Lamictal Green Strt Kit 25mg/100mg
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. @ COMMON USES: It is used to help control certain kinds of seizures.It is used to treat bipolar disorder.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant; Mood Stabilizer
Pharmacologic Class
Phenyltriazine Antiepileptic
Pregnancy Category
Not available
FDA Approved
Dec 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamotrigine is a medication used to treat certain types of seizures (epilepsy) and to help prevent mood swings in people with bipolar disorder. It works by calming overactive nerve signals in the brain. It's very important to start this medication at a very low dose and increase it slowly to reduce the risk of a serious skin rash.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well. It's crucial to swallow the medication whole, without chewing, breaking, or crushing it. If you have difficulty swallowing, discuss this with your doctor.
Important Safety Precautions
Do not change your dosage or stop taking this medication without consulting your doctor, as this may lead to seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dosage to minimize potential side effects. If you do stop taking the medication, you may need to restart at a lower dose and gradually increase it under your doctor's guidance.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore 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. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well. It's crucial to swallow the medication whole, without chewing, breaking, or crushing it. If you have difficulty swallowing, discuss this with your doctor.
Important Safety Precautions
Do not change your dosage or stop taking this medication without consulting your doctor, as this may lead to seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dosage to minimize potential side effects. If you do stop taking the medication, you may need to restart at a lower dose and gradually increase it under your doctor's guidance.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore 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. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed; do not stop suddenly without consulting your doctor.
- Report any new skin rash immediately to your doctor, as it could be serious.
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how this medication affects you, as it can cause dizziness or blurred vision.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double doses.
- If you are taking oral contraceptives, discuss with your doctor as they can affect lamotrigine levels.
- Carry a medical alert card or wear a bracelet stating you take lamotrigine if you have epilepsy.
Available Forms & Alternatives
Available Strengths:
- Lamictal 150mg Tablets
- Lamictal 200mg Tablets
- Lamictal 100mg Tablets
- Lamictal 25mg Tablets
- Lamictal 5mg Chewabl Disprsbl Tabs
- Lamictal 25mg Chewabl Disprsbl Tabs
- Lamictal Orange Strt Kit25mg/100mg
- Lamictal Blue Starter Kit 25mg
- Lamictal XR 25mg Tablets
- Lamictal XR 50mg Tablets
- Lamictal XR 100mg Tablets
- Lamictal XR 200mg Tablets
- Lamictal XR 25-50-100mg Titrtn Kit
- Lamictal XR 25-50mg Titration Kt 28
- Lamictal XR 50-100-200mg Titrtn Kit
- Lamictal ODT 25mg Tablets
- Lamictal ODT 50mg Tablets
- Lamictal ODT 100mg Tablets
- Lamictal ODT 200mg Tablets
- Lamictal ODT 25-50-100mg Tb Kt Orng
- Lamictal ODT 25-50mg Tb Kit Blue
- Lamictal ODT 50-100mg Tb Kit Green
- Lamictal Green Strt Kit 25mg/100mg
- Lamictal XR 300mg Tablets
- Lamictal XR 250mg Tablets
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial titration varies significantly based on concomitant medications. The 'Green Starter Kit' is for patients NOT taking valproate and NOT taking enzyme-inducing AEDs (e.g., carbamazepine, phenytoin, phenobarbital).
Dose Range:
25 - 700 mg
Condition-Specific Dosing:
epilepsy_monotherapy:
Initial: 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then increase by 50 mg/day every 1-2 weeks. Maintenance: 225-375 mg/day in 2 divided doses.
epilepsy_adjunctive_therapy_no_valproate_no_enzyme_inducers:
Initial: 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then increase by 50 mg/day every 1-2 weeks. Maintenance: 225-375 mg/day in 2 divided doses.
bipolar_disorder_monotherapy_or_adjunctive_no_valproate_no_enzyme_inducers:
Initial: 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then 100 mg once daily for 1 week, then 200 mg once daily. Maintenance: 200 mg/day (can go up to 400 mg/day).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for children under 2 years.
Child:
Epilepsy (2-12 years, adjunctive, NOT taking valproate and NOT taking enzyme-inducing AEDs): Initial: 0.6 mg/kg/day in 1-2 divided doses for 2 weeks, then 1.2 mg/kg/day for 2 weeks, then increase by 1.2 mg/kg/day every 1-2 weeks. Maintenance: 4.5-7.5 mg/kg/day (max 300 mg/day).
Adolescent:
Dosing similar to adults for epilepsy and bipolar disorder, depending on concomitant medications.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
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. Monitor clinical response.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Initial dose reduction by 50%. Subsequent dose escalation based on clinical response and tolerability.
