Drug Class Description
Triazines (anticonvulsants / anti-epileptics).

Generic Name
Lamotrigine

Drug Description
Lamictal Tablets containing 25mg lamotrigine.Lamictal Tablets containing 50mg lamotrigine.Lamictal Tablets containing 100mg lamotrigine.Lamictal Tablets containing 200mg lamotrigine.Lamictal Dispersible 2 mg contain 2 mg lamotrigine.Lamictal Dispersible 5 mg contain 5 mg lamotrigine.Lamictal Dispersible 25 mg contain 25 mg lamotrigine.Lamictal Dispersible 100 mg contain 100 mg lamotrigine.

Presentation
Lamictal tablets 25mg are pale yellowish brown, multifaceted, superelliptical unscored tablets, branded 'GSEC7'on one side, with '25' on the reverse.Lamictal Tablets 50mg are pale yellowish brown, multifaceted, superelliptical unscored tablets, branded 'GSEE1'on one side, with '50' on the reverse.Lamictal Tablets 100mg are pale yellowish brown, multifaceted, superelliptical unscored tablets, branded 'GSEE5'on one side, with '100' on the reverse.Lamictal Tablets 200mg are pale yellowish brown, multifaceted, superelliptical unscored tablets, branded 'GSEE7'on one side, with '200' on the reverse..Lamictal Dispersible 2mg are white to off-white round tablets with a blackcurrant odour. One side has a bevelled edge and is engraved with LTG over the number 2. The other side is engraved with two overlapping super-ellipses at right angles.Lamictal Dispersible 5mg are white elongated, biconvex, tablets with “5” on one side and “GSCL2” on the other.Lamictal Dispersible 25mg are white, multifaceted, super elliptical tablets with “25” on one side and “GSCL5” on the other.Lamictal Dispersible 100mg are white multifaceted, super elliptical tablets with “100” on one side and “GSCL7” on the other.

Indications
Epilepsy: Monotherapy in adults and children over 12 years of age: Simple partial seizures Complex partial seizures Secondarily generalised tonic-clonic seizures Primary generalised tonic-clonic seizures Monotherapy in children under 12 years of age is not recommended until such time as adequate information is made available from controlled trials in this particular target population.Add-on therapy in adults and children over 2 years of age Simple partial seizures Complex partial seizures Secondarily generalised tonic-clonic seizures Primary generalised tonic-clonic seizures Lamictal is also indicated for the treatment of seizures associated with Lennox-Gastaut Syndrome.

