Lamictal ODT 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. @ 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 derivative, Voltage-gated sodium channel blocker
Pregnancy Category
Category C
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 stabilize mood in people with bipolar disorder. It works by calming overactive brain signals. The ODT (Orally Disintegrating Tablet) form dissolves quickly in your mouth.
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.
It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. To take the medication correctly, place it on your tongue and let it dissolve. You don't need to drink water with it. Do not swallow the medication whole, and avoid chewing, breaking, or crushing it.
Important Safety Information
Do not change your dose or stop taking this medication without talking to your doctor first. Stopping the medication abruptly can cause seizures. If you need to stop taking the medication, your doctor will instruct you on how to gradually reduce the dose to minimize the risk of side effects.
If you've stopped taking the medication and need to restart it, consult with your doctor. You may need to begin with a lower dose and gradually increase it as directed by your doctor.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, and avoid storing it in a bathroom. Make sure to keep all medications 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 by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food.
It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. To take the medication correctly, place it on your tongue and let it dissolve. You don't need to drink water with it. Do not swallow the medication whole, and avoid chewing, breaking, or crushing it.
Important Safety Information
Do not change your dose or stop taking this medication without talking to your doctor first. Stopping the medication abruptly can cause seizures. If you need to stop taking the medication, your doctor will instruct you on how to gradually reduce the dose to minimize the risk of side effects.
If you've stopped taking the medication and need to restart it, consult with your doctor. You may need to begin with a lower dose and gradually increase it as directed by your doctor.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, and avoid storing it in a bathroom. Make sure to keep all medications 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 by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take exactly as prescribed; do not stop taking it suddenly, as this can cause seizures to worsen or new seizures to occur.
- Report any rash immediately to your doctor, even if it seems mild. This is a serious side effect.
- Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness or blurred vision.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.
- If you are taking oral contraceptives, discuss with your doctor as your lamotrigine dose may need adjustment.
- Avoid alcohol or other CNS depressants, as they can increase side effects like dizziness and drowsiness.
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:
Highly variable based on indication and concomitant medications. Requires slow titration over several weeks to minimize rash risk.
Dose Range:
25 - 700 mg
Condition-Specific Dosing:
Epilepsy (adjunctive, without valproate or enzyme-inducing AEDs):
Initial: 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks. Maintenance: 300-500 mg/day in 2 divided doses.
Epilepsy (adjunctive, with valproate):
Initial: 25 mg every other day for 2 weeks, then 25 mg daily for 2 weeks. Maintenance: 100-200 mg/day in 1-2 divided doses.
Epilepsy (adjunctive, with enzyme-inducing AEDs without valproate):
Initial: 50 mg daily for 2 weeks, then 100 mg daily in 2 divided doses for 2 weeks. Maintenance: 300-500 mg/day in 2 divided doses.
Bipolar I Disorder (maintenance):
Initial: 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then 100 mg daily for 1 week. Target maintenance: 200 mg/day (some patients may require 100 mg/day or 400 mg/day).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 2 years for monotherapy or adjunctive therapy for partial seizures. Approved for Lennox-Gastaut syndrome and partial seizures in children âĨ2 years.
Child:
Dosing is weight-based and depends on concomitant medications. For children 2-12 years, initial doses range from 0.3-0.6 mg/kg/day, titrated slowly. Maintenance doses vary widely (e.g., 1-15 mg/kg/day).
Adolescent:
Generally follows adult dosing guidelines, especially for those over 50 kg.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Consider dose reduction in patients with significant renal impairment. Use with caution.
Dialysis:
Lamotrigine is minimally dialyzable. Supplemental doses after dialysis are generally not required, but clinical monitoring is advised.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Initial, escalation, and maintenance doses should be reduced by approximately 25%.
Severe:
Initial, escalation, and maintenance doses should be reduced by approximately 50%.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that is thought to exert its anticonvulsant and mood-stabilizing effects by blocking voltage-sensitive sodium channels. This action stabilizes neuronal membranes, thereby inhibiting the release of excitatory neurotransmitters (primarily glutamate and aspartate) in the brain. It may also modulate voltage-gated calcium channels and inhibit neuronal firing.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1-4 hours (oral tablets), ODT may be slightly faster.
FoodEffect:
Minimal effect on absorption.