Severe:
Initial dose reduction by 75%. Subsequent dose escalation based on clinical response and tolerability.
Pharmacology
Mechanism of Action
Lamotrigine is an anticonvulsant that is thought to exert its anticonvulsant effects by inhibiting voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and inhibiting 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:
1.4-4.8 hours (oral)
FoodEffect:
Food slightly delays Tmax but does not affect the extent of absorption (AUC).
Distribution:
Vd:
0.9-1.3 L/kg
ProteinBinding:
55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); significantly affected by concomitant medications (e.g., valproate increases half-life, enzyme-inducing AEDs decrease half-life).
Clearance:
Approximately 30 mL/min/kg (adults)
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 8% (unchanged drug in urine)
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration to minimize rash risk)
PeakEffect:
Weeks to months (after reaching maintenance dose)
DurationOfAction:
24 hours (dosed once or twice daily)
Safety & Warnings
BLACK BOX WARNING
Serious Skin Rashes: Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. These include Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), which can result in death. The incidence of these serious rashes is greater in pediatric patients than in adults. Other factors that increase the risk of rash include coadministration with valproate, exceeding recommended initial doses, and exceeding recommended dose escalation.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
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
Inability to control eye movements
Flu-like symptoms
Painful periods
Changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts and Infections
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem: Hemophagocytic Lymphohistiocytosis (HLH)
This medication can cause a rare but life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor right away:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking (new or worsening)
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or experience any symptoms that concern you, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
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
Inability to control eye movements
Flu-like symptoms
Painful periods
Changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts and Infections
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem: Hemophagocytic Lymphohistiocytosis (HLH)
This medication can cause a rare but life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor right away:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking (new or worsening)
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or experience any symptoms that concern you, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any new skin rash (especially if severe, widespread, blistering, or accompanied by fever, swollen glands, or facial swelling)
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe stomach pain)
- Signs of blood problems (e.g., unusual bruising/bleeding, persistent sore throat, fever)
- Worsening depression, suicidal thoughts or behavior, or unusual changes in mood/behavior
- Severe dizziness, blurred or double vision, unsteadiness
- Swelling in hands or feet
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter 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 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 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.
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 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 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 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 using prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal ideation. Immediately contact your doctor if you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes. If you have suicidal thoughts or attempts, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or packaging, consult with your pharmacist.
Heart-Related Warnings
If you have a history of abnormal heart rhythms, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with pre-existing 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.
Birth Control and Hormone Interactions
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may increase during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy when taking this medication. Use an alternative form of birth control, such as a condom, 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 Management
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 laboratory personnel that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or using prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal ideation. Immediately contact your doctor if you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes. If you have suicidal thoughts or attempts, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or packaging, consult with your pharmacist.
Heart-Related Warnings
If you have a history of abnormal heart rhythms, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with pre-existing 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.
Birth Control and Hormone Interactions
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may increase during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy when taking this medication. Use an alternative form of birth control, such as a condom, 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 Management
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:
- Nystagmus (involuntary eye movements)
- Ataxia (loss of coordination)
- Impaired consciousness
- 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; there is no specific antidote.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels, increases risk of rash)
- Carbamazepine, Phenytoin, Phenobarbital, Primidone (decrease lamotrigine levels)
- Oral contraceptives containing estrogen (decrease lamotrigine levels)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/Ritonavir (decreases lamotrigine levels)
- Atazanavir/Ritonavir (decreases lamotrigine levels)
Moderate Interactions
- Acetaminophen (may slightly decrease lamotrigine levels with chronic high-dose use)
- Risperidone (lamotrigine may decrease risperidone levels)
- Sertraline (may decrease lamotrigine levels)
- Lithium (no significant pharmacokinetic interaction, but monitor for additive CNS effects)
Confidence Interactions
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To establish baseline for rash monitoring, especially due to Black Box Warning.
Timing: Prior to initiation
Renal function (BUN, Creatinine)
Rationale: Lamotrigine is renally eliminated; dose adjustment may be needed in severe impairment.
Timing: Prior to initiation
Hepatic function (ALT, AST, Bilirubin)
Rationale: Lamotrigine is hepatically metabolized; dose adjustment may be needed in moderate to severe impairment.
Timing: Prior to initiation
Complete Blood Count (CBC)
Rationale: Rare reports of hematologic abnormalities (e.g., neutropenia, anemia, thrombocytopenia).
