Lamotrigine 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 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 stabilize mood in people with bipolar disorder. It works by calming overactive nerve signals in the brain. This specific form is an orally disintegrating tablet (ODT), meaning it dissolves quickly in your mouth.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
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 to feel well.
To take your medication:
+ Place the tablet on your tongue and let it dissolve. You don't need to drink water with it.
+ Do not swallow the tablet whole, chew it, break it, or crush it.
Important Warnings
Do not change your dose or stop taking this medication without talking to your doctor first. Suddenly stopping this medication can cause seizures.
If you need to stop taking this medication, your doctor will instruct you on how to gradually reduce your dose to minimize the risk of side effects.
If you stop taking this medication and need to restart it, your doctor may prescribe a lower dose and gradually increase it to minimize side effects.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Do not store it in a bathroom.
Keep all medications in a safe place, 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 disposing of medications, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and take your next dose at the regular time.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
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 to feel well.
To take your medication:
+ Place the tablet on your tongue and let it dissolve. You don't need to drink water with it.
+ Do not swallow the tablet whole, chew it, break it, or crush it.
Important Warnings
Do not change your dose or stop taking this medication without talking to your doctor first. Suddenly stopping this medication can cause seizures.
If you need to stop taking this medication, your doctor will instruct you on how to gradually reduce your dose to minimize the risk of side effects.
If you stop taking this medication and need to restart it, your doctor may prescribe a lower dose and gradually increase it to minimize side effects.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Do not store it in a bathroom.
Keep all medications in a safe place, 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 disposing of medications, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and take your next dose at the regular time.
* 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 stop taking lamotrigine suddenly, as this can cause seizures to worsen or lead to withdrawal symptoms. Any dose changes must be done slowly under medical supervision.
- Do not take more than the prescribed dose, especially during the initial titration phase, as this increases the risk of serious skin rash.
- Report any new skin rash immediately to your doctor. This is a serious side effect that requires urgent medical attention.
- Avoid activities requiring mental alertness, such as driving or operating machinery, until you know how lamotrigine affects you, as it can cause dizziness, drowsiness, or blurred vision.
- If you are taking oral contraceptives, discuss this with your doctor, as they can affect lamotrigine levels and vice versa. Your doctor may need to adjust your lamotrigine dose or recommend an alternative contraceptive method.
- Avoid alcohol or other CNS depressants, as they can increase drowsiness and dizziness.
- Carry a medical alert card or wear medical identification indicating that you take lamotrigine, especially if you have epilepsy.
Available Forms & Alternatives
Available Strengths:
- Lamotrigine 150mg Tablets
- Lamotrigine 200mg Tablets
- Lamotrigine 25mg Tablets
- Lamotrigine 100mg Tablets
- Lamotrigine 25mg Chew/disprsbl Tab
- Lamotrigine 5mg Chew/disprsbl Tab
- Lamotrigine ER 50mg Tablets
- Lamotrigine ER 200mg Tablets
- Lamotrigine ER 100mg Tablets
- Lamotrigine 300mg ER Tablets
- Lamotrigine ER 25mg Tablets
- Lamotrigine ODT 25mg Tablets
- Lamotrigine ODT 50mg Tablets
- Lamotrigine Orge Strt Kit25/100mg
- Lamotrigine Blue Starter Kit 25mg T
- Lamotrigine Green Str Kit 25/100mg
- Lamotrigine ODT 100mg Tablets
- Lamotrigine ODT 200mg Tablets
- Lamotrigine ER 250mg Tablets
- Lamotrigine ODT 25-50-100mg Tb Kit
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable, requires slow titration. For epilepsy monotherapy: Initial 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then increase by 50-100 mg/day every 1-2 weeks. Maintenance 100-400 mg/day in 1-2 divided doses. For bipolar disorder maintenance: 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. Dosing significantly varies based on concomitant medications (e.g., valproate, enzyme-inducing AEDs, oral contraceptives).