Distribution:
Vd:
0.97-1.36 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); ~15 hours (with enzyme inducers); ~59 hours (with valproate)
Clearance:
Highly variable depending on concomitant medications.
ExcretionRoute:
Urine (primarily as glucuronide conjugates)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration schedule)
PeakEffect:
Steady state achieved after several weeks of titration.
DurationOfAction:
Related to half-life, typically once or twice daily dosing.
Safety & Warnings
BLACK BOX WARNING
Serious Skin Rashes: Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. These include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). The incidence of these rashes, which have resulted in death, is greater in pediatric patients than in adults. Other risk factors include concomitant use of valproate, exceeding recommended initial doses, and exceeding recommended dose escalation.
Side Effects
Serious Side Effects: Seek Medical Attention 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 help 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 increase the risk of bleeding, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem: Hemophagocytic Lymphohistiocytosis (HLH)
In rare cases, this medication can cause a life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical help 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 or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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 increase the risk of bleeding, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem: Hemophagocytic Lymphohistiocytosis (HLH)
In rare cases, this medication can cause a life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical help 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 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 blistering, peeling, or widespread redness)
- Fever, swollen glands, or flu-like symptoms
- Sores in your mouth or around your eyes
- Swelling of your face or lips
- Difficulty breathing or swallowing
- Unusual bruising or bleeding
- Yellowing of your skin or eyes (jaundice)
- Dark urine or severe stomach pain
- New or worsening depression, anxiety, or suicidal thoughts
- Changes in behavior or mood
- Severe dizziness, loss of coordination, or double vision
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 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 health problems, both current and past
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 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, 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 health problems, both current and past
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 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 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 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. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult with your pharmacist.
Heart-Related Warnings
If you have a history of abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heart rhythms can occur in individuals with certain heart conditions, which may lead to sudden death.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
Interactions with Birth Control
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may 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 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 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. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult with your pharmacist.
Heart-Related Warnings
If you have a history of abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heart rhythms can occur in individuals with certain heart conditions, which may lead to sudden death.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
Interactions with Birth Control
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may 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:
- Ataxia (loss of coordination)
- Nystagmus (involuntary eye movements)
- Increased seizures
- Decreased consciousness or coma
- Dizziness
- Headache
- Tachycardia
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive; there is no specific antidote.
Drug Interactions
Major Interactions
- Valproate (significantly increases lamotrigine levels, requiring dose reduction of lamotrigine)
- Carbamazepine, Phenytoin, Phenobarbital, Primidone (significantly decrease lamotrigine levels, requiring dose increase of lamotrigine)
- Estrogen-containing oral contraceptives (decrease lamotrigine levels, requiring dose increase of lamotrigine)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/Ritonavir, Atazanavir/Ritonavir (decrease lamotrigine levels)
Moderate Interactions
- Acetaminophen (may slightly decrease lamotrigine levels with chronic use)
- Sertraline (may slightly increase lamotrigine levels)
- Risperidone, Olanzapine, Lithium (potential for additive CNS effects, monitor for sedation or other CNS depression)
- Folic acid inhibitors (e.g., methotrexate, trimethoprim) - theoretical concern for additive folate deficiency, but not clinically significant for lamotrigine.
Minor Interactions
- Bupropion (may increase lamotrigine levels, monitor for adverse effects)
Monitoring
Baseline Monitoring
Skin examination
Rationale: To establish baseline and educate patient on rash symptoms, especially Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Timing: Prior to initiation
Renal and Hepatic function tests
Rationale: To assess baseline organ function, especially if impairment is suspected, as dose adjustments may be needed.
Timing: Prior to initiation (if clinically indicated)
Complete Blood Count (CBC)
Rationale: Rare reports of blood dyscrasias (e.g., neutropenia, aplastic anemia).
Timing: Prior to initiation (if clinically indicated)
Routine Monitoring
Clinical response (seizure frequency/severity, mood stability)
Frequency: Regularly during titration and maintenance
Target: Individualized, aiming for optimal control with minimal side effects.
Action Threshold: Lack of efficacy or intolerable side effects may warrant dose adjustment or alternative therapy.
Adverse effects monitoring (especially rash, CNS effects)
Frequency: Frequent during titration, then regularly during maintenance
Target: Absence of severe adverse effects.
