LAMOTRIGINE MYLAN

Posology If the calculated dose of lamotrigine (for example for treatment of children with epilepsy or 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.

4). The greater the interval of time since the previous dose, the more consideration should be given to escalation to the maintenance dose. 2), Lamotrigine should generally be escalated to the maintenance dose according to the appropriate schedule.

It is recommended that lamotrigine 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. Epilepsy The recommended dose escalation and maintenance doses for adults and adolescents aged 13 years and above (Table 1) and for children and adolescents aged 2 to 12 years (Table 2) are given below.

4). 5). 5), the treatment regimen as recommended for lamotrigine with concurrent valproate should be used. 6 mg/kg/day every one to two weeks until optimal response is achieved, with a maximum maintenance dose of 200 mg/day. 6 mg/kg/day every one to two weeks until optimal response is achieved, with a maximum of […]

The undesirable effects for epilepsy and bipolar disorder indications are based on available data from controlled clinical studies and other clinical experience and are listed in the table below. Frequency categories are derived from controlled clinical studies (epilepsy monotherapy (identified by†) and bipolar disorder (identified by §).

Where frequency categories differ between clinical trial data from epilepsy and bipolar disorder the most conservative frequency is shown. However, where no controlled clinical trial data are available, frequency categories have been obtained from other clinical experience.

The following convention has been utilised for the classification of undesirable effects: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10 000 to <1/1000), very rare (<1/10 000), not known (cannot be estimated from the available data).

4) Very rare Unsteadiness, movement disorders, worsening of Parkinson's disease3, extrapyramidal effects, choreoathetosis†, increase in seizure frequency Uncommon Diplopia†, blurred vision† Eye disorders Rare Conjunctivitis Gastrointestinal disorders Common Nausea†, vomiting†, diarrhoea†, dry mouth§ Hepatobiliary disorders Very rare Hepatic failure, hepatic dysfunction4, increased liver function tests Very common Skin rash5†§ Uncommon Alopecia, Photosensitivity reaction Rare Erythema multiforme, Stevens– Johnson Syndrome§ Very rare Toxic epidermal necrolysis, Drug Reaction with Eosinophilia and Systemic Symptoms Skin and subcutaneous tissue disorders Common Arthralgia§ Musculoskeletal and connective tissue disorders Very rare Lupus-like reactions Renal and urinary disorders Not known Tubulointerstitial nephritis, tubulointerstitial nephritis and uveitis syndrome General disorders and administration site conditions Common Tiredness†, pain§, back pain§.

Description of selected adverse reactions 1Haematological abnormalities and lymphadenopathy may or may not be associated with the Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/hypersensitivity syndrome (see Special Warnings and Precautions for use and Immune system disorders2).

Skin rash There have been reports of adverse skin reactions, which have generally occurred within the first eight weeks after initiation of lamotrigine treatment. The majority of rashes are mild and self-limiting, however serious rashes requiring hospitalisation and discontinuation of lamotrigine have also been reported.

8). Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. g. progressive skin rash often with blisters or mucosal lesions) are present, lamotrigine treatment should be discontinued.

The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of lamotrigine, lamotrigine must not be re-started in this patient at any time.

In adults enrolled in studies utilizing the current lamotrigine dosing recommendations the incidence of serious skin rashes is approximately 1 in 500 in epilepsy patients. Approximately half of these cases have been reported as Stevens–Johnson syndrome (1 in 1000).

In clinical trials in patients with bipolar disorder, the incidence of serious rash is approximately 1 in 1000. The risk of serious skin rashes in children is higher than in adults. Available data from a number of studies suggest the incidence of rashes associated with hospitalisation in children is 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 reaction to lamotrigine treatment in children that develop symptoms of rash and fever during the first eight weeks of therapy.

2). 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.

1.