BOX WARNING
SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF LAMICTAL. THE INCIDENCE OF THESE RASHES, WHICH HAVE INCLUDED STEVENS-JOHNSON SYNDROME, IS APPROXIMATELY 0.8% (8 PER 1,000) IN PEDIATRIC PATIENTS (AGE <16 YEARS) RECEIVING LAMICTAL AS ADJUNCTIVE THERAPY FOR EPILEPSY AND 0.3% (3 PER 1,000) IN ADULTS ON ADJUNCTIVE THERAPY FOR EPILEPSY. IN CLINICAL TRIALS OF BIPOLAR AND OTHER MOOD DISORDERS, THE RATE OF SERIOUS RASH WAS 0.08% (0.8 PER 1,000) IN ADULT PATIENTS RECEIVING LAMICTAL AS INITIAL MONOTHERAPY AND 0.13% (1.3 PER 1,000) IN ADULT PATIENTS RECEIVING LAMICTAL AS ADJUNCTIVE THERAPY. IN A PROSPECTIVELY FOLLOWED COHORT OF 1,983 PEDIATRIC PATIENTS WITH EPILEPSY TAKING ADJUNCTIVE LAMICTAL, THERE WAS 1 RASH-RELATED DEATH. IN WORLDWIDE POSTMARKETING EXPERIENCE, RARE CASES OF TOXIC EPIDERMAL NECROLYSIS AND/OR RASH-RELATED DEATH HAVE BEEN REPORTED IN ADULT AND PEDIATRIC PATIENTS, BUT THEIR NUMBERS ARE TOO FEW TO PERMIT A PRECISE ESTIMATE OF THE
RATE. BECAUSE THE RATE OF SERIOUS RASH IS GREATER IN PEDIATRIC PATIENTS THAN IN ADULTS, IT BEARS EMPHASIS THAT LAMICTAL IS APPROVED ONLY FOR USE IN PEDIATRIC PATIENTS BELOW THE AGE OF 16 YEARS WHO HAVE SEIZURES ASSOCIATED WITH THE LENNOX-GASTAUT SYNDROME OR IN PATIENTS WITH PARTIAL SEIZURES (SEE INDICATIONS). OTHER THAN AGE, THERE ARE AS YET NO FACTORS IDENTIFIED THAT ARE KNOWN TO PREDICT THE RISK OF OCCURRENCE OR THE SEVERITY OF RASH ASSOCIATED WITH LAMICTAL. THERE ARE SUGGESTIONS, YET TO BE PROVEN, THAT THE RISK OF RASH MAY ALSO BE INCREASED BY (1) COADMINISTRATION OF LAMICTAL WITH VALPROATE (INCLUDES VALPROIC ACID AND DIVALPROEX SODIUM), (2) EXCEEDING THE RECOMMENDED INITIAL DOSE OF LAMICTAL, OR (3) EXCEEDING THE RECOMMENDED DOSE ESCALATION FOR LAMICTAL. HOWEVER, CASES HAVE BEEN REPORTED IN THE ABSENCE OF THESE FACTORS. NEARLY ALL CASES OF LIFE-THREATENING RASHES ASSOCIATED WITH LAMICTAL HAVE OCCURRED WITHIN 2 TO 8 WEEKS OF TREATMENT INITIATION. HOWEVER, ISOLATED CASES HAVE BEEN REPORTED AFTER PROLONGED TREATMENT (E.G., 6 MONTHS). ACCORDINGLY, DURATION OF THERAPY CANNOT BE RELIED UPON AS A MEANS TO PREDICT THE POTENTIAL RISK HERALDED BY THE FIRST APPEARANCE OF A RASH. ALTHOUGH BENIGN RASHES ALSO OCCUR WITH LAMICTAL, IT IS NOT POSSIBLE TO PREDICT RELIABLY WHICH RASHES WILL PROVE TO BE SERIOUS OR LIFE THREATENING. ACCORDINGLY, LAMICTAL SHOULD ORDINARILY BE DISCONTINUED AT THE FIRST SIGN OF RASH, UNLESS THE RASH IS CLEARLY NOT DRUG RELATED. DISCONTINUATION OF TREATMENT MAY NOT PREVENT A RASH FROM BECOMING LIFE THREATENING OR PERMANENTLY DISABLING OR DISFIGURING.
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LAMICTAL SUMMARY
LAMICTAL (lamotrigine), an antiepileptic drug (AED) of the phenyltriazine class, is chemically unrelated to existing antiepileptic drugs.
Adjunctive Use: LAMICTAL is indicated as adjunctive therapy for partial seizures in adults and pediatric patients (>/=2 years of age).
LAMICTAL is also indicated as adjunctive therapy for the generalized seizures of Lennox-Gastaut syndrome in adult and pediatric patients (>/=2 years of age).
Monotherapy Use: LAMICTAL 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 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 (see DOSAGE AND ADMINISTRATION).
Safety and effectiveness in patients below the age of 16 other than those with partial seizures and the generalized seizures of Lennox-Gastaut syndrome have not been established (see BOXED WARNING).
