Lamictal Tablets 25 MG, 50 MG, 100 MG, 200 MG

Lamictal Tablets (25 MG, 50 MG, 100 MG, 200 MG) contains Lamotrigine which is a derivarive and chemically identified as 6-92,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine prepared by chemical synthesis. Lamotrigine is oral antiepileptic and anticonvulsant agent developed based on the observation that some antipileptic drugs possess antifolate activity. The exact mechanism by which it exhibits its anticonvulsant activity i not known but studies suggest that it may stabilize neuronal membranes by acting at voltage sensitive sodium channels.

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Lamictal Tablets Indications

Epilepsy

• Adults(over 12 years of age)

Lamictal is indicated to treat and for use as adjunctive or monotherapy in the treatment of epilepsy. For partial seizures and generalized serizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome.

• Children (2 to years of age)

Lamictal indicated as adjunctive therapy in the treatment of epilepsy. For partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastut syndrome.

After epileptic control has achieved during adjunctive therapy, concomitant anti-epileptic drugs (AEDs) may withdrawn. And patients continued on Lamictal Medicine indicated as monotherapy in the treatment of typical absence seizures.

Bipolar Disorder

• Adults (18 years of age and over)

Lamitcal Medicine indicated for the prevention of mood episodes in patients with bipolar, predominantly by preventing depressive episodes.

Lamictal Tablets Dosage Administration

Lamitcal Tablets should be swallowed whole. And it should not chewed or crushed. Lamitcal dispersible/chewable tablets may chewed dispersed in a small volume of water (at least enough to cover the whole tablets ) or swallowed whole with a little water.

If a calculated Lamictal Dose, e.g. for use in children between 5 to 12 years ( in epilepsy only). Or some patients who suffers with hepatic impairment, cannot divided into multiple lower strength tablets dosage. The Lamitcal dose to be administered is that equal to the nearest lower strength of whole tablets.

Restarting Therapy

Prescribes should assess the need for escalation to maintenance dose when restarting Lamitcal in patients who have discontinued Lamictal for any reason. Since the risk of serious rash is associated with high initial doses and exceeding the recommended dose escalation for Lamitcal. The greater the interval of time since the previous dose, the more consideration should given to escalation to the maintenance dose. When the interval since discontinuing Lamictal exceeds five half-lives,Lamictal should generally escalated to the maintenance dose according to the appropriate schedule.

Epilepsy

When concomitant anti-epileptic drugs are withdrawn to achieve Lamitcal monotherapy. Or other AEDs are added-on to treatment regimes containing lamotrigine, consideration should be given to the effect this may have on lamotrigine pharmacokinetics.

Dosage In Epilepsy Mono-therapy

Adults (over 12 years of age

The initial Lamictal dose in mono-therapy is Lamictal 25 mg once a day for two weeks. It followed by Lamictal 50 mg once a day for two weeks. Thereafter the dose should be increased by a maximum of Lamitcal 50 to Lamictal 100 mg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal responses is 100 to 200 mg/day given once day or in two divided doses .

Thereafter, the dose should be increased by increased a maximum of Lamitcal 100 mg every one to two weeks until the optimal response is achieved. The usual maintenance dose to for the response is 200 to 400 mg/day used in two divided doses. Some patients may required the medicine upto 700 mg /day of Lamictal to get the recovery results.

In those patients taking other medications that do not significantly inhibit or induce lamotrigine glucuronidation. The initial Lamitcal dose is 25 mg once a day for two weeks. Followed by lamictal 50 mg one time in a day for two weeks. Thereafter, the dose should be increased by a maximum of 50 to 100 mg every one to one to weeks until the optimal response is achieved. The maintenance dose to achieve an optimal response is 100 to 200 m/day given once a day or as two divided doses.

