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Lamotrigine (Lamotrigine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Epilepsy

Adjunctive Therapy: Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients ≥ 2 years of age:

  • partial seizures
  • primary generalized tonic-clonic seizures
  • generalized seizures of Lennox-Gastaut syndrome

Monotherapy: Lamotrigine tablets are indicated for conversion to monotherapy in adults (≥16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).

Safety and effectiveness of Lamotrigine 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

Lamotrigine tablets 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 Lamotrigine in the acute treatment of mood episodes has not been established.

The effectiveness of Lamotrigine as maintenance treatment was established in 2 placebo-controlled trials in patients with Bipolar I Disorder as defined by DSM-IV [see Clinical Studies (14.2)]. The physician who elects to prescribe Lamotrigine 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 life-threatening rash may be increased by (1) coadministration of Lamotrigine with valproate, (2) exceeding the recommended initial dose of Lamotrigine, or (3) exceeding the recommended dose escalation for Lamotrigine. 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 of Lamotrigine is exceeded and in patients with a history of allergy or rash to other AEDs.

It is recommended that Lamotrigine 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 Lamotrigine, 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 ( 12.3 )].

Lamotrigine Added to Drugs Known to Induce or Inhibit Glucuronidation: Drugs other than those listed in the Clinical Pharmacology section [see Clinical Pharmacology ( 12.3 )] have not been systematically evaluated in combination with Lamotrigine. 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 and doses of Lamotrigine may require adjustment based on clinical response.

Target Plasma Levels for Patients With Epilepsy or Bipolar Disorder: A therapeutic plasma concentration range has not been established for Lamotrigine. Dosing of Lamotrigine should be based on therapeutic response [see Clinical Pharmacology ( 12.3 )].

Women Taking Estrogen-Containing Oral Contraceptives:  Starting Lamotrigine in Women Taking Estrogen-Containing Oral Contraceptives: Although estrogen-containing oral contraceptives have been shown to increase the clearance of Lamotrigine [see Clinical Pharmacology ( 12.3 )], no adjustments to the recommended dose-escalation guidelines for Lamotrigine 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 Lamotrigine based on the concomitant AED or other concomitant medications (see Table 1 or Table 5). See below for adjustments to maintenance doses of Lamotrigine in women taking estrogen-containing oral contraceptives.

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

Taking Estrogen-Containing Oral Contraceptives: For women not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin that induce Lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology ], the maintenance dose of Lamotrigine will in most cases need to be increased, by as much as 2-fold over the recommended target maintenance dose, in order to maintain a consistent Lamotrigine plasma level [see Clinical Pharmacology ( 12.3 )].

Starting Estrogen-Containing Oral Contraceptives: In women taking a stable dose of Lamotrigine and not taking carbamazepine, phenytoin, phenobarbital, primidone, or  other drugs such as rifampin that induce Lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology ], the maintenance dose will in most cases need to be increased by as much as 2-fold in order 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 Lamotrigine 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 Lamotrigine in addition to carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin that induce Lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology], no adjustment to the dose of Lamotrigine should be necessary.

Stopping Estrogen-Containing Oral Contraceptives: For women not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin that induce Lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology ], the maintenance dose of Lamotrigine 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 Lamotrigine 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]. For women taking Lamotrigine in addition to carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin that induce Lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology ], no adjustment to the dose of Lamotrigine 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 Lamotrigine in the presence of progestogens alone will likely not be needed.

Patients With Hepatic Impairment: Experience in patients with hepatic impairment is limited. Based on a clinical pharmacology study in 24 patients with mild, moderate, and severe liver impairment [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )], 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 Lamotrigine 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 ( 8.7 ), Clinical Pharmacology ( 12.3 )]. Few patients with severe renal impairment have been evaluated during chronic treatment with Lamotrigine. Because there is inadequate experience in this population, Lamotrigine should be used with caution in these patients.

Discontinuation Strategy:  Epilepsy: For patients receiving Lamotrigine 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 experiences is observed.

If a decision is made to discontinue therapy with Lamotrigine, 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 ( 5.9 )].

Discontinuing carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin 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 Lamotrigine. In clinical trials in patients with Bipolar Disorder, 2 patients experienced seizures shortly after abrupt withdrawal of Lamotrigine. However, there were confounding factors that may have contributed to the occurrence of seizures in these bipolar patients. Discontinuation of Lamotrigine 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 ( 5.9 )].

