Lamictal 25mg Chewabl Disprsbl Tabs
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
Not available
FDA Approved
Dec 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamotrigine is a medication used to treat certain types of seizures (epilepsy) and to help prevent mood swings in people with bipolar disorder. It works by calming overactive nerve signals in the brain. It's very important to start this medication at a low dose and increase it very slowly to reduce the risk of a serious skin rash.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, 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're feeling well. You can swallow the tablet whole, chew it, or mix it with water or fruit juice. If you choose to chew the tablet, be sure to drink a little water or fruit juice to help with swallowing.
If you need to break up the tablet, you can do so by adding a liquid to cover the tablet in a glass or spoon. Wait at least 1 minute for the tablet to break up completely, then mix and drink.
Important Safety Information
Do not change your dose or stop taking this medication without consulting your doctor, as this can increase the risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to do so gradually to minimize the risk of side effects. If you've stopped taking this medication and need to restart, 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, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. 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. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore 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 dose, skip the missed dose and return to 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.
It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you're feeling well. You can swallow the tablet whole, chew it, or mix it with water or fruit juice. If you choose to chew the tablet, be sure to drink a little water or fruit juice to help with swallowing.
If you need to break up the tablet, you can do so by adding a liquid to cover the tablet in a glass or spoon. Wait at least 1 minute for the tablet to break up completely, then mix and drink.
Important Safety Information
Do not change your dose or stop taking this medication without consulting your doctor, as this can increase the risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to do so gradually to minimize the risk of side effects. If you've stopped taking this medication and need to restart, 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, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. 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. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore 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 dose, skip the missed dose and return to 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, as this can cause seizures or worsening mood.
- Report any new skin rash immediately to your doctor, as this can be a sign of a serious side effect.
- Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Avoid alcohol, as it can increase side effects.
- If you are taking oral contraceptives, discuss with your doctor as they can affect lamotrigine levels and vice versa.
- Chewable dispersible tablets can be chewed or dispersed in a small amount of water (at least 1 teaspoon or 5 mL) and then swallowed immediately.
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 individualized, requires slow titration to minimize rash risk. Initial dose typically 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 dose varies based on indication and concomitant medications.
Dose Range:
100 - 700 mg
Condition-Specific Dosing:
Epilepsy (monotherapy):
Maintenance: 225-375 mg/day in 2 divided doses.
Epilepsy (adjunctive, with valproate):
Maintenance: 100-400 mg/day in 1-2 divided doses.
Epilepsy (adjunctive, with enzyme-inducing AEDs):
Maintenance: 300-500 mg/day in 2 divided doses.
Bipolar I Disorder (maintenance):
Maintenance: 200 mg/day (up to 400 mg/day in some cases) in 1-2 divided doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (generally not recommended under 2 years due to rash risk and lack of efficacy data)
Child:
Dosing is weight-based and depends heavily on concomitant medications (e.g., with valproate, with enzyme-inducing AEDs, or without). Titration is slower and initial doses are lower (e.g., 0.15 mg/kg/day).
Adolescent:
Similar to adult dosing, but titration may be more cautious, especially if under 50 kg.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, but caution advised.
Severe:
Consider dose reduction in patients with significant renal impairment (CrCl < 30 mL/min). Initial dose may be reduced by 25-50%.
Dialysis:
Supplemental doses after dialysis are generally not needed as only a small fraction is removed. Monitor clinical response.