Table 1: Recommended Treatment Regimen In Epilepsy For Adults Over 12 years Of Age

Treatment Regimen		Weeks 1 to 2	Weeks 3 to 4	Maintenance Dose
Monotherapy		25 MG (Once a day)	50 MG (Once a Day)	100—-200 mg (Once a day or two divided doses) To achieve maintenance, doses may be increased by 50—-100 mg every one to two week.
Add-on therapy with valproate regardless of any concomitant medications		12.5 mg (given 25 Mg alternate days)	25 mg (Once a Day)	100—-200 mg (Once a day or two divided doses) To achieve maintenance, doses may be increased by 25—-50 mg every one to two week.
Add-on Therapy without valproate	This dosage regimen should be used with: Phenytoin Carbamazepine Phenobarbitone Primidone Or with other inducers of lamotrigine glucuronidation.	50 mg (Once a day)	100 mg (Two divided doses)	200—-400 mg (Two divided doses) To achieve maintenance, doses may be increased by 100 mg every one to two week.
	This dosage regimen should be used with other medications that do not significantly inhibit or induce lamotrigine glucuronidation.	25 mg (Once a day)	50 mg (Once a Day)	100—-200 mg (Once a day or two divided doses) To achieve maintenance, doses may be increased by 50-100 mg every one to two weeks.

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• Children

  (2 to 12 years of age)

In patients taking valproate with/without any other AED the initial Lamitcal dose is 0.15 mg/kg body weight/day given once a day for two weeks. The dose must followed by 0.3 mg/kg/day one time in a day for two weeks. Thereafter the dose should be increased by a maximum of 0.3 mg/kg every one to two weeks until the optimal response achieved.

Usually the maintenance lamictal dose to get the desired response set to 1 to 5 mg/kg/day given once a day or in two divided doses with a maximum of 200 mg/day. In those patients taking concomitant AEDs or other medications that induce lamotrigine glucuronidation with/without other AEDs (except valproate), the initial Lamitcal dose is 0.6 mg/kg body weight/day given in two divided doses for two weeks. Followed by 1.2 mg/kg every one to two weeks until the optimal response achieved. Meanwhile, maintenance dose which can get the desired response is 5 to 15 mg/kg/day given in two divided doses which can increased to a maximum of 400 mg/day.

Tablet 2: Recommended treatment regimen in Epilepsy for children aged 2—12 years (total daily dose in mg/kg body weight).

Treatment Regimen		Weeks 1 to 2	Weeks 3 to 4	Maintenance Dose
Monotherapy in typical absence seizures		0.3 mg/kg (one or two divided doses)	0.6 mg/kg (one or two divided doses)	0.6 mg/kg increments every one to two weeks to achieve a maintenance dose of 1—10 mg/kg (once a day or two divided doses) to a maximum of 200 mg/day.
Add-on therapy with valproate regardless of any other concomitant medications		0.15 mg/kg (once a day)	0.3 mg/kg (once a day)	0.3 mg/kg increments every one to two weeks to achieve a maintenance dose of 1—5 mg/kg (once a day or two divided doses) to a maximum of 200 mg/day
Add-on Therapy without valproate	This dosage regimen should be used with: Phenytoin Carbamazepine Phenobarbitone Primidone Or with other inducers of lamotrigine glucuronidation.	0.6 mg/kg (Two divided doses)	1.2 mg/kg (two divided doses)	1.2 mg/kg increments every one to two weeks to achieve a maintenance doses of 5—15 mg/kg (once a day or two divided doses) to a maximum of 400 mg/day.
	This dosage regimen should be used with other medications that do not significantly inhibit or induce lamotrigine glucuronidation.	0.3 mg/kg (one or two divided doses)	0.6 mg/kg (one or two divided doses)	0.6 mg/kg increments every one to two weeks to achieve a maintenance dose of 1—10 mg/kg (once a day or two divided doses) to a maximum of 200 mg/day.

Because of a risk of rash the initial dose and subsequent dose escalation should not exceed. Its possible that some patients aged from two to six years will require a maintenance lamictal dose at the higher end of the recommended dose range.

Epilepsy Monotherapy And Add-On Therapy

• Children Aged Less Than 2 Years

Lamotrigine has not been studied as monotherapy in children less than 2 years of age. Or as add on therapy in children less than 1 month of age. The safety and efficacy of lamotrigine as add on therapy of partial seizures in children aged 1 month to 2 years has not been established. Therefore Lamictal not recommended in children less than 2 years of age.