Epilepsy – Adjunctive Therapy

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

Patients Over 12 Years of Age: Recommended dosing guidelines are summarized in Table 1.

Table 1. Escalation Regimen for Lamotrigine in Patients Over 12 Years of Age With Epilepsy 
  For Patients TAKING Valproate 1 For Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone 2,or Valproate For Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidone and NOT TAKING Valproate
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)
Weeks 5 onwards 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 glucuronication
(in 1 or 2 divided doses)
225 to 375 mg/day
(in 2 divided doses)
300 to 500 mg/day  (in 2 divided doses)

1 Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of Lamotrigine [see Drug Interactions ( 7 ), Clinical Pharmacology  ( 12.3 )].
2 These drugs induce Lamotrigine glucuronidation and increase clearance [see Drug Interactions ( 7 ) Clinical Pharmacology ( 12.3 )]. Other drugs, which have similar effects include estrogen-containing oral contraceptives [see Drug Interactions ( 7 ), Clinical Pharmacology  ( 12.3 )]. Dosing recommendations for oral contraceptives can be found in General Dosing Considerations [see Dosage and Administration ( 2.1 )]. Patients on rifampin, or other drugs that induce Lamotrigine glucuronidation and increase clearance, should follow the same dosing titration/maintenance regimen as that used with anticonvulsants that have this effect.

Patients 2 to 12 Years of Age: 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. 

Table 2. Escalation Regimen for Lamotrigine in Patients 2 to 12 Years of Age With Epilepsy
  For Patients TAKING Valproate 1 For Patients NOT TAKING Carbamazepine,
Phenytoin,
Phenobarbital,  
Primidone 2   or
 Valproate
For Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or  Primidone and NOT TAKING Valproate
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
Weeks 5 onwards 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.

1 Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of Lamotrigine [see Drug Interactions (7), Clinical Pharmacology  (12.3)].
2 These drugs induce Lamotrigine glucuronidation and increase clearance [see Drug Interactions Clinical Pharmacology  (12.3)]. Other drugs, which have similar effects include estrogen-containing oral contraceptives [see Drug Interactions Clinical Pharmacology  (12.3)].
Dosing recommendations for oral contraceptives can be found in General Dosing Considerations [see Dosage and Administration ]. Patients on rifampin, or other drugs that induce Lamotrigine glucuronidation and increase clearance, should follow the same dosing titration/maintenance regimen as that used with anticonvulsants that have this effect.

Table 3. The Initial Weight-Based Dosing Guide for Patients 2 to 12 Years Taking Valproate (Weeks 1 to 4) With Epilepsy
If the patient’s weight is Give this daily dose, using the most appropriate combination of Lamotrigine 2-mg 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 studies in which the efficacy of Lamotrigine was established. In patients receiving multidrug regimens employing carbamazepine, phenytoin, phenobarbital, or primidone without valproate, maintenance doses of adjunctive Lamotrigine as high as 700 mg/day have been used. In patients receiving valproate alone, maintenance doses of adjunctive Lamotrigine as high as 200 mg/day have been used. The advantage of using doses above those recommended in Tables 1 through 4 has not been established in controlled trials.

Epilepsy – Conversion From Adjunctive Therapy to Monotherapy

The goal of the transition regimen is to effect the conversion to monotherapy with Lamotrigine under conditions that ensure adequate seizure control while mitigating the risk of serious rash associated with the rapid titration of Lamotrigine.

The recommended maintenance dose of Lamotrigine 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 of Lamotrigine should not be exceeded [see Boxed Warning ].

Conversion From Adjunctive Therapy With Carbamazepine, Phenytoin, Phenobarbital, or Primidone to Monotherapy With Lamotrigine: After achieving a dose of 500 mg/day of Lamotrigine according to the guidelines in Table 1, the concomitant 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 Lamotrigine: The conversion regimen involves 4 steps outlined in Table 4.

Table 4. Conversion From Adjunctive Therapy With Valproate to Monotherapy With Lamotrigine in Patients ≥16 Years of Age with Epilepsy

Lamotrigine

Valproate

Step 1

Achieve a dose of 200 mg/day according to guidelines in Table 1 (if not already on 200 mg/day).

Maintain previous stable dose.

Step 2

Maintain at 200 mg/day.

