Lamictal ODT 100mg Tablets
WARNING: Severe skin reactions may happen with this drug. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands. The chance of a skin reaction is raised in children between 2 and 17 years old. It may also be raised if you take valproic acid or divalproex sodium with this drug, if you start taking this drug at too high of a dose, or if your dose is raised too fast. Skin reactions have also happened without any of these. Talk with your doctor.Most cases of skin reactions have happened within 2 to 8 weeks of starting this drug, but some show up after longer treatment like 6 months. Talk with the doctor. @ COMMON USES: It is used to help control certain kinds of seizures.It is used to treat bipolar disorder.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant; Mood Stabilizer
Pharmacologic Class
Phenyltriazine derivative; Voltage-gated sodium channel blocker
Pregnancy Category
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. Lamictal ODT is an orally disintegrating tablet that dissolves quickly in your mouth.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food.
It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. To take the medication correctly, place the tablet on your tongue and let it dissolve. You don't need to drink water with it. Do not swallow the tablet 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 the risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually reduce the dose to minimize potential side effects. If you stop taking the 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, 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. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a local drug take-back program.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food.
It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. To take the medication correctly, place the tablet on your tongue and let it dissolve. You don't need to drink water with it. Do not swallow the tablet 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 the risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually reduce the dose to minimize potential side effects. If you stop taking the 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, 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. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a local drug take-back program.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take exactly as prescribed, do not stop abruptly without consulting your doctor, as this can worsen seizures or mood symptoms.
- Do not take more than the prescribed dose or increase the dose faster than instructed, as this increases the risk of serious skin rash.
- Report any new skin rash immediately to your doctor, especially if it's widespread, blistering, or accompanied by fever, swollen glands, or facial swelling.
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how this medication affects you, as it can cause dizziness or blurred vision.
- If you are taking oral contraceptives, discuss with your doctor as they can affect lamotrigine levels.
- Carry a medical alert card or wear a bracelet indicating you are taking lamotrigine, especially if you have epilepsy.
Available Forms & Alternatives
Available Strengths:
- Lamictal 150mg Tablets
- Lamictal 200mg Tablets
- Lamictal 100mg Tablets
- Lamictal 25mg Tablets
- Lamictal 5mg Chewabl Disprsbl Tabs
- Lamictal 25mg Chewabl Disprsbl Tabs
- Lamictal Orange Strt Kit25mg/100mg
- Lamictal Blue Starter Kit 25mg
- Lamictal XR 25mg Tablets
- Lamictal XR 50mg Tablets
- Lamictal XR 100mg Tablets
- Lamictal XR 200mg Tablets
- Lamictal XR 25-50-100mg Titrtn Kit
- Lamictal XR 25-50mg Titration Kt 28
- Lamictal XR 50-100-200mg Titrtn Kit
- Lamictal ODT 25mg Tablets
- Lamictal ODT 50mg Tablets
- Lamictal ODT 100mg Tablets
- Lamictal ODT 200mg Tablets
- Lamictal ODT 25-50-100mg Tb Kt Orng
- Lamictal ODT 25-50mg Tb Kit Blue
- Lamictal ODT 50-100mg Tb Kit Green
- Lamictal Green Strt Kit 25mg/100mg
- Lamictal XR 300mg Tablets
- Lamictal XR 250mg Tablets
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable, requires slow titration. Initial doses typically 25 mg daily or every other day, increasing gradually over weeks.
Dose Range:
25 - 700 mg
Condition-Specific Dosing:
epilepsy_monotherapy:
Initial: 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks. Maintenance: 100-400 mg/day in 1-2 divided doses.
epilepsy_adjunctive_therapy_with_enzyme_inducing_AEDs_without_valproate:
Initial: 50 mg once daily for 2 weeks, then 100 mg/day in 2 divided doses for 2 weeks. Maintenance: 300-500 mg/day in 2 divided doses.
epilepsy_adjunctive_therapy_with_valproate:
Initial: 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks. Maintenance: 100-200 mg/day in 1-2 divided doses.
bipolar_disorder_monotherapy:
Initial: 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then 100 mg once daily for 1 week. Target: 200 mg once daily (some patients may need 100 mg or 400 mg).
bipolar_disorder_with_valproate:
Initial: 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks, then 50 mg once daily for 1 week. Target: 100 mg once daily (some patients may need 200 mg).
bipolar_disorder_with_enzyme_inducing_AEDs_without_valproate:
Initial: 50 mg once daily for 2 weeks, then 100 mg/day in 2 divided doses for 2 weeks, then 200 mg/day in 2 divided doses for 1 week. Target: 400 mg/day in 2 divided doses (some patients may need 200 mg or 600 mg).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for general use; specific indications (e.g., Lennox-Gastaut syndrome) may have limited data for children >2 years.
Child:
Dosing is weight-based and depends on concomitant medications. For epilepsy (adjunctive therapy) in children 2-12 years, initial doses range from 0.3 mg/kg/day to 2 mg/kg/day, titrated slowly. Max doses vary (e.g., 5-15 mg/kg/day).