Bipolar Disorder

• Adults (18 years of age and over)

Lamictal recommended for use in bipolar patients at risk of future depressive episodes. The following transition regimen should followed to prevent recurrence of depressive episodes. The transition regimen psychotropic and anti epileptic drugs can be withdrawn if clinically indicated. The adjunctive therapy should considered for the prevention of manic episodes as efficacy with Lamictal in mania has not conclusively established.

Table 3: Recommended dose escalation tot he maintenance total daily stabilization dose for adults (18 years of age and over) treated for Bipolar Disorder

Treatment Regimen	Weeks 1 to 2	Weeks 3 to 4	Week 5	Maintenance Dose
Adjunt therapy with inhibitors of lamotrigine glucuronidation e.g. Valproate	12.5 mg (iven 25 mg alternate days)	25 mg (once a day)	50 mg (once a day or two divided doses)	100 mg (once a day or two divided doses) (maximum daily dose of 200 mg)
Adjunct therapy with inducers of lamotrigine glucuronidation in patients Not takin inhibitors such as Valproate. This dosage regimen should be used with: Phenytoin Carbamazepie Phenobarbitone Primidone Or with other inducers of lamotrigine glucuronidation	50 mg (once a day)	100 mg (Two divided doses)	200 mg (two divided doses)	300 mg in week 6, increasing to 400 mg/day if necessary in week 7 (two divided doses)
Monotherapy with Lamictal or Adjunctive therapy in patients taking other medications that do not significantly inhibit or induce lamotrigine glucuronidation	25 mg Once daily	50 mg (once a day or two divided doses)	100 mg (once a day or two divided doses)	200 mg (Range 100—400 mg) (once a day or two divided doses)

 

• Adjunct therapy with inducers Of Lamotrigine Glucuronidation e.g. Valproate.

In those patients taking glucuronidation inhibiting concomitant drugs such as valproate. The initial Lamictal doses is 25 mg ever alternate day for two weeks, followed by 25 mg once a day for two weeks. The dose should increased to 50 mg once a day (or in two divided doses) in weeks 5. The usual target medicine dose to get the desired response is 100 mg/day given one time a day or in two lamictal divided doses. However, this Lamictal Medicine dose might increased to a maximum daily dose of 200 mg, but it depend on clinical response.

In Those patients Currently Taking Drugs That Induce Lamotrigine Glumotrigine Glucurronidation and not taking valproate. The initial Lamictal dose is 50mg one time in a day and use for two weeks. Further this dose followed by 100 mg/day given in two divided daily Lamictal doses for two weeks . The dose should increased to 200 mg/day given as two divided doses in week 5. The dose may be increased in week 6 to 300 mg/day. However, the usual target dose to achieve optimal response is 400 mg/day given in two divided doses which may be given from week.

• Monotherapy With Lamictal Or Adjunctive Therapy In Patients Taking Other Medications That Do Not Significantly Induce Or Inhitbit Lamotrigine Glucuronidation

  .

The initial Lamictal dose is 25 mg once a day for two weeks, followed by 50 mg once a day (or in two divided doses ) for two weeks. Furthermore, Lamictal Medicine dose should increased to 100 mg/day in week 5. The usual target to achieve optimal response is 200 mg/day given once a day or as two divided doses. However, a dose ranged between 100 to 400 mg basically used in clinical trials. Once the target daily maintenance stabilization dose to achieved. Other psychotropic medications may be withdrawn as laid out in the dosage schedule below in Tablet 4.

Table 4: Maintenance stabilization total daily dose in adults (18 years of age and over) with Bipolar Disorder following withdrawal of concomitant psychotropic or anti epileptic drugs.