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 patients 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 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 LAMICTAL for periods extending beyond 18 months should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
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LAMICTAL NEWS HIGHLIGHTS Media Articles Related to Lamictal (Lamotrigine)
Bipolar Disorder - Eurand Announces FDA Approval Of EUR-1048 (Lamictal(R) ODT(TM)), Co-Developed With GlaxoSmithKline
Source: Bipolar News From Medical News Today [2009.05.12]
Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies, announced that the U.S. Food and Drug Administration (FDA) has approved EUR-1048, to be marketed as GlaxoSmithKline's (NYSE: GSK) Lamictal(R) ODT(TM) (lamotrigine) Orally Disintegrating Tablets.
Eurand Announces FDA Approval Of EUR-1048 (Lamictal(R) ODTTM), Co-Developed With GlaxoSmithKline
Source: Bipolar News From Medical News Today [2009.05.12]
Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies, announced that the U.S. Food and Drug Administration (FDA) has approved EUR-1048, to be marketed as GlaxoSmithKline's (NYSE: GSK) Lamictal® ODT™ (lamotrigine) Orally Disintegrating Tablets.
New Research Under Way To Study Treatment For Older Adults With Bipolar Disorder
Source: Bipolar News From Medical News Today [2009.05.08]
Continuing their groundbreaking research into the treatment of mood disorders in older adults, psychiatrists at the Weill Cornell Institute of Geriatric Psychiatry at the NewYork-Presbyterian Hospital/Westchester Division in White Plains will begin new studies on the effects of quetiapine (Seroquel: Astra Zeneca) and lamotrigine (Lamictal: GlaxoSmithKline).
Published Studies Related to Lamictal (Lamotrigine)
The efficacy of lamotrigine in clozapine-resistant schizophrenia: A systematic review and meta-analysis. [2009.01.29]
CONCLUSIONS: This meta-analysis suggests that lamotrigine [generic for Lamictal] augmentation may be an effective treatment for patients with clozapine-resistant schizophrenia. A substantial proportion of these most severely ill patients appeared to obtain clinically meaningful benefit from this combination treatment.
A single blind comparison of lithium and lamotrigine for the treatment of bipolar II depression. [2008.12]
BACKGROUND: Treatment studies are lacking for patients with bipolar II disorder (BDII). The objective of this study was to compare lamotrigine [generic for Lamictal] (LTG) and lithium (Li) monotherapy for the treatment of BDII depression... CONCLUSIONS: Lamotrigine and lithium were effective monotherapy for BDII depression, with comparable response and remission rates. Naturalistic design and lack of placebo limit conclusions, though patient history indicated long standing depression unlikely to be alleviated by time. Patients who received Li reported more side effects, but this did not appear to impact drop-out rates.
Lamotrigine does not prolong QTc in a thorough QT/QTc study in healthy subjects. [2008.09]
AIM: To characterize the effects of lamotrigine [generic for Lamictal] on QT interval in healthy subjects... CONCLUSIONS: Therapeutic doses of lamotrigine (50-200 mg b.d.) were not associated with QT prolongation in healthy subjects.
Attenuation of the effects of corticosteroids on declarative memory with lamotrigine. [2008.09]
An extensive animal literature suggests that excessive corticosteroid exposure is associated with changes in memory and the hippocampus... Results suggest that lamotrigine [generic for Lamictal] may improve declarative memory in patients taking prescription corticosteroids although differential dropout rate in the two groups is a concern.
Hyperandrogenism, ovulatory dysfunction, and polycystic ovary syndrome with valproate versus lamotrigine. [2008.08]
OBJECTIVE: To evaluate development of components of polycystic ovary syndrome (PCOS) and PCOS in women with epilepsy initiating valproate or lamotrigine [generic for Lamictal] therapy... INTERPRETATION: Development of HA occurred more frequently with valproate than lamotrigine, especially if medication was started at age younger than 26 years.
Clinical Trials Related to Lamictal (Lamotrigine)
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures [Active, not recruiting]
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine)
extended-release with placebo in the treatment of PGTC seizures. LAMICTAL extended-release is
an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do
not contain active medication. In this study, LAMICTAL extended-release or placebo tablets
will be added to current seizure treatments.
LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures [Completed]
This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the
treatment of newly-diagnosed typical absence seizures. Subjects will be children and
adolescents < 13 years of age. It will be conducted at multiple sites in the US. The study
will consist of 4 phases: Screen Phase (up to 1 week), Baseline Phase (24 hours), Escalation
Phase (up to 20 weeks) and Maintenance Phase (12 weeks). Subjects will receive increasing
doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by
hyperventilation (HV) for clinical signs and a 1-hr EEG at 2 consecutive weekly visits. At
that point, subjects will move into the 12-week Maintenance Phase. Subjects who do not
achieve seizure freedom upon reaching the maximum dose (10. 2mg/kg/day) with the specified
dose escalation will be discontinued from the study. During the Maintenance Phase, the
investigators will use their best effort to maintain the subjects at the efficacious dose
reached. If the subjects have unacceptable side effects or inadequate seizure control, the
doses of study drug can be increased or decreased as specified in the dosing schedule.