Adult Dosage
AdministrationLamictal Tablets should be swallowed whole with a little water.Lamictal Dispersible tablets may be chewed, dispersed in a small volume of water (at least enough to cover the whole tablet) or swallowed whole with a little water.To ensure a therapeutic dose is maintained the weight of a child must be monitored and the dose reviewed as weight changes occur.If a calculated dose of lamotrigine (e.g. for use in children and patients with hepatic impairment) does not equate to whole tablets the dose to be administered is that equal to the lower number of whole tablets.When concomitant antiepileptic drugs are withdrawn to achieve Lamictal monotherapy or other antiepileptic drugs (AEDs)/medications are added-on to treatment regimes containing Lamictal consideration should be given to the effect this may have on lamotrigine pharmacokinetics.Restarting TherapyPrescribers should assess the need for escalation to maintenance dose when restarting lamotrigine in patients who have discontinued lamotrigine for any reason, since the risk of serious rash is associated with high initial doses and exceeding the recommended dose escalation for lamotrigine. The greater the interval of time since the previous dose, the more consideration should be given to escalation to the maintenance dose. When the interval since discontinuing lamotrigine exceeds five half-lives, lamotrigine should generally be escalated to the maintenance dose according to the appropriate schedule, as though initiating therapy.Dosage in monotherapyAdults and children over 12 years (see Table 1)The initial Lamictal dose in monotherapy is 25mg once a day for two weeks, followed by 50mg once a day for two weeks. Thereafter, the dose should be increased by a maximum of 50mg-100mg every 1-2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 100 - 200mg/day given once a day or as two divided doses. Some patients have required 500mg/day of Lamictal to achieve the desired response.The initial dose and subsequent dose escalation should not be exceeded to minimise the risk of rash.Children aged 2 to 12 yearsThere is insufficient evidence available from appropriate studies in children, upon which to base dosage recommendations for monotherapy use in children under the age of 12 years.Dosage in add-on therapyAdults and children over 12 years (see Table 1)In patients taking valproate with / without any other anti-epileptic drug (AED) the initial Lamictal dose is 25 mg every alternate day for two weeks, followed by 25 mg once a day for two weeks. Thereafter, the dose should be increased by a maximum of 25-50mg every 1-2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 100-200mg/day given once a day or in two divided doses.In those patients taking concomitant AEDs or other medications that induce lamotrigine glucuronidation with / without other AED's (except valproate) the initial Lamictal dose is 50 mg once a day for two weeks, followed by 100 mg/day given in two divided doses for two weeks. Thereafter, the dose should be increased by a maximum of 100mg every 1-2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 200-400mg/day given in two divided doses. Some patients have required 700 mg/day of Lamictal to achieve the desired response.In those patients taking oxcarbazepine without any other inducers or inhibitors of lamotrigine glucuronidation, the initial lamotrigine dose is 25 mg once a day for two weeks, followed by 50 mg once a day for two weeks. Thereafter, the dose should be increased by a maximum of 50 to 100 mg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve an optimal response is 100 to 200 mg/day given once a day or as two divided doses.Table 1 Recommended treatment regimen for adults and children over 12 years of ageTreatment regimenWeeks 1 + 2Weeks 3 + 4Usual Maintenance DoseMonotherapy >25 mg (once a day)50 mg (once a day)100 – 200 mg (once a day or two divided doses) To achieve maintenance, doses may be increased by 50 – 100 mg every one to two weeksadd-on therapy with valproate regardless of any concomitant medications12.5 mg (given 25 mg on alternate days)25 mg once a day)100 – 200 mg (once a day or two divided doses) To achieve maintenance, doses may be increased by 25 – 50 mg every one to two weeksAdd-on therapy without valproateThis dosage regimen should be used with: Phenytoin Carbamazepine Phenobarbital primidone or with other inducers of lamotrigine glucuronidation.50 mg (once a day)100 mg (two divided doses)200 – 400 mg (two divided doses) To achieve maintenance, doses may be increased by 100 mg every one to two weeksWith oxcarbazepine without inducers or inhibitors of lamotrigine glucuronidation25 mg(once a day)50 mg(once a day)100 – 200 mg (once a day or two divided doses) To achieve maintenance, doses may be increased by 50 – 100 mg every one to two weeksNote: In patients taking AEDs where the pharmacokinetic interaction with lamotrigine is currently not known, the treatment regimen as recommended for lamotrigine with concurrent valproate should be used, thereafter, the dose should be increased until optimal