Treatment Regimen	Weeks 1	Weeks 2	3 Week Onwards
A following withdrawal of inhibitors of lamotrigine glucuronidation e.g. Valproate	Double the stabilization dose, not exceeding 100 mg/week i.e. 100 mg/day target stabilization dose will be increased in week 1 to 200 mg/day	Maintain this dose (200 mg/day) (two divided doses)
Following withdrawal of inducers of lamotrigine glucuronidation depending on original dose. This dosage regimen should be used with: Phenytoin Carbamazepine Phenobarbitone Primidone Or with other inducers of lamotrigine glucuronidation	400 mg	300 mg	200 mg
	300 mg	225 mg	150 mg
	200 mg	150 mg	100 mg
Following withdrawal of other medications that do not significantly inhibit or induce lamotrigine glucuronidation	Maintain target dose achieved in ose escalation (200 mg/day) (Two divided doses) Range 100-400 mg

 

• Following Withdrawal Of Adjunct Therapy With Inhibitors Of Lamotrigine Glucuronidation e.g. Valproate

The dose of Lamictal should be increased to double the original target stabilisation dose maintained at this,once valproate has been terminated.

• Following Withdrawal Of Adjunct Therapy With Inhibitors Glucuronidation Depending On Original Maintenance Doses. This Regimen Should Be Used With Phenytoin, Carbamazepine,Primidone Or Other Drungs Known To Induce Lamictal Glucuronidation

  .

The dose of Lamictal should be gredually reduced over three weeks as the glucuronidation inducer is withdrawn.

• Following Wthdrawl Of Adjunct Therapy With Other Melications That Do Not Significantly Inhibit Or Induce Lamotrigine Glucuronidation

  .

The target dose achieved in the dose escalation programe should be maintained throughout withdrawal of other medication.

• Adjustment Of Lamictal Daily dosing In Patients With Bipolar Following Addition Of Other Medications.

There is no clinical exoerience in adjusting the lamictal daily dose following the addition of other medications. However, based on drug interaction studies,the following recommencations can be made:

Table 5 : Adjustment Of Lamictal Daily Dosing In Adults (18 Years Of Age And Over) With Bipolar Disorder Following The Addition Of Other Medications

Treatment Regimen	Current Lamictal Stabilization Dose (mg/day)	Week 1	2 Week	Week 3 Onwards
Additon of inhibitors of lamotrigine glucuronidation e.g. Valproate, depending on original dose of Lamictal	200 mg	100 mg	Maintain this dose (100 mg/day)
	300 mg	150 mg	Maintain this dose (150 mg/day)
	400 mg	200 mg	Maintain this dose (200 mg/day)
Addition of inducers of lamotrigine glucuronidation in patients Not taking valproate and depending on original dose of Lamictal. This dosage regimen should be used with: Phenytoin Carbamazepine Phenobarbitone Primidone Or with other inducers of lamotrigine glucuronidation	200 mg	200 mg	300 mg	400 mg
	150 mg	150 mg	225 mg	300 mg
	100 mg	100 mg	150 mg	200 mg
Addition of other medications that do not significantly inhibit or induce lamotrigine glucuronidation	Maintain target dose achieved in dose escalation (200 mg/day) (range 100 – 400 mg)

Discontinuation Of Lamictal In Adult Patients With Bipolar Disorder

In clinical trials, there was no increase in the incidence, severity or type of adverse experiences following abrupt termination of Lamictal versus placebo. Therefore, patients may terminate Lamictal without a step-wise reduction of dose .

• Children And Adolescents (less then years of age )

Lamictal is not indicated for use in bipolar disorder in children and adolescents aged less then 18 years. Safety and efficacy of Lamictal in bipolar disorder has been established in this age group. Therefore a dosage recommendation cannot be made.

General Dosing Recommendations For Lamictal In Special Populations

• Woman Taking Hormonal Contraceptives

 

• Staring Lamictal In patients Already Taking Hormonal Contraceptives:

No adjustments to the recommended dose escalation guidelines for guidelines for Lamictal should be necessary solely based on the use of hormonal contraceptives. Dose escalation Guidelines for for Lamictal should be necessary solely based on the sue of hormonal contraceptives.

