Lamotrigine 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. @ COMMON USES: It is used to help control certain kinds of seizures.It is used to treat bipolar disorder.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
Not available
FDA Approved
Dec 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamotrigine is a medication used to treat certain types of seizures (epilepsy) and to help prevent extreme mood swings in adults with bipolar disorder. It works by stabilizing electrical activity in the brain.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
Do not alter the dose or stop taking the medication without consulting your doctor, as this may lead to seizures.
If you need to stop taking the medication, your doctor will instruct you on how to gradually taper off the dose to minimize the risk of side effects.
If you stop taking the medication and need to restart, your doctor may recommend starting at a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light and moisture.
Keep the medication in a dry place, away from the bathroom.
Store all medications in a safe 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 way to dispose of medications, 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 is close to the time for your next 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 dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
Do not alter the dose or stop taking the medication without consulting your doctor, as this may lead to seizures.
If you need to stop taking the medication, your doctor will instruct you on how to gradually taper off the dose to minimize the risk of side effects.
If you stop taking the medication and need to restart, your doctor may recommend starting at a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light and moisture.
Keep the medication in a dry place, away from the bathroom.
Store all medications in a safe 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 way to dispose of medications, 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 is close to the time for your next 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 dose.
Lifestyle & Tips
- Take exactly as prescribed, do not stop suddenly without consulting your doctor, as this can worsen seizures or mood.
- Follow the slow dose increase schedule carefully to reduce the risk of serious skin rash.
- Report any new rash or skin changes immediately to your doctor.
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how this medication affects you, as it can cause dizziness or blurred vision.
- If you are taking birth control pills, inform your doctor, as your lamotrigine dose may need adjustment.
- Do not take more than the prescribed 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:
Highly variable, requires slow titration. For epilepsy (monotherapy): Initial 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then increase by 50 mg/day every 1-2 weeks to maintenance of 100-400 mg/day in 1-2 divided doses. For bipolar disorder: 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 200 mg once daily. Dosing varies significantly with concomitant medications (e.g., valproate, enzyme-inducing AEDs).
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
epilepsy_monotherapy:
Initial 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then increase by 50 mg/day every 1-2 weeks to maintenance of 100-400 mg/day in 1-2 divided doses.
epilepsy_with_valproate:
Initial 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks, then increase by 25-50 mg/day every 1-2 weeks to maintenance of 100-200 mg/day in 1-2 divided doses.
epilepsy_with_enzyme_inducers:
Initial 50 mg once daily for 2 weeks, then 100 mg/day in 2 divided doses for 2 weeks, then increase by 100 mg/day every 1-2 weeks to maintenance of 300-500 mg/day in 2 divided doses.
bipolar_disorder:
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 200 mg once daily. Dosing adjustments needed with concomitant medications.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for <2 years (safety and efficacy not established).
Child:
Dosing for 2-12 years varies significantly based on concomitant AEDs. Requires slow titration. E.g., with valproate: Initial 0.15 mg/kg/day for 2 weeks, then 0.3 mg/kg/day for 2 weeks, then increase by 0.3 mg/kg/day every 1-2 weeks to maintenance of 1-5 mg/kg/day (max 200 mg/day). With enzyme-inducing AEDs: Initial 2 mg/kg/day for 2 weeks, then 5 mg/kg/day for 2 weeks, then increase by 5 mg/kg/day every 1-2 weeks to maintenance of 5-15 mg/kg/day (max 400 mg/day).
Adolescent:
Dosing for >12 years generally follows adult guidelines, with careful titration.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
Consider lower maintenance doses, especially if creatinine clearance <30 mL/min. Monitor clinical response.
Severe:
Consider lower maintenance doses (e.g., 25% reduction from standard dose). Monitor clinical response and adverse effects.
Dialysis:
Supplemental doses after dialysis are generally not needed as only a small amount is removed. Consider lower maintenance doses.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Reduce initial, escalation, and maintenance doses by approximately 25%.
Severe:
Reduce initial, escalation, and maintenance doses by approximately 50%. Monitor clinical response and adverse effects.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that stabilizes neuronal membranes and inhibits the release of excitatory neurotransmitters (primarily glutamate and aspartate). It is thought to achieve this by blocking voltage-sensitive sodium channels, thereby inhibiting the repetitive firing of neurons and preventing the generation of action potentials.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1.4-4.8 hours (oral)
FoodEffect:
Food slightly delays Tmax but does not affect the extent of absorption (AUC).
