Lamotrigine ER 250mg Tablets
WARNING: Severe skin reactions may happen with this drug. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands. The chance of a skin reaction is raised in children between 2 and 17 years old. It may also be raised if you take valproic acid or divalproex sodium with this drug, if you start taking this drug at too high of a dose, or if your dose is raised too fast. Skin reactions have also happened without any of these. Talk with your doctor.Most cases of skin reactions have happened within 2 to 8 weeks of starting this drug, but some show up after longer treatment like 6 months. Talk with the doctor.This drug is not approved for use in children younger than 13 years old. Talk with the doctor. @ COMMON USES: It is used to help control certain kinds of seizures.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant; Mood stabilizer
Pharmacologic Class
Phenyltriazine derivative; Voltage-gated sodium channel blocker
Pregnancy Category
Category C
FDA Approved
Jul 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamotrigine ER is an extended-release medication used to treat certain types of seizures (epilepsy) and bipolar disorder. It works by stabilizing electrical activity in the brain. Because it's extended-release, you take it once a day, and it releases the medicine slowly over time.
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 trouble swallowing, consult with 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 with 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 in a dry place. Avoid storing it in a bathroom.
Keep 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 disposal method, and consider participating in a local drug take-back program.
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 trouble swallowing, consult with 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 with 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 in a dry place. Avoid storing it in a bathroom.
Keep 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 disposal method, and consider participating in a local drug take-back program.
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 chew, crush, or divide the tablet.
- Do not stop taking this medication suddenly, as it can increase seizure frequency. Any dose changes or discontinuation should be done under medical supervision.
- Be aware of the risk of serious skin rash. Seek immediate medical attention if you develop any rash, fever, swollen glands, or facial swelling.
- Avoid or limit alcohol consumption, as it can increase side effects like dizziness and drowsiness.
- Use caution when driving or operating machinery until you know how the medication affects you, as it can cause dizziness or blurred vision.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.
Available Forms & Alternatives
Available Strengths:
- Lamotrigine 150mg Tablets
- Lamotrigine 200mg Tablets
- Lamotrigine 25mg Tablets
- Lamotrigine 100mg Tablets
- Lamotrigine 25mg Chew/disprsbl Tab
- Lamotrigine 5mg Chew/disprsbl Tab
- Lamotrigine ER 50mg Tablets
- Lamotrigine ER 200mg Tablets
- Lamotrigine ER 100mg Tablets
- Lamotrigine 300mg ER Tablets
- Lamotrigine ER 25mg Tablets
- Lamotrigine ODT 25mg Tablets
- Lamotrigine ODT 50mg Tablets
- Lamotrigine Orge Strt Kit25/100mg
- Lamotrigine Blue Starter Kit 25mg T
- Lamotrigine Green Str Kit 25/100mg
- Lamotrigine ODT 100mg Tablets
- Lamotrigine ODT 200mg Tablets
- Lamotrigine ER 250mg Tablets
- Lamotrigine ODT 25-50-100mg Tb Kit
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized, requiring slow titration over several weeks to minimize rash risk. Initial dose depends on concomitant medications. For patients not taking valproate or enzyme-inducing AEDs: Initial 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then 100 mg once daily for 1 week, then 150 mg once daily for 1 week, then 200 mg once daily. Maintenance: 200-400 mg once daily.
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
concomitant_valproate:
Initial 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks, then 50 mg once daily for 1 week, then 75 mg once daily for 1 week, then 100 mg once daily. Maintenance: 100-250 mg once daily.
concomitant_enzyme_inducers_without_valproate:
Initial 50 mg once daily for 2 weeks, then 100 mg once daily for 2 weeks, then 200 mg once daily for 1 week, then 300 mg once daily for 1 week, then 400 mg once daily. Maintenance: 400-600 mg once daily.
discontinuation:
Do not discontinue abruptly due to risk of increased seizure frequency. Taper over at least 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for ER formulation (Lamictal XR is approved for patients 13 years and older for partial-onset seizures).
Adolescent:
For partial-onset seizures (13 years and older): Dosing similar to adults, with titration based on concomitant medications. Refer to adult dosing guidelines.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required, but caution and close monitoring are advised.
Severe:
Use with caution. Reduced maintenance doses may be appropriate, especially in patients with significant renal impairment (CrCl < 30 mL/min).
