Lamictal XR 50-100-200mg 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
Nov 2006
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 'XR' means it's released slowly over time, so you usually take it once a day.
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 your medication as directed by your doctor or healthcare provider, even if you're feeling well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
Do not alter your 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 discontinue it to minimize the risk of side effects.
If you've stopped taking this medication, consult your doctor before restarting, as you may need to begin with a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your 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 local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
Do not alter your 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 discontinue it to minimize the risk of side effects.
If you've stopped taking this medication, consult your doctor before restarting, as you may need to begin with a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your 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 local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take Lamictal XR exactly as prescribed, usually once daily. Do not chew, crush, or split the extended-release tablets.
- Do not stop taking Lamictal XR suddenly, as this can cause serious problems, including increased seizures or withdrawal symptoms. Any dose changes should be made gradually under your doctor's supervision.
- Be aware of the risk of serious skin rash. Contact your doctor immediately if you develop any rash, fever, swollen glands, or mouth sores.
- Report any new or worsening mood changes, depression, or suicidal thoughts to your doctor right away.
- Avoid alcohol or other CNS depressants, as they can increase drowsiness and dizziness.
- Carry a medical alert card or wear medical identification stating that you take lamotrigine.
- 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.
- Women of childbearing potential should discuss contraception and pregnancy planning with their doctor due to potential drug interactions with oral contraceptives and risks during pregnancy.
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:
Titration schedules vary significantly based on concomitant medications and indication (epilepsy or bipolar disorder). The kit provides tablets for a gradual dose escalation.
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
Epilepsy (Adjunctive Therapy) - 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. Subsequent doses may be increased by 100 mg/day every week to a maintenance dose of 300-400 mg/day.
Epilepsy (Adjunctive Therapy) - Patients taking 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. Subsequent doses may be increased by 50 mg/day every week to a maintenance dose of 100-200 mg/day.
Epilepsy (Adjunctive Therapy) - Patients taking enzyme-inducing AEDs (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. Subsequent doses may be increased by 100 mg/day every week to a maintenance dose of 300-500 mg/day.
Bipolar I Disorder (Maintenance) - Patients NOT taking valproate or carbamazepine:
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. Maintenance dose is typically 200 mg/day.
Bipolar I Disorder (Maintenance) - Patients taking 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. Maintenance dose is typically 100 mg/day.
Bipolar I Disorder (Maintenance) - Patients taking carbamazepine:
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 dose is typically 400 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not approved for Lamictal XR in children under 13 years for epilepsy. For immediate-release lamotrigine, dosing varies by weight and concomitant medications for adjunctive treatment of partial seizures and generalized tonic-clonic seizures (âĨ2 years).
Adolescent:
For epilepsy (adjunctive therapy, âĨ13 years): Dosing follows adult guidelines based on concomitant medications. Not approved for bipolar disorder in adolescents.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
Reduced maintenance doses should be considered for patients with significant renal impairment (CrCl <30 mL/min). Initial titration should follow standard guidelines, but subsequent dose escalations should be based on clinical response.
Dialysis:
Supplemental doses after dialysis are not typically required as only a small fraction is removed by hemodialysis. Consider reduced maintenance doses.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
Initial, escalation, and maintenance doses should be reduced by approximately 25% for patients with moderate hepatic impairment (Child-Pugh Class B).
Severe:
Initial, escalation, and maintenance doses should be reduced by approximately 50% for patients with severe hepatic impairment (Child-Pugh Class C).
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 and may inhibit neuronal firing.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
4-12 hours (for XR formulation)
FoodEffect:
Food does not significantly affect the rate or extent of absorption of lamotrigine XR.
Distribution:
Vd:
0.97-1.36 L/kg
ProteinBinding:
Approximately 55% (primarily to albumin)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); ~70 hours (with valproate); ~14-15 hours (with enzyme-inducing AEDs)
Clearance:
Highly variable, dependent on concomitant medications
ExcretionRoute:
Renal (primarily as glucuronide conjugates)
Unchanged:
Approximately 2-8% (in urine)
Pharmacodynamics
OnsetOfAction:
Gradual (due to titration schedule)
PeakEffect:
Achieved after reaching stable maintenance dose (weeks to months)
DurationOfAction:
Extended (once daily dosing due to XR formulation)
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 fatal. The incidence of these rashes is higher in pediatric patients than in adults. Other risk factors include concomitant use of valproate, exceeding recommended initial doses, and rapid dose escalation. Benign rashes also occur, but it is not possible to predict which rashes will prove to be serious or life-threatening. Therefore, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related.
