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Lamictal

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Lamictal




Indications
Dosage
How Supplied

INDICATIONS

Epilepsy

Adjunctive Therapy

LAMICTAL is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:

  • partial-onset seizures.
  • primary generalized tonic-clonic (PGTC) seizures.
  • generalized seizures of Lennox-Gastaut syndrome.
Monotherapy

LAMICTAL is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). 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.

Bipolar Disorder

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 adults (aged 18 years and older) treated for acute mood episodes with standard therapy. The effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established.

The effectiveness of LAMICTAL as maintenance treatment was established in 2 placebocontrolled trials in patients with bipolar I disorder as defined by DSM-IV [see Clinical Studies]. 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.

DOSAGE AND ADMINISTRATION

General Dosing Considerations

Rash

There are suggestions, yet to be proven, that the risk of severe, potentially lifethreatening rash may be increased by (1) coadministration of LAMICTAL with valproate, (2) exceeding the recommended initial dose of LAMICTAL, or (3) exceeding the recommended dose escalation for LAMICTAL. However, cases have occurred in the absence of these factors [see BOXED WARNING]. Therefore, it is important that the dosing recommendations be followed closely.

The risk of nonserious rash may be increased when the recommended initial dose and/or the rate of dose escalation for LAMICTAL is exceeded and in patients with a history of allergy or rash to other AEDs.

LAMICTAL Starter Kits and LAMICTAL ODT® Patient Titration Kits provide LAMICTAL at doses consistent with the recommended titration schedule for the first 5 weeks of treatment, based upon concomitant medications, for patients with epilepsy (older than 12 years) and bipolar I disorder (aged 18 years and older) and are intended to help reduce the potential for rash. The use of LAMICTAL Starter Kits and LAMICTAL ODT Patient Titration Kits is recommended for appropriate patients who are starting or restarting LAMICTAL [see HOW SUPPLIED/ Storage and Handling].

It is recommended that LAMICTAL not be restarted in patients who discontinued due to rash associated with prior treatment with lamotrigine unless the potential benefits clearly outweigh the risks. If the decision is made to restart a patient who has discontinued LAMICTAL, the need to restart with the initial dosing recommendations should be assessed. The greater the interval of time since the previous dose, the greater consideration should be given to restarting with the initial dosing recommendations. If a patient has discontinued lamotrigine for a period of more than 5 half-lives, it is recommended that initial dosing recommendations and guidelines be followed. The half-life of lamotrigine is affected by other concomitant medications [see CLINICAL PHARMACOLOGY].

LAMICTAL Added to Drugs Known to Induce or Inhibit Glucuronidation

Because lamotrigine is metabolized predominantly by glucuronic acid conjugation, drugs that are known to induce or inhibit glucuronidation may affect the apparent clearance of lamotrigine. Drugs that induce glucuronidation include carbamazepine, phenytoin, phenobarbital, primidone, rifampin, estrogen-containing oral contraceptives, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Valproate inhibits glucuronidation. For dosing considerations for LAMICTAL in patients on estrogen-containing contraceptives and atazanavir/ritonavir, see below and Table 13. For dosing considerations for LAMICTAL in patients on other drugs known to induce or inhibit glucuronidation, see Table 1, Table 2, Table 5, Table 6, and Table 13.

Target Plasma Levels for Patients With Epilepsy or Bipolar Disorder

A therapeutic plasma concentration range has not been established for lamotrigine. Dosing of LAMICTAL should be based on therapeutic response [see CLINICAL PHARMACOLOGY].

Women Taking Estrogen-Containing Oral Contraceptives

Starting LAMICTAL in Women Taking Estrogen-Containing Oral Contraceptives: Although estrogen-containing oral contraceptives have been shown to increase the clearance of lamotrigine [see CLINICAL PHARMACOLOGY], no adjustments to the recommended dose-escalation guidelines for LAMICTAL should be necessary solely based on the use of estrogen-containing oral contraceptives. Therefore, dose escalation should follow the recommended guidelines for initiating adjunctive therapy with LAMICTAL based on the concomitant AED or other concomitant medications (see Table 1 or Table 5). See below for adjustments to maintenance doses of LAMICTAL in women taking estrogen-containing oral contraceptives.

