Lamictal XR 25-50-100mg Titrtn Kit
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
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 mood swings in adults with bipolar I disorder. It works by stabilizing electrical activity in the brain. The 'titration kit' helps you start the medication slowly to reduce the risk of side effects, especially a serious skin rash.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
Do not alter the dose or stop taking the medication without consulting your doctor, as this may lead to seizures.
If you need to stop taking the medication, your doctor will instruct you on how to gradually discontinue it to minimize the risk of side effects.
If you stop taking the 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
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 is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
Do not alter the dose or stop taking the medication without consulting your doctor, as this may lead to seizures.
If you need to stop taking the medication, your doctor will instruct you on how to gradually discontinue it to minimize the risk of side effects.
If you stop taking the 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
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 is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take Lamictal XR exactly as prescribed, usually once daily. Do not chew, crush, or split the extended-release tablets.
- Do not stop taking this medication suddenly, even if you feel better, as this can cause seizures to return or worsen. Any dose changes should be made gradually under your doctor's supervision.
- Be aware of the risk of a serious skin rash. Report any rash, fever, swollen glands, or mouth sores to your doctor immediately.
- 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 this 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. If you miss multiple doses, contact your doctor as you may need to restart at a lower dose.
- Inform your doctor and pharmacist about all other medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins, as many drugs can interact with lamotrigine.
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
Dosing & Administration
Adult Dosing
Standard Dose:
Lamictal XR Titration Kit is designed for the initial titration phase. Dosing varies significantly based on concomitant medications and indication (epilepsy or bipolar I disorder). The kit provides the first 4-5 weeks of treatment.
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
Epilepsy (Partial-Onset or Primary Generalized Tonic-Clonic Seizures):
Bipolar I Disorder (Maintenance):
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for Lamictal XR (approved for epilepsy in patients 13 years and older; not approved for bipolar disorder in pediatric patients).
Adolescent:
Approved for epilepsy in patients 13 years and older. Dosing follows adult titration schedules based on concomitant medications.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
Consider dose reduction in patients with significant renal impairment. Monitor clinical response.
Severe:
Consider dose reduction in patients with significant renal impairment. Monitor clinical response.
Dialysis:
Supplemental doses after dialysis are generally not required for immediate-release lamotrigine, but data for XR are limited. Monitor clinical response and adjust as needed.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
Reduce initial, escalation, and maintenance doses by approximately 25%.
Severe:
Reduce initial, escalation, and maintenance doses by approximately 50%.
Confidence:
Medium
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 (e.g., glutamate and aspartate). It also has weak effects on voltage-gated calcium channels.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 98% (oral)
Tmax:
4-6 hours (extended-release formulation)
FoodEffect:
Food does not significantly affect the rate or extent of absorption of Lamictal XR.
Distribution:
Vd:
0.97-1.3 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); significantly shorter with enzyme-inducing AEDs (e.g., 13-14 hours); significantly longer with valproate (e.g., 59-70 hours).
Clearance:
Approximately 30 mL/min/kg (monotherapy)
ExcretionRoute:
Renal (approximately 94% as metabolites, 2% as unchanged drug)
Unchanged:
Approximately 2% (renal)
Pharmacodynamics
OnsetOfAction:
Gradual, due to slow titration to minimize rash risk. Therapeutic effects may take several weeks.
PeakEffect:
Achieved after reaching stable maintenance dose, typically several weeks into therapy.
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) and toxic epidermal necrolysis (TEN), which can be life-threatening. The risk of serious rash is increased with higher initial doses, exceeding recommended dose escalation, or concomitant use of valproate. Benign rashes also occur, but it is not possible to predict which rashes will prove to be serious. Discontinue Lamictal XR at the first sign of rash, unless the rash is clearly not drug-related.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ 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
Balance problems or difficulty controlling eye movements
Flu-like symptoms
Painful periods or changes in menstrual cycle, including spotting or bleeding between periods
Additionally, this medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, seek medical attention immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems or difficulty walking (new or worsening symptoms)
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Sleep disturbances
Nose or throat irritation
Weight loss
Dry mouth
Back pain
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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
Balance problems or difficulty controlling eye movements
Flu-like symptoms
Painful periods or changes in menstrual cycle, including spotting or bleeding between periods
Additionally, this medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, seek medical attention immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems or difficulty walking (new or worsening symptoms)
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Sleep disturbances
Nose or throat irritation
Weight loss
Dry mouth
Back pain
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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, chills, body aches
- Swollen glands (lymph nodes)
- Sore throat, mouth sores, or eye irritation
- Swelling of the face, eyes, lips, or tongue
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine, severe fatigue
- Severe dizziness, loss of coordination, or unsteadiness
- Changes in vision (e.g., double vision, blurred vision)
- Worsening depression, suicidal thoughts, or unusual changes in mood or behavior (e.g., agitation, aggression, panic attacks, hallucinations)
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 as a result of the allergy.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
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 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 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 thoughts or behaviors. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
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 an abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heart rhythms can occur in individuals with certain heart conditions, which may lead to sudden death.
