LAMICTAL - LAMICTAL ODT

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Important Safety Information

Dosing Overview

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Dosing

Dosing convenience for a broad spectrum of ages and seizure types.

Pediatric Dosing

Pediatric dosing guidelines for patients 2 years and older:

Interactive Pediatric Dosing Illustrator. An easy-to-use, convenient way to calculate and print a dosing schedule for your pediatric patients

Adult Dosing

Adjunctive therapy for patients >12 years of age

Convert to monotherapy with confidence for patients ≥16 years taking carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED.

LAMICTAL is available in multiple tablet strengths

LAMICTAL ODT will rapidly disintegrate, and can be swallowed with or without water.

LAMICTAL Tablets should be swallowed whole.

Berry-flavored, chewable dispersible tablets can be chewed, dissolved in juice or water, or swallowed whole.

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

Initiate with ease

Ask your GlaxoSmithKline representative for free 5-week Sample Kits to help simplify titration for you and your patients >12 years—only with LAMICTAL and LAMICTAL ODT.

LAMICTAL		LAMICTAL ODT
Click to enlarge	For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate Clear, simple patient instructions For your patients older than 12 years	Click to enlarge
Click to enlarge	For Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, Rifampin, or Valproate Clear, simple patient instructions For your patients older than 12 years	Click to enlarge
Click to enlarge	For Patients Taking Valproate Clear, simple patient instructions For your patients older than 12 years	Click to enlarge

There are four different maintenance kits for LAMICTAL ODT, each with a different tablet strength of LAMICTAL ODT: 25 mg, 50 mg,
100 mg, and 200 mg. Each pack holds 30 tablets.

Maintenance Dosing Kit Charts

The dosing kits use convenient packaging to make it easy to keep track of taking your tablets. The kits are clearly labeled with dosing instructions.

Also available…

Easy-to-follow Starter Kits of LAMICTAL Tablets and Patient Titration Kits for LAMICTAL ODT are available in pharmacies.

How to use your dosing kit -
Follow these four steps

All dosing kits for LAMICTAL ODT are clearly labeled with dosing instructions and have easy-to-read directions for use.

		1. PRESS Press and hold tab at bottom. 2. PULL Pull out tablet sleeve.
		3. PEEL Peel printed backing away with dry hand to expose tablet.
		4. PLACE Gently place tablet into dry hand. Then put immediately on tongue and move around in mouth to dissolve. Can be swallowed with or without water.

Other dosing considerations

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

Conversely, the maintenance dose of LAMICTAL and LAMICTAL ODT 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.

Safety and effectiveness of LAMICTAL and LAMICTAL ODT 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.

PEDIATRIC DOSING MADE SIMPLE

For easy-to-follow pediatric dosing, calculate with the free Interactive Pediatric Dosing Illustrator.

CONVERSION TO MONOTHERAPY

Convert with the confidence of proven control. Learn more.

Important Safety Information About LAMICTAL and LAMICTAL ODT

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LAMICTAL ODT is another form of LAMICTAL.

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Cases of life-threatening serious rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death, have been caused by LAMICTAL. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include:

– coadministration with valproate

– exceeding recommended initial dose of LAMICTAL

– exceeding recommended dose escalation of LAMICTAL

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Benign rashes are also caused by LAMICTAL; however, it is not possible to predict which rashes will prove to be serious or life-threatening. LAMICTAL should be discontinued at the first sign of rash, unless the rash is clearly not drug-related (see Boxed Warning in Prescribing Information).

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Hypersensitivity reaction may be fatal or life-threatening. Early signs of hypersensitivity (eg, fever, lymphadenopathy) may present without rash; if signs present, patient should be evaluated immediately. LAMICTAL should be discontinued if alternate etiology for hypersensitivity signs is not found.

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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.

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Acute multiorgan failure has resulted (some cases fatal).

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Blood dyscrasias (eg, neutropenia, thrombocytopenia, pancytopenia) may result either with or without an associated hypersensitivity syndrome.

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Antiepileptic drugs, including LAMICTAL ODT, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.

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Patients treated with any antiepileptic drug for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

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Patients, their caregivers, and families should be informed that antiepileptic drugs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Medication Guide for LAMICTAL^® (lamotrigine) Tablets and LAMICTAL^® ODT™ (lamotrigine) Orally Disintegrating Tablets

Complete Prescribing Information and Medication Guide for LAMICTAL^® (lamotrigine) Tablets and LAMICTAL^® ODT™ (lamotrigine) Orally Disintegrating Tablets including Boxed Warning