Lamotrigine 5mg Chew/disprsbl Tab
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
Pharmacologic Class
Phenyltriazine derivative, Voltage-gated sodium channel blocker
Pregnancy Category
Not available (Risk Summary applies)
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 mood swings in people with bipolar disorder. It works by calming overactive nerve signals in the brain. It's very important to start this medication at a very low dose and slowly increase it over several weeks to months to reduce the risk of a serious skin rash.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you feel well. You can swallow the tablet whole, chew it, or mix it with water or fruit juice. If you chew the tablet, drink a small amount of water or fruit juice to help with swallowing.
To make the tablet easier to take, you can break it up by adding a liquid to cover the tablet in a glass or spoon. Wait at least 1 minute for the tablet to break up completely, then mix and drink. Do not change your dose or stop taking this medication without consulting your doctor, as this may cause seizures.
If you need to stop taking this medication, do not stop suddenly without talking to your doctor. You may be at a higher risk of side effects. Instead, your doctor will instruct you on how to gradually stop taking the medication. If you do stop taking the medication, you may need to restart at a lower dose and gradually increase the dose under your doctor's guidance.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications by throwing them away. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. You can also check with your pharmacist about drug take-back programs in your area.
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 return to your regular schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you feel well. You can swallow the tablet whole, chew it, or mix it with water or fruit juice. If you chew the tablet, drink a small amount of water or fruit juice to help with swallowing.
To make the tablet easier to take, you can break it up by adding a liquid to cover the tablet in a glass or spoon. Wait at least 1 minute for the tablet to break up completely, then mix and drink. Do not change your dose or stop taking this medication without consulting your doctor, as this may cause seizures.
If you need to stop taking this medication, do not stop suddenly without talking to your doctor. You may be at a higher risk of side effects. Instead, your doctor will instruct you on how to gradually stop taking the medication. If you do stop taking the medication, you may need to restart at a lower dose and gradually increase the dose under your doctor's guidance.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications by throwing them away. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. You can also check with your pharmacist about drug take-back programs in your area.
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 return to your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take exactly as prescribed; do not stop taking it suddenly without talking to your doctor, as this can cause seizures to worsen.
- Follow the slow dose titration schedule carefully to minimize the risk of serious skin rash.
- Report any new skin rash, fever, swollen glands, or facial swelling to your doctor immediately.
- Be aware that lamotrigine can cause dizziness or drowsiness, especially when starting the medication. Avoid driving or operating machinery until you know how it affects you.
- If you are taking birth control pills, tell your doctor, as they can affect lamotrigine levels and vice versa. You may need a dose adjustment or different birth control method.
- Avoid alcohol or other CNS depressants, as they can increase drowsiness.
- Maintain regular follow-up appointments with your doctor to monitor your condition and medication effectiveness.
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. Initial dose typically 25 mg daily for 2 weeks (monotherapy or with enzyme inhibitors like valproate), or 50 mg daily for 2 weeks (with enzyme inducers like carbamazepine/phenytoin). Titrated up every 1-2 weeks.
Dose Range:
25 - 700 mg
Condition-Specific Dosing:
Epilepsy (monotherapy):
Maintenance 200-400 mg/day (divided BID)
Epilepsy (with valproate):
Maintenance 100-200 mg/day (divided BID)
Epilepsy (with enzyme inducers):
Maintenance 300-500 mg/day (divided BID)
Bipolar I Disorder (maintenance):
Maintenance 100-400 mg/day (once daily or divided BID)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (generally not recommended under 2 years due to rash risk and lack of data)
Child:
Dosing is weight-based and depends on concomitant AEDs. For children 2-12 years, initial doses range from 0.15 mg/kg/day to 2 mg/kg/day, titrated up. Maintenance doses vary widely (e.g., 1-15 mg/kg/day).
Adolescent:
Generally follows adult dosing guidelines, with careful titration.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, but monitor for adverse effects.
Moderate:
No specific adjustment needed, but monitor for adverse effects.
Severe:
Consider a reduction in maintenance dose by 25% for patients with significant renal impairment (CrCl < 30 mL/min). Monitor clinical response and adverse effects.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed. Monitor clinical response and adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Consider a reduction in initial, escalation, and maintenance doses by 25%.