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%. Monitor closely for adverse effects.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that stabilizes neuronal membranes and inhibits the release of excitatory neurotransmitters (primarily glutamate and aspartate) by blocking voltage-sensitive sodium channels. It also weakly inhibits 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 (monotherapy)
ExcretionRoute:
Renal (94% as metabolites, 6% unchanged)
Unchanged:
Approximately 6%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration)
PeakEffect:
Weeks to months (after reaching maintenance dose)
DurationOfAction:
Related to half-life, but clinical effect is sustained with regular 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 deaths, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 16 years) 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.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to 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, or swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful periods or 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
Balance problems
Difficulty walking (new or worsening)
Other Side Effects
Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Sleep disturbances
Nose or throat irritation
Weight loss
Dry mouth
Back pain
Reporting Side Effects
If you have questions about side effects or experience any side effects 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 right away:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to 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, or swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful periods or 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
Balance problems
Difficulty walking (new or worsening)
Other Side Effects
Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Sleep disturbances
Nose or throat irritation
Weight loss
Dry mouth
Back pain
Reporting Side Effects
If you have questions about side effects or experience any side effects 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 skin rash (especially blistering, peeling, or widespread)
- Fever, swollen glands, or flu-like symptoms
- Sore throat or mouth sores
- Swelling of the face, eyes, lips, or tongue
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe muscle pain
- New or worsening depression, anxiety, or suicidal thoughts
- Changes in behavior (e.g., aggression, agitation, restlessness)
- Vision changes (e.g., double vision, blurred vision)
- Aseptic meningitis symptoms (severe headache, stiff neck, fever, nausea, vomiting, sensitivity to light, confusion)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure 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 medical history, including any health problems you have
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure 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 medical history, including any health problems you have
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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 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 thoughts or behaviors. 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 problem 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
To ensure you receive the correct medication, always verify the product's appearance, shape, color, size, and labeling. If you notice any changes, consult with your pharmacist.
Heart Problems
If you have an abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with certain heart conditions.
Pediatric Use
When 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 birth control methods may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based methods may be less effective in preventing pregnancy when taking this medication. Use alternative birth control methods, such as condoms, 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.
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 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 thoughts or behaviors. 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 problem 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
To ensure you receive the correct medication, always verify the product's appearance, shape, color, size, and labeling. If you notice any changes, consult with your pharmacist.
Heart Problems
If you have an abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with certain heart conditions.
Pediatric Use
When 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 birth control methods may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based methods may be less effective in preventing pregnancy when taking this medication. Use alternative birth control methods, such as condoms, 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.
Overdose Information
Overdose Symptoms:
- Nystagmus (involuntary eye movements)
- Ataxia (loss of coordination)
- Impaired consciousness
- Grand mal seizures
- Coma
- Intraventricular conduction delay (ECG changes)
What to Do:
Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive; there is no specific antidote. Gastric lavage may be considered if ingestion is recent. Hemodialysis is not highly effective.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels, increases rash risk)
- Carbamazepine (decreases lamotrigine levels, may increase carbamazepine epoxide levels)
- Phenytoin (decreases lamotrigine levels)
- Phenobarbital (decreases lamotrigine levels)
- Primidone (decreases lamotrigine levels)
- Rifampin (decreases lamotrigine levels)
- Estrogen-containing oral contraceptives (decreases lamotrigine levels, may cause breakthrough bleeding)
- Lopinavir/ritonavir (decreases lamotrigine levels)
- Atazanavir/ritonavir (decreases lamotrigine levels)
Moderate Interactions
- Paracetamol (acetaminophen) (may slightly decrease lamotrigine levels with chronic high doses)
- Risperidone (lamotrigine may decrease risperidone levels)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Aripiprazole (lamotrigine may decrease aripiprazole levels)
- Zidovudine (lamotrigine may increase zidovudine levels)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: Rare risk of blood dyscrasias (e.g., neutropenia, aplastic anemia).
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: Metabolized in the liver; baseline assessment for hepatic impairment.
Timing: Prior to initiation
Renal Function Tests (RFTs)
Rationale: Excreted renally; baseline assessment for renal impairment.
Timing: Prior to initiation
Skin Examination
Rationale: Baseline assessment for pre-existing skin conditions, and to educate patient on rash monitoring.
Timing: Prior to initiation
Routine Monitoring
Clinical response (seizure control, mood stability)
Frequency: Regularly during titration and maintenance
Target: Individualized
Action Threshold: Worsening symptoms, lack of efficacy, or intolerable side effects warrant dose adjustment or re-evaluation.
Adverse effects (especially rash)
Frequency: Daily during titration, then regularly
Target: Absence of rash
Action Threshold: Any new rash should prompt immediate discontinuation and medical evaluation due to risk of SJS/TEN.
Mental status/mood changes (e.g., suicidal ideation)
Frequency: Regularly, especially during initial therapy or dose changes
Target: Stable mood, absence of suicidal thoughts
Action Threshold: New or worsening depression, suicidal thoughts, or unusual changes in behavior require immediate assessment.
