Lamotrigine ODT 25-50-100mg Tb Kit
WARNING: Severe skin reactions may happen with this drug. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands. The chance of a skin reaction is raised in children between 2 and 17 years old. It may also be raised if you take valproic acid or divalproex sodium with this drug, if you start taking this drug at too high of a dose, or if your dose is raised too fast. Skin reactions have also happened without any of these. Talk with your doctor.Most cases of skin reactions have happened within 2 to 8 weeks of starting this drug, but some show up after longer treatment like 6 months. Talk with the doctor. @ 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
Pregnancy Category
Category C
FDA Approved
Jul 2009
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 electrical signals in the brain. The ODT (Orally Disintegrating Tablet) form dissolves quickly in your mouth, making it easier to take.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
Administration Instructions
To take this medication, 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 Warnings
Do not change your dose or stop taking this medication without consulting your doctor, as this can increase your risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dose to minimize potential side effects. If you stop taking this medication and need to restart it, your doctor may recommend starting with a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in a drug take-back program in your area.
Missing 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 dose, skip the missed dose and resume your regular 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. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
Administration Instructions
To take this medication, 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 Warnings
Do not change your dose or stop taking this medication without consulting your doctor, as this can increase your risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dose to minimize potential side effects. If you stop taking this medication and need to restart it, your doctor may recommend starting with a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in a drug take-back program in your area.
Missing 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 dose, skip the missed dose and resume your regular 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 without consulting your doctor, as this can cause withdrawal seizures or worsening of your condition.
- Report any rash immediately to your doctor, as it could be a sign of a serious, life-threatening reaction.
- Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Do not chew, crush, or split the ODT tablets. Place the tablet on your tongue and allow it to dissolve, then swallow with or without water.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, herbal supplements, and birth control pills, as they can affect lamotrigine levels.
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:
Initial dose varies based on concomitant medications and indication, followed by slow titration. Maintenance doses typically range from 100 mg/day to 500 mg/day.
Dose Range:
100 - 500 mg
Condition-Specific Dosing:
Epilepsy (Monotherapy, or with non-interacting AEDs):
Initial: 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks. Increase by 50-100 mg/day every 1-2 weeks. Maintenance: 250-375 mg/day (divided doses).
Epilepsy (with Valproate):
Initial: 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks. Increase by 25-50 mg/day every 1-2 weeks. Maintenance: 100-200 mg/day (divided doses).
Epilepsy (with Enzyme-Inducing AEDs, without Valproate):
Initial: 50 mg once daily for 2 weeks, then 100 mg/day (divided) for 2 weeks. Increase by 100 mg/day every 1-2 weeks. Maintenance: 300-500 mg/day (divided doses).
Bipolar I 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. Maintenance: 100-400 mg/day (once daily or divided).
Note on ODT Kit:
The 25-50-100mg kit is designed to facilitate the initial titration phase, providing specific doses for the first weeks of treatment.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Approved for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients âĨ2 years. Dosing is weight-based and highly dependent on concomitant medications (similar interaction principles as adults). Requires careful, slow titration. Consult specific guidelines for detailed weight-based dosing.
Adolescent:
For patients >12 years, dosing generally follows adult guidelines, with careful titration based on concomitant medications and indication.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor for adverse effects.
Moderate:
Consider lower maintenance doses and/or slower titration, especially if creatinine clearance <30 mL/min. Monitor for adverse effects.
Severe:
Consider lower maintenance doses and/or slower titration (e.g., 50% reduction in maintenance dose). Monitor for adverse effects.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed. Monitor clinical response and adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Consider a 25% reduction in initial, escalation, and maintenance doses (Child-Pugh Class B).
Severe:
Consider a 50% reduction in initial, escalation, and maintenance doses (Child-Pugh Class C). Monitor for adverse effects.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that is thought to exert its anticonvulsant and mood-stabilizing effects by inhibiting voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and modulating the release of excitatory neurotransmitters (e.g., glutamate and aspartate). It may also inhibit voltage-gated calcium channels and reduce synaptic release of glutamate.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1.4 to 4.8 hours (oral tablet); ODT formulation has similar PK profile.
FoodEffect:
Minimal effect on absorption.
Distribution:
Vd:
0.97 to 1.36 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-30 hours (can vary significantly with concomitant medications: ~15 hours with enzyme inducers, ~59 hours with valproate)
Clearance:
Approximately 0.3 mL/min/kg
ExcretionRoute:
Urine (94%, primarily as glucuronide conjugates), Feces (2%)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
Gradual (due to slow titration to minimize rash risk); therapeutic effects may take weeks to months.