Decrease to 500 mg/day by decrements no greater than 500 mg/day/week and then maintain the dose of 500 mg/day 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 AEDs Other Than Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate to Monotherapy With Lamotrigine:
No specific dosing guidelines can be provided for conversion to monotherapy with Lamotrigine with AEDs other than carbamazepine, phenobarbital, phenytoin, primidone, or valproate.

Bipolar Disorder

The goal of maintenance treatment with Lamotrigine 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 Lamotrigine 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, 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 Lamotrigine 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 Lamotrigine should be adjusted. For patients discontinuing valproate, the dose of Lamotrigine 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 that induce Lamotrigine glucuronidation, the dose of Lamotrigine 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 Lamotrigine may then be further adjusted to the target dose (200 mg) as clinically indicated.

If other drugs are subsequently introduced, the dose of Lamotrigine may need to be adjusted. In particular, the introduction of valproate requires reduction in the dose of Lamotrigine [see Drug Interactions (7), Clinical Pharmacology] .

To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of Lamotrigine should not be exceeded [see Boxed Warning ].

 

Table 5. Escalation Regimen for Lamotrigine for Patients With Bipolar Disorder
For Patients TAKING Valproate 1 For Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone 2, or Valproate For Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidone and NOT TAKING Valproate
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

1 Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of Lamotrigine [see Drug Interactions (7), Clinical Pharmacology ].
2 These drugs induce Lamotrigine glucuronidation and increase clearance [see Drug Interactions (7), Clinical Pharmacology]. Other drugs which have similar effects include estrogen- containing oral contraceptives [see Drug Interactions (7), Clinical Pharmacology ].
Dosing recommendations for oral contraceptives can be found in General Dosing Considerations [see Dosage and Administration]. Patients on rifampin, or other drugs that induce Lamotrigine glucuronidation and increase clearance, should follow the same dosing titration/ maintenance regimen as that used with anticonvulsants that have this effect.

Table 6. Dosage Adjustments to Lamotrigine for Patients With Bipolar Disorder Following Discontinuation of Psychotropic Medications
 

Discontinuation of Psychotropic Drugs (excluding Carbamazepine, Phenytoin, Phenobarbital, Primidone 1, or Valproate 2)

After Discontinuation of Valproate After Discontinuation of Carbamazepine, Phenytoin, Phenobarbital, or Primidone
Current dose of Lamotrigine (mg/day) 100

Current dose of Lamotrigine (mg/day) 400

Week 1 Maintain current dose of Lamotrigine 150 400
Week 2 Maintain current dose of Lamotrigine 200 300
Week 3 onward Maintain current dose of Lamotrigine 200 200
1 These drugs induce Lamotrigine glucuronidation and increase clearance [see Drug Interactions (7), Clinical Pharmacology ]. Other drugs which have similar effects include estrogen-containing oral contraceptives [see Drug Interactions (7), Clinical Pharmacology]. Dosing recommendations for oral contraceptives can be found in General Dosing Considerations [see Dosage and Administration ]. Patients on rifampin, or other drugs that induce Lamotrigine glucuronidation and increase clearance, should follow the same dosing titration/ maintenance regimen as that used with anticonvulsants that have this effect.
2 Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of Lamotrigine [see Drug Interactions (7), Clinical Pharmacology].

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

DOSAGE FORMS AND STRENGTHS

Tablets

25 mg: Round, white to off white tablets, debossed with 'J' and '245' on one side and scoreline on the other side

100 mg:  Round, white to off white tablets, debossed with 'J' and '246' on one side and scoreline on the other side

150 mg: Round, white to off white tablets, debossed with 'J' and '247' on one side and scoreline on the other side

200 mg: Round, white to off white tablets, debossed with 'J' and '248' on one side and scoreline on the other side

Potential Medication Errors

Patients should be strongly advised to visually inspect their tablets to verify that they are receiving Lamotrigine Tablets as well as the correct formulation of Lamotrigine Tablets each time they fill their prescription. Description of the Lamotrigine Tablets can be found in the Medication Guide that accompanies the product.

HOW SUPPLIED/STORAGE AND HANDLING

Lamotrigine Tablets USP, 25 mg

Round, white to off white tablets, debossed with ‘J’ and ‘245’ on one side and scoreline on the other side.

     Bottles of 100 tablets with Child Resistant Closure, NDC 59746-245-01 
     Bottles of 500 tablets with Plain Closure,   NDC 59746-245-05
     Bottles of 1000 tablets with Plain Closure, NDC 59746-245-10

Lamotrigine Tablets USP, 100 mg

Round, white to off white tablets, debossed with ‘J’ and ‘246’ on one side and scoreline on the other side.