Dose Range:
25 - 700 mg
Condition-Specific Dosing:
epilepsy_monotherapy:
Initial 25 mg QD for 2 weeks, then 50 mg QD for 2 weeks, then increase by 50-100 mg/day every 1-2 weeks. Maintenance 100-400 mg/day in 1-2 divided doses.
epilepsy_with_valproate:
Initial 25 mg every other day for 2 weeks, then 25 mg QD for 2 weeks, then increase by 25-50 mg/day every 1-2 weeks. Maintenance 100-200 mg/day in 1-2 divided doses.
epilepsy_with_enzyme_inducers:
Initial 50 mg QD for 2 weeks, then 100 mg/day in 2 divided doses for 2 weeks, then increase by 100 mg/day every 1-2 weeks. Maintenance 300-500 mg/day in 2 divided doses (up to 700 mg/day reported).
bipolar_disorder_maintenance:
Initial 25 mg QD for 2 weeks, then 50 mg QD for 2 weeks, then 100 mg QD for 1 week, then 200 mg QD. Dosing adjustments needed if on valproate or enzyme-inducing AEDs.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy not established in children <2 years for epilepsy, <18 years for bipolar disorder)
Child:
Epilepsy (2-12 years): Dosing is weight-based and depends on concomitant medications. E.g., with valproate: Initial 0.15 mg/kg/day for 2 weeks, then 0.3 mg/kg/day for 2 weeks, then increase by 0.3 mg/kg/day every 1-2 weeks. Maintenance 1-5 mg/kg/day. With enzyme-inducers: Initial 0.6 mg/kg/day 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 5-15 mg/kg/day. Monotherapy: Initial 0.3 mg/kg/day for 2 weeks, then 0.6 mg/kg/day for 2 weeks, then increase by 0.6 mg/kg/day every 1-2 weeks. Maintenance 5-15 mg/kg/day.
Adolescent:
Epilepsy (âĨ12 years): Adult dosing guidelines apply. Bipolar disorder: Not indicated for acute treatment or maintenance in pediatric patients <18 years.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution. Reduced maintenance doses may be appropriate for patients with significant renal impairment. Initial titration should follow standard guidelines, but subsequent dose increases should be based on clinical response and tolerability.
Dialysis:
Supplemental doses after dialysis are generally not required. Use with caution, monitor clinical response.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Reduce initial, escalation, and maintenance doses by approximately 25%.
Severe:
Reduce initial, escalation, and maintenance doses by approximately 50%. Use with extreme caution and close monitoring.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that is thought to exert its anticonvulsant and mood-stabilizing effects by inhibiting voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and inhibiting the release of excitatory neurotransmitters (primarily glutamate and aspartate). It also has weak effects on voltage-gated calcium channels and may modulate serotonin 5-HT3 receptors.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1.4 to 4.8 hours (oral)
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
0.97 to 1.36 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); significantly affected by concomitant medications (e.g., ~15 hours with enzyme inducers, ~59 hours with valproate).
Clearance:
Approximately 30 mL/min/kg (adults)
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 10% (unchanged drug in urine)
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration required to minimize rash risk)
PeakEffect:
Weeks to months (after reaching stable 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), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). The incidence of these rashes, which have resulted in deaths, is approximately 0.3% to 0.8% in pediatric patients (2 to 16 years of age) and 0.08% to 0.3% in adults. The risk of serious rash is increased by coadministration with valproate, exceeding recommended initial doses, or exceeding the recommended dose escalation for lamotrigine. Benign rashes also occur, but it is not possible to predict which rashes will prove to be serious. Therefore, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
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
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem (Hemophagocytic Lymphohistiocytosis)
In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking
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 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 immediately or seek medical attention:
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
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem (Hemophagocytic Lymphohistiocytosis)
In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking
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 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 blistering, peeling, or widespread)
- Fever, swollen glands, or facial swelling accompanying a rash
- Sore throat, mouth sores, or eye irritation
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe muscle pain or weakness
- Worsening of seizures
- New or worsening depression, suicidal thoughts or behavior
- Unusual changes in mood or behavior (e.g., agitation, aggression, panic attacks, restlessness, irritability, impulsivity, severe insomnia, hypomania, mania)
- 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 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 medical history, including any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the medication is suitable for your specific situation.
