BOXED WARNING
SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF LAMOTRIGINE. 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 LAMOTRIGINE 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 LAMOTRIGINE AS INITIAL MONOTHERAPY AND 0.13% (1.3 PER 1,000) IN ADULT PATIENTS RECEIVING LAMOTRIGINE AS ADJUNCTIVE THERAPY. IN A PROSPECTIVELY FOLLOWED COHORT OF 1,983 PEDIATRIC PATIENTS WITH EPILEPSY TAKING ADJUNCTIVE LAMOTRIGINE, 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 ASSOCIATED WITH LAMOTRIGINE. THERE ARE SUGGESTIONS, YET TO BE PROVEN, THAT THE RISK OF RASH MAY ALSO BE INCREASED BY (1) COADMINISTRATION OF LAMOTRIGINE WITH VALPROATE (INCLUDES VALPROIC ACID AND DIVALPROEX SODIUM), (2) EXCEEDING THE RECOMMENDED INITIAL DOSE OF LAMOTRIGINE, OR (3) EXCEEDING THE RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE. HOWEVER, CASES HAVE BEEN REPORTED IN THE ABSENCE OF THESE FACTORS.
NEARLY ALL CASES OF LIFE-THREATENING RASHES ASSOCIATED WITH LAMOTRIGINE 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 LAMOTRIGINE, IT IS NOT POSSIBLE TO PREDICT RELIABLY WHICH RASHES WILL PROVE TO BE SERIOUS OR LIFE THREATENING. ACCORDINGLY, LAMOTRIGINE 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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LAMOTRIGINE SUMMARY
Lamotrigine, an antiepileptic drug (AED) of the phenyltriazine class, is chemically unrelated to existing antiepileptic drugs.
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.
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NEWS HIGHLIGHTS
Published Studies Related to 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 Lamotrigine
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.
Lamotrigine and Oral Contraceptives [Terminated]
The present study evaluates the effect of oral contraceptives on lamotrigine plasma
concentrations in a double blind, placebo controlled, cross-over study in patients with
epilepsy.
Bioequivalence and Food Effect of 250mg of Lamotrigine XR [Active, not recruiting]
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.
Efficacy and Safety of Antidepressant Augmentation With Lamotrigine [Completed]
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Lamotrigine has an overall score of 7. The effectiveness score is 10 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
| | Lamotrigine review by 37 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | major depression |
| Dosage & duration: | | 25mg taken 2x per day for the period of 8 months |
| Other conditions: | | ADHD |
| Other drugs taken: | | Wellbutrin 450mg, Concerta 72mg | | |
Reported Results |
| Benefits: | | It started working immediately which was wonderful. My energy level increased, I was more interested in going out rather than hiding in my house. I've increased to 100mg 2x's a day. I've lost approximately 25 pounds but I think that's because of an interaction from the Concerta & Lamotrigine. |
| Side effects: | | Within 2 months I noticed my eyes felt strained all the time so I continually have to refocus. I get tremors in my hands every couple days and can't stop them from shaking. The worst - and the reason I'm choosing to change medications is the excessive sweating. I use clinical strength deodorant 3x's per day but I can't go through the summer being self conscious of how I smell. I constantly check my arm pits for sweat marks. |
| Comments: | | I started out with 25mg and moved quickly up to 200mg per day. I increased to 250mg but found no benefit so I dropped back down 200mg. If I didn't have the sweating side effect I would DEFINITELY continue to take this drug. |
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Page last updated: 2009-10-20
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