response is achieved. The initial dose and subsequent dose escalation should not be exceeded to minimise the risk of rash (see Special Warnings and Special Precautions for Use).Children aged 2 to 12 years (see Table 2)In patients taking valproate with / without any other anti-epileptic drug (AED), the initial Lamictal dose is 0.15 mg/kg bodyweight/day given once a day for two weeks, followed by 0.3 mg/kg/day given once a day for two weeks. Thereafter, the dose should be increased by a maximum of 0.3 mg/kg every 1-2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 1-5 mg/kg/day given once a day or in two divided doses.In those patients taking concomitantAEDs or other medications (see section 4.5) that induce lamotrigine glucuronidation with / without other AED's (except valproate) the initial Lamictal dose is 0.6 mg/kg bodyweight/day given in two divided doses for two weeks, followed by 1.2mg/kg/day for two weeks. Thereafter, the dose should be increased by a maximum of 1.2 mg/kg every 1-2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 5-15mg/kg/day given in two divided doses.In patients taking oxcarbazepine without any inducers or inhibitors of lamotrigine glucuronidation, the initial lamotrigine dose is 0.3 mg/kg bodyweight/day given once a day or in two divided doses for two weeks, followed by 0.6 mg/kg/day given once a day or in two divided doses for two weeks. Thereafter, the dose should be increased by a maximum of 0.6 mg/kg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 1 to 10 mg/kg/day given once a day or in two divided doses, with a maximum of 200 mg/day.Table 2 Recommended treatment regimen of Lamictal for children aged 2-12 years (Total daily dose in mg/kg bodyweight/day)Treatment regimenWeeks 1 + 2Weeks 3 + 4Usual Maintenance DoseAdd-on therapy with valproate regardless of any other concomitant medication0.15 mg/kg* (once a day)0.3 mg/kg (once a day)0.3 mg/kg increments every one to two weeks to achieve a maintenance dose of 1 – 5 mg/kg (once a day or two divided doses).Add-on therapy without valproateThis dosage regimen should be used with: phenytoin carbamazepine phenobarbital primidone or with other inducers of lamotrigine glucuronidation.0.6 mg/kg (two divided doses)1.2 mg/kg (two divided doses)1.2 mg/kg increments every one to two weeks to achieve a maintenance dose of 5 – 15 mg/kg (two divided doses).With oxcarbazepine without inducers or inhibitors of lamotrigine glucuronidation0.3 mg/kg (one or two divided doses)0.6 mg/kg (one or two divided doses)0.6 mg/kg increments every one to two weeks to achieve a maintenance dose of 1 - 10 mg/kg (once a day or two divided doses) to a maximum of 200 mg/day.Note: In patients taking AEDs where the pharmacokinetic interaction with lamotrigine is currently not known, the treatment regimen as recommended for lamotrigine with concurrent valproate should be used, thereafter, the dose should be increased until optimal response is achieved.* If the calculated daily dose in patients taking valproate is 1 to 2 mg, then 2 mg lamotrigine may be taken on alternate days for the first two weeks. If the calculated daily dose in patients taking valproate is less than 1 mg, then lamotrigine should not be administered.The initial dose and subsequent dose escalation should not be exceeded to minimise the risk of rash.It is likely that patients aged 2-6 years will require a maintenance dose at the higher end of the recommended range.Children aged less than 2 yearsThere is insufficient information on the use of Lamictal in children aged less than 2 years.Women and Hormonal Contraceptives(a) Starting lamotrigine in patients taking hormonal contraceptivesDose escalation should follow the guidelines recommended in Table 1 above(b) Starting hormonal contraceptives in patients taking lamotrigineFor women NOT taking inducers of lamotrigine glucuronidation such as phenytoin, carbamazepine, phenobarbital, primidone or rifampicin, the maintenance dose of lamotrigine may need to be increased by as much as two-fold, according to clinical response. For women taking lamotrigine in addition to inducers of lamotrigine glucoronidation, adjustment may not be necessary.(c) Stopping hormonal contraceptives in patients taking lamotrigineFor women NOT taking inducers of lamotrigine glucoronidation the maintenance dose of lamotrigine may need to be decreased by as much as 50%, according to clinical response.For women taking lamotrigine in addition to inducers of lamotrigine glucuronidation, adjustment may not be necessary.Pregnancy and post-partumDose adjustment may be necessary during pregnancy and post-partum.ElderlyNo dosage adjustment from recommended schedule is required. The pharmacokinetics of lamotrigine in this age group do not differ significantly from a non-elderly population.Hepatic ImpairmentInitial, escalation and maintenance doses should generally be reduced by approximately 50% in patients with moderate (Child-Pugh grade B) and 75% in severe (Child-Pugh grade C) hepatic impairment. Escalation and maintenance doses should be adjusted according to clinical response.

