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Important Safety Information
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Indications Overview
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| Frequently Asked Questions About LAMICTAL or LAMICTAL ODT Both you and your patients may have questions about LAMICTAL. The first set of questions below is designed to assist you in answering these questions. To obtain a patient-friendly pamphlet about LAMICTAL and LAMICTAL ODT, please contact your GlaxoSmithKline representative or call the GlaxoSmithKline Response Center at 1-888-825-5249. Jump to questions you or your staff may have about LAMICTAL> Questions your patients may ask There is a Medication Guide for LAMICTAL and LAMICTAL ODT that answers questions your patients may have. You can click here for a copy of the Medication Guide to print for your patients. Questions you or your staff may have about LAMICTAL and LAMICTAL ODT Print to obtain a copy of the questions and answers below.
Q. What dosages and formulations are available for LAMICTAL and LAMICTAL ODT? A. LAMICTAL is available as orally disintegrating tablets, scored tablets, and chewable dispersible tablets for maximum dosing flexibility. 
LAMICTAL ODT will rapidly disintegrate, and can be swallowed with or without water. LAMICTAL Tablets should be swallowed whole. Berry-flavored, chewable dispersible tablets can be chewed, dissolved in juice or water, or swallowed whole. 2-mg dosage of the chewable dispersible tablets available to healthcare professionals only from your representative or through the GlaxoSmithKline Response Center (1-888-825-5249). FREE 5-week Sample Kits help simplify titration for patients >12 years. Easy-to-follow Starter Kits are available by prescription for LAMICTAL Tablets and LAMICTAL ODT Orally Disintegrating Tablets. [ return to top ] Q. How are LAMICTAL and LAMICTAL ODT dosed? A. Dosing guidelines are available in the Prescribing Information for LAMICTAL and LAMICTAL ODT, or see the Dosing section of this Web site. [ return to top ] Q. What should I tell my patients before initiating LAMICTAL or LAMICTAL ODT? A. Prior to initiation of treatment with LAMICTAL or LAMICTAL ODT, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately. In addition, the patient should notify his or her physician if worsening of seizure control occurs. Patients, their caregivers, and families should be informed that antiepileptic drugs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. Patients should be advised that LAMICTAL and LAMICTAL ODT may cause dizziness, somnolence, and other symptoms and signs of central nervous system depression. Accordingly, they should be advised neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on LAMICTAL to gauge whether or not it adversely affects their mental and/or motor performance. Patients should be advised of the possibility of blood dyscrasias and/or acute multiorgan failure and to contact their physician immediately if they experience any signs or symptoms of these conditions. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Patients should be advised to notify their physician if they intend to breastfeed or are breastfeeding an infant. Women should be advised to notify their physician if they plan to start or stop use of oral contraceptives or other female hormonal preparations. Stopping or starting these products may cause side effects (such as dizziness, lack of coordination, or double vision) or decrease the effectiveness of LAMICTAL and LAMICTAL ODT. They should also be advised to promptly notify their physician if they experience changes in menstrual pattern (eg, breakthrough bleeding) while receiving LAMICTAL or LAMICTAL ODT in combination with these medications. Patients should be advised to notify their physician if they stop taking LAMICTAL or LAMICTAL ODT for any reason and not to resume LAMICTAL or LAMICTAL ODT without consulting their physician. Medication errors involving LAMICTAL have occurred. In particular the name LAMICTAL or lamotrigine can be confused with the names of other commonly used medications. Medication errors may also occur between the different formulations of LAMICTAL. 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 LAMICTAL, as well as the correct formulation of LAMICTAL, each time they fill their prescription. [ return to top ] Q. Do any medications interact with LAMICTAL or LAMICTAL ODT? A. You should be aware of the following: Valproate (VPA) reduces the clearance of LAMICTAL and LAMICTAL ODT. The dosage of LAMICTAL and LAMICTAL ODT required in the presence of VPA is less than half of that required in its absence. See Prescribing Information for LAMICTAL and LAMICTAL ODT. The interaction of LAMICTAL and several medications has been studied. A table that summarizes these interactions is included below. Please see complete Prescribing Information for full description of drug interactions. Summary of Drug Interactions With LAMICTAL
* From adjunctive clinical trials and volunteer studies. † Net effects were estimated by comparing the mean clearance values obtained in adjunctive clinical trials and volunteers studies. ‡ The effect of other hormonal contraceptive preparations or hormone replacement therapy on the pharmacokinetics of lamotrigine has not been systematically evaluated in clinical trials, although the effect may be similar to that seen with the ethinylestradiol/levonorgestrel combinations. §Modest decrease in levonorgestrel. ║Not administered, but an active metabolite of carbamazepine. ¶Slight decrease, not expected to be clinically relevant. #Not administered, but an active metabolite of oxcarbazepine. ** Slight increase not expected to be clinically relevant. <—> = No significant effect. ? = Conflicting data.
