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WARNING: SERIOUS SKIN RASHES
LAMICTAL® can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (2 to 16 years of age) 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 (2 to 16 years of age) 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.
Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash caused by 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 occurred in the absence of these factors.
Nearly all cases of life-threatening rashes caused by LAMICTAL have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash.
Although benign rashes are also caused by 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 [see Warnings and Precautions] .
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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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NEWS HIGHLIGHTS
Published Studies Related to Lamictal (Lamotrigine)
A preliminary study of lamotrigine in the treatment of affective instability in borderline personality disorder. [2009.09]
The objective of this study was to evaluate the effectiveness of lamotrigine in reducing affective instability in borderline personality disorder (BPD). We conducted a 12-week, double-blind, placebo-controlled study of 28 patients who met Revised Diagnostic Interview for Borderlines and Diagnostic and Statistical Manual of Mental Disorders, fourth edition criteria for BPD.
Cardiac function and antiepileptic drug treatment in the elderly: a comparison between lamotrigine and sustained-release carbamazepine. [2009.08]
PURPOSE: To investigate the comparative effects of carbamazepine (CBZ) and lamotrigine (LTG) on electrocardiography (ECG) parameters in elderly patients with newly diagnosed epilepsy. METHODS: The study was conducted in the Norwegian subcohort (n = 108) of an international randomized double-blind 40-week trial, which compared the efficacy and tolerability of LTG and sustained-release CBZ in patients aged 65 and older with newly diagnosed epilepsy...
Olanzapine/fluoxetine combination vs. lamotrigine in the 6-month treatment of bipolar I depression. [2009.07]
To determine the efficacy and tolerability of olanzapine/fluoxetine combination (OFC) compared with lamotrigine (Lam) for long-term treatment of bipolar I depression, this 25-wk, randomized, double-blind study compared OFC (6/25, 6/50, 12/25, or 12/50 mg/d, n=205) with Lam titrated to 200 mg/d (n=205) in patients with bipolar I disorder, depressed...
Attenuation of amygdala atrophy with lamotrigine in patients receiving corticosteroid therapy. [2009.06]
BACKGROUND: Excessive corticosteroid exposure is associated with atrophic effects on the human hippocampus and amygdala. These effects seem to be, at least in part, mediated through corticosteroid-induced release of glutamate. We previously reported that lamotrigine, a glutamate release inhibitor, significantly improved declarative memory but did not change hippocampal volume, as compared with placebo, in corticosteroid-treated patients. To our knowledge, no data are available on preventing or reversing the impact of corticosteroids on the amygdala... CONCLUSIONS: Results suggest that lamotrigine attenuated the effects of corticosteroids on the left amygdala. Larger trials are warranted to confirm these findings.
A double-blind randomized trial of mood stabilizer augmentation using lamotrigine and valproate for patients with schizophrenia who are stabilized and partially responsive. [2009.06]
CONCLUSIONS: Augmenting antipsychotics with the mood stabilizers of lamotrigine or divalproex sodium for most partially responsive patients with chronic schizophrenia did not seem to be a useful treatment strategy for improving the residual symptoms. The small sample size limits firm conclusions.
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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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 20 ratings/reviews, Lamictal has an overall score of 8.05. The effectiveness score is 8.30 and the side effect score is 8.20. 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 46 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | bipolar depression |
| Dosage & duration: | | 100MG taken 3/day for the period of 4 years |
| Other conditions: | | Allergies; back pain |
| Other drugs taken: | | Effexor; Allegra; Ketoprofen; Viagra | | |
Reported Results |
| Benefits: | | The combination of Lamictal and Effexor eliminated severe mood swings betweens hypomania and depression, and made my depression manageable. |
| Side effects: | | Possibly minor sexual side effects: more difficult to reach organism. |
| Comments: | | Morning: 1 capsule (150MG) Effexor XR; 1 tablet 100MG Lamictal.
Evening: 2 tablets 100MG Lamictal. |
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| | Lamictal review by 65 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | bipolar disorder and depression |
| Dosage & duration: | | 100 mg taken 50 mg twice daily for the period of still taking medication |
| Other conditions: | | Hep C |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I'm feeling more grounded; highs and lows are less extreme. You could say that my emotional 'playing field' is more level. |
| Side effects: | | There's one 'side effect' - and I'm purposely and playfully/sarcastically placing it within quotes: this stuff has increased my sex-drive manyfold! I don't know if this has been the case with other patients, and I'm curious to know if anyone else has had that experience.
I'm also presenting with a little 'feathery tickle', resulting in an annoying dry cough; perhaps this side effect will lessen as my body adapts to the medication. |
| Comments: | | My doctor started me on a minimal dose (25 mg) of Lamotrigine, and this will be prior to starting Interferon/Ribavarin treatment for the Hep-C I've got. (An antidepressant may be added in the near future as well.) Lamotrigine was prescribed to put me in a calmer state of mind, specifically because of the high anxiety effect I receive from antidepressants, which resulted in 2 visits to an emergency room - as well as a one month hospital stay due to extreme anxiety and paranoia.
So far/so good is this layman's analysis. |
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| | Lamictal review by 30 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Depression / Bipolar |
| Dosage & duration: | | 150 mg taken every day for the period of two years |
| Other conditions: | | Asthma |
| Other drugs taken: | | Prozac 80 mg, Wellbutrin XL 150 mg | | |
Reported Results |
| Benefits: | | I have a very difficult to treat depression. It does not respond, generally, to medication. That said, I have felt no benefit after taking Lamictal (lamotrigine)for two years. This does not mean you will not feel the effect. My case is unique. |
| Side effects: | | memory loss (antergrade amnesia); cognitive impairment; a general sense of mental numbness. I would describe it as a "fog." Short-term memory as well as long-term memory were effected. |
| Comments: | | |
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Page last updated: 2009-10-20
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