PeakEffect:
Not precisely defined for chronic therapeutic effect; plasma concentrations peak within hours of a dose.
DurationOfAction:
Sustained effect with chronic dosing; related to half-life and steady-state concentrations.
Confidence:
High
Safety & Warnings
BLACK BOX WARNING
Lamotrigine can cause serious skin 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 (aged 2 to 16 years) and 0.08% to 0.3% in adults. Risk factors include high initial doses, rapid dose escalation, and concomitant use of valproate. Benign rashes also occur, but it is not possible to predict which rashes will prove to be serious or life-threatening. Therefore, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful menstrual periods
Changes in menstrual cycle, including spotting or bleeding between periods
Additionally, 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
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
Balance problems
Difficulty walking
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following symptoms or if they persist or worsen:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Sleep disturbances
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
This is not an exhaustive list of possible side effects. If you have concerns about side effects or experience any symptoms not listed here, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful menstrual periods
Changes in menstrual cycle, including spotting or bleeding between periods
Additionally, 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
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
Balance problems
Difficulty walking
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following symptoms or if they persist or worsen:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Sleep disturbances
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
This is not an exhaustive list of possible side effects. If you have concerns about side effects or experience any symptoms not listed here, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any new or worsening skin rash (especially if accompanied by fever, swollen glands, mouth sores, or facial swelling)
- Fever, chills, body aches, or flu-like symptoms
- Swelling of the face, lips, or tongue
- Sore throat or mouth ulcers
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Severe muscle pain or weakness
- Changes in vision (e.g., blurred vision, double vision)
- Worsening depression, suicidal thoughts, or unusual changes in behavior or mood
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. This will help ensure your safety and prevent potential interactions with other medications.
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 medication.
Monitoring and Lab Tests
Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions 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 taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. 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 aseptic meningitis, a severe brain problem. 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 Problems
If you have an abnormal heartbeat, heart failure, or other heart problems, discuss your condition with your doctor, as this medication may increase the risk of abnormal heartbeats, which can lead to sudden death.
Pediatric Use
When used in children, this medication requires careful monitoring, as the risk of certain side effects may be higher in this population.
Birth Control and Hormone-Based Therapies
If you are taking birth control pills or other hormone-based therapies, inform your doctor, as these medications may interact with this drug. The effectiveness of birth control pills may be reduced, and the risk of side effects may increase during the week when the pills are not active. Consider using an additional form of birth control, such as a condom, to prevent 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, about your treatment. This will help ensure your safety and prevent potential interactions with other medications.
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 medication.
Monitoring and Lab Tests
Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions 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 taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. 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 aseptic meningitis, a severe brain problem. 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 Problems
If you have an abnormal heartbeat, heart failure, or other heart problems, discuss your condition with your doctor, as this medication may increase the risk of abnormal heartbeats, which can lead to sudden death.
Pediatric Use
When used in children, this medication requires careful monitoring, as the risk of certain side effects may be higher in this population.
Birth Control and Hormone-Based Therapies
If you are taking birth control pills or other hormone-based therapies, inform your doctor, as these medications may interact with this drug. The effectiveness of birth control pills may be reduced, and the risk of side effects may increase during the week when the pills are not active. Consider using an additional form of birth control, such as a condom, to prevent 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
- Coma
- Dizziness
- Headache
What to Do:
Seek immediate medical attention or call Poison Control (1-800-222-1222). Treatment is supportive; there is no specific antidote. Gastric lavage or activated charcoal may be considered if ingestion is recent.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels significantly, requiring lower lamotrigine doses)
- Carbamazepine, Phenytoin, Phenobarbital, Primidone (decrease lamotrigine levels significantly, requiring higher lamotrigine doses)
- Estrogen-containing Oral Contraceptives (can decrease lamotrigine levels, requiring dose adjustment)
- Rifampin (decreases lamotrigine levels)
Moderate Interactions
- Lopinavir/Ritonavir (can decrease lamotrigine levels)
- Atazanavir/Ritonavir (can decrease lamotrigine levels)
- Paracetamol (high doses, chronic use; may slightly decrease lamotrigine levels)
- Risperidone (lamotrigine may decrease risperidone levels)
Minor Interactions
- Sertraline (may slightly decrease lamotrigine levels)
- Lithium (no significant PK interaction, but monitor for additive CNS effects)
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To establish baseline for potential severe rash (SJS/TEN, DRESS).
Timing: Prior to initiation.
Renal and Hepatic function tests
Rationale: To guide initial dosing and identify need for dose adjustment in impaired patients.
Timing: Prior to initiation, if impairment is suspected or known.
Complete Blood Count (CBC)
Rationale: Rare reports of blood dyscrasias; establish baseline.
