Eczema, facial edema, photosensitivity, and pruritus each were reported in 2% of children receiving immediate-release lamotrigine as adjunctive therapy in controlled clinical trials. However, the dose is usually not more than 100 mg a day. Pain and infection each occurred in 5% and fever in 2% of adults receiving lamotrigine as monotherapy in a controlled trial. 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. These have included potentially Life-threatening cutaneous rashes Stevens-Johnson syndrome (SJS),toxic epidermal necrolysis (TEN) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS); also known as hypersensitivity syndrome (HSS) (See section 4.8)Patients should be advised of the signs and symptoms and monitored closely for skin reactions. Subsequent daily dosages should be increased every 1-2 weeks by 0.3 mg/kg (rounded down to the nearest whole tablet) until an effective daily maintenance dosage of 1-5 mg/kg (maximum of 200 mg/day in 1 or 2 divided doses) is reached.

Sinusitis and bronchospasm each were reported in 2% of children in these trials. The transition regimen involves escalating the dose of lamotrigine to a maintenance stabilisation dose over six weeks (Table 3) after which other psychotropic medicinal products and/or AEDs can be withdrawn, if clinically indicated (Table 4). Lamotrigine(Lamictal ) generic Lamepil (100 mg) is an anticonvulsant agent, prescribed for epilepsy and bipolar disorder either alone or combined with other medications. The reason is unclear.In children taking lamotrigine for the treament of typical absence seizures, efficacy may not be maintained in all patients.Arrhythmogenic ST-T abnormality and typical Brugada ECG pattern has been reported in patients treated with lamotrigine.The use of lamotrigine should be carefully considered in patients with Brugada syndrome.HLH has been reported in patients taking lamotrigine (see section 4.8).

However, the relative risk for suicidality was found to be higher in patients with epilepsy compared with patients who were given one of the drugs for psychiatric or other conditions.Based on the current analysis of the available data, FDA recommends that all patients who are currently receiving or beginning therapy with any anticonvulsant for any indication be closely monitored for the emergence or worsening of depression, suicidal thoughts or behavior (suicidality), and/or unusual changes in mood or behavior. Doses in the range 100 – 400 mg/day used in clinical trialsThis dosage regimen should be used with valproate regardless of any concomitant medicinal products100 mg/day – usual target dose for optimal response (once day or two divided doses)Maximum dose of 200 mg/day can be used depending on clinical responseThis dosage regimen should be used without valproate but with:300 mg/day in week 6, If necessary increasing to usual target dose of 400 mg/day in week 7, to achieve optimal response (two divided doses) In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the dose escalations as recommended for lamotrigine with concurrent valproate should be used.

This medicine should be used with caution in patients suffering from kidney impairment due to the increased risk of severe adverse effects. The transition regimen for converting patients from monotherapy with a hepatic enzyme-inducing anticonvulsant drug to lamotrigine monotherapy is a 2-step process; the goal of the transition regimen is to ensure adequate seizure control while minimizing the possibility of developing a serious rash associated with the rapid titration of lamotrigine.In the first step of the process, immediate-release lamotrigine therapy is added to the current drug regimen (which should be maintained at a fixed dosage) at a dosage of 50 mg once daily for 2 weeks, followed by 100 mg daily in 2 divided doses for 2 weeks; the daily dosage is then increased by 100 mg every 1-2 weeks until the maintenance dosage of 500 mg daily (in 2 divided doses) is reached. Your FSA Administrator might provide you with an FSA Debit Card to use toward FSA eligible expenses.

At day 21 postpartum, pups born to dams receiving the lower dosage (5 mg/kg daily) exhibited a longer latent period for open field exploration and a lower frequency of rearing. Dose increases should not exceed this rate, unless the clinical response supports larger increases. Plasma lamotrigine monitoring should be conducted before and during 2 weeks after starting or stopping lopinavir/ritonavir, in order to see if lamotrigine dose adjustment is needed (see section 4.5).No dose adjustment from the recommended schedule is required.