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Initiation & Dosing

FACT: The following independent clinical sources recommend LAMICTAL as a first-line maintenance therapy in bipolar disorder7,9

* 47 of 50 experts in the treatment of bipolar disorder responded to a survey, and their responses to 60 questions about treatment options were ranked using a validated 9-point scale.
 
Give your patients a head start—initiate LAMICTAL now as maintenance
therapy in patients treated with acute therapy.
 
Initiating LAMICTAL is similar in currently or recently manic patients
 

LAMICTAL can be titrated to an effective maintenance dose while patient is taking standard acute therapy

The effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established

Use beyond 18 months should be periodically reevaluated

LAMICTAL is easy to initiate with free 5-week sample kits or starter kits by prescription

 
 
Initiating LAMICTAL in adult patients with bipolar I disorder:
 
NOT TAKING carbamazepine, phenytoin, phenobarbital, primidone, rifampin, or valproate10
Weeks 1 & 2 Weeks 3 & 4 Week 5 Week 6
25 mg/day 50 mg/day 100 mg/day Target Dose
200 mg/day
After discontinuation of psychotropic drugs excluding carbamazepine, phenytoin, phenobarbital, primidone, rifampin, or valproate10
After discontinuation of valproate10
After discontinuation of carbamazepine, phenytoin, phenobarbital, primidone or rifampin10
Current dose of LAMICTAL Week 1 Week 2 Week 3 onward
400 mg/day 400 mg/day 300 mg/day 200 mg/day
 
Valproate has been shown to decrease the apparent clearance of lamotrigine.
Carbamazepine, phenytoin, phenobarbital, primidone, and rifampin have been shown to increase the apparent clearance of lamotrigine.
 
Important 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 Dosing and Administration section of the Prescribing Information for additional recommendations).

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

Please consult complete Prescribing Information for guidelines on titrating LAMICTAL, adjusting the dose if psychotropic medications are added or withdrawn during treatment, and for dosing in special populations.

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

 


Important Safety Information
  • Serious rashes requiring hospitalization and discontinuation of treatment have been reported with LAMICTAL, some of which have included Stevens-Johnson syndrome.

    —In clinical trials of bipolar and other mood disorders, the incidence of these rashes was 0.08% (0.8/1000) in adult patients receiving LAMICTAL as initial monotherapy and 0.13% (1.3/1000) in adult patients receiving LAMICTAL as adjunctive therapy.

    —The incidence of these rashes was approximately 0.3% (3/1000) in adult patients on adjunctive therapy for epilepsy. For further safety information on the increased risk of serious rash in pediatric patients with epilepsy, please see full Prescribing Information.
  • 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 (see Box Warning in Prescribing Information).
  • LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related.
LAMICTAL is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adult patients treated for acute mood episodes with standard therapy. The effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established.
Patient Information Leaflet for LAMICTAL® (lamotrigine)

Complete Prescribing Information for LAMICTAL

Complete Prescribing Information is provided in Adobe's Portable Document Format (PDF). To view these documents, you will need Adobe Acrobat Reader. If you do not have it and you are unable to or do not wish to download Acrobat Reader, but still wish to receive complete Prescribing Information, please click here .
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