Sign Out
Skin rash: The risk of serious skin rashes in children is higher than in adults.
In children, the initial presentation of a rash can be mistaken for an infection; physicians should consider the possibility of a reaction to Lamotrigine treatment 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; Concomitant use of Valproate.
Caution is also required when treating patients with a history of allergy or rash to other AEDs 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All patients (adults and children) who develop a rash should be promptly evaluated and Lamotrigine withdrawn immediately unless the rash is clearly not related to Lamotrigine treatment. It is recommended that Lamotrigine tablets not be restarted in patients who have discontinued due to rash associated with prior treatment with Lamotrigine unless the potential benefit clearly outweighs the risk. If the patient has developed SJS, TEN or DRESS with the use of Lamotrigine, treatment with Lamotrigine must not be restarted in this patient at any time.
Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial edema, abnormalities of the blood and liver and aseptic meningitis. The syndrome shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation and multiorgan failure. It is important to note that early manifestations of hypersensitivity (for example fever, lymphadenopathy) may be present even though rash is not evident. If such signs and symptoms are present the patient should be evaluated immediately and Lamotrigine discontinued if an alternative etiology cannot be established.
Aseptic meningitis was reversible on withdrawal of the drug in most cases, but recurred in a number of cases on re-exposure to Lamotrigine. Re-exposure resulted in a rapid return of symptoms that were frequently more severe. Lamotrigine should not be restarted in patients who have discontinued due to aseptic meningitis associated with prior treatment of Lamotrigine.
Clinical worsening and suicide risk: Suicidal ideation and behavior have been reported in patients treated with AEDs in several indications.
Potential for an increase risk of suicidal thoughts or behaviors.
Therefore patients should be monitored for signs of suicidal ideation and behaviors and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behavior emerge.
In patients with bipolar disorder, worsening of depressive symptoms and/or the emergence of suicidality may occur whether or not they are taking medications for bipolar disorder, including Lamotrigine tablets. Therefore patients receiving Lamotrigine tablets for bipolar disorder should be closely monitored for clinical worsening (including development of new symptoms) and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes. Certain patients, such as those with a history of suicidal behavior or thoughts, young adults, and those patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment, may be at a greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients who experience clinical worsening (including development of new symptoms) and/or the emergence of suicidal ideation/behavior, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Hormonal contraceptives: Effects of hormonal contraceptives on Lamotrigine efficacy: The use of an Ethinylestradiol/Levonorgestrel (30 μg/150 μg) combination increases the clearance of Lamotrigine by approximately two-fold resulting in decreased Lamotrigine levels. A decrease in Lamotrigine levels has been associated with loss of seizure control. Following titration, higher maintenance doses of Lamotrigine (by as much as two-fold) will be needed in most cases to attain a maximal therapeutic response. When stopping hormonal contraceptives, the clearance of Lamotrigine may be halved. Increases in Lamotrigine concentrations may be associated with dose-related adverse events. Patients should be monitored with respect to this (see Dosage & Administration).
Effects of Lamotrigine on hormonal contraceptive efficacy: The possibility of these changes (serum FSH and LH) resulting in decreased contraceptive efficacy in some patients taking hormonal preparations with Lamotrigine cannot be excluded. Therefore patients should be instructed to promptly report changes in their menstrual pattern, i.e. breakthrough bleeding.
Dihydrofolate reductase: Lamotrigine has a slight inhibitory effect on Dihydrofolic acid 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 hemoglobin 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.
Renal failure: Accumulation of the glucuronide metabolite is to be expected; caution should therefore be exercised in treating patients with renal failure.
Patients taking other preparations containing Lamotrigine: Lamotrigine should not be administered to patients currently being treated with any other preparation containing Lamotrigine without consulting a doctor.
Precautions relating to epilepsy: As with other AEDs, abrupt withdrawal of Lamotrigine may provoke rebound seizures. Unless safety concerns (for example rash) require an abrupt withdrawal, the dose of Lamotrigine should be gradually decreased over a period of two weeks.
A clinically significant worsening of seizure frequency instead of an improvement may be observed. In patients with more than one seizure type, the observed benefit of control for one seizure type should be weighed against any observed worsening in another seizure type.
Myoclonic seizures may be worsened by Lamotrigine.
Precautions relating to bipolar disorder: Children and adolescents below 18 years: Treatment with antidepressants is associated with an increased risk of suicidal thinking and behavior in children and adolescents with major depressive disorder and other psychiatric disorders.