Dialysis:
Supplemental doses after dialysis are generally not required as lamotrigine is minimally dialyzable. Monitor clinical response.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
Initial, escalation, and maintenance doses should be reduced by approximately 25%.
Severe:
Initial, escalation, and maintenance doses should be reduced by approximately 50%. Use with extreme caution and close monitoring.
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 inhibitory effects on voltage-gated calcium channels.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 98% (oral)
Tmax:
Approximately 4-6 hours (for ER formulation, can be up to 10 hours)
FoodEffect:
Food does not significantly affect the rate or extent of absorption of lamotrigine ER.
Distribution:
Vd:
Approximately 1.3 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (variable, affected by concomitant medications: ~15 hours with enzyme inducers, ~59 hours with valproate)
Clearance:
Approximately 30 mL/min (variable)
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 10% (unchanged drug in urine)
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration)
PeakEffect:
Achieved after reaching stable maintenance dose (weeks to months)
DurationOfAction:
Once daily dosing due to extended-release formulation and half-life.
Safety & Warnings
BLACK BOX WARNING
Serious Skin Rashes: Lamotrigine can cause serious skin rashes requiring hospitalization and discontinuation of treatment. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). The incidence of these rashes, which have resulted in deaths, is approximately 0.3% to 0.8% in pediatric patients (age 2-16 years) and 0.08% to 0.3% in adults. The risk of serious rash is increased by coadministration with valproate, exceeding recommended initial doses, or exceeding the recommended dose escalation.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ 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
Most people taking this medication do not experience serious side effects. However, some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Difficulty sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions 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 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ 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
Most people taking this medication do not experience serious side effects. However, some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Difficulty sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions 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 severe, blistering, or widespread)
- Fever, swollen glands, or facial swelling (signs of DRESS syndrome)
- Sore throat, mouth sores, or eye irritation
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Severe fatigue or weakness
- Worsening seizures or new types of seizures
- Changes in mood or behavior, including new or worsening depression, anxiety, agitation, or thoughts of self-harm
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 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 overall health status, including any existing medical conditions
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage 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, 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 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 overall health status, including any existing medical conditions
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be sure to 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 medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult with your pharmacist.
Heart Problems
If you have an abnormal heartbeat, heart failure, or other heart conditions, discuss the risks with your doctor. Abnormal heart rhythms can increase the risk of sudden death in individuals with certain heart problems.
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 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. Use alternative birth control methods, such as condoms, while taking this medication.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult with your doctor.
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 medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult with your pharmacist.
Heart Problems
If you have an abnormal heartbeat, heart failure, or other heart conditions, discuss the risks with your doctor. Abnormal heart rhythms can increase the risk of sudden death in individuals with certain heart problems.
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 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. Use alternative birth control methods, such as condoms, while taking this medication.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Dizziness
- Ataxia (loss of coordination)
- Nystagmus (involuntary eye movements)
- Decreased consciousness
- Coma
- Seizures (including status epilepticus)
- Cardiac conduction abnormalities (e.g., QRS prolongation)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including gastric lavage, activated charcoal, and close monitoring of vital signs and cardiac function.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels, increases risk of rash)
- Carbamazepine, Phenytoin, Phenobarbital, Primidone (decrease lamotrigine levels)
- Oral contraceptives containing estrogen (decrease lamotrigine levels)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/ritonavir, Atazanavir/ritonavir (decrease lamotrigine levels)
Moderate Interactions
- Risperidone (lamotrigine may decrease risperidone levels)
- Paroxetine, Sertraline (may decrease lamotrigine levels)
- Ethanol (additive CNS depression)
- Folic acid antagonists (e.g., methotrexate, trimethoprim) - theoretical interaction due to lamotrigine's weak dihydrofolate reductase inhibition.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for rare but serious hematologic reactions (e.g., neutropenia, aplastic anemia).
Timing: Prior to initiation
Liver function tests (LFTs)
Rationale: To establish baseline and monitor for rare but serious hepatic dysfunction.
Timing: Prior to initiation
Renal function tests (BUN, creatinine)
Rationale: To establish baseline, especially in patients with pre-existing renal impairment.
Timing: Prior to initiation
Skin examination
Rationale: To establish baseline and educate patient on rash recognition.