Adjustments to the Maintenance Dose of LAMICTAL in Women Taking Estrogen-Containing Oral Contraceptives:

  1. Taking Estrogen-Containing Oral Contraceptives: In women not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY], the maintenance dose of LAMICTAL will in most cases need to be increased by as much as 2-fold over the recommended target maintenance dose to maintain a consistent lamotrigine plasma level.
  2. Starting Estrogen-Containing Oral Contraceptives: In women taking a stable dose of LAMICTAL and not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY], the maintenance dose will in most cases need to be increased by as much as 2-fold to maintain a consistent lamotrigine plasma level. The dose increases should begin at the same time that the oral contraceptive is introduced and continue, based on clinical response, no more rapidly than 50 to 100 mg/day every week. Dose increases should not exceed the recommended rate (see Table 1 or Table 5) unless lamotrigine plasma levels or clinical response support larger increases. Gradual transient increases in lamotrigine plasma levels may occur during the week of inactive hormonal preparation (pill-free week), and these increases will be greater if dose increases are made in the days before or during the week of inactive hormonal preparation. Increased lamotrigine plasma levels could result in additional adverse reactions, such as dizziness, ataxia, and diplopia. If adverse reactions attributable to LAMICTAL consistently occur during the pill-free week, dose adjustments to the overall maintenance dose may be necessary. Dose adjustments limited to the pill-free week are not recommended. For women taking LAMICTAL in addition to carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY], no adjustment to the dose of LAMICTAL should be necessary.
  3. Stopping Estrogen-Containing Oral Contraceptives: In women not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY], the maintenance dose of LAMICTAL will in most cases need to be decreased by as much as 50% in order to maintain a consistent lamotrigine plasma level. The decrease in dose of LAMICTAL should not exceed 25% of the total daily dose per week over a 2-week period, unless clinical response or lamotrigine plasma levels indicate otherwise [see CLINICAL PHARMACOLOGY]. In women taking LAMICTAL in addition to carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY], no adjustment to the dose of LAMICTAL should be necessary.
Women and Other Hormonal Contraceptive Preparations or Hormone Replacement Therapy

The effect of other hormonal contraceptive preparations or hormone replacement therapy on the pharmacokinetics of lamotrigine has not been systematically evaluated. It has been reported that ethinylestradiol, not progestogens, increased the clearance of lamotrigine up to 2-fold, and the progestin-only pills had no effect on lamotrigine plasma levels. Therefore, adjustments to the dosage of LAMICTAL in the presence of progestogens alone will likely not be needed.

Patients Taking Atazanavir/Ritonavir

While atazanavir/ritonavir does reduce the lamotrigine plasma concentration, no adjustments to the recommended dose-escalation guidelines for LAMICTAL should be necessary solely based on the use of atazanavir/ritonavir. Dose escalation should follow the recommended guidelines for initiating adjunctive therapy with LAMICTAL based on concomitant AED or other concomitant medications (see Tables 1, 2, and 5). In patients already taking maintenance doses of LAMICTAL and not taking glucuronidation inducers, the dose of LAMICTAL may need to be increased if atazanavir/ritonavir is added, or decreased if atazanavir/ritonavir is discontinued [see CLINICAL PHARMACOLOGY].

Patients With Hepatic Impairment

Experience in patients with hepatic impairment is limited. Based on a clinical pharmacology study in 24 subjects with mild, moderate, and severe liver impairment [see Use in Specific Populations, CLINICAL PHARMACOLOGY], the following general recommendations can be made. No dosage adjustment is needed in patients with mild liver impairment. Initial, escalation, and maintenance doses should generally be reduced by approximately 25% in patients with moderate and severe liver impairment without ascites and 50% in patients with severe liver impairment with ascites. Escalation and maintenance doses may be adjusted according to clinical response.