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 medical history, including any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the medication is suitable for your specific situation.
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 aware that this medication may interfere with certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug.
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 suicidal thoughts or actions occur, 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
To avoid mix-ups, always verify that you have the correct medication, and check with your pharmacist if you notice any changes in the medication's appearance, such as shape, color, size, or labeling.
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 pre-existing heart conditions, which may lead to sudden death.
Pediatric Use
When administering this medication to children, use caution, as the risk of certain side effects may be higher in pediatric patients.
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 alternative forms of birth control, such as condoms, 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.
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 aware that this medication may interfere with certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug.
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 suicidal thoughts or actions occur, 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
To avoid mix-ups, always verify that you have the correct medication, and check with your pharmacist if you notice any changes in the medication's appearance, such as shape, color, size, or labeling.
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 pre-existing heart conditions, which may lead to sudden death.
Pediatric Use
When administering this medication to children, use caution, as the risk of certain side effects may be higher in pediatric patients.
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 alternative forms of birth control, such as condoms, 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.
Overdose Information
Overdose Symptoms:
- Nystagmus (involuntary eye movements)
- Ataxia (lack of coordination)
- Impaired consciousness
- Grand mal seizures
- Coma
- Intraventricular conduction delay (widened QRS on ECG)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally 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 serious rash)
- Carbamazepine (decreases lamotrigine levels)
- Phenytoin (decreases lamotrigine levels)
- Phenobarbital (decreases lamotrigine levels)
- Primidone (decreases lamotrigine levels)
- Oral contraceptives (estrogen-containing, decrease lamotrigine levels)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/ritonavir (decreases lamotrigine levels)
- Atazanavir/ritonavir (decreases lamotrigine levels)
- Dofetilide (potential for increased dofetilide levels, QT prolongation)
Moderate Interactions
- Acetaminophen (may slightly decrease lamotrigine levels with chronic high-dose use)
- Risperidone (lamotrigine may decrease risperidone levels)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Aripiprazole (lamotrigine may decrease aripiprazole levels)
- Zidovudine (lamotrigine may increase zidovudine levels)
- Folic acid inhibitors (e.g., methotrexate, trimethoprim - theoretical interaction, monitor)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for potential hematologic abnormalities (rare, but reported).
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
Skin assessment
Rationale: To establish baseline and educate patient on rash symptoms.
Timing: Prior to initiation
Routine Monitoring
Skin assessment for rash
Frequency: Daily during titration, then regularly
Target: Absence of rash
Action Threshold: Any new rash, especially if accompanied by fever, lymphadenopathy, or facial swelling, requires immediate discontinuation and medical evaluation.
Seizure frequency/severity (for epilepsy)
Frequency: Regularly, at each follow-up visit
Target: Reduction in seizures
Action Threshold: Increased seizure frequency or severity may indicate need for dose adjustment or alternative therapy.
Mood stability (for bipolar disorder)
Frequency: Regularly, at each follow-up visit
Target: Stabilization of mood, reduction in mood episodes
Action Threshold: Recurrence of mood episodes may indicate need for dose adjustment or alternative therapy.
Adverse effects (e.g., dizziness, ataxia, blurred vision, nausea)
Frequency: Regularly, at each follow-up visit
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Therapeutic Drug Monitoring (TDM)
Frequency: Not routinely recommended, but may be considered in specific situations (e.g., suspected non-adherence, drug interactions, renal/hepatic impairment, treatment failure, toxicity).
Target: Not well-defined, but generally 2-20 mcg/mL for epilepsy, 2-10 mcg/mL for bipolar disorder (highly variable and not directly correlated with efficacy/toxicity for all patients).
Action Threshold: Levels outside expected range or clinical correlation with efficacy/toxicity.