Child Dosage
Add-on therapy with enzyme inducers (not with valproate), under 2 years, not recommended; 2 - 12 years, initially 0.6mg/kg daily in two divided doses for 2 weeks, then 1.2mg/kg daily in two divided doses for 2 weeks. Then increase by maximum 1.2mg/kg increments every 1 - 2 weeks until optimal response. Usually 5-15mg/kg daily (given in two divided doses). Add-on therapy (with valproate), under 2 years, not recommended; 2 - 12 years, initially 0.15mg/kg once daily for 2 weeks, then 0.3mg/kg once daily for 2 weeks. Then increase by maximum 0 .3mg/kg increments every 1 - 2 weeks until optimal response. Usually, 1- 5mg/kg daily (given as a single dose or in two divided doses).

Contra Indications
Lamictal is contraindicated in individuals with known hypersensitivity to lamotrigine.

Special Precautions
There have been reports of adverse skin reactions, which have generally occurred within the first 8 weeks after initiation of lamotrigine (Lamictal) treatment. The majority of rashes are mild and self limiting, however rarely, serious potentially life threatening skin rashes including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported (see Undesirable Effects).The approximate incidence of serious skin rashes reported as SJS in adults and children over the age of 12 is 1 in 1000. The risk in children under the age of 12 is higher than in adults. Available data from a number of studies suggest that the incidence of rashes associated with hospitalisation in children under the age of 12 is from 1 in 300 to 1 in 100 (see Undesirable Effects).In children, the initial presentation of a rash can be mistaken for an infection; physicians should consider the possibility of a drug reaction in children that develop symptoms of rash and fever during the first eight weeks of therapy.Additionally the overall risk of rash appears to be strongly associated with:-• High initial doses of lamotrigine and exceeding the recommended dose escalation of lamotrigine therapy (see Posology and Method of Administration).• Concomitant use of valproate (See Posology and Method of Administration).Caution is also required when treating patients with a history of allergy or rash to other antiepileptic drugs as the frequency of non-serious rash after treatment with lamotrigine was approximately three times higher in these patients than in those without such history.All patients (adults and children) who develop a rash should be promptly eva luated and lamotrigine withdrawn immediately unless the rash is clearly not drug related. Lamotrigine should not be restarted in patients with previous hypersensitivity.Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedema and abnormalities of the blood and liver. The syndrome shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation (DIC) and multiorgan failure. It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though rash is not evident. Patients should be warned to seek immediate medical advice if signs and symptoms develop. If such signs and symptoms are present the patient should be eva luated immediately and Lamictal discontinued if an alternative aetiology cannot be establishedSpecialist contraceptive advice should be given to women who are of child-bearing age. Women of child-bearing age should be encouraged to use effective alternative non-hormonal methods of contraception.Effects of hormonal contraceptives on lamotrigine efficacy:Systemic lamotrigine concentrations are approximately halved during co-administration of oral contraceptives. This may result in reduced seizure control in women on a stable lamotrigine dose who start an oral contraceptive, or in adverse effects following withdrawal of an oral contraceptive. Dose adjustments of lamotrigine may be required.The effects of co-administration of other hormonal contraceptives and hormone replacement therapy have not been studied; they may similarly affect lamotrigine pharmacokinetic parameters.Effects of lamotrigine on hormonal contraceptive efficacy:An interaction study demonstrated some loss of suppression of the hypothalamic-pituitary-ovarian axis when 300mg lamotrigine was co-administered with a combined oral contraceptive. The impact of these changes on ovarian ovulatory activity is unknown. However, the possibility of decreased contraceptive efficacy cannot be excluded. Therefore, women should have a review of their contraception when starting lamotrigine, and the use of alternative non-hormonal methods of contraception should be encouraged. A hormonal contraceptive should only be used as the sole method of contraception if there is no other alternative. If the oral contraceptive pill is chosen as the sole method of contraception, women should be advised to promptly notify their physician if they experience changes in menstrual pattern (e.g. breakthrough bleeding) while taking Lamictal as this may be an indication of decreased contraceptive efficacy. Women taking Lamictal should notify their physician if they plan to start or stop use of oral contraceptives or other female hormonal preparations.As with other AEDs, abrupt withdrawal of Lamictal may provoke rebound seizures. Unless safety concerns (for example rash) require an abrupt withdrawal, the dose of Lamictal should be gradually decreased over a period of 2 weeks.During clinical experience with lamotrigine used as add-on therapy, there have been, rarely, deaths following rapidly progressive illnesses with status epilepticus, rhabdomyolysis, multiorgan dysfunction and disseminated intravascular coagulation (DIC). The contribution of lamotrigine to these events remains to be established.Lamictal is a weak inhibitor of dihydrofolate reductase hence there is a possibility of interference with folate metabolism during long-term therapy. However, during prolonged human dosing, lamotrigine did not induce significant changes in the haemoglobin concentration, mean corpuscular volume, or serum or red blood cell folate concentrations up to 1 year or red blood cell folate concentrations for up to 5 years.In single dose studies in subjects with end stage renal failure, plasma concentrations of lamotrigine were not significantly altered. However, accumulation of the glucuronide metabolite is to be expected; caution should therefore be exercised in treating patients with renal failure.In patients with severe hepatic impairment (Child-Pugh grade C) it has been shown that initial and maintenance doses should be reduced by 75%. Caution should be exercised when dosing this severely hepatically impaired population.

