Lamotrigine Green Str Kit 25/100mg
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 people with bipolar disorder. It works by calming overactive nerve signals in the brain. It's very important to start this medicine at a very low dose and increase it slowly to reduce the risk of a serious skin rash.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to 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're feeling 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've stopped taking the medication, consult your doctor before restarting, as you may need to begin with a lower dose and gradually increase 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 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 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'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 dose.
To get the most benefit from your medication, it's essential to 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're feeling 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've stopped taking the medication, consult your doctor before restarting, as you may need to begin with a lower dose and gradually increase 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 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 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'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 dose.
Lifestyle & Tips
- Take exactly as prescribed, do not stop suddenly without consulting your doctor.
- Do not crush, chew, or break extended-release tablets.
- Report any new skin rash immediately to your doctor.
- Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness or blurred vision.
- Avoid alcohol or other CNS depressants, as they can worsen side effects.
- If you are a woman of childbearing potential, discuss contraception with your doctor, as oral contraceptives can affect lamotrigine levels.
- Carry a medical alert card or wear a medical alert bracelet indicating you take lamotrigine for epilepsy.
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 individualized, slow titration required due to rash risk. Initial dose depends on concomitant medications.
Dose Range:
25 - 700 mg
Condition-Specific Dosing:
Epilepsy (monotherapy):
Initial: 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks. Increase by 50-100 mg/day every 1-2 weeks. Maintenance: 225-375 mg/day in 2 divided doses.
Epilepsy (with valproate):
Initial: 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks. Increase by 25-50 mg/day every 1-2 weeks. Maintenance: 100-200 mg/day in 1-2 divided doses.
Epilepsy (with enzyme-inducing AEDs without valproate):
Initial: 50 mg once daily for 2 weeks, then 100 mg/day in 2 divided doses for 2 weeks. Increase by 100 mg/day every 1-2 weeks. Maintenance: 300-500 mg/day in 2 divided doses.
Bipolar I Disorder (maintenance):
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. (Titration varies based on concomitant medications, similar to epilepsy titration schedules).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Dosing for epilepsy (2-12 years) is weight-based and depends on concomitant medications. Titration is critical. E.g., with valproate: 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 (1-5 mg/kg/day).
Adolescent:
Dosing for epilepsy (>=13 years) generally follows adult recommendations. Bipolar disorder maintenance is for adults only.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, but caution advised.
Severe:
Initial dose should be reduced by 25% for patients with significant renal impairment. Subsequent dose adjustments should be based on clinical response.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed. Monitor clinical response.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Initial, escalation, and maintenance doses should be reduced by 25%.
Severe:
Initial, escalation, and maintenance doses should be reduced by 50%. Monitor clinical response.
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 inhibiting the release of excitatory neurotransmitters (primarily glutamate and aspartate). It also has weak effects on voltage-gated calcium channels and may modulate serotonin 5-HT3 receptors.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1.4 to 4.8 hours (oral)
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
0.97 to 1.36 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); significantly prolonged with valproate (up to 70 hours) and shortened with enzyme-inducing AEDs (e.g., carbamazepine, phenytoin, phenobarbital, primidone) (13-14 hours).
Clearance:
Approximately 30 mL/min (adults)
ExcretionRoute:
Renal (approximately 94% as metabolites, 2% unchanged drug)
Unchanged:
Approximately 2%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration)
PeakEffect:
Weeks to months (after reaching maintenance dose)
DurationOfAction:
24 hours (dosed once or twice daily)
Confidence:
High
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), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). The incidence of these rashes, which have resulted in death, is approximately 0.3% to 0.8% in pediatric patients (2 to 16 years of age) and 0.08% to 0.3% in adults. The risk of serious rash is increased by coadministration with valproate, exceeding the recommended initial dose, or exceeding the recommended dose escalation.
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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful menstrual periods
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
Balance problems
Difficulty walking (new or worsening)
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, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Sleep disturbances
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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful menstrual periods
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
Balance problems
Difficulty walking (new or worsening)
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, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Sleep disturbances
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 accompanied by fever, swollen glands, or flu-like symptoms
- Swelling of the face, eyes, lips, or tongue
- Sore throat, mouth sores
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe muscle pain
- Worsening depression, suicidal thoughts, or unusual changes in behavior/mood
- New or worsening seizures
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, about your treatment. This will help ensure your safety and prevent potential interactions with other medications.
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 medication.
Monitoring and Lab Tests
Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor. Additionally, 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 medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. 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 problem called aseptic meningitis. If you experience symptoms such as headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
To avoid confusion, 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 a history of abnormal heartbeat, heart failure, or other heart problems, discuss the risks and benefits of this medication with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with pre-existing heart conditions.
Pediatric Use
When administering this medication to children, use 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 birth control methods 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 be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based methods may be less effective in preventing pregnancy while taking this medication. Consider using alternative birth control methods, such as condoms.
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 as needed.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. This will help ensure your safety and prevent potential interactions with other medications.
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 medication.
Monitoring and Lab Tests
Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor. Additionally, 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 medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. 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 problem called aseptic meningitis. If you experience symptoms such as headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
To avoid confusion, 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 a history of abnormal heartbeat, heart failure, or other heart problems, discuss the risks and benefits of this medication with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with pre-existing heart conditions.
Pediatric Use
When administering this medication to children, use 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 birth control methods 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 be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based methods may be less effective in preventing pregnancy while taking this medication. Consider using alternative birth control methods, such as condoms.
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 as needed.