Dose escalation should follow the recommended guidelines based on whether lamotrigine is added to valproate, or to an inducer of lamotrigine glucuronidation. Or whether lamictal is added to valproate or to an inducer of lamotrigine glucuronidation .

• Starting Hormonal Contraceptices In Patients Already Taking Maintenance Doses Of Lamictal And Not Taking Indurcers Of Lamotrigine Gucuronidation:

However, The maintenance doses of lamictal will in most cases need to be increased by as much as two -fold . Therefore, It is recommended that time the hormonal contraceptive is started, the lamotrigine dose is increased by 50 to mg/day every week,according to the individual clinical response. Most importantly, the dose increases should not exceed this rate,unless the clinical resposnse supports larger increases.

• Stopping Hormonal Contraceptives In Patients Already Taking Maintenance Doses Of Lamictal And Taking Inducers Of Lamotrigine Glucuronidation:

Firstly, The maintenance doses of Lamictul will in most cases need to be increased by as much as 50 %. Therefore, It is recommended to gradually decrease the daily dose of lamotrigine by 50 to 100 mg each week over a period of 3 weeks. Unless the clinical response indicates otherwise.

• Use With Atazanavir/Ritonavir

Although atazanavir/ritonavirhas been shown to reduce lamotrigine plasma concentrations. Meanwhile, No adjustments to the recommended guidelines for lamictmal should be necessary. Therefore, it Based on whether Lamictal is added to valproate,or to an inducer of lamotrigine glucuronidation. But the patients who have already taking maintenance doses of Limectal and not taking glucuronidation inducers. On the other hand, The Limictal dose may need to be increasedif atazanavir/ritonavir is discontinued.

• Elderly (over 65 years of age)

Most importantly, No dosage adjustment from recommended schedule is required. On the other hand, the pharmacokinetics of lemictal in this age group do not differ significantly from a non-elderly population.

• Hepatic Impairment

Initial, escalation and maintenance lamictal doses may generally reduced to approximately 50 % in patients who are with moderate (Child-pugh grade B). And it can reduced by 75% in severe (Child-pugh grade C) hepatic impairment. On the other hand, Escalation and maintenance and doses should adjusted according to clinical response .

• Renal Impairment

Firstly, the caution should be exercised when administering Lamictal to patients with renal failure. Furthermore, For patients with end-stage renal failure, initial dosage of Lamictal should based on patients AED regimen; reduced maintenance doses may be effective for patients with significant renal functional impairment .For more detailed pharmacokinetic information .

Lamictal Tablets Medicine Contraindications

Most importantly, Lamictal medicine and dispersible /chewable are contraindicated in individuals with known hypersensitivity to, lamotrigine. Or any other ingredient of the preparation.

Lamictal Tablets Drug Interactions

UdP-glucuromyl transferases have been identified as the enzymes responsible for metabolism of lamotrigine. Meanwhile, No data available that lamotrigine causes clinically significant induction. Or inhibition of hepatic oxidative drug - metaboling enzymes. And interactions between lamotrigine and drugs metabolised by cyto chrome p450 enymes are unlikely to occur. Lamotrigine may induce its own metabolism.

Effects Of Other Drugs On Glucuronidation Of Lamotrigine

Drugs That Significantly Inhibit Glucuronidation Of Lamotrigine	Medicine That Significantly Induce Glucuronidation Of Lamotrigine	Drugs That Do Not Significantly Inhibit Or Induce Glucuronidation Or Lamotrigine
Valproate	Carbamazepine Phenytoin Primidone Phenobarbitone Rifampicin Lopinavir/Ritonavir Atazanavir/Ritonavir Ethinylestradiol/Levonorgestrel combination	Lithium Bupropion Olanzapine Oxcarbazepine Flebamate Gabapentin Levetiracetam Pregabalin Topiramate Zonisamide Aripiprazole

 

• Interactions Involving AEDs

Valproate, with inhibits the glucrronidation of lamotrigne, reduces the metabolism of lamotrigine. And increases the mean half-life of lamotringine nearly two-fold. Certain anti-epileptic agents which induce hepatic drug-metaboling enzymes induce the metabolism gluroniding of lamotrigine and enhance the metablism of lamotrigine.