Safety will be assessed by monitoring adverse events, laboratory assessments, and serum
lamotrigine levels. Health outcomes assessments will also be conducted.
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures [Completed]
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine)
extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release
is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but
do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets
will be added to current seizure treatments.
Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25
mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg
(2 x 25 mg) dose administration under fasting conditions.
Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25
mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg
(2 x 25 mg) dose administration under fed conditions.
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LAMICTAL PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 15 ratings/reviews, Lamictal has an overall score of 8.40. The effectiveness score is 8.40 and the side effect score is 8.40. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Lamictal review by 24 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Bipolar Disorder, OCD Behaviors |
| Dosage & duration: | | 200 MG [start at 25 & work way up] taken nightly for the period of 5 Months |
| Other conditions: | | Bulimia, Depression, Anxiety |
| Other drugs taken: | | Lexapro | | |
Reported Results |
| Benefits: | | Diminished extreme highs& lows, decreased anxiety/panic attacks, diminished urges to self multilate [Felt absolutely compelled to punch my legs, arms, and head at times of anxiety attacks a way to numb pain of anxiety inside]. Mental clarity. Felt a sense of control over eating behaviors [Felt I had a choice to binge/purge or not]. This drug was a miracle as I admitted myself to the ER after feeling all loss of control over my extreme mood swings [very happy/joyfull to "no reason to live" the next minute], my bulimia, self-mutilation, & anxiety. I felt as if I was on a very thin thread of life, I was ready to quit seeking any sign of serenity, until I was given hope with Lamictal. I was able to hold on to life, with a promise that soon the medications will start working. Mental health issues run deep in my father's family. I've always been hesitant to solve my problems with meds, trying virtually every alternative medicine [even hypnotherapy]. I wish I would have looked into this earlier- knowing that my problems had deep genetic roots [chemical imbalace]. |
| Side effects: | | Made me a little sleepy, which actually helped my sleeping problems as well. Might have affected the ease to reach orgasm- however i think lexapro was the main culprit of that side effect having taken that med previously [lexapro has also helped my bulmia & depression]. |
| Comments: | | Started off at 25 mg, increaing to 50, 100, and now at 200mg, which I will stay at. 20 mg of lexapro, taken nightly as well, mainly for depression and anxiety.
Recommended to see a therapist twice a week, initially. [With a temporarily heavy work schedule- unable to make consistant appointments. However, i keep making leaps and bounds in tearms of behavioral health progress! I intend on following recommendations in the near future as my work load levels out. |
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| | Lamictal review by 44 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | bi-polar 2 |
| Dosage & duration: | | 400 mg taken twice a day ,am and pm for the period of 3 months at the 400 mg/prior 200 mg. |
| Other conditions: | | anxiety related to bi-polar 2 |
| Other drugs taken: | | geodon and klonopin and Zoloft | | |
Reported Results |
| Benefits: | | I feel much more stabilized on this drug. However the 200 mg.did quit working after about year and a half, and I was hospitalized with a mixed episode. My Lamictal was raised to 400 mg. 200 at night and 200 in the AM. I am told this is the highest theraputic level for this drug for treating bi-polar. I am much more even but am also still on Geodon and kolonpin once a day. I am weaning off of zoloft-am at 50 mg. once a day at moment. I feel the real med that has helped is the Lamictal, I hope to wean off the rest of meds after being stable for a length of time. |
| Side effects: | | I do not think I have or had any side affects. It is hard to tell because I am on more than one drug, and while in the hospital I was on others. I am also alcholic so like that Lamictal is not habit forming. I am afraid I will put on weight as others have reported. |
| Comments: | | Diagnosed with Bi-polar 2 WITH MIXED EPISODES AND RAPID CYCLING. Had been perscribed many SSRI'S, due to depression but never fully treated for bi-polar because I felt like I deserved and did not want to give up the few highs I had when not depressed. I also did not believe I was bi-polar when dignosed 12 years ago as an in-patient, because I had no understanding of mixed episodes and rapid cycling. I thought when I was hypo-manic, it was just a great relief and celebration of not being depressed. I was also not honest about my alcohol abuse until about 6 months ago, and have since stopped drinking, which allowed me to realize I was quelling the manis with alcohol, and with out it I was more unstable and manic. My only fear now is that without an anti-depressant I will suffer depression again. |
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| | Lamictal review by 80 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | mood stablizer for Bipoler disorder |
| Dosage & duration: | | 100mg taken two times a day for the period of 2 years |
| Other conditions: | | arthritis |
| Other drugs taken: | | Welbutrin | | |
Reported Results |
| Benefits: | | I took lamectal to replace Lithium hoping it will help stabilize my mood. But after two years of taking it, it did not seem working. |
| Side effects: | | I start the dose very small and gradually increased. I did not have any side effects. |
| Comments: | | I used to take lithium for my bipolar disorder and it worked great. Because of my age, and an episode of lithium toxicity, my doctor suggest I stop using lithium, instead, try Lamectal. I took Lamactal for two years now, I had three episodes of depression which was quite bad. I think Lamactal is not working. My doctor suggest to change to Depokote and give it a try. |
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Page last updated: 2009-05-12
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