Epsylam DT

Epsylam DT Dosage/Direction for Use

lamotrigine

Manufacturer:

Aurobindo Pharma

Distributor:

Unimed
Full Prescribing Info
Dosage/Direction for Use
Lamotrigine 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 a calculated dose of Lamotrigine, e.g. for use in children (epilepsy only) or patients with hepatic impairment, cannot be divided into multiple lower strength tablets, the dose to be administered is that equal to the nearest lower strength of whole tablets.
Restarting Therapy: Prescribers should assess the need for escalation to maintenance dose when restarting Lamotrigine in patients who have discontinued Lamotrigine for any reason, since the risk of serious rash is associated with high initial doses and exceeding the recommended dose escalation for Lamotrigine (see Precautions). The greater the interval of time since the previous dose, the more consideration should be given to escalation to the maintenance dose. When the interval since discontinuing Lamotrigine exceeds five half-lives, 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Epilepsy: When concomitant antiepileptic drugs are withdrawn to achieve Lamotrigine monotherapy or other AEDs are added-on to treatment regimes containing Lamotrigine, consideration should be given to the effect this may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 (see Interactions).
Dosage in Epilepsy Monotherapy: Adults (over 16 years of age) (see Table 1): The initial Lamotrigine dose in monotherapy is 25 mg once a day for two weeks, followed by 50 mg once a day for two weeks. Thereafter, the dose should be increased by a maximum of 50 to 100 mg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 100 to 200 mg/day given once a day or as two divided doses. Some patients have required 500 mg/day of Lamotrigine to achieve the desired response.
Because of a risk of rash the initial dose and subsequent dose escalation should not be exceeded (see Precautions).
Dosage in Epilepsy Add-On Therapy: Adults (over 12 years of age) (see Table 1): In patients taking valproate with/without any other AED, the initial Lamotrigine dose is 25 mg every alternate day for two weeks, followed by 25 mg once a day for two weeks. Thereafter, the dose should be increased by a maximum of 25 to 50 mg every one two weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal optimal response is 100 to 200 mg/day given once a day or in two divided doses.
In those patients taking concomitant AEDs or other medications (see Interactions) that induce Lamotrigine glucuronidation with/without other AEDs (except valproate), the initial Lamotrigine dose is 50 mg once a day for two weeks, followed by 100 mg/day given in two divided doses for two weeks.
Thereafter, the dose should be increased by a maximum of 100 mg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 200 to 400 mg/day given in two divided doses.
Some patients have required 700 mg/day of Lamotrigine to achieve the desired response.
In those patients taking oxcarbazepine without any other inducers or inhibitors of Lamotrigine glucuronidation, the initial Lamotrigine dose is 25 mg once a day for two weeks, followed by 50 mg once a day for two weeks. Thereafter, the dose should be increased by a maximum of 50 to 100 mg every one to two weeks until the optimal response is 100 to 200 mg/day given once a day or as two divided doses. (See Table 1.)

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Because of a risk of rash the initial dose and subsequent dose escalation should not be exceeded (see Precautions).
Children (2 to 12 years of age) (see Table 2): In patients taking valproate with/without any other AED, the initial Lamotrigine dose is 0.15 mg/kg bodyweight/day given once a day for two weeks, followed by 0.3 mg/kg/day once 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 is achieved. The usual maintenance dose to achieve optimal response is 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 (see Interactions) that induce Lamotrigine glucuronidation with/without other AEDs (except valproate), the initial Lamotrigine dose is 0.6 mg/kg bodyweight/day given in two divided doses for two weeks, followed by 1.2 mg/kg/day given in two divided doses for two weeks. Thereafter, the dose should be increased by a maximum of 1.2 mg/kg every one to two weeks until the optimal response is 5 to 15 mg/kg/day given in two divided doses, with a maximum of 400 mg/day.
In patients taking oxcarbazepine without any inducers or inhibitors of Lamotrigine glucuronidation, the initial Lamotrigine dose is 0.3 mg/kg bodyweight/day given once a day or in two divided doses for two weeks, followed by 0.6 mg/kg/day given once a day or in two divided doses for two weeks. Thereafter, the dose should be increased by a maximum of 0.6 mg/kg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 1 to 10 mg/kg/day given once a day or in two divided doses, with a maximum of 200 mg/day.
To ensure a therapeutic dose is maintained the weight of a child must be monitored and the dose reviewed as weight changes occur. (See Table 2.)