Symptom Monitoring
- Skin rash (especially blistering, peeling, or widespread)
- Fever
- Swollen lymph nodes
- Facial swelling
- Sore throat
- Mouth sores
- Eye irritation (conjunctivitis)
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe muscle pain or weakness
- Changes in seizure pattern
- Changes in mood or behavior (e.g., new or worsening depression, suicidal thoughts, anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania)
- Dizziness
- Ataxia (lack of coordination)
- Blurred or double vision
- Nausea
- Vomiting
- Headache
Special Patient Groups
Pregnancy
Lamotrigine is generally considered one of the safer antiepileptic drugs during pregnancy, but it is not without risk. Data from pregnancy registries suggest a low risk of major congenital malformations, but a slightly increased risk of oral clefts has been reported in some studies (though this finding is inconsistent across studies). The benefits of seizure control during pregnancy often outweigh the risks of medication. Dose adjustments may be needed during pregnancy due to changes in lamotrigine clearance.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of oral clefts (cleft lip/palate), though data are conflicting and overall risk is low. Close monitoring of lamotrigine levels may be considered due to potential for decreased levels.
Second Trimester:
Clearance of lamotrigine may increase, potentially leading to decreased serum levels and loss of seizure control. Dose adjustments may be necessary.
Third Trimester:
Clearance of lamotrigine continues to increase. Dose adjustments may be necessary. Monitor for potential withdrawal symptoms in the neonate if maternal levels are high at delivery.
Lactation
Lamotrigine is excreted into breast milk. Infant serum concentrations can be significant (up to 50% of maternal levels). Monitor breastfed infants for adverse effects such as drowsiness, poor feeding, rash, and apnea. Breastfeeding may be considered if the infant is monitored closely and the benefits outweigh the risks. Some experts suggest avoiding breastfeeding if the infant is premature or has impaired renal/hepatic function.
Infant Risk:
L3 (Moderate risk) - Monitor infant for drowsiness, poor feeding, rash, apnea. Consider therapeutic drug monitoring in the infant if concerns arise.
Pediatric Use
Safety and efficacy for epilepsy have been established in patients 2 years and older. Safety and efficacy for bipolar disorder have not been established in pediatric patients <18 years. Pediatric patients (especially <16 years) have a higher risk of developing serious skin rashes compared to adults. Dosing is weight-based and complex, requiring careful titration.
Geriatric Use
Use with caution. Elderly patients may be more sensitive to the adverse effects of lamotrigine, particularly dizziness, ataxia, and rash. Start with lower doses and titrate more slowly. Monitor renal and hepatic function, as age-related decline in these functions may affect lamotrigine clearance.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rashes (SJS/TEN). Patients must be educated thoroughly on this.
- Any rash, especially if accompanied by systemic symptoms (fever, lymphadenopathy, facial swelling), should prompt immediate discontinuation and medical evaluation.
- Dosing is highly dependent on concomitant medications. Valproate significantly increases lamotrigine levels, while enzyme-inducing AEDs (carbamazepine, phenytoin, phenobarbital) and oral contraceptives significantly decrease them. Adjustments are crucial.
- Lamotrigine ODT can be taken with or without water. It should be placed on the tongue and allowed to dissolve, then swallowed.
- While not routinely monitored, TDM can be useful in cases of suspected non-adherence, drug interactions, renal/hepatic impairment, or treatment failure/toxicity.
- Lamotrigine is a common choice for women of childbearing potential with epilepsy due to its relatively lower teratogenic risk compared to some other AEDs, but careful counseling and monitoring are still essential.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Oxcarbazepine, Phenytoin, Valproate, Topiramate, Zonisamide, Gabapentin, Pregabalin, Lacosamide, Perampanel, Rufinamide, Clobazam, Eslicarbazepine, Felbamate, Tiagabine, Vigabatrin.
- For Bipolar Disorder (Maintenance): Lithium, Valproate, Carbamazepine, Quetiapine, Olanzapine, Aripiprazole, Lurasidone.
Cost & Coverage
Average Cost:
$100 - $300 per 30 tablets (200mg ODT)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.