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Lamotrigine (Lamotrigine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Epilepsy:

Adjunctive Use:

Lamotrigine is indicated as adjunctive therapy for partial seizures, the generalized seizures of Lennox-Gastaut syndromein adults and pediatric patients (≥2 years of age).

Monotherapy Use

Lamotrigine is indicated for conversion to monotherapy in adults with partial seizures. who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single 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 (see DOSAGE AND ADMINISTRATION).

Bipolar Disorder :

Lamotrigine 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 patients 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 of 18 months' duration in patients with Bipolar I Disorder as defined by DSM-IV (see CLINICAL STUDIES: Bipolar Disorder). The physician who elects to use lamotrigine for periods extending beyond 18 months should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

Epilepsy:

Adjunctive Use:

Lamotrigine is indicated as adjunctive therapy for partial seizures, the generalized seizures of Lennox-Gastaut syndrome in adult and pediatric patients (≥2 years of age).

Monotherapy Use:

Lamotrigine is indicated for conversion to monotherapy in adults with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single 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
  3. for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.

Bipolar Disorder

Lamotrigine 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 patients treated for acute mood episodes with standard therapy. The effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.

General Dosing Considerations for Epilepsy and Bipolar Disorder Patients:

The risk of nonserious rash is increased when the recommended initial dose and/or the rate of dose escalation of lamotrigine is exceeded. 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
  3. exceeding the recommended dose escalation for lamotrigine.

However, cases have been reported in the absence of these factors (see BOXED WARNING). Therefore, it is important that the dosing recommendations be followed closely.

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.

Lamotrigine Added to Drugs Known to Induce or Inhibit Glucuronidation:

Drugs other than those listed in PRECAUTIONS: Drug Interactions have not been systematically evaluated in combination with lamotrigine. Since 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.

The half-life of lamotrigine is affected by other concomitant medications (see CLINICAL PHARMACOLOGY: Pharmacokinetics and Drug Metabolism).

See also DOSAGE AND ADMINISTRATION: Special Populations:.

Special Populations:

Women and Oral Contraceptives:

Starting Lamotrigine in Women Taking Oral Contraceptives:

Although estrogen-containing oral contraceptives have been shown to increase the clearance of lamotrigine (see PRECAUTIONS: Drug Interactions), 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 (see Table 11). See below for adjustments to maintenance doses of lamotrigine in women taking estrogen-containing oral contraceptives.

Adjustments to the Maintenance Dose of Lamotrigine:

(1) Taking Estrogen Containing Oral Contraceptives:

For women not taking carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, 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 PRECAUTIONS: Drug Interactions:).

(2) Starting Estrogen-Containing Oral Contraceptives:

In women taking a stable dose of lamotrigine and not taking carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, 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 unless lamotrigine plasma levels or clinical response support larger increases (see Table 11, column 2). 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 events, such as dizziness, ataxia, and diplopia (see PRECAUTIONS: Drug Interactions:). If adverse events 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 rifampin, no adjustment should be necessary to the dose of lamotrigine.

(3) Stopping Estrogen-Containing Oral Contraceptives:

For women not taking carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, 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 PRECAUTIONS: Drug Interactions:). For women taking lamotrigine in addition to carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, 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 dysfunction (see 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 Functional Impairment:

Initial doses of lamotrigine should be based on patients' AED regimen (see above); reduced maintenance doses may be effective for patients with significant renal functional impairment (see CLINICAL PHARMACOLOGY). 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.

Epilepsy:

Adjunctive Therapy With lamotrigine for Epilepsy:

This section provides specific dosing recommendations for patients 2 to 12 years of age and patients greater than 12 years of age. Within each of these age-groups, specific dosing recommendations are provided depending upon concomitant AED (Table 9 for patients 2 to 12 years of age and Table 11 for patients greater than 12 years of age). A weight based dosing guide for pediatric patients on concomitant valproate is provided in Table 10.

Patients 2 to 12 Years of Age:

Recommended dosing guidelines are summarized in Table 9.

Note that some of the starting doses and dose escalations listed in Table 9 are different than those used in clinical trials; however, the maintenance doses are the same as in clinical trials. Smaller starting doses and slower dose escalations than those used in clinical trials are recommended because of the suggestions 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 lamotrigine tablets (chewable, dispersible) is 5 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 and PATIENT INFORMATION for a description of the available sizes of lamotrigine tablets (chewable, dispersible).

Table 9. Escalation Regimen for Lamotrigine in Patients 2 to 12 Years of Age With Epilepsy
For Patients Taking Valproate (see Table 10 for weight-based dosing guide) For Patients Taking AEDs Other Than Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate 1 For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, 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 10 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 10 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

1 Rifampin and estrogen-containing oral contraceptives have also been shown to increase the apparent clearance of lamotrigine (see PRECAUTIONS: Drug Interactions).

Note: Only whole tablets should be used for dosing

Table 10. 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

Patients Over 12 Years of Age:

Recommended dosing guidelines are summarized in Table 11.

Table 11. Escalation Regimen for Lamotrigine in Patients Over 12 Years of Age With Epilepsy
For Patients Taking Valproate For Patients Taking AEDs Other Than Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate 1 For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, 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 400 mg/day (1 or 2 divided doses) 100 mg to 200 mg/day with valproate alone 225 to 375 mg/day (in 2 divided doses) 300 to 500 mg/day (in 2 divided doses)

1 Rifampin and estrogen-containing oral contraceptives have also been shown to increase the apparent clearance of lamotrigine (see PRECAUTIONS: Drug Interactions:).