Overdose Information
Overdose Symptoms:
- Nystagmus (involuntary eye movements)
- Ataxia (loss of coordination)
- Impaired consciousness
- Grand mal seizures
- Coma
- Intraventricular conduction delay (ECG changes)
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Treatment is supportive; there is no specific antidote.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels, requiring significant dose reduction of lamotrigine)
- Carbamazepine, Phenytoin, Phenobarbital, Primidone (decrease lamotrigine levels, requiring significant dose increase of lamotrigine)
- Estrogen-containing oral contraceptives (decrease lamotrigine levels, requiring dose increase of lamotrigine)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/ritonavir, Atazanavir/ritonavir (decrease lamotrigine levels)
Moderate Interactions
- Risperidone (lamotrigine may decrease risperidone levels)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Paroxetine (may decrease lamotrigine levels)
- Sertraline (may decrease lamotrigine levels)
- Folic acid inhibitors (e.g., trimethoprim) - theoretical interaction, may affect lamotrigine metabolism
Minor Interactions
- Acetaminophen (may slightly decrease lamotrigine levels, usually not clinically significant)
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
Routine Monitoring
Skin examination
Frequency: Regularly, especially during titration and first 8 weeks of therapy
Target: Absence of rash
Action Threshold: Any new rash should prompt immediate evaluation and potential discontinuation.
Clinical efficacy (seizure frequency/mood stability)
Frequency: Regularly, especially during titration and dose adjustments
Target: Reduction in seizure frequency or stabilization of mood
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
Adverse effects (dizziness, ataxia, blurred vision, nausea, headache)
Frequency: Regularly, especially during titration
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Lamotrigine plasma concentrations (Therapeutic Drug Monitoring - TDM)
Frequency: Not routinely recommended for all patients, but useful in specific situations (e.g., suspected non-adherence, drug interactions, renal/hepatic impairment, pregnancy, toxicity, or lack of efficacy).
Target: 1-15 mcg/mL (variable, clinical correlation is key)
Action Threshold: Levels outside expected range or not correlating with clinical picture may prompt dose adjustment.
Symptom Monitoring
- Skin rash (especially blistering, peeling, or widespread)
- Fever
- Swollen lymph nodes
- Swelling of face, eyes, lips, or tongue
- Sore throat
- Mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe muscle pain
- Unexplained weakness or fatigue
- Worsening of depression or suicidal thoughts/behavior
- New or worsening mood changes, anxiety, or agitation
- Changes in seizure pattern
- Dizziness, blurred vision, double vision, unsteadiness
Special Patient Groups
Pregnancy
Lamotrigine is generally considered one of the safer antiepileptic drugs during pregnancy compared to some older AEDs, but risks still exist. It is recommended to use the lowest effective dose and monitor lamotrigine levels, as they can decrease during pregnancy. Enrollment in pregnancy registries (e.g., North American Antiepileptic Drug Pregnancy Registry) is encouraged.
Trimester-Specific Risks:
First Trimester:
Increased risk of oral clefts (cleft lip/palate) has been reported in some studies, though the absolute risk is low and debated. Other major congenital malformations are not consistently increased.
Second Trimester:
No specific increased risks beyond general pregnancy risks.
Third Trimester:
Lamotrigine levels may decrease significantly, potentially leading to loss of seizure control. Close monitoring and dose adjustments may be necessary. Neonatal withdrawal symptoms are rare but possible.
Lactation
Lamotrigine is excreted into breast milk. The amount transferred to the infant can be significant. Monitor breastfed infants for adverse effects such as rash, drowsiness, poor feeding, and apnea. Weigh the benefits of breastfeeding against the potential risks to the infant.
Infant Risk:
Moderate risk (L3). Monitor infant for rash, sedation, poor feeding, and apnea. Some infants may experience no adverse effects, while others may require formula supplementation or discontinuation of breastfeeding.
Pediatric Use
Approved for epilepsy in patients 2 years and older. The risk of serious rash is higher in pediatric patients (2-16 years) than in adults. Dosing is weight-based and requires careful titration. Not approved for bipolar disorder in pediatric patients.
Geriatric Use
Use with caution. Start at the lower end of the dosing range and titrate slowly due to potential for decreased renal/hepatic function and increased sensitivity to adverse effects. Monitor for dizziness, ataxia, and cognitive side effects.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rash. Patients must be educated on this.
- Concomitant medications significantly impact lamotrigine dosing. Valproate requires a much slower titration and lower maintenance dose, while enzyme-inducing AEDs (carbamazepine, phenytoin, phenobarbital) require a faster titration and higher maintenance dose.
- Oral contraceptives containing estrogen can significantly reduce lamotrigine levels, potentially leading to loss of seizure control or mood stability. Dose adjustments may be needed.
- Patients should be advised to report any rash immediately. Discontinuation is usually required for any new rash, especially if severe or accompanied by systemic symptoms.
- Lamotrigine is effective for both focal and generalized seizures, including Lennox-Gastaut syndrome. It is also a first-line mood stabilizer for bipolar I disorder maintenance.
- While TDM is not always necessary, it can be very useful in cases of suspected non-adherence, drug interactions, pregnancy, renal/hepatic impairment, or when efficacy/toxicity is unclear.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Phenytoin, Topiramate, Oxcarbazepine, Zonisamide, Gabapentin, Pregabalin.
- For Bipolar Disorder (maintenance): Lithium, Valproate, Olanzapine, Quetiapine, Aripiprazole, Cariprazine.
Cost & Coverage
Average Cost:
Varies widely by strength and quantity, e.g., $30-$200+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, 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. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.
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. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.