Lamictal XR 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 Antiepileptic
Pregnancy Category
Category C
FDA Approved
Jun 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamictal XR is an extended-release medication used to treat certain types of seizures (epilepsy) and to help prevent extreme mood swings in adults with bipolar I disorder. It works by stabilizing electrical activity in the brain. It's taken once a day.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
It's essential to swallow the medication whole, without chewing, breaking, or crushing it. If you have difficulty swallowing, consult your doctor for guidance. Do not alter the dose or stop taking this medication without consulting your doctor, as this may lead to seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dose to minimize the risk of side effects. If you stop taking this medication and need to restart it, your doctor may recommend starting at a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep 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. If you have questions about the best way to dispose of your medication, consult your pharmacist, who may be aware of 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. However, 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 the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
It's essential to swallow the medication whole, without chewing, breaking, or crushing it. If you have difficulty swallowing, consult your doctor for guidance. Do not alter the dose or stop taking this medication without consulting your doctor, as this may lead to seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dose to minimize the risk of side effects. If you stop taking this medication and need to restart it, your doctor may recommend starting at a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep 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. If you have questions about the best way to dispose of your medication, consult your pharmacist, who may be aware of 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. However, 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 the missed one.
Lifestyle & Tips
- Take exactly as prescribed, do not crush, chew, or divide the tablet.
- Do not stop taking this medication suddenly, as it can lead to increased seizure risk or worsening mood symptoms. Any changes should be made under medical supervision.
- Report any new skin rash immediately to your doctor, as it could be a sign of a serious, life-threatening reaction.
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how this medication affects you, as it can cause dizziness or blurred vision.
- Inform your doctor about all other medications, including over-the-counter drugs, herbal supplements, and especially hormonal birth control, as they can interact with Lamictal XR.
- Carry a medical alert card or wear a bracelet indicating you are taking lamotrigine, especially if you have epilepsy.
Available Forms & Alternatives
Available Strengths:
- Lamictal 150mg Tablets
- Lamictal 200mg Tablets
- Lamictal 100mg Tablets
- Lamictal 25mg Tablets
- Lamictal 5mg Chewabl Disprsbl Tabs
- Lamictal 25mg Chewabl Disprsbl Tabs
- Lamictal Orange Strt Kit25mg/100mg
- Lamictal Blue Starter Kit 25mg
- Lamictal XR 25mg Tablets
- Lamictal XR 50mg Tablets
- Lamictal XR 100mg Tablets
- Lamictal XR 200mg Tablets
- Lamictal XR 25-50-100mg Titrtn Kit
- Lamictal XR 25-50mg Titration Kt 28
- Lamictal XR 50-100-200mg Titrtn Kit
- Lamictal ODT 25mg Tablets
- Lamictal ODT 50mg Tablets
- Lamictal ODT 100mg Tablets
- Lamictal ODT 200mg Tablets
- Lamictal ODT 25-50-100mg Tb Kt Orng
- Lamictal ODT 25-50mg Tb Kit Blue
- Lamictal ODT 50-100mg Tb Kit Green
- Lamictal Green Strt Kit 25mg/100mg
- Lamictal XR 300mg Tablets
- Lamictal XR 250mg Tablets
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Dosage is highly individualized and requires slow titration based on concomitant medications and indication.
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
Bipolar I Disorder (Maintenance) - Monotherapy or with non-inducing agents:
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. Target: 200 mg/day. Max: 400 mg/day.
Bipolar I Disorder (Maintenance) - With Valproate:
Initial: 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks, then 50 mg once daily for 1 week, then 100 mg once daily. Target: 100 mg/day. Max: 200 mg/day.
Bipolar I Disorder (Maintenance) - With Enzyme Inducers (e.g., Carbamazepine, Phenytoin, Phenobarbital) 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. Target: 400 mg/day. Max: 400 mg/day.
Partial-Onset Seizures (Adjunctive Therapy) - With Valproate:
Initial: 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks, then 50 mg once daily for 1 week, then 100 mg once daily. Target: 100-200 mg/day. Max: 200 mg/day.
Partial-Onset Seizures (Adjunctive Therapy) - With Enzyme Inducers (e.g., Carbamazepine, Phenytoin, Phenobarbital) 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. Target: 400-600 mg/day. Max: 600 mg/day.
Partial-Onset Seizures (Adjunctive Therapy) - With other agents (not valproate or enzyme inducers):
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. Target: 200-400 mg/day. Max: 400 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for Lamictal XR. Lamictal (immediate-release) is approved for partial-onset seizures and generalized tonic-clonic seizures in patients âĨ2 years of age, and for Lennox-Gastaut syndrome in patients âĨ2 years of age. Dosing for XR in pediatric patients is not specified in the package insert.
