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LAMOTRIGINE RUDIPHARM is a brand name for Lamotrigine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Epilepsy Adults and adolescents aged 13 years and above - Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic-clonic seizures. - Seizures associated with Lennox-Gastaut syndrome. Lamotrigine is given as adjunctive therapy but may be the initial antiepileptic drug (AED) to…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Lamotrigine tablets should be swallowed whole, and should not be chewed or crushed. Lamotrigine chewable/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.
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. 3 mg/kg/day (once a day or two divided […]
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) Unsteadiness, movement disorders, worsening of Parkinson's disease 3, extrapyramidal effects, choreoathetosis†, increase in seizure frequency Very common Common Uncommon Rare Very rare Eye disorders Diplopia†, blurred vision† Conjunctivitis Uncommon Rare Gastrointestinal disorders Nausea†, vomiting†, diarrhoea†, dry mouth§ Common Hepatobiliary disorders Hepatic failure, hepatic dysfunction4, increased liver function tests Very rare Skin and subcutaneous tissue disorders Skin rash5†§ Alopecia, photosensitivity reaction Erythema multiforme, Stevens–Johnson Syndrome§ Toxic epidermal necrolysis Drug Reaction with Eosinophilia and Systemic2 Symptoms Very common Uncommon Rare Very rare Very rare Musculoskeletal and connective tissue disorders Arthralgia§ Lupus-like reactions Common Very rare Renal and urinary disorders Tubulointerstitial nephritis, tubulointerstitial nephritis and uveitis syndrome Not known General disorders and administration site conditions Tiredness†, pain§, back pain§ Common Description of selected adverse reactions 1 Haematological 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 disorders).
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). 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.
HLA-B*1502 allele in individuals of Asian (primarily Han Chinese and Thai) origin has been shown to be associated with the risk of developing SJS/TEN when treated with lamotrigine. If these patients are known to be positive for HLA-B*1502, use of lamotrigine should be carefully considered.
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 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.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 Rash has also been reported as part of this syndrome, also known as DRESS. This condition is associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedema, and abnormalities of the blood, liver and kidney.
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.
4). 3 These effects have been reported during other clinical experience. There have been reports that lamotrigine may worsen parkinsonian symptoms in patients with pre-existing Parkinson's disease, and isolated reports of extrapyramidal effects and choreoathetosis in patients without this underlying condition.
4 Hepatic dysfunction usually occurs in association with hypersensitivity reactions but isolated cases have been reported without overt signs of hypersensitivity. 5 In clinical trials in adults, skin rashes occurred in up to 8-12% of patients taking lamotrigine and in 5-6% of patients taking placebo.
The skin rashes led to the withdrawal of lamotrigine treatment in 2% of patients. 4). Serious potentially life-threatening skin rashes, including Stevens–Johnson syndrome and toxic epidermal necrolysis (Lyell's Syndrome) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported.
4). 2). There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with lamotrigine. The mechanism by which lamotrigine affects bone metabolism has not been identified.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
If the patient has developed SJS, TEN or DRESS with the use of lamotrigine, treatment with lamotrigine must not be re-started in this patient at any time. Rash has also been reported as part of DRESS; also known as hypersensitivity syndrome.
8). 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 aetiology 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. 8). In several cases, the reaction occurred with a high dose (400 mg or more), upon dose escalation or rapid up-titration.
If lamotrigine-associated photosensitivity is suspected in a patient showing signs of photosensitivity (such as an exaggerated sunburn), treatment discontinuation should be considered. g. use of protective clothing and sunscreens). 8).
HLH is characterised by signs and symptoms, like fever, rash, neurological symptoms, hepatosplenomegaly, lymphadenopathy, cytopenias, high serum ferritin, hypertriglyceridaemia and abnormalities of liver function and coagulation. Symptoms occur generally within 4 weeks of treatment initiation, HLH can be life threatening.
Patients should be informed of the symptoms associated with HLH and should be advised to seek medical attention immediately if they experience these symptoms while on lamotrigine therapy. Immediately evaluate patients who develop these signs and symptoms and consider a diagnosis of HLH.
Lamotrigine should be promptly discontinued unless an alternative aetiology can be established. Clinical worsening and suicide risk Suicidal ideation and behaviour have been reported in patients treated with AEDs in several indications.
A meta-analysis of randomised placebo- controlled trials of AEDs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for lamotrigine.
Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical […]