Lamotrigine ER 200mg 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 derivative; Voltage-gated sodium channel blocker
Pregnancy Category
Category C
FDA Approved
May 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamotrigine ER is an extended-release medication used to treat certain types of seizures (epilepsy) and to help stabilize mood in people with bipolar disorder. It works by calming overactive nerve signals in the brain. The extended-release form means you take it once a day.
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 it as prescribed by your doctor or healthcare provider, even if you're feeling well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult with your doctor for guidance.
Do not alter the dose or stop taking this medication without consulting your doctor, as this may 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've stopped taking this medication and need to restart, your doctor may recommend beginning with a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep all medications in a safe and secure location, 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 disposal methods, and consider participating in 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.
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 a 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 it as prescribed by your doctor or healthcare provider, even if you're feeling well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult with your doctor for guidance.
Do not alter the dose or stop taking this medication without consulting your doctor, as this may 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've stopped taking this medication and need to restart, your doctor may recommend beginning with a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep all medications in a safe and secure location, 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 disposal methods, and consider participating in 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.
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 a 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, as it can cause seizures to worsen or lead to withdrawal symptoms. Any dose changes must be made under medical supervision.
- Be aware of the risk of serious skin rash. Report any rash, fever, swollen glands, or facial swelling to your doctor immediately.
- Avoid alcohol or other CNS depressants, as they can increase drowsiness and dizziness.
- Use caution when driving or operating machinery until you know how this medication affects you, as it can cause dizziness or blurred vision.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.
Available Forms & Alternatives
Available Strengths:
- Lamotrigine 150mg Tablets
- Lamotrigine 200mg Tablets
- Lamotrigine 25mg Tablets
- Lamotrigine 100mg Tablets
- Lamotrigine 25mg Chew/disprsbl Tab
- Lamotrigine 5mg Chew/disprsbl Tab
- Lamotrigine ER 50mg Tablets
- Lamotrigine ER 200mg Tablets
- Lamotrigine ER 100mg Tablets
- Lamotrigine 300mg ER Tablets
- Lamotrigine ER 25mg Tablets
- Lamotrigine ODT 25mg Tablets
- Lamotrigine ODT 50mg Tablets
- Lamotrigine Orge Strt Kit25/100mg
- Lamotrigine Blue Starter Kit 25mg T
- Lamotrigine Green Str Kit 25/100mg
- Lamotrigine ODT 100mg Tablets
- Lamotrigine ODT 200mg Tablets
- Lamotrigine ER 250mg Tablets
- Lamotrigine ODT 25-50-100mg Tb Kit
Dosing & Administration
Adult Dosing
Standard Dose:
Initial titration is critical. For epilepsy (adjunctive or monotherapy): 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then 100 mg once daily for 1 week, then 150 mg once daily for 1 week, then 200 mg once daily. Maintenance dose typically 200-400 mg once daily. Dosing must be adjusted based on concomitant medications (e.g., valproate, enzyme-inducing AEDs, oral contraceptives).
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
epilepsy_monotherapy:
Initial: 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then 100 mg once daily for 1 week, then 150 mg once daily for 1 week, then 200 mg once daily. Maintenance: 200-400 mg once daily.
epilepsy_adjunctive_with_valproate:
Initial: 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks, then 50 mg once daily for 1 week, then 100 mg once daily for 1 week. Maintenance: 100-200 mg once daily.
epilepsy_adjunctive_with_enzyme_inducers:
Initial: 50 mg once daily for 2 weeks, then 100 mg once daily for 2 weeks, then 200 mg once daily for 1 week, then 300 mg once daily for 1 week, then 400 mg once daily. Maintenance: 400-600 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for ER formulation below 13 years of age for epilepsy.
Adolescent:
For partial-onset seizures (≥13 years of age): Follow adult titration guidelines based on concomitant medications. Maintenance dose typically 200-400 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor for adverse effects.
Moderate:
Consider lower maintenance doses in patients with significant renal impairment. Monitor for adverse effects.
Severe:
Consider lower maintenance doses (e.g., 50% reduction) in patients with significant renal impairment (CrCl < 30 mL/min). Monitor for adverse effects.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small amount is removed. Monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Consider a 25% reduction in initial, escalation, and maintenance doses (Child-Pugh Class B).
Severe:
Consider a 50% reduction in initial, escalation, and maintenance doses (Child-Pugh Class C).
Confidence:
Medium
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that stabilizes neuronal membranes and inhibits the release of excitatory neurotransmitters (primarily glutamate and aspartate) by blocking voltage-sensitive sodium channels. It also has weak effects on voltage-gated calcium channels.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
4-10 hours (ER formulation)
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
0.97-1.36 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (variable, significantly affected by concomitant medications: ~15 hours with enzyme inducers, ~59 hours with valproate)
Clearance:
Not available
ExcretionRoute:
Renal (approximately 94% as metabolites, 2% unchanged)
Unchanged:
Approximately 2%
Pharmacodynamics
OnsetOfAction:
Gradual (due to titration schedule)
PeakEffect:
Achieved after several weeks of titration to maintenance dose.