However, There have reports of central nervous system events including dizziness, ataxia , blurred vision and nausea in patients taking carbamazepine following the introduction of lamictal. Meanwhile, these events usually resolve when the dose of carbanazepine reduced. A similar effect seen during a study of lamotrigine and oxcarbazepine in healthy adult volunteers. But dose reduction not investigated. In a study in healthy adult volunteers using doses of 200 mg lamotringine. And 1200 mg oxcarbazepine, oxcarbazepine did not after the metabolism of lamotrigine and lamotrigine not alter the metablism of oxcarbazepine.

Firstly, In a study in healthy volunteers using doses of 200 mg lamotrigine and 1200 mg oxcarbazepine did not alter the metabolism of lamotrigine and lamotrigine did not alter the metabolism of oxcarbazepine.

However, Steady state through plasma concentrations of lamotrigine were not affected by concomitant pregabalin (200 mg 3 times daily) administration. Moreover, There are no pharmacokinetic interactions between lamotrigine drug and pregabalin medicine.

• Interactions Involving Other Psychoactive gents

On the other hand, the pharmacokinetics of lithium after 2 g of anhydrous lithium gluconate given twice daily for six days to 20 healthy subjects not altered by co-administration of 100 mg/day lamictal. Furthermore, Multiple oral doses of bupropion had no statistically significant effects on the single dose pharmacokinetics of lamictal in 12 subjects and only a slight increase in the AUC of lamotrigine glucuronide.

Meanwhile, In vitro inhitbition experiments indicated that the formation of lamortrigine’s primary metabolite the 2-N-glucuronide minimally affected by co-incubation with amitriptyline, bupropion, clonazepam, fluoxetine, haloperidol or lorazepam.

Furthermore, the Bufuralol metabolism data from human liver microsome suggested that lamotrigine do not decrease the clearance of drugs eliminated predominantly by CYP2D6. Results of invitro experiments proves that clearance of lamotrigine most unlikely to affected by clozapine, phenelzine, risperidone, sertradine or trazodone.

• Interactions Involving Laboratory Tests

Most importantly, Lamictmal has reported to interfere with the assay used in some rapid urine drug screens. Which may result the false positive readings, particularly for phencyclidine (PCP). Therefore, A more specific alternative chemical method should used to confirm a positive result .

Lamictal In Pregnancy And Lactation

Firstly, the administration of lamotringine did not impair fertility in animal reproductive studies. Meanwhile, there is no experience of the effect of lamictal on human fertility.

Lamictal In Pregnancy

Meanwhile, Postmarking data from several prospective pregnancy registries have documented out comes in 8700 women exposed to lamictal montherapy during the first trimester of pregnancy. Overall, these data do not suggest a substantial increase in the risk for major congenital malformations. Although data from a limited number of registries have reported an increase in the risk of isolated oral cleft malformations a competed case control study did not demonstrate an increased risk of oral clefts compared to other major congenital malformation following exposure to lamotrigine.

Meanwhile, the data on use of lamictal in polytherapy combinations insufficient to assess whether the risk of malformation associated with other agents affected by concomitant Lamictal use. In addition, As with other medicines, lamictal tablets should only used during pregnancy if the expected benefits outweigh the potential risks. On the other hand, Physiological changes during pregnancy may affect lamotriine levels and/or therapeutic effect. There have reports of decreased lamotrigine levels during pregnancy. Most importantly, Appropriate clinical management of pregnant women during lamictal therapy should assured.

Lamictal Tablets In Lactation

Lamotrigine has reported to pass into breast milk in highly variable concentrations. Which results that lamotrigine levels in infants of up to approximately 50 % of the mother. Therefore in some breast fed infants serum concentrations of lamotrigine may reach levels at which pharmacological effects occur. The potential benefits of breasts of breastfeeding should weighed against the potential risk of adverse effects occurring in the infant.

