Where is lamictal manufacturer

There is no published evidence about changing brands of lamotrigine in children. If there are concerns around epilepsy control with brand change in a particular child, this can be discussed with a paediatrician or neurologist.

Patients who are currently taking a regimen involving a combination of lower e. Patients or caregivers can be reassured that the different brands of lamotrigine have been assessed as bioequivalent, and there are no known issues with taking a regimen including two different brands of lamotrigine. Generic medicines are designated as bioequivalent and contain the same dose of active ingredient, however, it is possible that some patients may absorb a slightly lower or higher amount of medicine when they change to a different brand due to slight differences in bioavailability which are within the accepted margin of error.

If a patient is going to experience any symptoms as a result of the brand change, expert opinion is that these will almost certainly occur within the first eight weeks following the change.

Therefore, reassure patients that they will receive support and follow-up after changing their brand to ensure they are not experiencing any difficulties. The nocebo effect is when patients experience symptoms that are caused by anticipating adverse effects rather than actual adverse effects of a medicine.

This can be influenced by extensive media coverage of an issue or discussion on social media, as well as by the language that a health professional uses when discussing symptoms and signs to be aware of. The nocebo effect is discussed in more detail here: www. One of the key dilemmas when changing patients with epilepsy to another brand of medicine is that if seizures occur it is difficult to determine whether a change in brand is the cause of their altered seizure control.

Any seizure activity following brand change is unlikely to be because of the change, but it cannot be ruled out. Expert opinion is that seizure activity more than eight weeks following the change will not be as a result of the change. Some patients with epilepsy are likely to have seizures regardless of which formulation of medicine they are prescribed and there are many other factors which may affect seizure control, e.

If a patient has a seizure within the first eight weeks of a medicine brand change, application can be made to NZTA for consideration of a six-month stand down period instead of the standard 12 months. For a generic medicine to be approved for therapeutic use, manufacturers must present clinical evidence to Medsafe to demonstrate that the medicine is bioequivalent to the originator brand of medicine or a suitable alternative, known as the reference medicine.

Bioequivalence studies measure aspects of absorption and blood levels of the active ingredient including the area under the curve AUC , which reflects the extent and duration of exposure to the active ingredient, and the maximum plasma concentration C max. Typically, bioequivalence studies are conducted in healthy patients.

One concern which had been raised in relation to antiepileptic medicines was whether results in healthy patients accurately reflect absorption in patients with epilepsy. Each study reported that generic and innovator Lamictal formulations of lamotrigine were bioequivalent in patients with epilepsy. Further information on bioequivalence studies and the approval process for generic medicines is available at:.

When a brand change is implemented, pharmacists should check that patients are aware they are being dispensed a different brand than the medicine they may be used to, and address any questions or concerns. Discussion about an upcoming brand change is also useful to prepare patients for the change that will need to occur when their current brand is no longer funded. When a different brand is dispensed, pharmacists can show the patient what their new medicine looks like and emphasise that the active ingredient remains the same.

The three currently funded brands of lamotrigine have a similar appearance, size and flavouring, with tablet shape being the main difference between brands Table 3.

Evidence suggests that changes in the appearance of a medicine may influence adherence, 8, 31 therefore this is a crucial time to ensure that patients are aware of the brand change and to address any potential issues.

Table 3: Currently funded formulations of 25 mg, 50 mg, and mg lamotrigine tablets and their appearance. Tablet size increases with strength. The tablet sizes for each strength are similar between brands.

Patients should be followed up after changing from Lamictal or Arrow-Lamotrigine branded tablets to Logem to check on medicine adherence and whether patients or caregivers have any concerns regarding the alteration in medicine regimen. If clinical symptoms and signs have emerged since the brand change, consider whether they could be caused by small differences in absorption of medicine with the new brand, or whether other factors could explain the occurrence, e. If these symptoms occur, consider requesting a serum lamotrigine level and discuss with a neurologist, paediatrician or psychiatrist as appropriate.

If the patient is already taking the maximum dose of lamotrigine or the dose increase does not improve symptoms, discuss with or refer to a neurologist, paediatrician or psychiatrist as appropriate. The Neurological and Mental Health Subcommittees of PTAC considered whether monitoring serum levels of lamotrigine would aid in clinical management during a brand change, however, they concluded that based on available evidence this would be of little benefit as monitoring is generally used to check for adherence, possible toxicity or during pregnancy.

Clinical trials have found that there is some dose to dose variation in serum levels of lamotrigine; importantly, these variations are similar for patients who change from the originator brand to a generic formulation of lamotrigine and patients who continue to take the originator brand.