Adolescent:
Generally follows adult dosing guidelines for epilepsy and bipolar disorder, with careful titration.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, but monitor for adverse effects.
Severe:
Consider a reduction in maintenance dose by 25% for patients with significant renal impairment (CrCl < 30 mL/min).
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 needed.
Moderate:
Reduce initial, escalation, and maintenance doses by approximately 25%.
Severe:
Reduce initial, escalation, and maintenance doses by approximately 50%. Monitor for adverse effects.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that stabilizes neuronal membranes and modulates neurotransmitter release. Its primary mechanism is thought to involve the blockade of voltage-sensitive sodium channels, which inhibits the release of excitatory neurotransmitters, particularly glutamate and aspartate. It may also weakly inhibit voltage-gated calcium channels and modulate serotonin 5-HT3 receptors.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1.4 to 4.8 hours (oral tablets); ODT may be slightly faster.
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 (monotherapy); highly variable based on concomitant medications.
ExcretionRoute:
Renal (approximately 94% as metabolites, 6% unchanged drug)
Unchanged:
Approximately 6%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration to minimize rash risk)
PeakEffect:
Weeks to months (after reaching target maintenance dose)
DurationOfAction:
24 hours (allows for once or twice daily dosing)
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) and toxic epidermal necrolysis (TEN), which can be fatal. The incidence of these serious rashes is greater in pediatric patients than in adults. Other risk factors include concomitant use with valproate, exceeding recommended initial doses, and rapid dose escalation. Lamotrigine can also cause aseptic meningitis and hemophagocytic lymphohistiocytosis (HLH), a rare but life-threatening immune reaction.
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Balance problems
Uncontrolled 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)
This medication can cause a rare but life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor right away:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Trouble walking (new or worsening)
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or experience any symptoms that concern you, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Balance problems
Uncontrolled 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)
This medication can cause a rare but life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor right away:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Trouble walking (new or worsening)
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions 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:
- New or worsening skin rash (especially widespread, blistering, or painful)
- Fever, sore throat, swollen glands, or other signs of infection
- Swelling of the face, eyes, lips, or tongue
- Mouth sores or ulcers
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe muscle pain or weakness
- Headache, stiff neck, nausea, vomiting, rash, or sensitivity to light (signs of aseptic meningitis)
- Persistent fever, rash, enlarged lymph nodes, or unusual bleeding/bruising (signs of HLH)
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.
Additionally, 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 or have had
This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, 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.
Additionally, 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 or have had
This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, 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 are necessary to monitor your condition. Follow your doctor's instructions for scheduling these tests. 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 your doctor. These substances may interact with your medication and increase the risk of adverse effects.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or actions. This risk may be higher 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 condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
To ensure you receive the correct medication, always verify the product's appearance, shape, color, size, and labeling. If you notice any changes, consult your pharmacist.
Cardiovascular Risks
If you have a history of abnormal heart rhythms, heart failure, or other heart problems, discuss your condition with your doctor. Abnormal heartbeats can occur in individuals with certain 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 this population.
Interactions with Hormonal Birth Control
Birth control pills and other hormone-based birth control methods may affect the levels of this medication in your body. Consult your doctor before starting or stopping any hormonal birth control. The risk of side effects may increase when taking birth control pills during the week when the pills are not active. Additionally, hormonal birth control methods may not be effective in preventing pregnancy while 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 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, 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 are necessary to monitor your condition. Follow your doctor's instructions for scheduling these tests. 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 your doctor. These substances may interact with your medication and increase the risk of adverse effects.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or actions. This risk may be higher 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 condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
To ensure you receive the correct medication, always verify the product's appearance, shape, color, size, and labeling. If you notice any changes, consult your pharmacist.
Cardiovascular Risks
If you have a history of abnormal heart rhythms, heart failure, or other heart problems, discuss your condition with your doctor. Abnormal heartbeats can occur in individuals with certain 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 this population.
Interactions with Hormonal Birth Control
Birth control pills and other hormone-based birth control methods may affect the levels of this medication in your body. Consult your doctor before starting or stopping any hormonal birth control. The risk of side effects may increase when taking birth control pills during the week when the pills are not active. Additionally, hormonal birth control methods may not be effective in preventing pregnancy while 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 your doctor to adjust your treatment plan.
Overdose Information
Overdose Symptoms:
- Ataxia (loss of coordination)
- Nystagmus (involuntary eye movements)
- Increased seizures
- Decreased consciousness
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive; there is no specific antidote. Hemodialysis is not effective in removing lamotrigine.
Drug Interactions
Major Interactions
- Valproate (valproic acid, divalproex sodium): Significantly increases lamotrigine levels, requiring a lower lamotrigine starting dose and slower titration to reduce rash risk.
- Carbamazepine, Phenytoin, Phenobarbital, Primidone: Significantly decrease lamotrigine levels, requiring a higher lamotrigine starting dose and faster titration.
- Estrogen-containing oral contraceptives: Can significantly decrease lamotrigine levels, potentially leading to loss of seizure control or mood stabilization. Dose adjustments may be needed.
- Rifampin: Decreases lamotrigine levels.