Adolescent:
Not established for Lamictal XR. For patients 13-17 years, dosing for bipolar disorder or epilepsy would generally follow adult guidelines, but specific XR pediatric data is limited.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
Use with caution. Reduced maintenance doses may be appropriate for patients with significant renal impairment (CrCl < 30 mL/min).
Dialysis:
Supplemental doses after dialysis are not typically required as only a small fraction is removed by hemodialysis. However, close monitoring is advised.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
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 caution and monitor closely.
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 modulating the release of excitatory neurotransmitters (primarily glutamate and aspartate). It may also inhibit voltage-gated calcium channels and weakly inhibit dihydrofolate reductase.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 98% (oral)
Tmax:
Approximately 4-6 hours (Lamictal XR)
FoodEffect:
Food does not significantly affect the rate or extent of absorption of Lamictal XR.
Distribution:
Vd:
Approximately 0.9-1.3 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); significantly affected by concomitant medications (e.g., valproate increases half-life, enzyme inducers decrease half-life).
Clearance:
Approximately 0.3-0.4 mL/min/kg (monotherapy)
ExcretionRoute:
Renal (approximately 94% as metabolites, 2% unchanged)
Unchanged:
Approximately 2%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration to therapeutic levels)
PeakEffect:
Weeks to months (after reaching target dose)
DurationOfAction:
Once daily dosing due to extended-release formulation and half-life.
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 deaths, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 16 years) 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
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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, 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
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful periods or changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts and Infections
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 (HLH)
In rare cases, this medication can cause a life-threatening immune system problem called 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 do not experience serious side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention 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
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 right away:
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, 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
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful periods or changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts and Infections
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 (HLH)
In rare cases, this medication can cause a life-threatening immune system problem called 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 do not experience serious side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention 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
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 it's widespread, blistering, or painful
- Fever, swollen glands, or facial swelling
- Sore throat or mouth sores
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe fatigue or weakness
- Worsening depression, suicidal thoughts, or unusual changes in behavior/mood
- Severe dizziness or loss of coordination
- Blurred or double vision
- Severe headache
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 symptoms you experienced.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
This will help your doctor determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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 symptoms you experienced.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
This will help your doctor determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be sure to discuss any concerns with your doctor. Additionally, inform all your healthcare providers and 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 using prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal ideation. Immediately contact your doctor if you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or packaging, consult with your pharmacist.
Heart-Related Warnings
If you have a history of abnormal heart rhythms, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heartbeats can occur in individuals with certain heart conditions, which may lead to sudden death.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
Interactions with Birth Control
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may increase 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 an alternative form of birth control, such as a condom.
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 discuss any concerns 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 using prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal ideation. Immediately contact your doctor if you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or packaging, consult with your pharmacist.
Heart-Related Warnings
If you have a history of abnormal heart rhythms, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heartbeats can occur in individuals with certain heart conditions, which may lead to sudden death.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
Interactions with Birth Control
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may increase 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 an alternative form of birth control, such as a condom.
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:
- Ataxia (lack of coordination)
- Nystagmus (involuntary eye movements)
- Increased seizures
- Decreased consciousness
- Coma
What to Do:
Seek immediate medical attention or call 911. There is no specific antidote. Treatment is supportive. Consider activated charcoal if ingestion is recent. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels significantly, requiring dose reduction)
- Carbamazepine, Phenytoin, Phenobarbital, Primidone, Rifampin (decrease lamotrigine levels significantly, requiring dose increase)
- Estrogen-containing oral contraceptives (decrease lamotrigine levels, requiring dose increase; lamotrigine may also decrease contraceptive efficacy)
- Dofetilide (potential for increased dofetilide levels, though clinical significance with lamotrigine is less clear than with other AEDs)
Moderate Interactions
- Lopinavir/Ritonavir (decreases lamotrigine levels)
- Atazanavir/Ritonavir (decreases lamotrigine levels)
- Risperidone (lamotrigine may decrease risperidone levels)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Paroxetine (may decrease lamotrigine levels)
- Sertraline (may decrease lamotrigine levels)
- Lithium (additive CNS effects, monitor for toxicity)
- Bupropion (potential for increased seizure risk, though direct interaction with lamotrigine is not well-established)
Minor Interactions
- Acetaminophen (may slightly decrease lamotrigine levels with chronic high-dose use)
- Folic acid (lamotrigine may interfere with folate metabolism, but clinical significance is usually minor)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for rare hematologic abnormalities (e.g., neutropenia, aplastic anemia).
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for rare hepatic dysfunction.
Timing: Prior to initiation
Renal Function Tests (Creatinine, BUN)
Rationale: To establish baseline, especially if renal impairment is suspected.
Timing: Prior to initiation
Skin examination
Rationale: To document baseline skin condition before starting a drug with a serious rash risk.