Timing: Prior to initiation
Routine Monitoring
Skin for rash
Frequency: Daily during titration, then regularly
Target: Absence of rash
Action Threshold: Any new rash, especially if severe, widespread, or accompanied by fever, lymphadenopathy, or facial swelling, requires immediate discontinuation and medical evaluation.
Seizure frequency/Mood stability
Frequency: Regularly (e.g., monthly initially, then every 3-6 months)
Target: Optimal control with minimal side effects
Action Threshold: Increased seizure frequency, worsening mood symptoms, or intolerable side effects warrant dose adjustment or re-evaluation.
Suicidal ideation/behavior
Frequency: Regularly, especially during initial therapy or dose changes
Target: Absence of new or worsening suicidal thoughts/behaviors
Action Threshold: Any report of suicidal ideation or behavior requires immediate clinical assessment and intervention.
Drug levels (therapeutic drug monitoring)
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: Not well-defined, but generally 2-20 mcg/mL for epilepsy; 3-14 mcg/mL for bipolar disorder (guidance only, clinical response is primary).
Action Threshold: Levels outside expected range, especially if correlated with clinical symptoms or lack of efficacy.
Symptom Monitoring
- Skin rash (any type, especially severe, widespread, or blistering)
- Fever, swollen glands, facial swelling
- Sore throat, mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- New or worsening depression, anxiety, or irritability
- Panic attacks
- Insomnia
- Aggressiveness, agitation, restlessness
- Mania or hypomania
- Other unusual changes in behavior or mood
- Suicidal thoughts or attempts
- Changes in seizure pattern
- Dizziness, blurred vision, double vision, unsteadiness
Special Patient Groups
Pregnancy
Lamotrigine crosses the placenta. While older classification was Category C, current data suggest it is associated with a small increased risk of oral clefts when used in the first trimester, particularly at higher doses. However, the risk is generally considered low, and the benefits of seizure control often outweigh the risks. Enrollment in a pregnancy registry is recommended.
Trimester-Specific Risks:
First Trimester:
Small increased risk of oral clefts (e.g., cleft lip/palate).
Second Trimester:
No specific increased risk of malformations identified.
Third Trimester:
May see decreased lamotrigine levels due to increased clearance; monitor clinical response. Potential for withdrawal symptoms in neonate if discontinued abruptly.
Lactation
Lamotrigine is excreted into breast milk. The amount varies, and some infants may experience adverse effects (e.g., rash, apnea, drowsiness). Monitor breastfed infants for rash, drowsiness, poor feeding, and apnea. Weigh benefits of breastfeeding against potential risks.
Infant Risk:
L3 (Moderately Safe) - Monitor infant for adverse effects.
Pediatric Use
Approved for epilepsy in children âĨ2 years of age and for bipolar disorder in adolescents âĨ18 years. Dosing requires careful titration based on age, weight, and concomitant medications. Higher incidence of serious rash in pediatric patients.
Geriatric Use
No specific dose adjustment based on age alone. Start with lower doses and titrate slowly, monitoring for adverse effects, especially dizziness and ataxia, due to potential for decreased renal/hepatic function and polypharmacy.
Clinical Information
Clinical Pearls
- The 'Green Starter Kit' is specifically designed for patients NOT taking valproate and NOT taking enzyme-inducing AEDs (e.g., carbamazepine, phenytoin, phenobarbital). Different starter kits exist for other concomitant medication profiles.
- Slow titration is CRITICAL to minimize the risk of serious rash. Do not accelerate the titration schedule.
- Educate patients thoroughly about the signs and symptoms of serious rash and the importance of immediate discontinuation and medical attention if a rash develops.
- Lamotrigine levels can be significantly affected by other medications, particularly valproate (increases levels) and enzyme-inducing AEDs/oral contraceptives (decrease levels). Adjust dosing accordingly.
- While therapeutic drug monitoring is not routinely recommended, it can be useful in specific situations (e.g., pregnancy, suspected non-adherence, drug interactions, renal/hepatic impairment, or when clinical response is unclear).
- Lamotrigine is effective for both focal and generalized seizures, including Lennox-Gastaut syndrome. It is also a first-line mood stabilizer for bipolar depression.
Alternative Therapies
- Levetiracetam (Keppra)
- Topiramate (Topamax)
- Carbamazepine (Tegretol)
- Valproate (Depakote)
- Oxcarbazepine (Trileptal)
- Gabapentin (Neurontin)
- Pregabalin (Lyrica)
- Lithium
- Quetiapine (Seroquel)
- Lurasidone (Latuda)
Cost & Coverage
Average Cost:
$100 - $300+ per 30 tablets (for brand Lamictal, generic is much lower)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (generic) or Tier 2-3 (brand)
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, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.