Lamictal XR 50mg Tablets
WARNING: Severe skin reactions may happen with this drug. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands. The chance of a skin reaction is raised in children between 2 and 17 years old. It may also be raised if you take valproic acid or divalproex sodium with this drug, if you start taking this drug at too high of a dose, or if your dose is raised too fast. Skin reactions have also happened without any of these. Talk with your doctor.Most cases of skin reactions have happened within 2 to 8 weeks of starting this drug, but some show up after longer treatment like 6 months. Talk with the doctor.This drug is not approved for use in children younger than 13 years old. Talk with the doctor. @ COMMON USES: It is used to help control certain kinds of seizures.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant, Mood Stabilizer
Pharmacologic Class
Phenyltriazine Antiepileptic
Pregnancy Category
Category C
FDA Approved
Jun 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamictal XR is an extended-release medication used to treat certain types of seizures (epilepsy) and to help prevent extreme mood swings in adults with bipolar I disorder. It works by stabilizing electrical activity in the brain. Because of the risk of a serious skin rash, it's very important to start with a low dose and slowly increase it over several weeks, exactly as your doctor prescribes.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well. It's crucial to swallow the medication whole, without chewing, breaking, or crushing it. If you have difficulty swallowing, discuss this with your doctor.
Important Safety Precautions
Do not change your dose or stop taking this medication without consulting your doctor, as this can lead to seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dose to minimize the risk of side effects. If you do stop taking the medication, you may need to restart at a lower dose and gradually increase it under your doctor's guidance.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, and avoid storing it in the bathroom. Ensure that all medications are kept out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well. It's crucial to swallow the medication whole, without chewing, breaking, or crushing it. If you have difficulty swallowing, discuss this with your doctor.
Important Safety Precautions
Do not change your dose or stop taking this medication without consulting your doctor, as this can lead to seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dose to minimize the risk of side effects. If you do stop taking the medication, you may need to restart at a lower dose and gradually increase it under your doctor's guidance.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, and avoid storing it in the bathroom. Ensure that all medications are kept out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed, do not crush, chew, or split the extended-release tablets.
- Do not stop taking this medication suddenly without consulting your doctor, as it can lead to increased seizures or withdrawal symptoms.
- Avoid alcohol or other CNS depressants, as they can increase side effects like dizziness and drowsiness.
- Be aware of the risk of serious skin rash; report any rash immediately to your doctor.
- Carry a medical alert card or wear medical identification indicating you are taking lamotrigine.
- If you are a woman of childbearing potential, discuss contraception and pregnancy planning with your doctor due to potential interactions with oral contraceptives and risks during pregnancy.
Available Forms & Alternatives
Available Strengths:
- Lamictal 150mg Tablets
- Lamictal 200mg Tablets
- Lamictal 100mg Tablets
- Lamictal 25mg Tablets
- Lamictal 5mg Chewabl Disprsbl Tabs
- Lamictal 25mg Chewabl Disprsbl Tabs
- Lamictal Orange Strt Kit25mg/100mg
- Lamictal Blue Starter Kit 25mg
- Lamictal XR 25mg Tablets
- Lamictal XR 50mg Tablets
- Lamictal XR 100mg Tablets
- Lamictal XR 200mg Tablets
- Lamictal XR 25-50-100mg Titrtn Kit
- Lamictal XR 25-50mg Titration Kt 28
- Lamictal XR 50-100-200mg Titrtn Kit
- Lamictal ODT 25mg Tablets
- Lamictal ODT 50mg Tablets
- Lamictal ODT 100mg Tablets
- Lamictal ODT 200mg Tablets
- Lamictal ODT 25-50-100mg Tb Kt Orng
- Lamictal ODT 25-50mg Tb Kit Blue
- Lamictal ODT 50-100mg Tb Kit Green
- Lamictal Green Strt Kit 25mg/100mg
- Lamictal XR 300mg Tablets
- Lamictal XR 250mg Tablets
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable due to titration and concomitant medications. Initial dose typically 25 mg daily (or every other day with valproate) for 2 weeks, then titrated up. Maintenance doses vary by indication and concomitant medications.
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
Bipolar I Disorder (Maintenance):
Initial: 25 mg daily for 2 weeks (if not on valproate or enzyme inducer). Titrate to 50 mg daily (weeks 3-4), 100 mg daily (week 5), then 200 mg daily (week 6). Max 200 mg/day. If on valproate, initial 25 mg every other day, titrate slower. If on enzyme inducer, initial 50 mg daily, titrate faster.
Adjunctive Treatment of Partial Seizures:
Initial: 25 mg daily for 2 weeks (if not on valproate or enzyme inducer). Titrate to 50 mg daily (weeks 3-4), 100 mg daily (week 5), then 200 mg daily (week 6). Maintenance 200-400 mg/day. If on valproate, initial 25 mg every other day, titrate slower. If on enzyme inducer, initial 50 mg daily, titrate faster to 300-500 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for Lamictal XR. Lamictal (immediate-release) is approved for certain pediatric seizure types.