Therapeutic Drug Monitoring (TDM)
Frequency: Not routinely recommended, but may be useful in specific situations (e.g., suspected non-adherence, toxicity, pregnancy, significant drug interactions, renal/hepatic impairment).
Target: Varies by indication and individual (e.g., 3-14 mcg/mL for epilepsy, 2-10 mcg/mL for bipolar disorder)
Action Threshold: Levels outside target range, especially if correlated with clinical symptoms or lack of efficacy.
Symptom Monitoring
- Skin rash (any type, especially blistering or widespread)
- Fever
- Swollen lymph nodes
- Swelling of face, eyes, lips, or tongue
- Sore throat, mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe muscle pain
- Unexplained weakness or fatigue
- New or worsening depression, anxiety, or irritability
- Panic attacks
- Insomnia
- Aggressive, angry, or violent behavior
- Impulsivity
- Restlessness
- Mania or hypomania
- Suicidal thoughts or attempts
- Aseptic meningitis symptoms (headache, fever, nausea, vomiting, stiff neck, rash, sensitivity to light, confusion)
Special Patient Groups
Pregnancy
Lamotrigine crosses the placenta. While generally considered a relatively safer antiepileptic drug during pregnancy compared to some others, it is not without risk. Data from pregnancy registries suggest a low risk of major congenital malformations, but a potential for increased risk of oral clefts (though this is debated and not consistently found across all studies). Folic acid supplementation is recommended for all women of childbearing potential on AEDs. Lamotrigine levels may decrease significantly during pregnancy, requiring dose adjustments, and then increase postpartum, requiring further adjustment.
Trimester-Specific Risks:
First Trimester:
Potential, albeit low, risk of major congenital malformations, including oral clefts. Close monitoring and dose adjustment may be needed due to pharmacokinetic changes.
Second Trimester:
Continued monitoring of lamotrigine levels and clinical response; dose adjustments likely.
Third Trimester:
Continued monitoring; dose adjustments may be needed. Levels may drop significantly, increasing seizure risk. Postpartum, levels will rise, increasing risk of toxicity.
Lactation
Lamotrigine is excreted into breast milk in significant amounts. The relative infant dose (RID) can be high (e.g., 10-20%). Monitor breastfed infants for adverse effects such as drowsiness, poor feeding, rash, and apnea. Weigh the benefits of breastfeeding against the potential risks to the infant.
Infant Risk:
Moderate risk (L3). Monitor for drowsiness, poor feeding, rash, and apnea. Consider therapeutic drug monitoring in the infant if concerns arise.
Pediatric Use
Higher incidence of serious rash (SJS/TEN) in pediatric patients (2-16 years) compared to adults. Dosing is weight-based and requires very slow titration, especially in children under 6 years or those on valproate. Not recommended for use as initial adjunctive therapy in patients under 2 years of age due to lack of efficacy data and increased risk of rash.
Geriatric Use
Start with lower doses and titrate slowly, similar to adult recommendations but with increased caution. Monitor renal and hepatic function more closely due to age-related decline. Increased sensitivity to adverse effects may occur.
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 on this and the importance of reporting any rash immediately.
- Concomitant medications, especially valproate (increases lamotrigine levels) and enzyme-inducing AEDs (decreases lamotrigine levels), significantly impact lamotrigine dosing and half-life. Dose adjustments are crucial.
- Lamotrigine is effective for both focal and generalized seizures, and is a first-line agent for bipolar depression.
- Chewable dispersible tablets can be chewed or dissolved in water, offering flexibility for patients who have difficulty swallowing pills.
- Aseptic meningitis is a rare but serious adverse effect that can occur with lamotrigine; patients should be aware of symptoms like headache, fever, stiff neck, and rash.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Phenytoin, Topiramate, Oxcarbazepine, Zonisamide, Gabapentin, Pregabalin.
- For Bipolar Disorder (Mood Stabilizers): Lithium, Valproate, Carbamazepine, Quetiapine, Olanzapine, Lurasidone, Cariprazine.
Cost & Coverage
Average Cost:
Varies widely, e.g., $10-$50 for 30 tablets of generic 25mg per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate 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 critical information, including the name of the medication taken, the amount, and the time it was taken.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate 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 critical information, including the name of the medication taken, the amount, and the time it was taken.