Distribution:
Vd:
0.9-1.3 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); significantly affected by concomitant medications (e.g., ~15 hours with enzyme inducers, ~59 hours with valproate)
Clearance:
Approximately 0.3-0.4 mL/min/kg
ExcretionRoute:
Renal (approximately 94% as metabolites, 2% as unchanged drug)
Unchanged:
Approximately 2%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration to minimize rash risk)
PeakEffect:
Weeks to months (after reaching stable maintenance dose)
DurationOfAction:
Related to half-life; typically dosed once or twice daily.
Safety & Warnings
BLACK BOX WARNING
Serious Skin Rashes: Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. These include Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can result in death. The incidence of these rashes, which have been reported in both adults and children, is higher in children than in adults. The risk of 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 or life-threatening. 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 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 cycles
Additionally, 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
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, seek medical attention immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance or trouble walking (new or worsening symptoms)
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or persist:
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
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 cycles
Additionally, 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
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, seek medical attention immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance or trouble walking (new or worsening symptoms)
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or persist:
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
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 spreads, blisters, or is accompanied by fever, swollen glands, facial swelling, or mouth sores.
- Signs of allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
- Signs of liver problems: nausea, vomiting, dark urine, yellowing of skin or eyes (jaundice), loss of appetite.
- Signs of blood problems: unusual bruising or bleeding, pale skin, unusual tiredness, fever, chills, body aches, flu-like symptoms.
- Worsening of depression, suicidal thoughts, or unusual changes in behavior or mood.
- Severe dizziness, blurred vision, double vision, or loss of coordination.
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.
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 medical history, including any health problems you have
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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.
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 medical history, including any health problems you have
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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 inform all your healthcare providers and laboratory 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. 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-Related Warnings
If you have a history of 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 administering this medication to children, use caution, as the risk of certain side effects may be higher in pediatric patients.
Interactions with Birth Control
Birth control pills and other hormone-based contraceptives may alter 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 when taking this medication. Use alternative forms of birth control, such as condoms, to prevent pregnancy.
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 inform all your healthcare providers and laboratory 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. 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-Related Warnings
If you have a history of 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 administering this medication to children, use caution, as the risk of certain side effects may be higher in pediatric patients.
Interactions with Birth Control
Birth control pills and other hormone-based contraceptives may alter 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 when taking this medication. Use alternative forms of birth control, such as condoms, to prevent pregnancy.
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:
- Ataxia (loss of coordination)
- Nystagmus (uncontrolled eye movements)
- Increased seizures
- Decreased consciousness
- Coma
What to Do:
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. There is no specific antidote; treatment is supportive.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels, significantly increases risk of serious rash)
- Oral contraceptives (estrogen-containing, can decrease lamotrigine levels)
- Enzyme-inducing AEDs (e.g., carbamazepine, phenytoin, phenobarbital, primidone; decrease lamotrigine levels)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/ritonavir (decreases lamotrigine levels)
- Atazanavir/ritonavir (decreases lamotrigine levels)
Moderate Interactions
- Acetaminophen (high doses, chronic use; may slightly decrease lamotrigine levels)
- Risperidone (lamotrigine may decrease risperidone levels)
- Sertraline (may slightly increase lamotrigine levels)
- Lithium (potential for neurotoxicity, monitor for adverse effects)
- Bupropion (may increase lamotrigine levels)
Minor Interactions
- Paroxetine (may slightly increase lamotrigine levels)
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine)
Rationale: To guide initial dosing and assess need for dose adjustment in impairment.
Timing: Prior to initiation
Hepatic function (ALT, AST, bilirubin)
Rationale: To guide initial dosing and assess need for dose adjustment in impairment.
Timing: Prior to initiation
Complete Blood Count (CBC) with differential
Rationale: Although rare, serious hematologic reactions (e.g., neutropenia, aplastic anemia) have been reported.
Timing: Prior to initiation
Skin examination
Rationale: To establish baseline and monitor for rash.
Timing: Prior to initiation
Routine Monitoring
Clinical response (seizure frequency/severity, mood stability)
Frequency: Regularly during titration and maintenance
Target: Individualized based on therapeutic goals
Action Threshold: Worsening symptoms or lack of efficacy may require dose adjustment or alternative therapy.