If a patient with epilepsy experiences a seizure after changing brands of lamotrigine, it is possible that this is related to the brand change, but also possible that this was a random occurrence or influenced by other factors, such as acute illnesses, co-morbidities, changes in daily routine or other medicines which may affect seizure control or the efficacy of antiepileptic medicines.

Discuss with patients that a change in seizure control may not be related to the brand change, and it does not necessarily mean that the Logem brand should be discontinued. If patients are having difficulty after being changed to Logem and require an additional appointment to discuss concerns, clinicians can invoice PHARMAC for the General Practitioner co-payment fee i. Funding is available to assist patients in accessing a non-funded brand of lamotrigine if there are exceptional clinical difficulties.

This could include a patient who clinicians believe would be unable to manage a change in brand, e. On 15th November, , the application criteria were widened to allow prescribers to make an application to PHARMAC for ongoing funding for individuals:. If patients wish to continue taking another brand of lamotrigine at their own personal cost after 1 October, , they should discuss the price and availability of supplies with a pharmacist.

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Hello there! Remember me. Medicine subsidy Mental health Neurology. The funded brand of lamotrigine is changing Changes in funded brands of antiepileptic medicines can lead to concern from patients or caregivers that the medicine they are receiving is not the same and may not be as effective.

Please login to save this article. Log in. Lamotrigine is used for the treatment of epilepsy and some mood disorders The evidence behind the decision to change brands MHRA classification system Changing patients to another brand of lamotrigine. Lamotrigine is used for the treatment of epilepsy and some mood disorders Lamotrigine is an antiepileptic medicine used in the treatment of patients with focal, generalised or absence seizures.

The evidence behind the decision to change brands One of the key considerations for a brand change involving an antiepileptic medicine is the likelihood of this affecting seizure control or mood stabilisation. The clinical expert advisory assessment of lamotrigine brand changing On 29 August, , PHARMAC released a proposal to move from three funded brands of lamotrigine to one funded brand.

MHRA classification system Classification system for antiepileptic medicines and brand changing proposed by the Commission on Human Medicines, United Kingdom, in and revised in Carbamazepine Phenobarbital Phenytoin Primidone Category 2 Antiepileptic medicines which do not clearly fit into either of the other two categories based on evidence available at the time of assessment Clobazam Clonazepam Lamotrigine Sodium valproate Topiramate Category 3 Antiepileptic medicines where the potential for clinically relevant differences between brands to exist was low Ethosuximide Gabapentin Lacosamide Levetiracetam Pregabalin Vigabatrin.

Changing patients to another brand of lamotrigine Discuss the brand change and address questions and concerns Brand changes for antiepileptic medicines can be a cause of apprehension or concern for parents or caregivers. Is it ok for my child to change brands? Can I combine brands? Will I notice any difference when I change brands? Will the brand change affect my driver licence?

Bioequivalence studies of lamotrigine For a generic medicine to be approved for therapeutic use, manufacturers must present clinical evidence to Medsafe to demonstrate that the medicine is bioequivalent to the originator brand of medicine or a suitable alternative, known as the reference medicine. Advice at the pharmacy When a brand change is implemented, pharmacists should check that patients are aware they are being dispensed a different brand than the medicine they may be used to, and address any questions or concerns.

Patients may notice a difference in the shape of their tablets When a different brand is dispensed, pharmacists can show the patient what their new medicine looks like and emphasise that the active ingredient remains the same. The reverse side has a line marked on it. Tablet appearance White to off-white Round with a flat face White to off-white, rounded edges with a raised centre White to off-white Shield-shaped 25 mg 50 mg mg Tablet size Tablet size increases with strength.

Patient follow-up Patients should be followed up after changing from Lamictal or Arrow-Lamotrigine branded tablets to Logem to check on medicine adherence and whether patients or caregivers have any concerns regarding the alteration in medicine regimen. Symptoms which could indicate that patients are absorbing an increased dose of lamotrigine include: 7 Headache Nausea Tremor Dizziness Irritability Blurred vision or visual disturbances If these symptoms occur, consider requesting a serum lamotrigine level and discuss with a neurologist, paediatrician or psychiatrist as appropriate.

Routine monitoring of serum levels is not necessary The Neurological and Mental Health Subcommittees of PTAC considered whether monitoring serum levels of lamotrigine would aid in clinical management during a brand change, however, they concluded that based on available evidence this would be of little benefit as monitoring is generally used to check for adherence, possible toxicity or during pregnancy. If needed, funding to cover the cost of a follow-up appointment is available If patients are having difficulty after being changed to Logem and require an additional appointment to discuss concerns, clinicians can invoice PHARMAC for the General Practitioner co-payment fee i.

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