipolar Disorder In Adults

The most common adverse reactions seen in association with the use of LAMICTAL as monotherapy (100 to 400 mg/day) in adultpatients (aged 18 to 82 years) with bipolar disorder in the 2 double-blind, placebo-controlled trials of 18 months' duration areincluded in Table 12. Adverse reactions that occurred in at least 5% of patients and were numerically more frequent during thedose-escalation phase of LAMICTAL in these trials (when patients may have been receiving concomitant medications) comparedwith the monotherapy phase were: headache (25%), rash (11%), dizziness (10%), diarrhea (8%), dream abnormality (6%), andpruritus (6%).

During the monotherapy phase of the double-blind, placebo-controlled trials of 18 months' duration, 13% of 227 patients whoreceived LAMICTAL (100 to 400 mg/day), 16% of 190 patients who received placebo, and 23% of 166 patients who receivedlithium discontinued therapy because of an adverse reaction. The adverse reactions that most commonly led to discontinuation ofLAMICTAL were rash (3%) and mania/hypomania/mixed mood adverse reactions (2%). Approximately 16% of 2,401 patientswho received LAMICTAL (50 to 500 mg/day) for bipolar disorder in premarketing trials discontinued therapy because of anadverse reaction, most commonly due to rash (5%) and mania/hypomania/mixed mood adverse reactions (2%).

The overall adverse reaction profile for LAMICTAL was similar between females and males, between elderly and nonelderlypatients, and among racial groups.

Table 12: Adverse Reactions in 2 Placebo-Controlled Trials in Adult Patients with Bipolar I Disorder^a,b

Body System/ Adverse Reaction	Percent of Patients Receiving LAMICTAL (n = 227)	Percent of Patients Receiving Placebo (n = 190)
General
Back pain	8	6
Fatigue	8	5
Abdominal pain	6	3
Digestive
Nausea	14	11
Constipation	5	2
Vomiting	5	2
Nervous System
Insomnia	10	6
Somnolence	9	7
Xerostomia (dry mouth)	6	4
Respiratory
Rhinitis	7	4
Exacerbation of cough	5	3
Pharyngitis	5	4
Skin
Rash (nonserious)c	7	5
aAdverse reactions that occurred in at least 5% of patients treated with LAMICTAL and at a greater incidence than placebo. bPatients in these trials were converted to LAMICTAL (100 to 400 mg/day) or placebo monotherapy from add-on therapy withother psychotropic medications. Patients may have reported multiple adverse reactions during the trial; thus, patients may beincluded in more than 1 category. cIn the overall bipolar and other mood disorders clinical trials, the rate of serious rash was 0.08% (1 of 1,233) of adult patientswho received LAMICTAL as initial monotherapy and 0.13% (2 of 1,538) of adult patients who received LAMICTAL as adjunctivetherapy [see WARNINGS AND PRECAUTIONS].

Other reactions that occurred in 5% or more patients but equally or more frequently in the placebo group included: dizziness,mania, headache, infection, influenza, pain, accidental injury, diarrhea, and dyspepsia.

Adverse reactions that occurred with a frequency of <5% and >1% of patients receiving LAMICTAL and numerically morefrequent than placebo were:

General: Fever, neck pain.

Cardiovascular: Migraine.

Digestive: Flatulence.

Metabolic and Nutritional: Weight gain, edema.

Musculoskeletal: Arthralgia, myalgia.

Nervous System: Amnesia, depression, agitation, emotional lability, dyspraxia, abnormal thoughts, dream abnormality,hypoesthesia.

Respiratory: Sinusitis.

Urogenital: Urinary frequency.

Adverse Reactions following Abrupt Discontinuation

In the 2 controlled clinical trials, there was no increase in the incidence,severity, or type of adverse reactions in patients with bipolar disorder after abruptly terminating therapy with LAMICTAL. In theclinical development program in adults with bipolar disorder, 2 patients experienced seizures shortly after abrupt withdrawal ofLAMICTAL [see WARNINGS AND PRECAUTIONS].