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 or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Shortness of breath, significant weight gain, or swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Changes in balance or coordination
Inability to control eye movements
Flu-like symptoms
Painful periods or changes in menstrual cycle, including spotting or bleeding between 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
Changes in balance or trouble walking (new or worsening)
Other Side Effects
Most people do not experience significant side effects while taking this medication. However, some common side effects may occur, including:
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
If any of these side effects bother you or persist, contact your doctor for advice. 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 or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Shortness of breath, significant weight gain, or swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Changes in balance or coordination
Inability to control eye movements
Flu-like symptoms
Painful periods or changes in menstrual cycle, including spotting or bleeding between 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
Changes in balance or trouble walking (new or worsening)
Other Side Effects
Most people do not experience significant side effects while taking this medication. However, some common side effects may occur, including:
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
If any of these side effects bother you or persist, contact your doctor for advice. 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 skin rash (especially if severe, widespread, blistering, or accompanied by fever, swollen glands, facial swelling, or mouth sores)
- Fever, chills, body aches, or flu-like symptoms
- Swollen lymph nodes
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe muscle pain or weakness
- New or worsening depression, anxiety, or irritability
- Thoughts of harming yourself or others
- Changes in behavior or mood (e.g., agitation, restlessness, panic attacks, aggression, mania)
- Worsening seizures
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
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 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 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 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 lab 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 (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 thoughts or behaviors. 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-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 birth control methods 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 methods may be less effective in preventing pregnancy when taking this medication. Use an alternative form of birth control, such as a condom, to minimize the risk of 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 to adjust your treatment plan as needed.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, 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 lab 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 (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 thoughts or behaviors. 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-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 birth control methods 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 methods may be less effective in preventing pregnancy when taking this medication. Use an alternative form of birth control, such as a condom, to minimize the risk of 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 to adjust your treatment plan as needed.
Overdose Information
Overdose Symptoms:
- Dizziness
- Blurred vision
- Lack of coordination (ataxia)
- Nystagmus (involuntary eye movements)
- Increased seizures
- Decreased consciousness
- Coma
What to Do:
Seek immediate medical attention or call 911. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels significantly, requiring dose reduction)
- Carbamazepine, Phenytoin, Phenobarbital, Primidone (decrease lamotrigine levels significantly, requiring dose increase)
- Estrogen-containing oral contraceptives (decrease lamotrigine levels, requiring dose increase)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/Ritonavir (decreases lamotrigine levels)
- Atazanavir/Ritonavir (decreases lamotrigine levels)
Moderate Interactions
- Paracetamol (acetaminophen) (may slightly decrease lamotrigine levels with chronic high-dose use)
- Risperidone (lamotrigine may decrease risperidone levels)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Bupropion (may increase lamotrigine levels, though less pronounced than valproate)
Monitoring
Baseline Monitoring
Baseline seizure frequency/mood state
Rationale: To establish a baseline for assessing treatment efficacy.
Timing: Prior to initiation of therapy
Renal and Hepatic Function Tests (e.g., SCr, BUN, ALT, AST, bilirubin)
Rationale: To identify pre-existing impairment that may require dose adjustment.
Timing: Prior to initiation of therapy, especially if suspected impairment
Routine Monitoring
Clinical response (seizure frequency, mood stability)
Frequency: Regularly during titration and maintenance
Target: Reduction in seizure frequency, stabilization of mood
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy
Adverse effects (especially skin rash)
Frequency: Daily during initial titration, then regularly
Target: Absence of rash or other serious adverse reactions
Action Threshold: Any sign of rash (especially severe, progressive, or accompanied by fever, lymphadenopathy, facial edema) requires immediate discontinuation and medical evaluation.
Signs/symptoms of suicidal ideation or behavior
Frequency: Regularly, especially during initial therapy and dose changes
Target: Absence of suicidal thoughts or behaviors
Action Threshold: Emergence or worsening of suicidal thoughts/behaviors requires immediate clinical assessment and intervention.
Complete Blood Count (CBC) with differential
Frequency: Periodically, or if signs of hematologic abnormalities (e.g., fever, sore throat, bruising)
Target: Within normal limits
Action Threshold: Significant abnormalities may warrant discontinuation.