Patients With Renal Impairment

Initial doses of LAMICTAL should be based on patients' concomitant medications (see Tables 1-3 or Table 5); reduced maintenance doses may be effective for patients with significant renal impairment [see Use In Specific Populations, CLINICAL PHARMACOLOGY]. Few patients with severe renal impairment have been evaluated during chronic treatment with LAMICTAL. Because there is inadequate experience in this population, LAMICTAL should be used with caution in these patients.

Discontinuation Strategy

Epilepsy: For patients receiving LAMICTAL in combination with other AEDs, a re-evaluation of all AEDs in the regimen should be considered if a change in seizure control or an appearance or worsening of adverse reactions is observed.

If a decision is made to discontinue therapy with LAMICTAL, a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) is recommended unless safety concerns require a more rapid withdrawal [see WARNINGS AND PRECAUTIONS].

Discontinuing carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation should prolong the half-life of lamotrigine; discontinuing valproate should shorten the half-life of lamotrigine.

Bipolar Disorder: In the controlled clinical trials, there was no increase in the incidence, type, or severity of adverse reactions following abrupt termination of LAMICTAL. In clinical trials in patients with bipolar disorder, 2 patients experienced seizures shortly after abrupt withdrawal of LAMICTAL. However, there were confounding factors that may have contributed to the occurrence of seizures in these patients with bipolar disorder. Discontinuation of LAMICTAL should involve a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) unless safety concerns require a more rapid withdrawal [see WARNINGS AND PRECAUTIONS].

Epilepsy—Adjunctive Therapy

This section provides specific dosing recommendations for patients older than 12 years and patients aged 2 to 12 years. Within each of these age-groups, specific dosing recommendations are provided depending upon concomitant AEDs or other concomitant medications (see Table 1 for patients older than 12 years and Table 2 for patients aged 2 to 12 years). A weight-based dosing guide for patients aged 2 to 12 years on concomitant valproate is provided in Table 3.

Patients Older Than 12 Years

Recommended dosing guidelines are summarized in Table 1.

Table 1: Escalation Regimen for LAMICTAL in Patients Older Than 12 Years With Epilepsy

  In Patients TAKING Valproatea In Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone,b or Valproatea In Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb and NOT TAKING Valproatea
Weeks 1 and 2 25 mg every other day 25 mg every day 50 mg/day
Weeks 3 and 4 25 mg every day 50 mg/day 100 mg/day (in 2 divided doses)
Week 5 onward to maintenance Increase by 25 to 50 mg/day every 1 to 2 weeks. Increase by 50 mg/day every 1 to 2 weeks. Increase by 100 mg/day every 1 to 2 weeks.
Usual maintenance dose 100 to 200 mg/day with valproate alone

100 to 400 mg/day with valproate and other drugs that induce glucuronidation
(in 1 or 2 divided doses)
225 to 375 mg/day (in 2 divided doses) 300 to 500 mg/day (in 2 divided doses)
a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].
b Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see General Dosing Considerations]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see General Dosing Considerations, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

Patients Aged 2 to 12 Years

Recommended dosing guidelines are summarized in Table 2.

Smaller starting doses and slower dose escalations than those used in clinical trials are recommended because of the suggestion that the risk of rash may be decreased by smaller starting doses and slower dose escalations. Therefore, maintenance doses will take longer to reach in clinical practice than in clinical trials. It may take several weeks to months to achieve an individualized maintenance dose. Maintenance doses in patients weighing less than 30 kg, regardless of age or concomitant AED, may need to be increased as much as 50%, based on clinical response.

The smallest available strength of LAMICTAL Chewable Dispersible Tablets is 2 mg, and only whole tablets should be administered. If the calculated dose cannot be achieved using whole tablets, the dose should be rounded down to the nearest whole tablet [see HOW SUPPLIED/ Storage and Handling and Medication Guide].