Timing: Prior to initiation
Routine Monitoring
Clinical assessment for rash (SJS/TEN)
Frequency: Daily during titration, then regularly
Target: Absence of new or worsening rash
Action Threshold: Any new rash, especially if severe, widespread, or associated with fever/systemic symptoms, requires immediate discontinuation.
Clinical assessment for signs of hypersensitivity syndrome (DRESS)
Frequency: Regularly, especially during first 8 weeks
Target: Absence of fever, lymphadenopathy, facial edema, hepatic/renal dysfunction, eosinophilia
Action Threshold: Any suspicion of DRESS requires immediate discontinuation and medical evaluation.
Seizure frequency/mood stability
Frequency: Regularly (e.g., monthly during titration, then every 3-6 months)
Target: Reduction in seizure frequency or stabilization of mood symptoms
Action Threshold: Worsening symptoms or inadequate control may require dose adjustment or alternative therapy.
Adverse effects (e.g., dizziness, ataxia, blurred vision, headache, nausea)
Frequency: Regularly
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects may require dose adjustment or discontinuation.
Lamotrigine serum levels (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, treatment failure, toxicity).
Target: Generally 3-15 mcg/mL (for epilepsy, less defined for bipolar)
Action Threshold: Levels outside target range, especially if correlated with clinical response or toxicity, may warrant dose adjustment.
Symptom Monitoring
- Skin rash (especially widespread, blistering, or painful)
- Fever
- Swollen lymph nodes
- Facial swelling
- Sore throat
- Mouth sores
- Eye irritation/redness
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe fatigue
- Worsening depression or suicidal thoughts/behavior
- New or worsening mood changes
- Dizziness
- Blurred or double vision
- Unsteadiness/ataxia
- Headache
- Nausea/vomiting
Special Patient Groups
Pregnancy
Lamotrigine is a Category C drug. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is a potential for increased risk of oral clefts, though data are conflicting and the absolute risk is low. Pregnancy can decrease lamotrigine levels, potentially leading to loss of seizure control or mood stability, requiring dose adjustments.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of oral clefts (e.g., cleft lip/palate), though recent data suggest the risk is small and may not be significantly higher than background population risk. Close monitoring of lamotrigine levels is recommended due to potential for decreased levels.
Second Trimester:
Lamotrigine levels may continue to decrease. Monitor clinical response and consider dose adjustments.
Third Trimester:
Lamotrigine levels may continue to decrease. Monitor clinical response and consider dose adjustments. Levels typically return to pre-pregnancy levels postpartum, requiring dose reduction to avoid toxicity.
Lactation
Lamotrigine is excreted into breast milk. The relative infant dose (RID) is generally considered to be in the L3 (moderate risk) category. Monitor breastfed infants for adverse effects such as rash, drowsiness, poor feeding, and apnea. Benefits of breastfeeding should be weighed against potential risks.
Infant Risk:
L3 (Moderate Risk) - Monitor for rash, drowsiness, poor feeding, apnea. Some infants may experience adverse effects, but many tolerate exposure well.
Pediatric Use
Lamictal XR is not approved for pediatric patients under 13 years of age. The immediate-release formulation is approved for certain indications in patients 2 years and older. Due to the risk of serious rash, careful titration is crucial in all age groups, especially pediatric patients where the risk is higher.
Geriatric Use
Use with caution. Elderly patients may be more sensitive to the adverse effects of lamotrigine, particularly dizziness, ataxia, and sedation. Start with lower doses and titrate slowly. Monitor renal and hepatic function, as age-related decline in these functions may affect lamotrigine clearance.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is slow dose titration to minimize the risk of serious skin rashes (SJS/TEN/DRESS). Patients must be educated on this.
- Concomitant medications, especially valproate and enzyme-inducing AEDs (carbamazepine, phenytoin, phenobarbital), significantly alter lamotrigine levels and require specific titration schedules.
- Oral contraceptives containing estrogen can significantly decrease lamotrigine levels, potentially leading to loss of seizure control or mood stability. Dose adjustments may be necessary.
- Patients should be advised to report any rash immediately and discontinue the drug if a serious rash is suspected.
- Lamotrigine XR is taken once daily and should not be crushed, chewed, or divided.
- While therapeutic drug monitoring (TDM) is not routinely required, it can be helpful in cases of suspected non-adherence, drug interactions, pregnancy, renal/hepatic impairment, or treatment failure/toxicity.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Oxcarbazepine, Topiramate, Zonisamide, Gabapentin, Pregabalin, Phenytoin, Phenobarbital.
- For Bipolar I Disorder (Maintenance): Lithium, Valproate, Carbamazepine, Olanzapine, Quetiapine, Aripiprazole, Lurasidone.
Cost & Coverage
Average Cost:
$300 - $600+ per 30 tablets (250mg XR)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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 is a patient fact sheet that provides crucial information. 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 with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.