Conversion From Adjunctive Therapy With Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate as the Single AED to Monotherapy With Lamotrigine in Patients ≥ 16 Years of Age With Epilepsy:

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 Table 11, 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 (see Table 12).

Table 12. 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 11 (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 per 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 Antiepileptic Drugs 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.

Usual Maintenance Dose for Epilepsy:

The usual maintenance doses identified in Tables 9-11 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 9-12 has not been established in controlled trials.

Discontinuation Strategy for Patients With Epilepsy:

For patients receiving lamotrigine in combination with other AEDs, a reevaluation 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 PRECAUTIONS).

Discontinuing carbamazepine, phenytoin, phenobarbital, or primidone should prolong the half-life of lamotrigine; discontinuing valproate should shorten the half-life of lamotrigine.

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 rifampin, which 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 to 200 mg/day (see CLINICAL STUDIES: Bipolar Disorder:). 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 13. If other psychotropic medications are withdrawn following stabilization, the dose of lamotrgine 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 14). For patients discontinuing carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, 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 14). The dose of lamotrigine may then be further adjusted to the target dose (200 mg) as clinically indicated.

Dosage adjustments will be necessary in most patients who start or stop estrogen-containing oral contraceptives while taking lamotrigine (see DOSAGE AND ADMINISTRATION: Special Populations: Women and Oral Contraceptives: Adjustments to the Maintenance Dose of Lamotrigine:).

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 CLINICAL PHARMACOLOGY: Drug Interactions).

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 13. Escalation Regimen for Lamotrigine for Patients With Bipolar Disorder 1
For Patients Not Taking Carbamazepine (or Other Enzyme-Inducing Drugs 2) or Valproate 3 For Patients Taking Valproate For Patients Taking Carbamazepine (or Other Enzyme-Inducing Drugs) and Not Taking Valproate
Weeks 1 and 2 25 mg daily 25 mg every other day 50 mg daily
Weeks 3 and 4 50 mg daily 25 mg daily 100 mg daily, in divided doses
Week 5 100 mg daily 50 mg daily 200 mg daily, in divided doses
Week 6 200 mg daily 100 mg daily 300 mg daily, in divided doses
Week 7 200 mg daily 100 mg daily up to 400 mg daily, in divided doses.

1 See CLINICAL PHARMACOLOGY: Drug Interactions and PRECAUTIONS: Drug Interactions: for a description of known drug interactions
2 Carbamazepine, phenytoin, phenobarbital, primidone, rifampin, have been shown to increase the apparent clearance of lamotrigine.
3 Valproate has been shown to decrease the apparent clearance of lamotrigine.

Table 14. Adjustments to Lamotrigine Dosing for Patients With Bipolar Disorder Following Discontinuation of Psychotropic Medications 1
Discontinuation of Psychotropic Drugs (excluding Valproate 2, Carbamazepine, or Other Enzyme-Inducing Drugs 3) After Discontinuation of Valproate After Discontinuation of Carbamazepine or Other Enzyme-Inducing Drugs
Current Lamotrigine dose (mg/day) 100 Current Lamotrigine dose (mg/day) 400
Week 1 Maintain current lamotrigine dose 150 400
Week 2 Maintain current lamotrigine dose 200 300
Week 3 onward Maintain curent lamotrigine dose 200 200
1 See CLINICAL PHARMACOLOGY: Drug Interactions and PRECAUTIONS: Drug Interactions: for a description of known drug interactions.
2 Valproate has been shown to decrease the apparent clearance of lamotrigine.
3 Carbamazepine, phenytoin, phenobarbital, primidone, rifampin, have been shown to increase the apparent clearance of lamotrigine.

There is no body of evidence available to answer the question of how long the patient should remain on lamotrigine therapy. Systematic evaluation of the efficacy of lamotrigine in patients with either depression or mania who responded to standard therapy during an acute 8 to 16 week treatment phase and were then randomized to lamotrigine or placebo for up to 76 weeks of observation for affective relapse demonstrated a benefit of such maintenance treatment (see CLINICAL STUDIES: Bipolar Disorder:). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.

Discontinuation Strategy in Bipolar Disorder:

As with other AEDs, lamotrigine should not be abruptly discontinued. In the controlled clinical trials, there was no increase in the incidence, type, or severity of adverse experiences 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.

Administration of Lamotrigine Tablets (Chewable, Dispersible):

Lamotrigine tablets (chewable, dispersible) 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 lamotrigine tablets (chewable, dispersible), 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.

HOW SUPPLIED

Lamotrigine Tablets (Chewable, Dispersible), 5 mg White to off-white, caplet, flat faced beveled edged, uncoated tablets with score-line on one side and "228" debossed on the other side.

Bottles of 90 (NDC 68462-228-90)
Bottles of 100 (NDC 68462-228-01)
Bottles of 1000 (NDC 68462-228-10)

Lamotrigine Tablets (Chewable, Dispersible), 25 mg White to off-white, circular, flat faced beveled edged, uncoated tablets with "G" debossed on one side and "229" debossed on the other side.

Bottles of 90 (NDC 68462-229-90)
Bottles of 100 (NDC 68462-229-01)
Bottles of 1000 (NDC 68462-229-10)

Store at 20 o to 25 C (68 o to 77 F); excursions permitted to 15 o to 30 C (59 o to 86 F) [see USP Controlled Room Temperature].

Manufactured by:
Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115
www.glenmarkgenerics.com

February 2009

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