Action Threshold: Any signs of severe rash (e.g., fever, facial swelling, lymphadenopathy, mucosal involvement) require immediate discontinuation. Significant CNS effects (e.g., severe dizziness, ataxia) may require dose adjustment.
Suicidal ideation/behavior
Frequency: Regularly, especially during initial therapy and dose changes
Target: Absence of suicidal thoughts or behaviors.
Action Threshold: Any emergence or worsening of suicidal thoughts or behaviors requires immediate clinical evaluation and intervention.
Symptom Monitoring
- Skin rash (especially blistering, peeling, widespread redness)
- Fever
- Swollen lymph nodes
- Facial swelling
- Sore throat
- Mouth sores
- Eye irritation (redness, swelling)
- Unusual bruising or bleeding
- Worsening depression or mood changes
- New or worsening suicidal thoughts or behaviors
- Signs of liver problems (e.g., yellowing skin/eyes, dark urine, severe stomach pain)
- Signs of blood problems (e.g., persistent sore throat, fever, unusual tiredness, pale skin)
- Dizziness
- Ataxia (loss of coordination)
- Blurred or double vision
- Headache
- Nausea/vomiting
Special Patient Groups
Pregnancy
Lamotrigine is classified as Pregnancy Category C. While registry data suggest a potential increased risk of oral clefts (e.g., cleft lip/palate) when exposed during the first trimester, the overall absolute risk is considered low. The decision to use lamotrigine during pregnancy should weigh the potential risks to the fetus against the benefits of seizure control for the mother. Lamotrigine clearance may increase during pregnancy, potentially requiring dose adjustments.
Trimester-Specific Risks:
First Trimester:
Potential slightly increased risk of oral clefts. Close monitoring of lamotrigine levels may be considered due to increased clearance.
Second Trimester:
Increased lamotrigine clearance may continue, requiring dose adjustments to maintain therapeutic levels.
Third Trimester:
Increased lamotrigine clearance may continue. Monitor for potential withdrawal symptoms in the neonate if maternal dose is high.
Lactation
Lamotrigine is excreted into breast milk. The amount varies, but infant serum concentrations can be significant. Monitor breastfed infants for adverse effects such as rash, sedation, poor feeding, and weight gain. The benefits of breastfeeding should be weighed against the potential risks to the infant. L3 (Moderately Safe).
Infant Risk:
Low to moderate risk. Potential for rash, sedation, poor feeding, and weight gain. Monitor infant closely.
Pediatric Use
The risk of serious rash (SJS/TEN) is higher in pediatric patients (especially those under 16 years) compared to adults. Dosing is complex, weight-based, and depends on concomitant medications. Approved for adjunctive treatment of partial seizures and Lennox-Gastaut syndrome in patients âĨ2 years of age. Not recommended for monotherapy in children <16 years.
Geriatric Use
Start with lower doses and titrate slowly, similar to adult dosing but with increased caution. Monitor closely for adverse effects, particularly CNS effects (dizziness, ataxia) and rash, as geriatric patients may be more sensitive to these effects. Renal and hepatic function should be considered.
Clinical Information
Clinical Pearls
- The slow titration schedule is paramount to minimize the risk of serious skin rashes. Patients must be educated on this.
- Significant drug interactions exist, particularly with valproate (increases lamotrigine levels) and enzyme-inducing AEDs/oral contraceptives (decrease lamotrigine levels). Dose adjustments are crucial.
- Lamotrigine is unique in its dual indication for epilepsy and bipolar disorder, making it a valuable option for patients with comorbid conditions.
- ODT formulation offers convenience for patients who have difficulty swallowing tablets or prefer not to take with water.
- While therapeutic drug monitoring (TDM) is not routinely recommended, it can be useful in specific situations (e.g., suspected non-adherence, toxicity, drug interactions, pregnancy, or lack of efficacy).
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Topiramate, Oxcarbazepine, Zonisamide, Phenytoin, Gabapentin, Pregabalin.
- For Bipolar I Disorder (maintenance): Lithium, Valproate, Carbamazepine, Quetiapine, Olanzapine, Aripiprazole, Lurasidone.
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 30 tablets (200mg ODT)
Generic Available:
Yes
Insurance Coverage:
Generic lamotrigine is typically covered as Tier 1 or Tier 2. Brand-name Lamictal ODT may be Tier 3 or higher, requiring prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which 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, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.