Adverse effects (especially rash, hypersensitivity symptoms, CNS effects)
Frequency: Daily during titration, then regularly during maintenance
Target: Absence of severe adverse effects
Action Threshold: Any sign of serious rash (e.g., fever, facial swelling, lymphadenopathy) requires immediate discontinuation. Significant CNS effects may require dose reduction.
Drug interactions
Frequency: Whenever new medications are added or discontinued
Target: Stable lamotrigine levels and clinical response
Action Threshold: Adjust lamotrigine dose as per guidelines when interacting drugs are introduced or withdrawn.
Therapeutic Drug Monitoring (TDM)
Frequency: Not routinely recommended, but can be considered in specific situations (e.g., suspected non-adherence, drug interactions, renal/hepatic impairment, pregnancy, treatment failure, toxicity)
Target: Epilepsy: 3-14 mcg/mL (free and total levels vary by lab); Bipolar: 2-10 mcg/mL (less established)
Action Threshold: Levels outside target range may warrant dose adjustment or investigation of adherence/interactions.
Symptom Monitoring
- Skin rash (especially widespread, blistering, or painful)
- Fever
- Swollen lymph nodes (lymphadenopathy)
- Facial swelling
- Sore throat
- Mouth sores
- Eye irritation (conjunctivitis)
- Unusual bruising or bleeding
- Fatigue or weakness
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Worsening of seizures
- Changes in mood or behavior (e.g., depression, suicidal thoughts, aggression, agitation)
- Dizziness
- Blurred vision or double vision
- Ataxia (lack of coordination)
Special Patient Groups
Pregnancy
Use during pregnancy should be carefully considered, weighing potential benefits against risks. While some studies suggest a slightly increased risk of oral clefts, overall risk is low, and uncontrolled seizures or mood episodes pose greater risks. Monotherapy at the lowest effective dose is preferred. Pregnancy registries are recommended.
Trimester-Specific Risks:
First Trimester:
Slightly increased risk of oral clefts (e.g., cleft lip/palate) reported in some studies, particularly at higher doses or in combination with other AEDs. However, data are conflicting, and overall absolute risk is low.
Second Trimester:
Generally considered safer than first trimester for organogenesis, but continued monitoring of maternal levels may be needed due to potential for decreased lamotrigine levels.
Third Trimester:
Maternal lamotrigine levels may decrease significantly during the third trimester, potentially leading to loss of seizure control. Postpartum levels may rebound, increasing risk of toxicity. Monitor levels and adjust dose as needed.
Lactation
Lamotrigine is excreted into breast milk. While generally considered compatible with breastfeeding, monitor the infant for adverse effects.
Infant Risk:
L3 (Moderately Safe). Monitor breastfed infants for drowsiness, poor feeding, rash, and apnea. Infant serum levels should be monitored if concerns arise.
Pediatric Use
Safety and efficacy not established for children under 2 years of age. Children are at a higher risk of developing serious skin rashes compared to adults, especially if initial doses or titration rates are exceeded, or if co-administered with valproate. Careful titration based on weight and concomitant medications is crucial.
Geriatric Use
No specific dose adjustments are generally needed based on age alone, but elderly patients may have age-related decreases in renal or hepatic function, which could necessitate dose adjustments. Start with lower doses and titrate slowly. Monitor for increased sensitivity to adverse effects (e.g., dizziness, ataxia).
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rash. Adherence to this schedule is paramount.
- Patients should be educated to report any rash immediately, as it may be a sign of a life-threatening reaction (SJS/TEN).
- Dosing is highly dependent on concomitant medications, especially valproate (which increases lamotrigine levels) and enzyme-inducing AEDs/oral contraceptives (which decrease lamotrigine levels). Always check for drug interactions.
- Lamotrigine is effective for both focal and generalized seizures, and for the maintenance treatment of bipolar I disorder.
- Therapeutic drug monitoring (TDM) is not routinely recommended but can be useful in specific situations (e.g., pregnancy, suspected non-adherence, drug interactions, renal/hepatic impairment, treatment failure, toxicity).
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Oxcarbazepine, Phenytoin, Valproate, Topiramate, Zonisamide, Gabapentin, Pregabalin, Lacosamide, Perampanel, Rufinamide, Clobazam, Eslicarbazepine acetate, Cannabidiol.
- For Bipolar Disorder (Mood Stabilizers): Lithium, Valproate, Carbamazepine, Olanzapine, Quetiapine, Lurasidone, Cariprazine, Asenapine, Risperidone, Aripiprazole.
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 200mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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 provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.