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LAMICTAL ODT is bioequivalent to LAMICTAL Tablets

Available in 25-mg, 50-mg, 100-mg and 200-mg strengths.

Pleasant-tasing, orally disintegrating tablet that is easy to swallow.

There is no AB-rated generic for LAMICTAL ODT.7

 

Initiation & Dosing

 
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

The physician who elects to prescribe LAMICTAL for periods extending beyond 16 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient

LAMICTAL and LAMICTAL ODT are easy to initiate with kits available by prescription.

 
 
Initiating LAMICTAL and LAMICTAL ODT in adult patients with bipolar I disorder:
 
NOT TAKING carbamazepine, phenytoin, phenobarbital, primidone, rifampin, or valproate
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 valproate
After discontinuation of valproate
After discontinuation of carbamazepine, phenytoin, phenobarbital, primidone, or rifampin
Current dose of LAMICTAL Week 1 Week 2 Week 3 onward
400 mg/day 400 mg/day 300 mg/day 200 mg/day
 
†Carbamazepine, phenytoin, phenobarbital, primidone, and rifampin have been shown to increase the apparent
clearance of lamotrigine.
 
‡Valproate has been shown to decrease the apparent clearance of lamotrigine. Includes valproic acid and
divalproex sodium.
 
 
Important dosing considerations

  • For women starting estrogen-containing oral contraceptives and not taking carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, the maintenance dose of LAMICTAL or LAMICTAL ODT 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 or 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 and Use in Specific Populations sections 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 or LAMICTAL ODT, 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.
 
Formulations of LAMICTAL

There are three different formulations of LAMICTAL. See below for pictures of the actual tablets.
 

Starter Kits, Patient Titration Kits, and Maintenance Packs

If you want to start a new patient on LAMICTAL or LAMICTAL ODT, use the Patient Titration Kits for LAMICTAL ODT and Patient Starter Kits for LAMICTAL for a convenient way to get started.

  • Ask your GlaxoSmithKline representative about free 5-week Patient Titration Kits for LAMICTAL ODT and Patient Starter Kits for LAMICTAL for new patients and 14-day conversion kits for patients switching to LAMICTAL ODT from LAMICTAL.
The Patient Titration Kits for LAMICTAL ODT and Patient Starter Kits for LAMICTAL provide 5 weeks of therapy of LAMICTAL or LAMICTAL ODT and come in different packages depending on other medications the patient is taking:

LAMICTAL TABLETS   LAMICTAL ODT

Click to enlarge
  • For patients who are taking valproate§


Click to enlarge


Click to enlarge
  • For patients who are TAKING carbamazepine, phenytoin, phenobarbital, primidone, or rifampin and are NOT TAKING valproate§


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  • For patients who are NOT TAKING carbamazepine, phenytoin, phenobarbital, primidone, rifampin, or valproate§


Click to enlarge


§Includes valproic acid and divalproex sodium.

The kits contain LAMICTAL or LAMICTAL ODT in the proper dosages that are clearly marked day by day for each week.

Use easy 1:1 conversion to switch patients already taking a maintenance dose of LAMICTAL Tablets to LAMICTAL ODT

Use the Maintenance Packs of LAMICTAL ODT available by prescription to help patients stay on track with their daily dose.

There are four different Maintenance Packs 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.

Each daily dose clearly marked in unique blister pack.

 
Maintenance Dosing Kit Charts

The Maintenance Packs use convenient packaging to help make it easy for patients to keep track of taking their tablets. The kits are clearly labeled with dosing instructions.
 
LAMICTAL ODT: Patient Instructions

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

FOLLOW THESE 4 STEPS
  1. PRESS
Press and hold tab at bottom.

2. PULL
Pull out table 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.
 
Important Safety Information

  • 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.
  • 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.

LAMICTAL and LAMICTAL ODT are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (≥18 years of age) treated for acute mood episodes with standard therapy. The effectiveness of LAMICTAL and LAMICTAL ODT in the acute treatment of mood episodes has not been established.

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

Complete Prescribing Information for LAMICTAL® (lamotrigine) and LAMICTAL® ODT (lamotrigine) Orally Disintegrating Tablets

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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