Lamictal

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Pediatric Dosing of LAMICTAL

We are proud of the 16-year reputation for proven efficacy and tolerability that LAMICTAL has established over the course of more than 5 million patient exposures worldwide.1These benefits are demonstrated in patients as young as 2 years and throughout adulthood.

LAMICTAL is indicated as adjunctive therapy for partial seizures, primary generalized tonic clonic seizures and the generalized seizures of Lennox-Gastaut syndrome (LGS) in pediatric patients (>2 years of age).

Dosing advantages for younger patients:

2-mg dosage available to healthcare professionals only from your representative or through the GlaxoSmithKline Response Center (1-888-825-5249); 5-mg and 25-mg tablets available from your representative and through retail pharmacies
No blood monitoring required—an important benefit for younger patients and their parents

Dosing guidelines for patients 2 to 12 years of age

Escalation Regimen for LAMICTAL in Patients 2 to 12 Years of Age With Epilepsy
	For Patients Taking Valproate (see Table 10 of Prescribing Information for weight-based dosing guide)	For Patients Taking AEDs Other Than Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate	For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone* and Not Taking Valproate
Weeks 1 and 2	0.15mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet (see table below for weight-based dosing guide).	0.3 mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet.	0.6 mg/kg/day in 2 divided doses, rounded down to the nearest whole tablet.
Weeks 3 and 4	0.3 mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet (see table below for weight-based dosing guide).	0.6 mg/kg/day in 2 divided doses, rounded down to the nearest whole tablet.	1.2 mg/kg/day in 2 divided doses, rounded down to the nearest whole tablet.
Weeks 5 onwards to maintenance	The dose should be increased every 1 to 2 weeks as follows: calculate 0.3 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose.	The dose should be increased every 1 to 2 weeks as follows: calculate 0.6 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose	The dose should be increased every 1 to 2 weeks as follows: calculate 1.2 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose
Usual Maintenance Dose	1 to 5 mg/kg/day (maximum 200 mg/day in 1 or 2 divided doses). 1 to 3 mg/kg/day with valproate alone	4.5 to 7.5 mg/kg/day (maximum 300 mg/day in 2 divided doses)	5 to 15 mg/kg/day (maximum 400 mg/day in 2 divided doses)
Maintenance dose in patients less than 30 kg	May need to be increased by as much as 50%, based on clinical response	May need to be increased by as much as 50%, based on clinical response	May need to be increased by as much as 50%, based on clinical response

Note: Only whole tablets should be used for dosing^*Rifampin and estrogen-containing oral contraceptives have also been shown to increase the apparent clearance of lamotrigine (see PRECAUTIONS: Drug Interactions).

The Initial Weight-Based Dosing Guide for Patients 2 to 12 Years Taking Valproate (Weeks 1 to 4) With Epilepsy
If the patient’s weight is		Give this daily dose, using the most appropriate combination of LAMICTAL 2-mg and 5-mg tablets
Greater than	And less than	Weeks 1 and 2	Weeks 3 and 4
6.7 kg	14 kg	2 mg every other day	2 mg every day
14.1 kg	27 kg	2 mg every day	4 mg every day
27.1 kg	34 kg	4 mg every day	8 mg every day
34.1 kg	40 kg	5 mg every day	10 mg every day

Other dosing considerations

For women starting estrogen-containing oral contraceptives and not taking carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, the maintenance dose of LAMICTAL will in most cases need to be increased, by as much as twofold over the recommended target maintenance dose, in order to maintain a consistent lamotrigine plasma level.

Conversely, the maintenance dose of LAMICTAL will in most cases need to be decreased by as much as 50% if estrogen-containing oral contraceptives are stopped in these patients.

Adverse events consistent with elevated levels of lamotrigine (such as dizziness, ataxia, and diplopia) may occur during the week of inactive hormone preparation (pill-free week). (See DOSAGE AND ADMINISTRATION section of the Prescribing Information for additional recommendations.)

Adjustments to maintenance doses also may be necessary during pregnancy and following delivery.

Dose adjustments are recommended for patients with hepatic or renal functional impairment.

If you have any questions about the pediatric indications or the pediatric dosing guidelines for LAMICTAL, or if you would like to contact your representative to obtain a convenient, pocket-sized dosing tool, please call the GlaxoSmithKline Response Center at 1-888-825-5249.

THE 2004 AAN/AES TREATMENT GUIDELINES

Evidence-based treatment guidelines support the use of LAMICTAL. These guidelines preceded publication of the study supporting the FDA approval of the PGTC seizure indication for LAMICTAL. For more information, click here.

•	Safety and effectiveness of LAMICTAL have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs
Important Safety Information
•	Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of LAMICTAL, some of which have included Stevens-Johnson syndrome
	— Epilepsy clinical trials: The incidence of these rashes is approximately 0.8% (8/1000) in pediatric patients (age <16 years) receiving LAMICTAL as adjunctive therapy for epilepsy and 0.3% (3/1000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1983 pediatric patients with epilepsy taking adjunctive LAMICTAL, there was 1 rash-related death
	— Mood disorders: In clinical trials of bipolar and other mood disorders, the incidence of these rashes was 0.08% (0.8/1000) in adults receiving LAMICTAL as initial monotherapy and 0.13% (1.3/1000) in adult patients receiving LAMICTAL as adjunctive therapy
•	In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate
•	Hypersensitivity reactions, some fatal or life-threatening, have occurred in association with the use of LAMICTAL. It is important to note that early manifestations of hypersensitivity (eg, fever, lymphadenopathy) may be present even though a rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately, and LAMICTAL should be discontinued if an alternative etiology cannot be established
•	Prior to initiation of treatment with LAMICTAL, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately
•	To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded
•	LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related
Complete Prescribing Information for LAMICTAL® (lamotrigine) Tablets