[ return to top ] Q. How can I simplify titration with LAMICTAL and LAMICTAL ODT? A. Many AEDs require titration to effective dose—only LAMICTAL offers 5-week Sample Kits or Starter Kits available by prescription to make it simple for you and your patients older than 12 years. The green kit is for patients taking carbamazepine, phenytoin, primidone, phenobarbital, or rifampin and not taking valproate (includes valproic acid and divalproex sodium). The orange kit is for patients not taking carbamazepine, phenytoin, phenobarbital, primidone, rifampin, or valproate, and the blue kit is for patients taking valproate. They include clear, simple patient instructions.
[ return to top ] Q. Can I be confident converting my adult patients to monotherapy with LAMICTAL from carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED? A. The Expert Consensus Opinion for the Treatment of Epilepsy, published in 2005 in Epilepsy & Behavior, reported the results of a survey taken among 51 leading physicians treating epilepsy (43 of 48 responded).1 The survey was designed to address key decision points in the management of epilepsy and seizures. Participants were asked to rank the order in which they would recommend certain therapies and to rate those choices using a 9-point scale. The Expert Consensus Guideline Series: Treatment of Epilepsy was sponsored by unrestricted educational grants from Abbott Laboratories, GlaxoSmithKline, Novartis Pharmaceuticals, and UCB Pharma, Inc. The opinions expressed in this survey are those of the expert panel. Dosages, indications, and methods of use referred to in the guideline may reflect the clinical experience of the editors, professional literature, or other clinical sources. When asked which monotherapy they would choose after the failure of initial monotherapy, 91% of the responding physicians recommended LAMICTAL when the first monotherapy was carbamazepine or phenytoin. This overwhelming confidence in the proven seizure control and tolerability of LAMICTAL is supported by more than 19 years of worldwide postmarketing experience and more than 5 million patient exposures worldwide—and growing.2†† Safety and effectiveness of LAMICTAL and LAMICTAL ODT 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. ††Based on kg of lamotrigine sold. References: 1. Karceski S, Morrell M, Carpenter D. Treatment of epilepsy in adults: expert opinion, 2005. Epilepsy & Behavior, 2005:7(S1-S64). 2. Data on file, GlaxoSmithKline. [ return to top ] |
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| Important Safety Information About LAMICTAL and LAMICTAL ODT | ||||
| • | LAMICTAL ODT is another form of LAMICTAL. | |||
| • | Cases of life-threatening serious rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death, have been caused by LAMICTAL. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include:
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| • | Benign rashes are also caused by LAMICTAL; however, it is not possible to predict which rashes will prove to be serious or life-threatening. LAMICTAL should be discontinued at the first sign of rash, unless the rash is clearly not drug-related (see Boxed Warning in Prescribing Information). | |||
| • | Hypersensitivity reaction may be fatal or life-threatening. Early signs of hypersensitivity (eg, fever, lymphadenopathy) may present without rash; if signs present, patient should be evaluated immediately. LAMICTAL should be discontinued if alternate etiology for hypersensitivity signs is not found. | |||
| • | Prior to initiation of treatment with LAMICTAL, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately. | |||
| • | Acute multiorgan failure has resulted (some cases fatal). | |||
| • | Blood dyscrasias (eg, neutropenia, thrombocytopenia, pancytopenia) may result either with or without an associated hypersensitivity syndrome. | |||
| • | Antiepileptic drugs, including LAMICTAL ODT, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. | |||
| • | Patients treated with any antiepileptic drug for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. | |||
| • | Patients, their caregivers, and families should be informed that antiepileptic drugs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. | |||
Medication Guide for LAMICTAL® (lamotrigine) Tablets and LAMICTAL® ODT™ (lamotrigine) Orally Disintegrating Tablets |
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Complete Prescribing Information and Medication Guide for LAMICTAL® (lamotrigine) Tablets and LAMICTAL® ODT™ (lamotrigine) Orally Disintegrating Tablets including Boxed Warning |
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