Lamotrigine plasma concentrations
Frequency: Not routinely recommended, but may be useful in specific situations (e.g., suspected non-adherence, drug interactions, renal/hepatic impairment, pregnancy, or lack of efficacy/toxicity at expected doses)
Target: Typically 3-14 mcg/mL for epilepsy, 2-10 mcg/mL for bipolar (therapeutic ranges are not well-defined and vary by lab)
Action Threshold: Levels outside expected range may prompt dose adjustment or investigation of adherence/interactions.
Symptom Monitoring
- Skin rash (any type, especially severe or widespread)
- Fever
- Swollen lymph nodes
- Facial swelling
- Sore throat
- Mouth sores
- Unusual bruising or bleeding
- Worsening seizures
- New or worsening depression, anxiety, or panic attacks
- Agitation, restlessness, irritability
- Aggressive, angry, or violent behavior
- Insomnia
- Impulsivity
- Hypomania or mania
- Other unusual changes in behavior or mood
- Suicidal thoughts or attempts
Special Patient Groups
Pregnancy
Lamotrigine is classified as Pregnancy Category C. While data from pregnancy registries suggest it may be associated with a lower risk of major congenital malformations compared to some other antiepileptic drugs, there is still a potential risk, particularly for oral clefts (though this risk is debated and may be small). Dose adjustments may be necessary during pregnancy due to changes in lamotrigine clearance. Women should be counseled on the risks and benefits, and enrollment in a pregnancy registry (e.g., North American Antiepileptic Drug Pregnancy Registry) is recommended.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of oral clefts (cleft lip/palate), though data are conflicting and the absolute risk is low. Increased clearance may lead to subtherapeutic levels.
Second Trimester:
Increased clearance may continue, potentially requiring dose adjustments to maintain therapeutic levels.
Third Trimester:
Increased clearance may continue. Monitor for potential withdrawal symptoms in the neonate if maternal levels are high at delivery.
Lactation
Lamotrigine is excreted into breast milk. The amount transferred to the infant can be significant, and infant serum levels can approach therapeutic levels. Monitor breastfed infants for adverse effects such as rash, drowsiness, poor feeding, and apnea. Weigh the benefits of breastfeeding against the potential risks to the infant.
Infant Risk:
L3 (Moderately Safe) - Potential for adverse effects in the infant, but generally considered compatible with breastfeeding with careful monitoring.
Pediatric Use
Lamictal XR is approved for adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures in patients 13 years and older. It is not approved for use in children under 13 years for epilepsy or for bipolar disorder in any pediatric age group. Pediatric patients (especially <16 years) have a higher risk of serious skin rash. Dosing in children for immediate-release lamotrigine is weight-based and complex, depending on concomitant medications.
Geriatric Use
Use with caution in elderly patients, as they may be more susceptible to adverse effects (e.g., dizziness, ataxia, rash) and may have age-related decreases in renal or hepatic function, which could affect lamotrigine clearance. Start with lower doses and titrate slowly, monitoring closely for adverse effects and drug interactions.
Clinical Information
Clinical Pearls
- The Lamictal XR titration kit is designed to help patients follow the slow dose escalation required to minimize the risk of serious skin rash.
- Emphasize the critical importance of slow titration and not missing doses, especially during the initial phase, to reduce rash risk.
- Patients should be educated to report any rash immediately, regardless of how mild it appears, as it's impossible to distinguish benign from serious rashes early on.
- Lamotrigine levels can be significantly affected by other medications (e.g., valproate increases levels, enzyme-inducing AEDs and oral contraceptives decrease levels), requiring substantial dose adjustments.
- Lamictal XR is taken once daily, which can improve adherence compared to multiple daily doses of immediate-release formulations.
- While the primary indication for XR is epilepsy and bipolar maintenance, immediate-release lamotrigine has off-label uses for other mood disorders and neuropathic pain.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Oxcarbazepine, Valproate, Topiramate, Zonisamide, Phenytoin, Gabapentin, Pregabalin, Lacosamide, Rufinamide, Clobazam, Perampanel, Eslicarbazepine acetate, Brivaracetam, Cannabidiol, Fenfluramine, Stiripentol, Vigabatrin, Ethosuximide (for absence seizures).
- For Bipolar I Disorder (Maintenance): Lithium, Valproate, Carbamazepine, Olanzapine, Quetiapine, Aripiprazole, Lurasidone, Cariprazine, Asenapine.
Cost & Coverage
Average Cost:
$300 - $600 per 30 tablets (XR, varying strengths)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand Lamictal XR); Tier 1 (for generic lamotrigine immediate-release)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.