Lamictal Tablets Effects On Ability to Drive And Use Machines

Two volunteer studies have demonstrated that the effect of lamictal tablets on fine visual motor co-ordination, eye movements, body way and subjective sedative effects did not differ from placebo. However, In clinical trials with lamictal side effects of a neurological character such as dizziness and dialopia have been reported. Therefore, patients should see how lamictal therapy affects them before driving or operating machinery.

Epilepsy

Furthermore, an individual variation in response to all anti-epilaptic drug therapy shown. So patients should consult their physician on the specific problems of driving and epilepsy.

Lamictal Side Effects

Most importantly, the adverse reactions identified from epilepsy or bipolar disorder clinical trial data have divided into indication specific sections.

Epilepsy

Furthermore, the following adverse reactions identified during epilepsy clinical trials and should considered alongside those seen in the bipolar disorder clinical trials and post-marketing sections for an overall safety profile of lamictal.

Skin And Subcutaneous Disorders

Very Common: Skin Rash

Rare : Stevens Johnson syndrome

Very Rare: Toxic epidermal necrolysis

In double blind add on clinical trials in adults skin rashes occurred in up to 10 % of patients taking lamictal tablets and in 5 % of patients taking placebo . The skin rashes led to the withdrawal of lamictal treatment and resoles on withdrawal of lamictal treatment and resolves on withdrawal of lamictal tablets.

Rarely, serious potentially life-threatening skin rashes, including stevens-johnson syndrome and toxic epidermal necrolysis(Lyell’s syndrome) have been reported. Although the majority of the patients get recover on drug withdrawal. However, some of the patients experience irreversible scarring and there have rare cases of associated death.

Firstly, The overall risk of rash appears to strongly associated with:

• High initial doses of lamictal and exceeding the recommended dose escalation of lamictal tablets therapy.
• Concomitant use of valproate.

Furthermore, Rash has also reported as parted as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms.

Blood And Lymphatic system Disorders

Very Rare Haematogical abnormalities (including, neutropenia, leucopenia, anaemia, thromboctopenia,pancytopenia,aplastic anaemia, agranulocytosis), lymphadenopathy haematological abnormalities and laymphadenopathy may or may not be associated with the hypersensitivity syndrome.

Immune System Disorders

Very Rare:

Firstly, Hypersensitivity syndrome (Inducding such syptoms as , fever , lamphadenopthethy , factial oedeme , symtptoms including fever , lamphadenophathy , factial oedeme and abnormalities multi organ failure) Rash has also reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedma and abnormalities of the blood and liver.

Meanwhile, The syndrome shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation (DIC) and mulit-orgen failure. It important to note that early manifestations of hypersensitivity (e.g. fever , lamphadenopathy ) may presenteven through not evident. If these or like these symptoms noticed than the patients should looked closely immediately and lamictal tablets disconnected if an alternative aetiology cannot established .

Psychiatric Disorders

Common : Aggression , Irritability

Very Rare : Tics , hallucinations , confusion

Nervous System Disorders

Very common : Headache

Common: Somnolence, insomnia, dizziness, tremor

Uncommon : Ataxia

Rare : Nystagmus

Eye Disorders

Uncommon: Diplopia, Blurred vision

Gastrointestinal Disorders

Common : Nausea , vomiting , diarrhoea

Hepatobiliary Disorders

Very Rare: Increased liver function tests , hepatic dysfunction , hepatic failure

Hepatic dysfunction usually occurs in association with hypersensitivity reactions but isolated have reported without overt signs of hypersensitivity.

Musculoskeletal Disorders

Very Rare : Lupus like reactions

General Disorders And Connective Tissue Disorders

Common : Tiredness

Bipolar Disorder

Meanwhile, the following adverse reaction identified during bipolar discorded clinical trials and should considers alongside those seen in the epilepsy clinical trials and post marketing sections for an overall safety profile of Lamictal tablets.

Skin And Subcutaneous Tissue Disorders

Rare: Skin rash

Psychiatric Disorders

Very Rare: Nightmares

Nervous System Disorders

Very Common: Somnolence, Ataxia, Headache, Dizziness

Common: Nystagmus, Tremor, Insomnia

Rare: Aseptic meningitis

Very Rare: Agitation, unsteadiness, movement disorders, worsening of Parkionson’s disease, extrapyramidal effects, choreoathetosis.