DurationOfAction:
24 hours (ER formulation)
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Serious skin rashes requiring hospitalization and discontinuation of treatment have been reported. 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 been fatal in rare cases, is greater in pediatric patients than in adults. Other risk factors include concomitant use with valproate, exceeding recommended initial doses, and rapid dose escalation. Benign rashes also occur, but it is not possible to predict which rashes will prove to be serious.
Side Effects
Serious 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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Shortness of breath, significant weight gain, or 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 or coordination
Inability to control eye movements
Flu-like symptoms
Painful periods or changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts
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)
In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (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 or trouble walking (new or worsening)
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or if they bother you or do not go away, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Difficulty sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or want to report any 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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Shortness of breath, significant weight gain, or 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 or coordination
Inability to control eye movements
Flu-like symptoms
Painful periods or changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts
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)
In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (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 or trouble walking (new or worsening)
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or if they bother you or do not go away, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Difficulty sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or want to report any 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 or worsening skin rash (especially if accompanied by fever, swollen glands, or facial swelling)
- Signs of allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Worsening seizures or new types of seizures
- Changes in mood or behavior (e.g., new or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, severe restlessness, suicidal thoughts or actions)
- Signs of liver problems (yellowing of skin/eyes, dark urine, severe stomach pain, nausea/vomiting)
- Signs of blood problems (unusual bleeding/bruising, fever, sore throat, pale skin)
- Aseptic meningitis symptoms (severe headache, fever, stiff neck, nausea, vomiting, sensitivity to light)
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, any of 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.
Additionally, to ensure safe treatment, 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 existing health problems
This information will help your doctor determine whether it is safe 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 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, any of 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.
Additionally, to ensure safe treatment, 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 existing health problems
This information will help your doctor determine whether it is safe 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 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 thoughts or behaviors. Immediately contact your doctor if you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes. 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. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
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 Problems
If you have an abnormal heartbeat, heart failure, or other heart conditions, discuss the risks with your doctor. Abnormal heart rhythms can occur in people with certain heart problems, 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.
Birth Control and Hormone Interactions
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 when taking birth control pills during the week when the pills are inactive. Discuss alternative birth control methods, such as condoms, with your doctor, as birth control pills and other hormone-based contraceptives may not be effective in preventing pregnancy 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 Management
If your seizures change or worsen after starting this medication, consult with your doctor to adjust your treatment plan.
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 thoughts or behaviors. Immediately contact your doctor if you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes. 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. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
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 Problems
If you have an abnormal heartbeat, heart failure, or other heart conditions, discuss the risks with your doctor. Abnormal heart rhythms can occur in people with certain heart problems, 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.
Birth Control and Hormone Interactions
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 when taking birth control pills during the week when the pills are inactive. Discuss alternative birth control methods, such as condoms, with your doctor, as birth control pills and other hormone-based contraceptives may not be effective in preventing pregnancy 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 Management
If your seizures change or worsen after starting this medication, consult with your doctor to adjust your treatment plan.
Overdose Information
Overdose Symptoms:
- Dizziness
- Ataxia (loss of coordination)
- Nystagmus (involuntary eye movements)
- Decreased consciousness
- Coma
- Seizures
- Cardiac conduction abnormalities (e.g., QRS prolongation)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. There is no specific antidote.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels significantly, increasing risk of rash)
- Carbamazepine (decreases lamotrigine levels)
- Phenytoin (decreases lamotrigine levels)
- Phenobarbital (decreases lamotrigine levels)
- Primidone (decreases lamotrigine levels)
- Rifampin (decreases lamotrigine levels)
- Estrogen-containing oral contraceptives (decreases lamotrigine levels)
Moderate Interactions
- Lopinavir/ritonavir (decreases lamotrigine levels)
- Atazanavir/ritonavir (decreases lamotrigine levels)
- Risperidone (lamotrigine may decrease risperidone levels)
- Paracetamol/Acetaminophen (may decrease lamotrigine levels with chronic high-dose use)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine)
Rationale: To assess baseline kidney function, as lamotrigine is primarily renally eliminated.
Timing: Prior to initiation
Hepatic function (ALT, AST, bilirubin)
Rationale: To assess baseline liver function, as lamotrigine is metabolized in the liver.
Timing: Prior to initiation
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for potential hematologic abnormalities (e.g., neutropenia, aplastic anemia) associated with severe hypersensitivity reactions.
Timing: Prior to initiation
Dermatologic assessment
Rationale: To establish baseline skin condition and educate patient on signs of serious rash.