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Because of a risk of rash the initial dose and subsequent dose escalation should not be exceeded (see Precautions).
It is likely that patients aged two to six years will require a maintenance dose at the higher end of the recommended range.
Children aged less than 2 years: There is insufficient information on the use of Lamotrigine in children aged less than two years.
Bipolar Disorder: Adults (18 years of age and over): Because of the risk of rash the initial dose and subsequent dose escalation should not be exceeded (see Precautions).
Lamotrigine is recommended for use in bipolar patients at risk for a future depressive episode.
The following transition regimen should be followed to prevent recurrence of depressive episodes. The transition regimen involves escalating the dose of Lamotrigine to a maintenance stabilization dose over six weeks (see Table 3) after which other psychotropic and/or antiepileptic drugs can be withdrawn, if clinically indicated (see Table 4).
Adjunctive therapy should be considered for the prevention of manic episodes, as efficacy with Lamotrigine in mania has not been conclusively established. (See Table 3.)

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**The target stabilization dose will alter depending on clinical response.
Adjunct therapy with inhibitors of Lamotrigine glucuronidation e.g. valproate: In patients taking glucuronidation inhibiting concomitant drugs such as valproate the initial Lamotrigine dose is 25 mg every alternate day for two weeks, followed by 25 mg once a day for two weeks. The dose should be increased to 50 mg once a day (or in two divided doses) in week 5. The usual target dose to achieve optimal response is 100 mg/day given once a day or in two divided doses. However, the dose can be increased to a maximum daily dose of 200 mg, depending on clinical response.
Adjunct therapy with inducers of Lamotrigine glucuronidation in patients NOT taking inhibitors such as valproate. This dosage regimen should be used with phenytoin, carbamazepine, phenobarbitone, primidone and other drugs known to induce Lamotrigine glucuronidation (see Interactions): In those patients currently taking drugs that induce Lamotrigine glucuronidation and not taking valproate, the initial Lamotrigine dose is 50 mg once a day for two weeks, followed by 100 mg/day given in two divided doses for two weeks. The dose should be increased to 200 mg/day given as two divided doses in week 5. The dose may 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 7.
Monotherapy with Lamotrigine or Adjunctive therapy in patients taking lithium, bupropion, olanzapine, oxcarbazepine, or other agents known not to significantly induce or inhibit Lamotrigine glucuronidation: The initial Lamotrigine dose in patients who are taking lithium, bupropion, olanzapine, oxcarbazepine and are not taking inducers or inhibitors of Lamotrigine glucuronidation or are taking Lamotrigine in monotherapy, is 25 mg once a day for two weeks, followed by 50 mg once a day (or in two divided doses) for two weeks. The dose should be increased to 100 mg/day in week 5. The usual target dose to achieve optimal response is 200 mg/day given once a day or as two divided doses. However, a range of 100 to 400 mg was used in clinical trials.
Once the target daily maintenance stabilization dose has been achieved, other psychotropic medications may be withdrawn as laid out in the dosage schedule as follows (see Table 4).