Mania/Hypomania/Mixed Episodes

During the double-blind, placebo-controlled clinical trials in bipolar I disorder in which adultswere converted to monotherapy with LAMICTAL (100 to 400 mg/day) from other psychotropic medications and followed for up to18 months, the rates of manic or hypomanic or mixed mood episodes reported as adverse reactions were 5% for patients treatedwith LAMICTAL (n = 227), 4% for patients treated with lithium (n = 166), and 7% for patients treated with placebo (n = 190). Inall bipolar controlled trials combined, adverse reactions of mania (including hypomania and mixed mood episodes) were reportedin 5% of patients treated with LAMICTAL (n = 956), 3% of patients treated with lithium (n = 280), and 4% of patients treated withplacebo (n = 803).

Other Adverse Reactions Observed In All Clinical Trials

LAMICTAL has been administered to 6,694 individuals for whom complete adverse reaction data was captured during all clinicaltrials, only some of which were placebo controlled. During these trials, all adverse reactions were recorded by the clinicalinvestigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals havingadverse reactions, similar types of adverse reactions were grouped into a smaller number of standardized categories using modifiedCOSTART dictionary terminology. The frequencies presented represent the proportion of the 6,694 individuals exposed toLAMICTAL who experienced an event of the type cited on at least 1 occasion while receiving LAMICTAL. All reported adversereactions are included except those already listed in the previous tables or elsewhere in the labeling, those too general to beinformative, and those not reasonably associated with the use of the drug.

Adverse reactions are further classified within body system categories and enumerated in order of decreasing frequency using thefollowing definitions: frequent adverse reactions are defined as those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare adverse reactions are those occurring in fewer than 1/1,000 patients.

Body As A Whole

Infrequent: Allergic reaction, chills, malaise.

Cardiovascular System

Infrequent: Flushing, hot flashes, hypertension, palpitations, postural hypotension, syncope, tachycardia, vasodilation.

Dermatological

Infrequent: Acne, alopecia, hirsutism, maculopapular rash, skin discoloration, urticaria.

Rare: Angioedema, erythema, exfoliative dermatitis, fungal dermatitis, herpes zoster, leukoderma, multiforme erythema, petechialrash, pustular rash, Stevens-Johnson syndrome, vesiculobullous rash.

Digestive System

Infrequent: Dysphagia, eructation, gastritis, gingivitis, increased appetite, increased salivation, liver function tests abnormal, mouthulceration.

Rare: Gastrointestinal hemorrhage, glossitis, gum hemorrhage, gum hyperplasia, hematemesis, hemorrhagic colitis, hepatitis,melena, stomach ulcer, stomatitis, tongue edema.

Endocrine System

Rare: Goiter, hypothyroidism.

Hematologic and Lymphatic System

Infrequent: Ecchymosis, leukopenia.

Rare: Anemia, eosinophilia, fibrin decrease, fibrinogen decrease, iron deficiency anemia, leukocytosis, lymphocytosis, macrocyticanemia, petechia, thrombocytopenia.

Metabolic And Nutritional Disorders

Infrequent: Aspartate transaminase increased.

Rare: Alcohol intolerance, alkaline phosphatase increase, alanine transaminase increase, bilirubinemia, general edema, gammaglutamyl transpeptidase increase, hyperglycemia.

Musculoskeletal System

Infrequent: Arthritis, leg cramps, myasthenia, twitching.

Rare: Bursitis, muscle atrophy, pathological fracture, tendinous contracture.

Nervous System

Frequent: Confusion, paresthesia.

Infrequent: Akathisia, apathy, aphasia, central nervous system depression, depersonalization, dysarthria, dyskinesia, euphoria,hallucinations, hostility, hyperkinesia, hypertonia, libido decreased, memory decrease, mind racing, movement disorder,myoclonus, panic attack, paranoid reaction, personality disorder, psychosis, sleep disorder, stupor, suicidal ideation.

Rare: Choreoathetosis, delirium, delusions, dysphoria, dystonia, extrapyramidal syndrome, faintness, grand mal convulsions,hemiplegia, hyperalgesia, hyperesthesia, hypokinesia, hypotonia, manic depression reaction, muscle spasm, neuralgia, neurosis,paralysis, peripheral neuritis.

Respiratory System

Infrequent: Yawn.

Rare: Hiccup, hyperventilation.

Special Senses

Frequent: Amblyopia.

Infrequent: Abnormality of accommodation, conjunctivitis, dry eyes, ear pain, photophobia, taste perversion, tinnitus.

Rare: Deafness, lacrimation disorder, oscillopsia, parosmia, ptosis, strabismus, taste loss, uveitis, visual field defect.