Timing: Prior to initiation
Routine Monitoring
Clinical response (seizure frequency/severity, mood stability)
Frequency: Regularly during titration and maintenance
Target: Optimal seizure control with minimal side effects; stable mood.
Action Threshold: Worsening seizures, new or worsening mood symptoms, or intolerable side effects warrant dose adjustment or re-evaluation.
Adverse effects (especially rash, fever, lymphadenopathy, facial swelling)
Frequency: Daily during initial titration, then regularly
Target: Absence of severe skin reactions or hypersensitivity symptoms.
Action Threshold: Any signs of severe rash (e.g., Stevens-Johnson syndrome, TEN, DRESS) require immediate discontinuation and medical evaluation.
Serum lamotrigine levels (therapeutic drug monitoring)
Frequency: Not routinely recommended, but may be useful in specific situations (e.g., suspected non-adherence, drug interactions, renal/hepatic impairment, pregnancy, or lack of efficacy/toxicity at expected doses).
Target: Typically 3-14 mcg/mL (for epilepsy), but clinical response is paramount.
Action Threshold: Levels outside expected range in context of clinical picture may warrant dose adjustment.
Symptom Monitoring
- Skin rash (especially widespread, blistering, or painful)
- Fever
- Swollen lymph nodes
- Facial swelling
- Sore throat
- Mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe fatigue
- Worsening seizures
- Changes in mood or behavior (e.g., depression, suicidal thoughts, aggression, agitation)
- Aseptic meningitis symptoms (headache, fever, nausea, vomiting, stiff neck, rash, photophobia)
Special Patient Groups
Pregnancy
Lamotrigine crosses the placenta. While historically classified as Category C, data from pregnancy registries suggest that the overall risk of major congenital malformations, including oral clefts, may be lower than initially estimated, particularly at lower doses. However, risks are not entirely absent. Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus. Dose adjustments may be needed during pregnancy due to changes in lamotrigine clearance.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, particularly oral clefts, though data is evolving and risk appears lower than some other AEDs. Neural tube defects are not consistently linked.
Second Trimester:
Clearance of lamotrigine may increase, potentially leading to decreased serum levels and loss of seizure control. Close monitoring and dose adjustments may be necessary.
Third Trimester:
Clearance of lamotrigine may continue to increase. Monitor for seizure control. Neonatal withdrawal symptoms are rare but possible.
Lactation
Lamotrigine is excreted into breast milk in significant amounts. Monitor breastfed infants for adverse effects such as rash, drowsiness, poor feeding, and poor weight gain. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for lamotrigine, and any potential adverse effects on the breastfed infant.
Infant Risk:
L3 (Moderate risk) - Monitor infant for drowsiness, poor feeding, rash, and poor weight gain. Serum levels in infants can be significant.
Pediatric Use
Lamotrigine ER is approved for partial-onset seizures in patients 13 years and older. The safety and effectiveness of Lamotrigine ER in pediatric patients under 13 years of age have not been established. The risk of serious rash is higher in pediatric patients.
Geriatric Use
Start with lower initial doses and titrate slowly, as elderly patients may be more sensitive to the effects of lamotrigine and may have age-related decreases in renal or hepatic function. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Slow titration is paramount to minimize the risk of serious skin rash. Do not accelerate the titration schedule.
- Patients should be educated thoroughly about the signs and symptoms of serious skin rash and instructed to seek immediate medical attention if they occur.
- Concomitant use of valproate significantly increases lamotrigine levels, requiring a much slower and lower titration schedule.
- Concomitant use of enzyme-inducing AEDs (e.g., carbamazepine, phenytoin) or estrogen-containing oral contraceptives significantly decreases lamotrigine levels, requiring a faster and higher titration schedule.
- Lamotrigine ER is taken once daily and should not be crushed, chewed, or split.
- While therapeutic drug monitoring is not routinely recommended, it can be useful in specific situations (e.g., suspected non-adherence, drug interactions, pregnancy, renal/hepatic impairment, or lack of efficacy/toxicity).
Alternative Therapies
- Other antiepileptic drugs (e.g., Levetiracetam, Carbamazepine, Valproate, Oxcarbazepine, Topiramate, Zonisamide, Gabapentin, Pregabalin)
- Other mood stabilizers (e.g., Lithium, Valproate, Carbamazepine, Quetiapine, Olanzapine)
Cost & Coverage
Average Cost:
$100 - $300+ per 30 tablets (200mg ER)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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 receive a refill of your medication. 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 reporting the incident, be prepared to provide detailed information about the overdose, including the medication taken, the amount consumed, 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 receive a refill of your medication. 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 reporting the incident, be prepared to provide detailed information about the overdose, including the medication taken, the amount consumed, and the time it occurred.