Pediatric Use
When 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 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 an alternative form of birth control, such as a condom, 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-Specific Warnings
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 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 thoughts or behaviors. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
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 an abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heart rhythms can occur in individuals with certain heart conditions, which may lead to sudden death.
Pediatric Use
When 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 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 an alternative form of birth control, such as a condom, 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-Specific Warnings
If your seizures change or worsen after starting this medication, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Severe dizziness or unsteadiness
- Blurred vision or double vision
- Severe drowsiness or unconsciousness
- Increased seizures
- Coma
- Cardiac conduction abnormalities (e.g., QRS prolongation)
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels, requiring significant dose reduction)
- Carbamazepine (decreases lamotrigine levels, requiring dose increase)
- Phenytoin (decreases lamotrigine levels, requiring dose increase)
- Phenobarbital (decreases lamotrigine levels, requiring dose increase)
- Primidone (decreases lamotrigine levels, requiring dose increase)
- Oral Contraceptives (containing estrogen, can decrease lamotrigine levels, requiring dose increase)
- Rifampin (decreases lamotrigine levels, requiring dose increase)
- Lopinavir/Ritonavir (decreases lamotrigine levels)
- Atazanavir/Ritonavir (decreases lamotrigine levels)
Moderate Interactions
- Ethinyl estradiol/levonorgestrel (can decrease lamotrigine levels)
- Paracetamol/Acetaminophen (high doses may decrease lamotrigine levels)
- Sertraline (may decrease lamotrigine levels)
- Risperidone (lamotrigine may increase risperidone levels)
Confidence Interactions
Monitoring
Baseline Monitoring
Baseline skin assessment
Rationale: To identify any pre-existing skin conditions and establish a baseline for monitoring for serious rash.
Timing: Prior to initiation of therapy.
Renal and Hepatic Function Tests (e.g., BUN, creatinine, ALT, AST, bilirubin)
Rationale: To assess baseline organ function, as dose adjustments are required in moderate to severe impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical monitoring for rash (e.g., Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis)
Frequency: Daily during titration, then regularly throughout therapy.
Target: Absence of rash.
Action Threshold: Any new rash should be promptly evaluated. Discontinue lamotrigine at the first sign of rash unless it is clearly not drug-related.
Monitoring for signs of hypersensitivity syndrome (DRESS)
Frequency: Regularly, especially during the first 8 weeks.
Target: Absence of fever, lymphadenopathy, facial edema, or other systemic symptoms.
Action Threshold: Discontinue immediately if suspected.
Seizure frequency/severity (for epilepsy)
Frequency: Regularly, at each follow-up visit.
Target: Reduction in seizure frequency/severity.
Action Threshold: Lack of efficacy may warrant dose adjustment or alternative therapy.
Mood stability/symptoms (for bipolar disorder)
Frequency: Regularly, at each follow-up visit.
Target: Stabilization of mood, reduction in depressive or manic symptoms.
Action Threshold: Lack of efficacy or worsening symptoms may warrant dose adjustment or alternative therapy.
Drug interactions and concomitant medications review
Frequency: At each visit, especially when adding or discontinuing interacting medications.
Target: Appropriate lamotrigine dosing based on interactions.
Action Threshold: Adjust lamotrigine dose as per guidelines when interacting drugs are added or removed.
Lamotrigine plasma concentrations (therapeutic drug monitoring)
Frequency: Not routinely recommended, but may be useful in specific situations (e.g., suspected non-adherence, significant drug interactions, renal/hepatic impairment, pregnancy, or lack of efficacy/toxicity at expected doses).