Timing: Prior to initiation
Routine Monitoring
Clinical response (seizure frequency/severity, mood stability)
Frequency: Regularly during titration and maintenance
Target: Individualized
Action Threshold: Worsening symptoms, lack of efficacy, or intolerable side effects
Adverse effects (especially rash, dizziness, ataxia, headache, nausea)
Frequency: Regularly, especially during titration
Target: Absence or tolerability
Action Threshold: Appearance of serious rash, signs of DRESS, or other severe adverse reactions
Skin examination and patient education on rash
Frequency: Ongoing, especially during the first 8 weeks of therapy
Target: Absence of rash
Action Threshold: Any new rash, particularly if accompanied by fever, lymphadenopathy, or facial swelling; immediate discontinuation and medical evaluation required.
Suicidal ideation/behavior
Frequency: Regularly, especially at initiation and dose changes
Target: Absence
Action Threshold: Any new or worsening suicidal thoughts or behavior; immediate psychiatric evaluation.
Symptom Monitoring
- Skin rash (any type, especially blistering or widespread)
- Fever
- Swollen lymph nodes (lymphadenopathy)
- Facial swelling
- Sore throat
- Mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe fatigue
- Worsening seizures
- New or worsening depression, anxiety, or agitation
- Panic attacks
- Insomnia
- Irritability
- Hostility or aggression
- Impulsivity
- Restlessness
- Mania or hypomania
Special Patient Groups
Pregnancy
Lamotrigine is excreted into breast milk. The decision to breastfeed should consider the potential for infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Monitor breastfed infants for adverse effects such as rash, apnea, drowsiness, and poor feeding.
Trimester-Specific Risks:
First Trimester:
Some studies suggest a potential, though small, increased risk of oral clefts (cleft lip/palate) when lamotrigine is used during the first trimester, particularly at higher doses. However, other studies and meta-analyses have not consistently confirmed this risk or found it to be very low. The overall risk of major congenital malformations appears to be low.
Second Trimester:
No specific increased risks identified beyond general population rates.
Third Trimester:
No specific increased risks identified beyond general population rates. Neonatal withdrawal symptoms are not typically associated with lamotrigine.
Lactation
Lamotrigine is excreted into breast milk. The decision to breastfeed should consider the potential for infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Monitor breastfed infants for adverse effects such as rash, apnea, drowsiness, and poor feeding.
Infant Risk:
L3 (Moderately safe) - Significant amounts are excreted into breast milk, but serious adverse effects in infants are rare. Monitor infant for rash, sedation, poor feeding, and apnea.
Pediatric Use
Lamotrigine ER (Lamictal XR) is approved for partial-onset seizures in patients 13 years and older. Safety and efficacy have not been established in pediatric patients younger than 13 years. The risk of serious rash is higher in pediatric patients (2-16 years) compared to adults.
Geriatric Use
Use with caution in elderly patients. Start with lower doses and titrate slowly, as elderly patients may be more sensitive to the adverse effects (e.g., dizziness, ataxia). Renal and hepatic function should be considered.
Clinical Information
Clinical Pearls
- Slow titration is paramount to minimize the risk of serious skin rash. Do not accelerate the titration schedule.
- Patients must be educated about the signs and symptoms of serious skin rashes (SJS, TEN, DRESS) and instructed to seek immediate medical attention if they occur.
- Dosing must be adjusted when co-administered with valproate (lower dose needed) or enzyme-inducing AEDs/oral contraceptives (higher dose needed).
- Lamotrigine ER should be swallowed whole; do not chew, crush, or divide.
- Monitor for changes in mood or behavior, including suicidal ideation, especially at the beginning of treatment or with dose changes.
- Therapeutic drug monitoring (TDM) is generally not routinely recommended but can be useful in specific situations (e.g., suspected non-adherence, toxicity, or lack of efficacy, especially when interacting drugs are involved).
Alternative Therapies
- Other antiepileptic drugs (AEDs) for partial-onset seizures: Levetiracetam, Carbamazepine, Oxcarbazepine, Phenytoin, Topiramate, Zonisamide, Lacosamide, Gabapentin, Pregabalin.
- Other mood stabilizers for bipolar disorder: Lithium, Valproate, Carbamazepine, Atypical antipsychotics (e.g., Quetiapine, Olanzapine, Aripiprazole).
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or Non-Formulary (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial resource 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, we encourage you to discuss them 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 detailed information about the medication taken, including the dosage, timing, and circumstances surrounding the overdose.