Severe:
Consider a reduction in initial, escalation, and maintenance doses by 50%. Monitor clinical response and adverse effects closely.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that is thought to exert its anticonvulsant effects by inhibiting voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and modulating the release of excitatory neurotransmitters (e.g., glutamate and aspartate). It also has weak effects on voltage-gated calcium channels.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1-4 hours
FoodEffect:
Minimal effect on absorption rate or extent.
Distribution:
Vd:
0.97-1.36 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
25-33 hours (monotherapy); significantly shorter with enzyme inducers (e.g., 13-14 hours) and longer with enzyme inhibitors (e.g., 59-70 hours with valproate)
Clearance:
Approximately 30 mL/min (monotherapy)
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 10% (in urine)
Pharmacodynamics
OnsetOfAction:
Gradual (due to slow titration)
PeakEffect:
Not directly applicable for seizure control due to chronic dosing and titration; peak plasma concentrations occur 1-4 hours post-dose.
DurationOfAction:
Dependent on half-life and dosing frequency (typically BID dosing for maintenance).
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 approximately 0.3% to 0.8% of pediatric patients (2 to 16 years of age) and 0.08% to 0.3% of adult patients, is higher in pediatric patients than in adults. The risk of serious rashes is increased by coadministration with valproate, exceeding the recommended initial dose, or exceeding the recommended dose escalation for lamotrigine. Benign rashes are also common, but it is not possible to predict reliably 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
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 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
+ 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, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance or trouble walking (new or worsening)
Other Possible Side Effects
Most people do not experience significant side effects while taking this medication. However, some individuals may encounter mild or moderate side effects. If you experience any of the following symptoms, contact your doctor if they bother you or do not resolve on their own:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness or tremors
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 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
+ 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, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance or trouble walking (new or worsening)
Other Possible Side Effects
Most people do not experience significant side effects while taking this medication. However, some individuals may encounter mild or moderate side effects. If you experience any of the following symptoms, contact your doctor if they bother you or do not resolve on their own:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness or tremors
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 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 blistering, peeling, or widespread)
- Fever
- Swollen lymph nodes
- Swelling of the face, eyes, or lips
- Sore throat or mouth sores
- Difficulty breathing or swallowing
- Yellowing of the skin or eyes (jaundice)
- Unusual bruising or bleeding
- Severe muscle pain or weakness
- Worsening depression or new suicidal thoughts/behavior
- Severe dizziness or loss of coordination
- Vision changes (e.g., double vision, blurred vision)
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 or have had
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 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 or have had
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 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 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 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 immediate medical attention 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 appearances or names. 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 this with your doctor, as abnormal heartbeats can increase the risk of 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.
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 be increased 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 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 immediate medical attention 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 appearances or names. 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 this with your doctor, as abnormal heartbeats can increase the risk of 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.
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 be increased 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:
- Nystagmus (involuntary eye movements)
- Ataxia (loss of coordination)
- Impaired consciousness
- Seizures (including status epilepticus)
- Coma
- QRS prolongation (cardiac toxicity)
What to Do:
Seek immediate medical attention or call 911. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels significantly, increasing rash risk)
- Carbamazepine (decreases lamotrigine levels)
- Phenytoin (decreases lamotrigine levels)
- Phenobarbital (decreases lamotrigine levels)
- Primidone (decreases lamotrigine levels)
- Oral Contraceptives (estrogen-containing, can decrease lamotrigine levels, leading to loss of seizure control)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/ritonavir (decreases lamotrigine levels)
- Atazanavir/ritonavir (decreases lamotrigine levels)
Moderate Interactions
- Ethinyl estradiol/norgestimate (decreases lamotrigine levels)
- Paracetamol/Acetaminophen (may decrease lamotrigine levels with chronic high-dose use)
- Risperidone (lamotrigine may decrease risperidone levels)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Aripiprazole (lamotrigine may decrease aripiprazole levels)
- Bupropion (may increase lamotrigine levels)
Minor Interactions
- Sertraline (may decrease lamotrigine levels)
Monitoring
Baseline Monitoring
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for rare hepatic dysfunction.