Table 2: Escalation Regimen for LAMICTAL in Patients Aged 2 to 12 Years With Epilepsy

  In Patients TAKING Valproatea In Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone,b or Valproatea In Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb and NOT TAKING Valproatea
Weeks 1 and 2 0.15 mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet (see Table 3 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 3 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
Week 5 onward 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.
a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].
b Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see General Dosing Considerations]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see General Dosing Considerations, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

Table 3: The Initial Weight-Based Dosing Guide for Patients Aged 2 to 12 Years Taking Usual Adjunctive Maintenance Dose for Epilepsy:

If the patient’s weight is Give this daily dose, using the most appropriate combination of LAMICTAL 2- 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

Usual Adjunctive Maintenance Dose for Epilepsy

The usual maintenance doses identified in Tables 1 and 2 are derived from dosing regimens employed in the placebo-controlled adjunctive trials in which the efficacy of LAMICTAL was established. In patients receiving multidrug regimens employing carbamazepine, phenytoin, phenobarbital, or primidone without valproate, maintenance doses of adjunctive LAMICTAL as high as 700 mg/day have been used. In patients receiving valproate alone, maintenance doses of adjunctive LAMICTAL as high as 200 mg/day have been used. The advantage of using doses above those recommended in Tables 1-4 has not been established in controlled trials.

Epilepsy—Conversion From Adjunctive Therapy To Monotherapy

The goal of the transition regimen is to attempt to maintain seizure control while mitigating the risk of serious rash associated with the rapid titration of LAMICTAL.

The recommended maintenance dose of LAMICTAL as monotherapy is 500 mg/day given in 2 divided doses.

To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations for LAMICTAL should not be exceeded [see BOXED WARNING].

Conversion From Adjunctive Therapy With Carbamazepine, Phenytoin, Phenobarbital, or Primidone to Monotherapy With LAMICTAL

After achieving a dose of 500 mg/day of LAMICTAL using the guidelines in Table 1, the concomitant enzyme-inducing AED should be withdrawn by 20% decrements each week over a 4-week period. The regimen for the withdrawal of the concomitant AED is based on experience gained in the controlled monotherapy clinical trial.

Conversion From Adjunctive Therapy With Valproate to Monotherapy With LAMICTAL

The conversion regimen involves the 4 steps outlined in Table 4.

Table 4: Conversion From Adjunctive Therapy With Valproate to Monotherapy With LAMICTAL in Patients Aged 16 Years and Older With Epilepsy

  LAMICTAL Valproate
Step 1 Achieve a dose of 200 mg/day according to guidelines in Table 1. Maintain established stable dose.
Step 2 Maintain at 200 mg/day. Decrease dose by decrements no greater than 500 mg/day/week to 500 mg/day and then maintain for 1 week.
Step 3 Increase to 300 mg/day and maintain for 1 week. Simultaneously decrease to 250 mg/day and maintain for 1 week.
Step 4 Increase by 100 mg/day every week to achieve maintenance dose of 500 mg/day. Discontinue.

Conversion From Adjunctive Therapy With Antiepileptic Drugs Other Than Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate to Monotherapy With LAMICTAL

No specific dosing guidelines can be provided for conversion to monotherapy with LAMICTAL with AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate.

Bipolar Disorder

The goal of maintenance treatment with LAMICTAL is to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. The target dose of LAMICTAL is 200 mg/day (100 mg/day in patients taking valproate, which decreases the apparent clearance of lamotrigine, and 400 mg/day in patients not taking valproate and taking either carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitor lopinavir/ritonavir that increase the apparent clearance of lamotrigine). In the clinical trials, doses up to 400 mg/day as monotherapy were evaluated; however, no additional benefit was seen at 400 mg/day compared with 200 mg/day [see Clinical Studies]. Accordingly, doses above 200 mg/day are not recommended. Treatment with LAMICTAL is introduced, based on concurrent medications, according to the regimen outlined in Table 5. If other psychotropic medications are withdrawn following stabilization, the dose of LAMICTAL should be adjusted.