Timing: Prior to initiation.
Routine Monitoring
Clinical response (seizure frequency/severity, mood stability)
Frequency: Regularly during titration and maintenance.
Target: Individualized based on therapeutic goals.
Action Threshold: Worsening symptoms or lack of efficacy may require dose adjustment or alternative therapy.
Adverse effects (especially rash, fever, lymphadenopathy, facial swelling)
Frequency: Daily during titration, then regularly.
Target: Absence of severe symptoms.
Action Threshold: Any signs of severe rash (e.g., SJS/TEN, DRESS) require immediate discontinuation and medical evaluation. Other intolerable side effects may require dose adjustment or discontinuation.
Lamotrigine plasma concentrations
Frequency: Not routinely recommended, but useful in specific situations.
Target: Typically 2-20 mcg/mL (varies by lab and indication).
Action Threshold: Consider if suspected toxicity, non-response, significant drug interactions, or adherence issues. Adjust dose to achieve therapeutic range or manage toxicity.
Symptom Monitoring
- Skin rash (any type, especially widespread or blistering)
- Fever
- Swollen lymph nodes (lymphadenopathy)
- Facial swelling
- Sore throat
- Mouth sores or ulcers
- Eye irritation or conjunctivitis
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Severe muscle pain or weakness
- Flu-like symptoms
- Worsening seizures
- Changes in mood or behavior (e.g., new or worsening depression, anxiety, agitation, suicidal thoughts)
- Dizziness, ataxia, blurred vision, diplopia
Special Patient Groups
Pregnancy
Use during pregnancy should be carefully considered, weighing potential benefits against risks. Lamotrigine is excreted into breast milk. Pregnancy can decrease lamotrigine levels, requiring dose adjustments.
Trimester-Specific Risks:
First Trimester:
Some studies suggest a potential, though debated, slight increase in the risk of oral clefts (e.g., cleft lip/palate) when exposed during the first trimester. However, large registry data generally show a low risk of major congenital malformations compared to the general population. The risk of untreated epilepsy or bipolar disorder to the mother and fetus must also be considered.
Second Trimester:
No specific increased risks identified beyond general pregnancy risks. Lamotrigine levels may decrease, requiring dose adjustment.
Third Trimester:
No specific increased risks identified beyond general pregnancy risks. Lamotrigine levels may continue to decrease, requiring dose adjustment. Monitor infant for potential withdrawal symptoms if mother's dose was high.
Lactation
Lamotrigine is excreted into breast milk. Breastfeeding is generally considered compatible with lamotrigine use, but infants should be monitored for adverse effects.
Infant Risk:
L3 (Moderately Safe). Monitor breastfed infants for signs of adverse effects such as rash, sedation, poor feeding, or poor weight gain. Plasma levels in infants are generally low, but individual variability exists.
Pediatric Use
Approved for certain seizure types in children âĨ2 years. Requires careful, slow, weight-based titration due to increased risk of severe rash in this population. Not approved for bipolar disorder in pediatric patients.
Geriatric Use
Start with lower initial doses and titrate slowly, as geriatric patients may be more sensitive to the effects of lamotrigine and may have age-related decreases in renal or hepatic function. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of severe, life-threatening skin rashes (SJS/TEN, DRESS). Patients must be thoroughly educated on this.
- Concomitant medications, especially valproate (increases lamotrigine levels) and enzyme-inducing AEDs (decreases lamotrigine levels), significantly impact lamotrigine dosing and require specific titration schedules.
- Oral disintegrating tablets (ODT) are designed to dissolve on the tongue and can be taken without water, which can be beneficial for patients with dysphagia or those who prefer not to take pills with water.
- Patients should be advised to report any rash immediately, regardless of appearance, and to discontinue the medication unless otherwise instructed by a healthcare professional.
- Lamotrigine can cause aseptic meningitis, though rare. Symptoms include headache, fever, nausea, vomiting, nuchal rigidity, rash, photophobia, and somnolence. Discontinue if suspected.
- Suicidal ideation and behavior are a risk with all antiepileptic drugs; monitor patients for new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior.
Alternative Therapies
- Other antiepileptic drugs (e.g., Levetiracetam, Topiramate, Carbamazepine, Valproate, Oxcarbazepine, Phenytoin)
- Other mood stabilizers for bipolar disorder (e.g., Lithium, Valproate, Carbamazepine, Quetiapine, Olanzapine)
Cost & Coverage
Average Cost:
Varies widely by pharmacy, dosage, and quantity (e.g., $30-$200+ for a 30-day supply of generic, higher for brand). per 30 tablets
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, or require prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 is a valuable resource that provides important information. 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.