Adolescent:
Dosing for adolescents (13 years and older) for partial seizures is similar to adult dosing, with careful titration based on concomitant medications.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
Consider dose reduction in patients with significant renal impairment. Use with caution.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed by hemodialysis. Monitor clinical response.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
Reduce initial, escalation, and maintenance doses by approximately 25%.
Severe:
Reduce initial, escalation, and maintenance doses by approximately 50%. Use with caution and monitor closely.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that is thought to exert its anticonvulsant and mood-stabilizing effects by inhibiting voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and modulating the release of excitatory neurotransmitters (e.g., glutamate and aspartate). It may also inhibit voltage-gated calcium channels and modulate serotonin 5-HT3 receptors.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 98% (oral)
Tmax:
Extended-release: 4-10 hours (single dose), 6-12 hours (multiple dose)
FoodEffect:
Food does not significantly affect the rate or extent of absorption of lamotrigine XR.
Distribution:
Vd:
0.97-1.3 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (single dose, healthy adults); highly variable with concomitant medications (e.g., ~15 hours with enzyme inducers, ~59 hours with valproate).
Clearance:
Approximately 30 mL/min (healthy adults)
ExcretionRoute:
Renal (approximately 94% as metabolites, 6% unchanged)
Unchanged:
Approximately 6%
Pharmacodynamics
OnsetOfAction:
Titration required; therapeutic effects are gradual, typically over several weeks.
PeakEffect:
Achieved after several weeks of titration to maintenance dose.
DurationOfAction:
Once daily dosing due to extended-release formulation and half-life.
Safety & Warnings
BLACK BOX WARNING
Serious Skin Rashes: Lamotrigine can cause serious skin rashes requiring hospitalization and discontinuation of treatment. These include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). The incidence of these rashes, which have resulted in deaths, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 16 years) and 0.08% to 0.3% in adults. The risk of serious rash is increased by coadministration with valproate, exceeding recommended initial doses, or exceeding the recommended dose escalation for lamotrigine. Benign rashes also occur, but it is not possible to predict which rashes will prove to be serious. Therefore, 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.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Changes in balance
Inability to control eye movements
Flu-like symptoms
Painful periods
Changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts and Infections
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem: Hemophagocytic Lymphohistiocytosis (HLH)
In rare cases, this medication can cause a life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Changes in balance
Inability to control eye movements
Flu-like symptoms
Painful periods
Changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts and Infections
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem: Hemophagocytic Lymphohistiocytosis (HLH)
In rare cases, this medication can cause a life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any new skin rash, especially if it's severe, blistering, peeling, or accompanied by fever, swollen glands, or facial swelling.
- Signs of allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
- Signs of liver problems: nausea, vomiting, loss of appetite, dark urine, yellowing of skin or eyes (jaundice).
- Signs of blood problems: fever, chills, sore throat, swollen gums, mouth sores, pale skin, easy bruising or bleeding.
- Worsening mood, new or worsening depression, anxiety, panic attacks, trouble sleeping, agitation, hostility, impulsivity, irritability, or thoughts about suicide or harming yourself.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be sure to discuss any concerns with your doctor. Additionally, inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal ideation. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult with your pharmacist.
Heart-Related Warnings
If you have an abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heart rhythms can occur in individuals with certain heart conditions, which may lead to sudden death.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
Interactions with Birth Control
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may increase during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy. Use an alternative form of birth control, such as a condom, while taking this medication.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure-Specific Warnings
If your seizures change or worsen after starting this medication, consult with your doctor.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be sure to discuss any concerns with your doctor. Additionally, inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal ideation. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult with your pharmacist.
Heart-Related Warnings
If you have an abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heart rhythms can occur in individuals with certain heart conditions, which may lead to sudden death.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
Interactions with Birth Control
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may increase during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy. Use an alternative form of birth control, such as a condom, while taking this medication.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure-Specific Warnings
If your seizures change or worsen after starting this medication, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Ataxia (loss of coordination)
- Nystagmus (involuntary eye movements)
- Increased seizures
- Decreased consciousness
- Coma
What to Do:
Seek immediate medical attention or call 911. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Valproate (valproic acid, divalproex sodium): Significantly increases lamotrigine levels, requiring a 50% reduction in lamotrigine dose and slower titration to reduce rash risk.
- Carbamazepine, Phenytoin, Phenobarbital, Primidone: Significantly decrease lamotrigine levels, requiring increased lamotrigine dose and faster titration.
- Estrogen-containing oral contraceptives: Can significantly decrease lamotrigine levels, requiring dose adjustments. Breakthrough seizures or mood symptoms may occur.
- Rifampin: Decreases lamotrigine levels.
Moderate Interactions
- Lopinavir/ritonavir, Atazanavir/ritonavir: May decrease lamotrigine levels.
- Risperidone: May increase lamotrigine levels (less significant than valproate).
- Paracetamol (acetaminophen): High doses may slightly decrease lamotrigine levels.
- Sertraline: May slightly decrease lamotrigine levels.
Note Interactions
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for potential hematologic abnormalities (rare).
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for potential hepatic dysfunction (rare).