Target: Generally 2-20 mcg/mL (varies by indication and individual response).
Action Threshold: Levels outside target range, especially with clinical signs of toxicity or lack of efficacy, may warrant dose adjustment.
Symptom Monitoring
- Skin rash (any type, especially blistering or widespread)
- Fever
- Swollen lymph nodes
- Swelling of face, eyes, lips, or tongue
- Sore throat, mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe fatigue
- Changes in vision (e.g., double vision, blurred vision)
- Dizziness, unsteadiness, ataxia
- Headache
- Nausea, vomiting
- Tremor
- Changes in mood or behavior (e.g., depression, suicidal thoughts, aggression, agitation, hallucinations)
Special Patient Groups
Pregnancy
Lamotrigine is classified as Pregnancy Category C. While animal studies show some developmental toxicity, human data from pregnancy registries suggest that lamotrigine may be associated with a lower risk of major congenital malformations compared to some other antiepileptic drugs, particularly when used as monotherapy. However, there is a potential for increased risk of oral clefts, though data are conflicting. The decision to use lamotrigine during pregnancy should weigh the potential benefits against the risks. Women of childbearing potential should be counseled and encouraged to enroll in a pregnancy registry.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of oral clefts (e.g., cleft lip/palate), though data are inconsistent. Risk of major congenital malformations generally considered lower than some other AEDs.
Second Trimester:
No specific increased risks identified beyond general pregnancy risks.
Third Trimester:
No specific increased risks identified beyond general pregnancy risks. Lamotrigine levels may decrease during pregnancy, requiring dose adjustments, and may increase postpartum.
Lactation
Lamotrigine is excreted into breast milk. While some infants may experience adverse effects (e.g., rash, apnea, drowsiness), many breastfed infants show no adverse effects. Monitor breastfed infants for rash, drowsiness, poor feeding, and apnea. The benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
L3 (Moderately Safe) - Monitor infant for adverse effects.
Pediatric Use
Lamictal XR is approved for epilepsy in patients 13 years and older. It is not approved for bipolar disorder in pediatric patients. Dosing in adolescents (13 years and older) follows adult titration schedules based on concomitant medications. The risk of serious rash may be higher in pediatric patients than in adults.
Geriatric Use
No specific dose adjustments are generally required based solely on age, but elderly patients may be more sensitive to the effects of lamotrigine and may have age-related decreases in renal or hepatic function, which would necessitate dose adjustments. Start with lower doses and titrate slowly, monitoring for adverse effects.
Clinical Information
Clinical Pearls
- The Lamictal XR Titration Kit is crucial for safe initiation of therapy. Adherence to the slow titration schedule is paramount to minimize the risk of serious skin rashes.
- Patients must be educated about the signs and symptoms of serious skin rashes (SJS/TEN) and hypersensitivity syndrome (DRESS) and instructed to seek immediate medical attention if they occur.
- Concomitant medications, especially valproate and enzyme-inducing AEDs (e.g., carbamazepine, phenytoin), significantly alter lamotrigine metabolism and require specific dose adjustments during titration and maintenance.
- Oral contraceptives containing estrogen can decrease lamotrigine levels, potentially leading to loss of seizure control or mood stabilization. Dose adjustments may be necessary.
- Abrupt discontinuation of lamotrigine can precipitate rebound seizures or worsening of mood symptoms. Tapering is generally recommended.
- While therapeutic drug monitoring is not routinely recommended, it can be useful in specific situations, such as suspected non-adherence, significant drug interactions, or in patients with renal/hepatic impairment or during pregnancy.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Phenytoin, Topiramate, Oxcarbazepine, Zonisamide, Gabapentin, Pregabalin, Lacosamide, Perampanel.
- For Bipolar Disorder (Maintenance): Lithium, Valproate, Carbamazepine, Quetiapine, Olanzapine, Aripiprazole, Lurasidone.
Cost & Coverage
Average Cost:
Check current market data per kit
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand-name Lamictal XR); Tier 1 or 2 (for generic lamotrigine extended-release, if available)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides additional information. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to 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 details about the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides additional information. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to 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 details about the medication taken, the amount consumed, and the time it occurred.