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Starter Kits
Starter Kits and Patient Titration Kits

Starter Kits for LAMICTAL and Patient Titration Kits for LAMICTAL ODT are available by prescription for patients >12 years

LAMICTAL   LAMICTAL ODT

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For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate
  • Clear, simple patient instructions
  • For your patients older than 12 years

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For Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, Rifampin, or Valproate
  • Clear, simple patient instructions
  • For your patients older than 12 years

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For Patients Taking Valproate
  • Clear, simple patient instructions
  • For your patients older than 12 years

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The kits are specifically designed to provide the recommended initial dose and dose escalation regimen for the first 5 weeks of treatment. To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL and LAMICTAL ODT should not be exceeded.

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.

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.



EVENTS CALENDAR
Help your patients track their seizures and their side effects with the easy-to-follow events calendar.




Important Safety Information About LAMICTAL and LAMICTAL ODT
LAMICTAL ODT is another form of LAMICTAL.
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
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).
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.
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.
Acute multiorgan failure has resulted (some cases fatal).
Blood dyscrasias (eg, neutropenia, thrombocytopenia, pancytopenia) may result either with or without an associated hypersensitivity syndrome.
Antiepileptic drugs, including LAMICTAL ODT, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
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.
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
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