Urogenital System

Infrequent: Abnormal ejaculation, hematuria, impotence, menorrhagia, polyuria, urinary incontinence.

Rare: Acute kidney failure, anorgasmia, breast abscess, breast neoplasm, creatinine increase, cystitis, dysuria, epididymitis, femalelactation, kidney failure, kidney pain, nocturia, urinary retention, urinary urgency.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of LAMICTAL. Because these reactions are reportedvoluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causalrelationship to drug exposure.

Blood And Lymphatic

Agranulocytosis, hemolytic anemia, lymphadenopathy not associated with hypersensitivity disorder.

Gastrointestinal

Esophagitis.

Hepatobiliary Tract And Pancreas

Pancreatitis.

Immunologic

Hypogammaglobulinemia, lupus-like reaction, vasculitis.

Lower Respiratory

Apnea.

Musculoskeletal

Rhabdomyolysis has been observed in patients experiencing hypersensitivity reactions.

Nervous System

Aggression, exacerbation of Parkinsonian symptoms in patients with pre-existing Parkinson's disease, tics.

Non-site Specific

Progressive immunosuppression.

Renal And Urinary Disorders

Tubulointerstitial nephritis (has been reported alone and in association with uveitis).

DRUG INTERACTIONS

Significant drug interactions with LAMICTAL are summarized in this section.

Uridine 5'-diphospho-glucuronyl transferases (UGT) have been identified as the enzymes responsible for metabolism oflamotrigine. Drugs that induce or inhibit glucuronidation may, therefore, affect the apparent clearance of lamotrigine. Strong ormoderate inducers of the cytochrome P450 3A4 (CYP3A4) enzyme, which are also known to induce UGT, may also enhance themetabolism of lamotrigine.

Those drugs that have been demonstrated to have a clinically significant impact on lamotrigine metabolism are outlined in Table13. Specific dosing guidance for these drugs is provided in the Dosage and Administration section [see DOSAGE AND ADMINISTRATION].

Additional details of these drug interaction studies are provided in the Clinical Pharmacology section [see CLINICAL PHARMACOLOGY].

Table 13: Established and Other Potentially Significant Drug Interactions

Concomitant Drug	Effect on Concentration of Lamotrigine or Concomitant Drug	Clinical Comment
Estrogen-containing oral contraceptive preparations containing 30 meg ethinylestradiol and 150 meg levonorgestrel	↓ lamotrigine	Decreased lamotrigine concentrations approximately 50%.
	↓levonorgestrel	Decrease in levonorgestrel component by 19%.
Carbamazepine and carbamazepine epoxide	↓ lamotrigine ? carbamazepine epoxide	Addition of carbamazepine decreases lamotrigine concentration approximately 40%. May increase carbamazepine epoxide levels.
Lopinavir/ritonavir	↓ lamotrigine	Decreased lamotrigine concentration approximately 50%.
Atazanavir/ritonavir	↓lamotrigine	Decreased lamotrigine AUC approximately 32%.
Phenobarbital/primidone	↓lamotrigine	Decreased lamotrigine concentration approximately 40%.
Phenytoin	↓lamotrigine	Decreased lamotrigine concentration approximately 40%.
Rifampin	↓ lamotrigine	Decreased lamotrigine AUC approximately 40%.
Valproate	↓ lamotrigine ? valproate	Increased lamotrigine concentrations slightly more than 2-fold. There are conflicting study results regarding effect of lamotrigine on valproate concentrations: 1) a mean 25% decrease in valproate concentrations in healthy volunteers, 2) no change in valproate concentrations in controlled clinical trials in patients with epilepsy.
↓ = Decreased (induces lamotrigine glucuronidation). ↑ = Increased (inhibits lamotrigine glucuronidation). ? = Conflicting data.

Effect Of LAMICTAL On Organic Cationic Transporter 2 Substrates

Lamotrigine is an inhibitor of renal tubular secretion via organic cationic transporter 2 (OCT2) proteins [see CLINICAL PHARMACOLOGY]. This may result in increased plasma levels of certain drugs that are substantially excreted via this route.Coadministration of LAMICTAL with OCT2 substrates with a narrow therapeutic index (e.g., dofetilide) is not recommended.

Read the entire FDA prescribing information for Lamictal (Lamotrigine)