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Following withdrawal of adjunct therapy with inhibitors of Lamotrigine glucuronidation e.g. valproate: The dose of Lamotrigine should be increased to double the original target stabilization dose and maintained at this, once valproate has been terminated.
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 (see Interactions): The dose of Lamotrigine should be gradually reduced over three weeks as the glucuronidation inducer is withdrawn.
Following withdrawal of other psychotropic or AED drugs with no significant pharmacokinetic interaction with Lamotrigine e.g. lithium, bupropion, olanzapine, excarbazepine: The target dose achieved in the dose escalation programme should be maintained throughout withdrawal of the other medication.
Adjustment of Lamotrigine daily dosing in patients with Bipolar Disorder following addition of other medications There is no clinical experience in adjusting the Lamotrigine daily dose following the addition of other medications. However, based on drug interaction studies, the following recommendations can be made (see Table 5, as follows).

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Discontinuation of Lamotrigine in patients with Bipolar Disorder: Children and adolescents (less than 18 years of age): Lamotrigine is not indicated for use in bipolar disorder in children and adolescents aged less than 18 years (see Precautions). Safety and efficacy of Lamotrigine bipolar disorder has not been evaluated in this age group. Therefore, a dosage recommendation cannot be made.
General Dosing Recommendations for Lamotrigine in Special Patient Population: Women taking hormonal contraceptives: Starting Lamotrigine in patients already taking hormonal contraceptives: Although an oral contraceptive has been shown to increase the clearance of Lamotrigine (see Precautions and Interactions), no adjustment to the recommended dose escalation guidelines for Lamotrigine should be necessary solely based on the use of hormonal contraceptives. Dose escalation should follow the recommended guidelines based on whether Lamotrigine is added to valproate (an inhibitor of Lamotrigine glucuronidation), or to an inducer of Lamotrigine glucuronidation, or whether Lamotrigine is added in the absence of valproate or an inducer of Lamotrigine glucuronidation (see Table 1 for epilepsy and Table 3 for bipolar disorder patients).
Starting hormonal contraceptives in patients already taking maintenance doses of Lamotrigine and not taking inducers of Lamotrigine glucuronidation: The maintenance dose of Lamotrigine will in most cases need to be increased by as much as two-fold (see Precautions and Interactions). It is recommended that from the time that the hormonal contraceptive is started, the Lamotrigine dose is increased by 50 to 100 mg/day every week, according to the individual clinical response. Dose increases should not exceed this rate, unless the clinical response supports larger increases.
Stopping hormonal contraceptives in patients already taking maintenance doses of Lamotrigine, and not taking inducers of Lamotrigine glucuronidation: The maintenance dose of Lamotrigine will in most cases need to be decreased by as much as 50% (see Precautions and Interactions). It is recommended to gradually decrease the daily dose of Lamotrigine by 50 to 100 mg each week (at a rate not exceeding 25% of the total daily dose per week) over a period of 3 weeks, unless the clinical response indicates otherwise.
Use with atazanavir/ritonavir: Although atazanavir/ritonavir has been shown to reduce Lamotrigine plasma concentrations (see Interactions), no adjustments to the recommended dose escalation guidelines for Lamotrigine should be necessary solely based on the use of atazanavir/ritonavir. Dose escalation should follow the recommended guidelines based on whether Lamotrigine is added to valproate (an inhibitor of Lamotrigine glucuronidation), or to an inducer of Lamotrigine glucuronidation, or whether Lamotrigine is added, or decreased if atazanavir/ritonavir is discontinued.
Elderly (over 65 years of age): No dosage adjustment from recommended schedule is required. The pharmacokinetics of Lamotrigine in this age group do not differ significantly from a non-elderly adult population.
Hepatic impairment: Initial escalation and maintenance doses should generally be reduced by approximately 50% in patients with moderate (Child-Pugh grade B) and 75% in severe (Child-Pugh grade C) hepatic impairment. Escalation and maintenance doses should be adjusted according to clinical response.
Renal impairment: Caution should be exercised when administering Lamotrigine to patients with renal failure. For patients with end-stage renal failure, initial doses of Lamotrigine should be based on patients' AED regimen; reduced maintenance doses may be effective for patients with significant renal functional impairment (see Precautions).
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