Lamictal XR 200mg 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
Pharmacologic Class
Phenyltriazine derivative; Voltage-gated sodium channel blocker
Pregnancy Category
Not available
FDA Approved
May 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamictal XR is an extended-release tablet used to help control certain types of seizures (epilepsy) in people 13 years and older. It works by calming overactive nerves in the brain. It's also used to help prevent mood swings in adults with bipolar disorder, but the XR form is primarily for epilepsy.
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 with a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light and moisture.
Keep the medication in a dry place, away from the bathroom.
Store 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 way to dispose of medications, 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 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 with a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light and moisture.
Keep the medication in a dry place, away from the bathroom.
Store 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 way to dispose of medications, 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 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 exactly as prescribed, do not crush, chew, or divide the extended-release tablets.
- Do not stop taking this medication suddenly, as it can lead to increased seizures or withdrawal symptoms. Any changes should be made under medical supervision.
- Avoid activities requiring mental alertness, such as driving or operating machinery, until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Report any new or worsening skin rash immediately to your doctor.
- Be aware of potential interactions with other medications, especially birth control pills and other seizure medications. Always inform your doctor and pharmacist about all medications you are taking.
- Carry a medical alert card or wear a medical alert bracelet indicating you take lamotrigine for 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:
Dosing is highly individualized and depends on concomitant medications. Typically initiated at 25 mg daily for 2 weeks, then titrated up. For patients not taking enzyme-inducing AEDs or valproate, maintenance is often 200-400 mg daily.
Dose Range:
25 - 600 mg
Condition-Specific Dosing:
adjunctive_therapy_with_valproate:
Initial: 25 mg every other day for 2 weeks, then 25 mg daily for 2 weeks. Titrate to maintenance of 100-250 mg daily.
adjunctive_therapy_with_enzyme_inducers_without_valproate:
Initial: 50 mg daily for 2 weeks, then 100 mg daily for 2 weeks. Titrate to maintenance of 300-500 mg daily.
adjunctive_therapy_without_enzyme_inducers_or_valproate:
Initial: 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks. Titrate to maintenance of 200-400 mg daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for Lamictal XR (approved for âĨ13 years for epilepsy). For Lamictal (immediate release), dosing is weight-based and depends on concomitant medications, typically starting at 0.3-0.6 mg/kg/day.
Adolescent:
For patients âĨ13 years of age, dosing follows adult guidelines based on concomitant medications.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Consider a reduction in maintenance dose for patients with significant renal impairment. Use with caution.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed. Monitor clinical response.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Consider a 25% reduction in initial, escalation, and maintenance doses.
Severe:
Consider a 50% reduction in initial, escalation, and maintenance doses.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that is thought to exert its anticonvulsant effects by inhibiting voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and modulating the release of excitatory neurotransmitters (e.g., glutamate and aspartate). It also has weak effects on voltage-gated calcium channels.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
Approximately 4-6 hours (for XR formulation, can be longer, up to 10 hours)
FoodEffect:
Food does not significantly affect the rate or extent of absorption of Lamictal XR.
Distribution:
Vd:
Approximately 1.2 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (can vary significantly with concomitant medications: ~15 hours with enzyme inducers, ~59 hours with valproate)
Clearance:
Approximately 0.3 mL/min/kg
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
Gradual (due to slow titration)
PeakEffect:
Achieved after several weeks of titration to maintenance dose.
DurationOfAction:
24 hours (due to extended-release formulation)
Confidence:
High
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 serious rashes is greater 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
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 immediate 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 or irregular menstrual periods
Low blood cell counts, which can increase the risk of:
+ Infections (fever, chills, or sore throat)
+ Bleeding problems (unexplained bruising or bleeding)
+ Anemia (feeling extremely tired or weak)
Additionally, an immune system disorder called hemophagocytic lymphohistiocytosis (HLH) has been associated with this medication. HLH can be life-threatening. Seek immediate medical attention if you experience:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance or coordination
Difficulty walking (new or worsening symptoms)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness or tremors
Difficulty sleeping
Nose or throat irritation
Weight loss
Dry mouth
Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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 or irregular menstrual periods
Low blood cell counts, which can increase the risk of:
+ Infections (fever, chills, or sore throat)
+ Bleeding problems (unexplained bruising or bleeding)
+ Anemia (feeling extremely tired or weak)
Additionally, an immune system disorder called hemophagocytic lymphohistiocytosis (HLH) has been associated with this medication. HLH can be life-threatening. Seek immediate medical attention if you experience:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance or coordination
Difficulty walking (new or worsening symptoms)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness or tremors
Difficulty sleeping
Nose or throat irritation
Weight loss
Dry mouth
Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any new or worsening skin rash (especially if accompanied by fever, swollen glands, or flu-like symptoms)
- Swelling of the face, eyes, lips, or tongue
- Sore throat, mouth sores
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe muscle pain or weakness
- New or worsening depression, anxiety, or suicidal thoughts/behavior
- Changes in mood or behavior (e.g., agitation, aggression, panic attacks, restlessness)
- Vision changes (e.g., blurred vision, double vision)
- Severe dizziness or unsteadiness
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication in combination with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication in combination with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be sure to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (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 changes in mood or behavior. 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 heartbeats can increase the risk of sudden death in individuals with certain heart conditions.
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.
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 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 (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 changes in mood or behavior. 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 heartbeats can increase the risk of sudden death in individuals with certain heart conditions.
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.