For patients discontinuing valproate, the dose of LAMICTAL should be doubled over a 2-week period in equal weekly increments (see Table 6). For patients discontinuing carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation, the dose of LAMICTAL should remain constant for the first week and then should be decreased by half over a 2-week period in equal weekly decrements (see Table 6). The dose of LAMICTAL may then be further adjusted to the target dose (200 mg) as clinically indicated.

If other drugs are subsequently introduced, the dose of LAMICTAL may need to be adjusted. In particular, the introduction of valproate requires reduction in the dose of LAMICTAL [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].

To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded [see BOXED WARNING].

Table 5: Escalation Regimen for LAMICTAL in Patients With Bipolar Disorder

  In Patients TAKING Valproatea In Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone,b or Valproatea In Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb and NOT TAKING Valproatea
Weeks 1 and 2 25 mg every other day 25 mg daily 50 mg daily
Weeks 3 and 4 25 mg daily 50 mg daily 100 mg daily, in divided doses
Week 5 50 mg daily 100 mg daily 200 mg daily, in divided doses
Week 6 100 mg daily 200 mg daily 300 mg daily, in divided doses
Week 7 100 mg daily 200 mg daily up to 400 mg daily, in divided doses
a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].
b Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see General Dosing Considerations]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see General Dosing Considerations, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

Table 6: Dosage Adjustments to LAMICTAL in Patients With Bipolar Disorder Following Discontinuation of Psychotropic Medications

  Discontinuation of Psychotropic Drugs (excluding Valproate,a Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb) After Discontinuation of Valproatea After Discontinuation of Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb
Current dose of LAMICTAL (mg/day) 100 Current dose of LAMICTAL (mg/day) 400
Week 1 Maintain current dose of LAMICTAL 150 400
Week 2 Maintain current dose of LAMICTAL 200 300
Week 3 onward Maintain current dose of LAMICTAL 200 200
a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].
b Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see General Dosing Considerations]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see General Dosing Considerations, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

The benefit of continuing treatment in patients who had been stabilized in an 8- to 16- week open-label phase with LAMICTAL was established in 2 randomized, placebo-controlled clinical maintenance trials [see Clinical Studies]. However, the optimal duration of treatment with LAMICTAL has not been established. Thus, patients should be periodically reassessed to determine the need for maintenance treatment.

Administration Of LAMICTAL Chewable Dispersible Tablets

LAMICTAL Chewable Dispersible Tablets may be swallowed whole, chewed, or dispersed in water or diluted fruit juice. If the tablets are chewed, consume a small amount of water or diluted fruit juice to aid in swallowing.

To disperse LAMICTAL Chewable Dispersible Tablets, add the tablets to a small amount of liquid (1 teaspoon, or enough to cover the medication). Approximately 1 minute later, when the tablets are completely dispersed, swirl the solution and consume the entire quantity immediately. No attempt should be made to administer partial quantities of the dispersed tablets.

Administration Of LAMICTAL ODT Orally Disintegrating Tablets

LAMICTAL ODT Orally Disintegrating Tablets should be placed onto the tongue and moved around in the mouth. The tablet will disintegrate rapidly, can be swallowed with or without water, and can be taken with or without food.

Dosage Forms And Strengths

Tablets

25 mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25.”

100 mg, peach, scored, shield-shaped tablets debossed with “LAMICTAL” and “100.”

150 mg, cream, scored, shield-shaped tablets debossed with “LAMICTAL” and “150.”

200 mg, blue, scored, shield-shaped tablets debossed with “LAMICTAL” and “200.”

Chewable Dispersible Tablets

2 mg, white to off-white, round tablets debossed with “LTG” over “2.”

5 mg, white to off-white, caplet-shaped tablets debossed with “GX CL2.”

25 mg, white, super elliptical-shaped tablets debossed with “GX CL5.”

Orally Disintegrating Tablets

25 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “25” on the other side.

50 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other side.

100 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “100” on the other side.

200 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “200” on the other side.