Interactions
UDP-glucuronyl transferases have been identified as the enzymes responsible for metabolism of lamotrigine. There is no evidence that lamotrigine causes clinically significant induction or inhibition of hepatic oxidative drug-metabolising enzymes, and interactions between lamotrigine and drugs metabolised by cytochrome P450 enzymes are unlikely to occur. Lamotrigine may induce its own metabolism but the effect is modest and unlikely to have significant clinical consequences.Table 3 Effects of other drugs on glucuronidation of lamotrigineDrugs that significantly inhibit glucuronidation of lamotrigineDrugs that significantly induce glucuronidation of lamotrigineDrugs that do not significantly inhibit or induce glucuronidation of lamotrigineva lproateCarbamazepineOlanzapinePhenytoinOxcarbazepinePrimidonePhenobarbitalRifampicinEthinylestradiol/ levonorgestrel combination** Other hormonal contraceptives and hormone replacement therapy have not been studied; they may similarly affect lamotrigine pharmacokinetic parameters.Interactions involving AEDs Certain antiepileptic agents which induce drug-metabolising enzymes (such as phenytoin, carbamazepine, phenobarbital and primidone) induce the glucuronidation of lamotrigine and enhance the metabolism of lamotrigine and may increase dose requirements.Sodium valproate, which inhibits the glucuronidation of lamotrigine, reduces the metabolism of lamotrigine and increases the mean half life of lamotrigine nearly two fold.Although changes in the plasma concentrations of other antiepileptic drugs have been reported, controlled studies have shown no evidence that lamotrigine affects the plasma concentrations of concomitant antiepileptic drugs. Evidence from in vitro studies indicates that lamotrigine does not displace other antiepileptic drugs from protein binding sites.There have been reports of central nervous system events including headache, nausea, blurred vision, dizziness, diplopia and ataxia in patients taking carbamazepine following the introduction of lamotrigine. These events usually resolve when the dose of carbamazepine is reduced. A similar effect was seen during a study of lamotrigine and oxcarbazepine in healthy adult volunteers, but dose reduction was not investigated.In a study in healthy adult volunteers using doses of 200 mg lamotrigine and 1200 mg oxcarbazepine, oxcarbazepine did not alter the metabolism of lamotrigine and lamotrigine did not alter the metabolism of oxcarbazepine.Interactions involving other psychoactive agentsIn a study in healthy adult volunteers, 15 mg olanzapine reduced the AUC and Cmax of lamotrigine by an average of 24% and 20%, respectively. Therefore an effect of this magnitude is generally not expected to be clinically relevant but may be important to consider in some patients. Lamotrigine at 200 mg did not affect the pharmacokinetics of olanzapine.Interactions involving Oral ContraceptivesEffect of oral contraceptives on lamotrigine:Systemic lamotrigine concentrations are approximately halved during co-administration of oral contraceptives. This may result in reduced seizure control after the addition of an oral contraceptive, or adverse effects following withdrawal of an oral contraceptive. Dose adjustments of lamotrigine may be required.In a study of 16 female volunteers, 30 mcg ethinylestradiol/150 mcg levonorgestrel in a combined oral contraceptive pill caused an approximately two-fold increase in lamotrigine oral clearance, resulting in an average 52% and 39% reduction in lamotrigine AUC and Cmax, respectively. Serum lamotrigine concentrations gradually increased during the course of the week of inactive medication (e.g. "pill-free" week), with pre-dose concentrations at the end of the week of inactive medication being, on average, approximately two-fold higher than during co-therapy.The effect of other hormonal contraceptive products or hormone replacement therapy has not been eva luated although the effect may be similar.Effect of lamotrigine on oral contraceptives:Co-administration of 300mg lamotrigine in a study of 16 female volunteers had no effect on the pharmacokinetics of the ethinylestradiol component of a combined oral contraceptive pill. A modest increase in oral clearance of the levonorgestrel component was observed, resulting in an average 19% and 12% reduction in levonorgestrel AUC and Cmax, respectively. Measurement of serum follicle-stimulating hormone (FSH), luteinising hormone (LH) and estradiol during the study indicated some loss of suppression of ovarian hormonal activity, although measurement of serum progesterone indicated that there was no hormonal evidence of ovulation in any of the 16 subjects. The impact of the modest increase in levonorgestrel clearance, and the changes in serum FSH and LH, on ovarian ovulatory activity is unknown. Vaginal bleeding was reported by some volunteers (see section 4.4). The effects of doses of lamotrigine other than 300mg/day have not been studied and studies with other female hormonal preparations have not been conducted.