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:
- Nystagmus (involuntary eye movements)
- Ataxia (loss of coordination)
- Impaired consciousness
- Grand mal seizures
- Coma
- Intraventricular conduction delay (ECG changes)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive, including gastric lavage, activated charcoal, and close monitoring of vital signs and cardiac function.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels, increases risk of rash)
- Carbamazepine (decreases lamotrigine levels)
- Phenytoin (decreases lamotrigine levels)
- Phenobarbital (decreases lamotrigine levels)
- Primidone (decreases lamotrigine levels)
- Oral Contraceptives (estrogen-containing) (decrease lamotrigine levels)
Moderate Interactions
- Rifampin (decreases lamotrigine levels)
- Lopinavir/Ritonavir (decreases lamotrigine levels)
- Atazanavir/Ritonavir (decreases lamotrigine levels)
- Dofetilide (lamotrigine may increase dofetilide levels)
- Risperidone (lamotrigine may decrease risperidone levels)
Minor Interactions
- Paracetamol (acetaminophen) (may slightly decrease lamotrigine levels with chronic use)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for potential hematologic abnormalities (rare).
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for potential hepatic dysfunction (rare).
Timing: Prior to initiation
Renal Function Tests (RFTs)
Rationale: To establish baseline, especially if renal impairment is suspected.
Timing: Prior to initiation
Routine Monitoring
Clinical response (seizure frequency/severity)
Frequency: Regularly during titration and maintenance
Target: Optimal seizure control with minimal side effects
Action Threshold: Increased seizure frequency or intolerable side effects warrant dose adjustment or re-evaluation.
Adverse effects (especially rash)
Frequency: Daily during titration, then regularly
Target: Absence of severe rash or other serious adverse events
Action Threshold: Any sign of rash (especially widespread, blistering, or involving mucous membranes) requires immediate discontinuation.
Mood and behavior changes
Frequency: Regularly
Target: Stable mood, absence of suicidal ideation or unusual behavioral changes
Action Threshold: Emergence or worsening of depression, suicidal thoughts, or unusual behavior requires immediate evaluation.
Lamotrigine plasma concentrations (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, or lack of efficacy/toxicity at usual doses).
Target: Typically 3-14 mcg/mL (for epilepsy), but clinical response is paramount.
Action Threshold: Levels outside the range, especially if correlated with clinical symptoms or lack of efficacy, may warrant dose adjustment.
Symptom Monitoring
- Skin rash (any type, especially blistering, widespread, or involving mucous membranes)
- 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 muscle pain
- Unexplained weakness or fatigue
- New or worsening depression
- Suicidal thoughts or behavior
- Anxiety, agitation, panic attacks
- Insomnia
- Irritability
- Hostility, aggression
- Impulsivity
- Mania or hypomania
- Restlessness
- Tremor
- Dizziness
- Blurred vision or double vision
- Nausea, vomiting
Special Patient Groups
Pregnancy
Use during pregnancy should be carefully considered, weighing potential benefits against risks. Lamotrigine crosses the placenta. Data from pregnancy registries suggest a small increased risk of oral clefts, particularly with higher doses or polytherapy. Monotherapy is generally preferred over polytherapy if possible. Folic acid supplementation is recommended for all women of childbearing potential taking AEDs.
Trimester-Specific Risks:
First Trimester:
Small increased risk of oral clefts (e.g., cleft lip/palate).
Second Trimester:
Not specifically associated with major malformations beyond the first trimester.
Third Trimester:
Potential for withdrawal symptoms in the neonate if discontinued abruptly. Monitor maternal lamotrigine levels, as they may decrease during pregnancy due to increased clearance.
Lactation
Lamotrigine is excreted into breast milk. The relative infant dose (RID) is generally low to moderate (L3). Monitor breastfed infants for adverse effects such as rash, drowsiness, poor feeding, and poor weight gain. Breastfeeding may be considered with careful monitoring.
Infant Risk:
L3 (Moderately Safe)
Pediatric Use
Lamictal XR is approved for adjunctive therapy of partial-onset seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients 13 years of age and older. Not recommended for children younger than 13 years due to increased risk of serious rash and lack of efficacy data for XR formulation in younger age groups. Dosing for younger children typically uses the immediate-release formulation and is weight-based with careful titration.
Geriatric Use
No specific dose adjustment is generally required based on age alone, but elderly patients may be more sensitive to adverse effects (e.g., dizziness, ataxia). Start with lower doses and titrate slowly, monitoring for side effects and drug interactions. Renal and hepatic function should be considered.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rashes. Adherence to the titration schedule is paramount.
- Patients must be educated to report any rash immediately. Discontinuation is usually required at the first sign of rash unless clearly non-drug related.
- Dosing is highly dependent on concomitant medications, especially valproate (which increases lamotrigine levels) and enzyme-inducing AEDs/oral contraceptives (which decrease lamotrigine levels).
- Lamotrigine XR is taken once daily, which can improve adherence compared to multiple daily doses of immediate-release formulations.
- While TDM is not routinely required, it can be useful in specific situations like suspected non-adherence, drug interactions, pregnancy, or renal/hepatic impairment.
- Patients should be monitored for suicidal ideation and behavior, as with all AEDs.
Alternative Therapies
- Levetiracetam (Keppra)
- Topiramate (Topamax)
- Zonisamide (Zonegran)
- Oxcarbazepine (Trileptal)
- Carbamazepine (Tegretol)
- Valproate (Depakote)
- Phenytoin (Dilantin)
- Gabapentin (Neurontin)
- Pregabalin (Lyrica)
Cost & Coverage
Average Cost:
$300 - $600+ per 30 tablets (200mg 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 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 quantity, and the time it occurred.