Timing: Prior to initiation
Renal Function (CrCl, BUN, Creatinine)
Rationale: To assess baseline kidney function, especially important for dose adjustments in severe impairment.
Timing: Prior to initiation
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for rare hematologic abnormalities (e.g., neutropenia, aplastic anemia).
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, lack of efficacy, or significant mood instability may require dose adjustment or alternative therapy.
Adverse effects (especially rash, hypersensitivity symptoms)
Frequency: Daily during initial titration, then regularly
Target: Absence of severe rash or systemic hypersensitivity reactions.
Action Threshold: Any new rash, fever, lymphadenopathy, facial swelling, or other signs of hypersensitivity require immediate discontinuation and medical evaluation.
Suicidal ideation/behavior
Frequency: Regularly, especially during initial therapy and dose changes
Target: Absence of suicidal thoughts or behaviors.
Action Threshold: Any report of suicidal ideation or behavioral changes requires immediate assessment and intervention.
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, anxiety, agitation, suicidal thoughts)
- Dizziness
- Blurred or double vision
- Headache
- Nausea/vomiting
Special Patient Groups
Pregnancy
Use during pregnancy should be carefully considered, weighing the risks of uncontrolled seizures to the mother and fetus against the potential risks of lamotrigine. Data from pregnancy registries suggest a small increased risk of oral clefts, but overall risk is low. Monotherapy is generally preferred over polytherapy. Therapeutic drug monitoring may be considered as lamotrigine levels can decrease during pregnancy.
Trimester-Specific Risks:
First Trimester:
Potential small increased risk of oral clefts (e.g., cleft lip/palate) based on some registry data, though overall risk remains low. Risk of major congenital malformations is generally considered comparable to the general population or other AEDs.
Second Trimester:
Levels may decrease, potentially leading to loss of seizure control. Monitor clinical response and consider therapeutic drug monitoring.
Third Trimester:
Levels may continue to decrease. Monitor clinical response. Consider monitoring infant for signs of lamotrigine exposure (e.g., sedation, rash) post-delivery.
Lactation
Lamotrigine is excreted into breast milk. While generally considered compatible with breastfeeding (L3), infants should be monitored for adverse effects such as rash, sedation, poor feeding, or apnea. Breastfeeding can be considered if the infant is monitored closely.
Infant Risk:
L3 (Moderately Safe) - Monitor infant for rash, sedation, poor feeding, apnea. Consider therapeutic drug monitoring in the infant if concerns arise.
Pediatric Use
Higher incidence of serious skin rash (SJS/TEN) compared to adults, especially in children under 16 years. Dosing is weight-based and requires careful, slow titration. Not recommended for use in children under 2 years of age due to lack of data and increased rash risk.
Geriatric Use
Start with lower doses and titrate slowly due to potential for decreased clearance and increased sensitivity to adverse effects. Monitor renal and hepatic function. Generally well-tolerated if titrated appropriately.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rashes (SJS/TEN). Any deviation from the recommended schedule, especially rapid dose escalation or high initial doses, significantly increases this risk.
- Patients must be educated to report any rash immediately. While most rashes are benign, it's impossible to predict which will become serious, so discontinuation is usually recommended at the first sign of rash.
- Significant drug interactions exist, particularly with valproate (increases lamotrigine levels) and enzyme-inducing AEDs (e.g., carbamazepine, phenytoin, phenobarbital, primidone, rifampin) which decrease lamotrigine levels. Oral contraceptives also significantly decrease lamotrigine levels.
- Lamotrigine chewable/dispersible tablets can be swallowed whole, chewed, or dispersed in a small amount of water or diluted fruit juice.
- Therapeutic drug monitoring (TDM) is not routinely recommended but can be useful in specific situations, such as suspected toxicity, non-response, significant drug interactions, or during pregnancy.
Alternative Therapies
- Levetiracetam (Keppra)
- Topiramate (Topamax)
- Carbamazepine (Tegretol)
- Valproate (Depakote)
- Oxcarbazepine (Trileptal)
- Zonisamide (Zonegran)
- Gabapentin (Neurontin)
- Pregabalin (Lyrica)
- Phenytoin (Dilantin)
- Phenobarbital
Cost & Coverage
Average Cost:
Not available per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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.