     Bottles of 100 tablets with Child Resistant Closure, NDC 59746-246-01
     Bottles of 1000 tablets with Plain Closure, NDC 59746-246-10

Lamotrigine Tablets USP, 150 mg

Round, white to off white tablets, debossed with ‘J’ and ‘247’ on one side and scoreline on the other side.

     Bottles of 60 tablets with Child Resistant Closure, NDC 59746-247-60
     Bottles of 500 tablets with Plain Closure, NDC 59746-247-05

Lamotrigine Tablets USP, 200 mg

Round, white to off white tablets, debossed with ‘J’ and ‘248’ on one side and scoreline on the other side.

     Bottles of 60 tablets with Child Resistant Closure, NDC 59746-248-60
     Bottles of 500 tablets with Plain Closure, NDC 59746-248-05

Storage:

Store at 20 - 25°C (68 - 77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.  

PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication Guide).

Rash

Prior to initiation of treatment with Lamotrigine, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.

Multiorgan Hypersensitivity Reactions, Blood Dyscrasias and Organ Failure

Patients should be instructed that multiorgan hypersensitivity reactions and acute multiorgan failure may occur with Lamotrigine. Isolated organ failure or isolated blood dyscrasias without evidence of multiorgan hypersensitivity may also occur. Patients should contact their physician immediately if they experience any signs or symptoms of these conditions [see Warnings and Precautions ( 5.2 , 5.3)].

Suicidal Thinking and Behavior

Patients, their caregivers, and families should be counseled that AEDs, including Lamotrigine, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of 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.

Worsening of Seizures

Patients should be advised to notify their physician if worsening of seizure control occurs.

Central Nervous System Adverse Effects

Patients should be advised that Lamotrigine may cause dizziness, somnolence, and other symptoms and signs of central nervous system (CNS) depression. Accordingly, they should be advised neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on Lamotrigine to gauge whether or not it adversely affects their mental and/or motor performance.

Pregnancy and Nursing

Patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy. Patients should be advised to notify their physicians if they intend to breastfeed or are breastfeeding an infant.

Patients should also be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 [see Use in Specific Populations ].

Patients who intend to breastfeed should be informed that Lamotrigine is present in breast milk and that they should monitor their child for potential adverse effects of this drug. Benefits and risks of continuing breastfeeding should be discussed with the patient.

Oral Contraceptive Use

Women should be advised to notify their physician if they plan to start or stop use of oral contraceptives or other female hormonal preparations. Starting estrogen-containing oral contraceptives may significantly decrease Lamotrigine plasma levels and stopping estrogen-containing oral contraceptives (including the “pill-free” week) may significantly increase Lamotrigine plasma levels [see Warnings and Precautions (5.9), Clinical Pharmacology]. Women should also be advised to promptly notify their physician if they experience adverse reactions or changes in menstrual pattern (e.g., break-through bleeding) while receiving Lamotrigine in combination with these medications.

Discontinuing Lamotrigine Tablets

Patients should be advised to notify their physician if they stop taking Lamotrigine for any reason and not to resume Lamotrigine without consulting their physician.

Aseptic Meningitis

Patients should be advised that Lamotrigine may cause aseptic meningitis. Patients should be advised to notify their physician immediately if they develop signs and symptoms of meningitis such as headache, fever, nausea, vomiting, stiff neck, rash, abnormal sensitivity to light, myalgia, chills, confusion, or drowsiness while taking Lamotrigine.

Potential Medication Errors

Medication errors involving Lamotrigine have occurred. In particular the name Lamotrigine can be confused with the names of other commonly used medications. Medication errors may also occur between the different formulations of Lamotrigine. To reduce the potential of medication errors, write and say Lamotrigine clearly. Description of the Lamotrigine Tablets can be found in the Medication Guide that accompanies the product to highlight the distinctive markings, colors, and shapes that serve to identify the different presentations of the drug and thus may help reduce the risk of medication errors. To avoid a medication error of using the wrong drug or formulation, patients should be strongly advised to visually inspect their tablets to verify that they are Lamotrigine, as well as the correct formulation of Lamotrigine, each time they fill their prescription [see Dosage Forms and Strengths How Supplied/Storage and Handling].

Manufactured By:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA
Rev. # 10/12

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