Potential Medication Errors

Patients should be strongly advised to visually inspect their tablets to verify that they are receiving LAMICTAL, as opposed to other medications, and that they are receiving the correct formulation of lamotrigine each time they fill their prescription. Depictions of the LAMICTAL Tablets, Chewable Dispersible Tablets, and Orally Disintegrating Tablets can be found in the Medication Guide.

HOW SUPPLIED

Storage And Handling

LAMICTAL (lamotrigine) Tablets

25 mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25”, bottles of 100 (NDC 0173-0633-02).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.

100 mg, peach, scored, shield-shaped tablets debossed with “LAMICTAL” and “100”, bottles of 100 (NDC 0173-0642-55).

150 mg, cream, scored, shield-shaped tablets debossed with “LAMICTAL” and “150”, bottles of 60 (NDC 0173-0643-60).

200 mg, blue, scored, shield-shaped tablets debossed with “LAMICTAL” and “200”, bottles of 60 (NDC 0173-0644-60).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.

LAMICTAL (lamotrigine) Starter Kit for Patients Taking Valproate (Blue Kit)

25 mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25”, blisterpack of 35 tablets (NDC 0173-0633-10).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.

LAMICTAL (lamotrigine) Starter Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate (Green Kit)

25 mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25” and 100 mg, peach, scored, shield-shaped tablets debossed with “LAMICTAL” and “100”, blisterpack of 98 tablets (84/25-mg tablets and 14/100-mg tablets) (NDC 0173-0817-28).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.

LAMICTAL (lamotrigine) Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate (Orange Kit)

25 mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25” and 100 mg, peach, scored, shield-shaped tablets debossed with “LAMICTAL” and “100”, blisterpack of 49 tablets (42/25-mg tablets and 7/100-mg tablets) (NDC 0173-0594-02).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.

LAMICTAL (lamotrigine) Chewable Dispersible Tablets

2 mg, white to off-white, round tablets debossed with “LTG” over “2”, bottles of 30 (NDC 0173-0699-00). ORDER DIRECTLY FROM GlaxoSmithKline 1-800-334-4153.

5 mg, white to off-white, caplet-shaped tablets debossed with “GX CL2”, bottles of 100 (NDC 0173-0526-00).

25 mg, white, super elliptical-shaped tablets debossed with “GX CL5”, bottles of 100 (NDC 0173-0527-00).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.

LAMICTAL ODT (lamotrigine) Orally Disintegrating Tablets

25 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “25” on the other, Maintenance Packs of 30 (NDC 0173-0772-02).

50 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other, Maintenance Packs of 30 (NDC 0173-0774-02).

100 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “100” on the other, Maintenance Packs of 30 (NDC 0173-077602).

200 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “200” on the other, Maintenance Packs of 30 (NDC 0173-077702).

Store between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).

LAMICTAL ODT (lamotrigine) Patient Titration Kit for Patients Taking Valproate (Blue ODT Kit)

25 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “25” on the other, and 50 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other, blisterpack of 28 tablets (21/25-mg tablets and 7/50-mg tablets) (NDC 0173-0779-00).

LAMICTAL ODT (lamotrigine) Patient Titration Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate (Green ODT Kit)

50 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other, and 100 mg, white to off-white, round, flat-faced, radiusedged tablets debossed with “LAMICTAL” on one side and “100” on the other, blisterpack of 56 tablets (42/50-mg tablets and 14/100-mg tablets) (NDC 0173-0780-00).

LAMICTAL ODT (lamotrigine) Patient Titration Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate (Orange ODT Kit)

25 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “25” on the other, 50 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other, and 100 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “100” on the other, blisterpack of 35 (14/25-mg tablets, 14/50-mg tablets, and 7/100-mg tablets) (NDC 0173-0778-00).

Store between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).

Blisterpacks

If the product is dispensed in a blisterpack, the patient should be advised to examine the blisterpack before use and not use if blisters are torn, broken, or missing.

Distributed by: GlaxoSmithKline, Research Triangle Park, NC 27709. December 2014

Last reviewed on RxList: 1/28/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
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