Timing: Prior to initiation
Renal Function Tests (Creatinine, BUN)
Rationale: To establish baseline, especially if renal impairment is suspected.
Timing: Prior to initiation
Concomitant Medications Review
Rationale: Crucial for determining initial dosing and titration schedule due to significant drug interactions.
Timing: Prior to initiation
Routine Monitoring
Clinical monitoring for rash (e.g., Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, DRESS syndrome)
Frequency: Daily during titration, then regularly
Target: Absence of rash
Action Threshold: Any new rash, especially if severe, widespread, or accompanied by fever, lymphadenopathy, or facial swelling, requires immediate discontinuation and medical evaluation.
Monitoring for worsening depression, suicidal thoughts or behavior, or unusual changes in behavior
Frequency: Regularly, especially during initial therapy and dose changes
Target: Stable mood/behavior
Action Threshold: Report any new or worsening psychiatric symptoms immediately.
Therapeutic Drug Monitoring (TDM) - Lamotrigine levels
Frequency: Not routinely recommended for all patients, but may be useful in specific situations (e.g., suspected non-adherence, drug interactions, renal/hepatic impairment, pregnancy, treatment failure, toxicity).
Target: Varies by indication and individual response (e.g., 2-20 mcg/mL for epilepsy, 2-15 mcg/mL for bipolar disorder)
Action Threshold: Levels outside target range or inconsistent with clinical response/toxicity.
Symptom Monitoring
- Skin rash (especially blistering, peeling, widespread, or involving mucous membranes)
- Fever, swollen lymph nodes, facial swelling
- Sore throat, mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe muscle pain or weakness
- New or worsening depression, anxiety, agitation, panic attacks
- Insomnia, irritability, hostility, aggressiveness
- Impulsivity, akathisia (restlessness)
- Hypomania, mania
- Suicidal thoughts or behavior
- Changes in seizure frequency or type (if for epilepsy)
- Dizziness, ataxia, blurred vision, diplopia, headache, nausea, vomiting
Special Patient Groups
Pregnancy
Category C. Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus. Data from pregnancy registries suggest a potential increased risk of oral clefts (e.g., cleft lip/palate) when lamotrigine is used during the first trimester, though more recent data from some registries have not consistently shown this increased risk. Monotherapy is generally preferred over polytherapy if medication is necessary.
Trimester-Specific Risks:
First Trimester:
Potential increased risk of oral clefts (cleft lip/palate), though data are conflicting. Close monitoring of lamotrigine levels may be needed as levels can decrease during pregnancy.
Second Trimester:
Lamotrigine levels may continue to decrease, potentially requiring dose adjustments.
Third Trimester:
Lamotrigine levels may continue to decrease. Monitor for seizure control or mood stability. Levels typically return to pre-pregnancy levels postpartum, requiring dose reduction.
Lactation
Lamotrigine is excreted into breast milk. The decision to breastfeed should consider the benefit of breastfeeding to the infant, the mother's clinical need for lamotrigine, and any potential adverse effects on the breastfed infant. Monitor breastfed infants for drowsiness, poor feeding, rash, and poor weight gain.
Infant Risk:
L3 (Moderate risk). Potential for drowsiness, rash, and poor feeding in breastfed infants. Therapeutic drug monitoring in the infant may be considered.
Pediatric Use
Lamictal XR is not approved for pediatric patients under 13 years of age. Lamictal (immediate-release) is approved for certain seizure types in children 2 years and older. The risk of serious rash is higher in pediatric patients (0.3-0.8%) compared to adults (0.08-0.3%).
Geriatric Use
No specific dose adjustments are generally required based on age alone, but elderly patients may be more sensitive to side effects (e.g., dizziness, ataxia). Start with lower doses and titrate slowly, monitoring for adverse effects and drug interactions.
Clinical Information
Clinical Pearls
- The slow titration schedule is paramount to minimize the risk of serious, life-threatening skin rashes (SJS/TEN/DRESS). Emphasize adherence to the titration schedule to patients.
- Concomitant medications, especially valproate and enzyme-inducing AEDs (carbamazepine, phenytoin, phenobarbital), drastically alter lamotrigine pharmacokinetics and necessitate specific dosing adjustments.
- Lamotrigine XR is taken once daily, which can improve adherence compared to immediate-release formulations.
- While a black box warning exists for rash, the overall incidence of serious rash is low when titration guidelines are followed. However, any rash should be evaluated promptly.
- Consider therapeutic drug monitoring in situations of suspected non-adherence, drug interactions, renal/hepatic impairment, pregnancy, or if clinical response is suboptimal or toxicity is suspected.
- Lamotrigine is generally well-tolerated in terms of cognitive side effects compared to some other AEDs.
Alternative Therapies
- For Bipolar I Disorder (Maintenance): Lithium, Valproate, Quetiapine, Olanzapine, Aripiprazole, Cariprazine.
- For Partial Seizures (Adjunctive): Levetiracetam, Carbamazepine, Oxcarbazepine, Phenytoin, Topiramate, Zonisamide, Lacosamide, Perampanel, Brivaracetam.
Cost & Coverage
Average Cost:
$300 - $600 per 30 tablets (50mg XR)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.