Furthermore, there have been reports that Lamictal tablets may worsen parkinsonian symptoms in patients with pre-existing Parkinson’s disease, and isolated reports of extrapyramidal effects and choreoathetosisi in patients without this underlying condition.

Eye Disorders

Very Common: Diplopia, Blurred vision

Rare: Conjunctivitis

Gastrointestinal Disorders

Very Common: Nausea, Vomiting

Common: Diarrhoea

Epilepsy Only

Nervous System Disorders

Very Rare: Increase in seizure frequency

Lamictal Overdosage

Acute ingestion of doses in excess of 10 to 20 times the maximum therapeutic dose have reported including fatal cases. Furthermore, Overdose has resulted in symptoms including nystagmus , ataxia , impaired consciousness , grand mal convulsion and coma .QRS brodening (intraventricular conducation dealy ) hass also observed in over dose patients .

On the other hand, In the event of over dosage, the patient should admitted to hospital and given appropriate supportive therapy as clinically indicated or as recommended by the national by the national poisons center, where available.

Lamictal Tablets Special patient Populations

• Children

Firstly, the cleareance adjusted for bodyweghit is higher in children than in adults with the highest values in children under fiver years. Meanwhile, The half life of lamotrigine is generally shorter in children than in adults with a mean value of approximately 7 hours when given co administered with enzyme-inducing drugs such as carbamazepine and phenytoin and increase to the values of 45 to 50 hours when co-administered with valproate alone.

• Elderly

Meanwhile, Results of a population pharmacokinetic analysis including both young abd elderly patients with epilepsy , enrolled in the same trials , indicated that the clearance of lamotrigine did not change to a clinically relevant extent. After single doses apparent clearance decreased by 12 %from 35 ml / min at age 20 to 30 mal / min at 70 tears . The decrease after 48 weeks of treatment was 10 % healthy elderly subjects following a 150 mg single dose . Consequently, The mean clearance in the elderly (0.39 ml /min/kg ) lives withdied the range of the mean clearance value (0.31/to 0.65 ml/min/kg ) obtaining in 9 studies with non elderly aduts after single doses of 30 to 450 mg .

• Patients with renal impairment

Twelve volunteers with chronic renal failure 6 individuals undergoing haemodialysis each given a single 100 mg dose of lamotrigine . Mean CL/F 0.42 mL/min/kg in healthy volunteers. Mean plasma half live 42.9 hours (chronic renal failure ), 57.4 hours (between haemodialysis )and 13.0 hours (during haemodialysis), compared to 26.2 hours in healthy volunteers . On average, approximately 20% (Range =5.6 to 35.1 ) of the amount of lamotrigine present in the body eliminated during a 4 hours haemodialysis session. However, For this patient population , initial doses of lamictal should based on patients AEd regimen : reduced maintenance doses may effective for patients with signifcant renal .

• Patients With Hepatic Impairment

However, single dose pharmacokinetic study performed in 24 subjects with various degrees of hepatic impairment and 12 healthy subjects a controls. The median apparent clearance of lamotrigine 0.31 , 0.24 or 0.10 ml / min/kg in patients with Grade A,B, or C (child-pugh classification) hepatic impatic impairment, respectively, compared to 0.34 ml/min/kg in the healthy controls, initial escalation. Meanwhile, the maintenance doses should generally reduced by approximately 50 % in patient with moderate (children pugh Greade B)and 75 % in patients with severe (children pugh Grade C ) hepatioc impairment. Furthermore, Escalation and maintenance doses should adjusted to according to clinical response.

Lamictal Tablets Storage Instructions

Firstly, store the medicine below 30 C temperature. Keep it on a dry place. Most importantly, protect the medicine from sunlight and heat. Meanwhile, always remember to keep all the medicine out of the reach of the children.

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Lamictal Tablets (25 mg, 50 mg, 100 mg, 200 mg)