Adverse Reactions
In double-blind, add-on clinical trials, skin rashes occurred in up to 10% of patients taking lamotrigine and in 5% of patients taking placebo. The skin rashes led to the withdrawal of lamotrigine treatment in 2% of patients. The rash, usually maculopapular in appearance, generally appears within eight weeks of starting treatment and resolves on withdrawal of lamotrigine.Rarely, serious potentially life threatening skin rashes, including Stevens Johnson syndrome and toxic epidermal necrolysis (Lyell Syndrome) have been reported. Although the majority recover on drug withdrawal, some patients experience irreversible scarring and there have been rare cases of associated death.The approximate incidence of serious skin rashes reported as SJS in adults and children over the age of 12 is 1 in 1000. The risk in children under the age of 12 is higher than in adults. Available data from a number of studies suggest that the incidence in children under the age of 12 requiring hospitalisation due to rash ranges from 1 in 300 to 1 in 100.In children, the initial presentation of a rash can be mistaken for an infection; physicians should consider the possibility of a drug reaction in children that develop symptoms of rash and fever during the first eight weeks of therapy.Additionally the overall risk of rash appears to be strongly associated with:-High initial doses of lamotrigine and exceeding the recommended dose escalation of lamotrigine therapy (see Posology and Method of Administration).Concomitant use of valproateAll patients (adults and children) who develop a rash should be promptly eva luated and lamotrigine withdrawn immediately unless the rash is clearly not drug related.Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedema and abnormalities of the blood and liver. The syndrome shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation (DIC) and multiorgan failure. It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though rash is not evident. Patients should be warned to seek immediate medical advice if signs and symptoms develop. If such signs and symptoms are present the patient should be eva luated immediately and Lamictal discontinued if an alternative aetiology cannot be establishedAdverse experiences reported during Lamictal monotherapy trials include headache, tiredness, rash, nausea, dizziness, drowsiness and insomnia.Other adverse experiences have included diplopia, blurred vision, conjunctivitis, dizziness, drowsiness, headache, tiredness, gastrointestinal disturbance (including vomiting and diarrhoea), irritability/aggression, tremor, agitation, confusion and hallucinations. Very rarely, lupus-like reactions have been reported.There have been reports of haematological abnormalities which may or may not be associated with the hypersensitivity syndrome. These have included neutropenia, leucopenia, anaemia, thrombocytopenia, pancytopenia, and very rarely aplastic anaemia and agranulocytosis.Movement disorders such as tics, unsteadiness, ataxia, nystagmus and tremor have also been reported. There have been reports that Lamictal may worsen parkinsonian symptoms in patients with pre-existing Parkinson's disease, and isolated reports of extrapyramidal effects and choreoathetosis in patients with this underlying condition. Very rarely, increase in seizure frequency has been reported.Elevations of liver function tests and rare reports of hepatic dysfunction, including hepatic failure, have been reported. Hepatic dysfunction usually occurs in association with hypersensitivity reactions but isolated cases have been reported without overt signs of hypersensitivity.Additionally, arthralgia, pain and back pain were reported commonly during the clinical development programme for lamotrigine in bipolar disorder.

Manufacturer
GlaxoSmithKline(GSK)

Drug Availability
(POM)

Updated
22 June 2009