Moderate Interactions
- Lopinavir/Ritonavir, Atazanavir/Ritonavir: May decrease lamotrigine levels.
- Risperidone: Lamotrigine may decrease risperidone levels.
- Paroxetine, Sertraline: May slightly decrease lamotrigine clearance.
- Topiramate: Co-administration may increase lamotrigine levels slightly, but generally not clinically significant.
Minor Interactions
- Acetaminophen: May slightly decrease lamotrigine levels with chronic high-dose use.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for potential hematologic abnormalities (e.g., blood dyscrasias, HLH).
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for potential hepatic impairment.
Timing: Prior to initiation
Renal Function Tests (e.g., CrCl)
Rationale: To establish baseline and guide dosing in patients with renal impairment.
Timing: Prior to initiation
Skin assessment
Rationale: To establish baseline and educate patient on recognizing rash.
Timing: Prior to initiation
Routine Monitoring
Skin assessment
Frequency: Daily during titration, then regularly
Target: Absence of new rash
Action Threshold: Any new rash, especially widespread or blistering, requires immediate medical evaluation and potential discontinuation.
Clinical response (seizure frequency/mood stability)
Frequency: Regularly, especially during titration and dose adjustments
Target: Reduction in seizure frequency or stabilization of mood symptoms
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
Adverse effects monitoring (e.g., dizziness, ataxia, blurred vision, headache)
Frequency: Regularly
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Lamotrigine plasma concentrations (therapeutic drug monitoring)
Frequency: Only if clinically indicated (e.g., suspected toxicity, lack of efficacy, significant drug interactions, renal/hepatic impairment, pregnancy)
Target: Generally 2-20 mcg/mL for epilepsy, but individual response is key.
Action Threshold: Levels outside target range or inconsistent with clinical picture may warrant dose adjustment.
Symptom Monitoring
- Skin rash (especially widespread, blistering, or painful)
- 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
- Signs of aseptic meningitis (headache, fever, nausea, vomiting, stiff neck, rash, sensitivity to light)
- Signs of hemophagocytic lymphohistiocytosis (HLH) (fever, rash, enlarged lymph nodes, hepatosplenomegaly, cytopenias)
Special Patient Groups
Pregnancy
Lamotrigine crosses the placenta. While older classification was Category C, current data suggest a low risk of major congenital malformations, but a potential small increased risk of oral clefts (cleft lip/palate) has been observed in some studies, though this remains controversial and may be influenced by other factors. Use during pregnancy should be carefully weighed against the risks of untreated epilepsy or bipolar disorder. Monotherapy at the lowest effective dose is generally preferred.
Trimester-Specific Risks:
First Trimester:
Potential small increased risk of oral clefts (cleft lip/palate), though data are conflicting. Folic acid supplementation is recommended for all women of childbearing potential on AEDs.
Second Trimester:
Generally considered safer than first trimester for organogenesis, but continued monitoring of lamotrigine levels may be necessary as clearance can increase during pregnancy.
Third Trimester:
Clearance may continue to increase, potentially requiring dose adjustments. Monitor for withdrawal symptoms in neonates if maternal levels are high at delivery.
Lactation
Lamotrigine is excreted into breast milk. Infant serum concentrations can be significant. Monitor breastfed infants for adverse effects such as rash, drowsiness, poor feeding, and apnea. Breastfeeding may be considered if the infant is monitored closely and the benefits outweigh the risks. Consult with a healthcare provider.
Infant Risk:
Moderate risk (L3). Potential for drowsiness, poor feeding, rash, and apnea in the infant. Monitor infant closely.
Pediatric Use
Approved for adjunctive treatment of partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients âĨ2 years of age. Also approved for maintenance treatment of bipolar I disorder in adolescents âĨ10 years of age. Higher incidence of serious rash in pediatric patients compared to adults. Careful titration and monitoring are crucial.
Geriatric Use
Use with caution in elderly patients, as they may have age-related decreases in renal or hepatic function, which could affect lamotrigine clearance. Start with lower doses and titrate slowly, monitoring for adverse effects and drug levels if clinically indicated.
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.
- Concomitant use of valproate significantly increases lamotrigine levels, requiring a much lower starting dose and slower titration.
- Concomitant use of enzyme-inducing AEDs (carbamazepine, phenytoin, phenobarbital) or oral contraceptives significantly decreases lamotrigine levels, requiring higher doses.
- Any new rash, especially during the titration phase, should prompt immediate medical evaluation and potential discontinuation of the drug.
- Lamotrigine ODT can be taken with or without water. It should be placed on the tongue and allowed to dissolve, then swallowed.
- Abrupt discontinuation can precipitate seizures or mood destabilization; taper gradually over at least 2 weeks unless rash or other serious adverse event necessitates immediate cessation.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Phenytoin, Topiramate, Oxcarbazepine, Zonisamide, Gabapentin, Pregabalin, Lacosamide, Rufinamide, Clobazam, Perampanel, Cannabidiol.
- For Bipolar Disorder (Mood Stabilizers): Lithium, Valproate (divalproex sodium), Carbamazepine, Atypical antipsychotics (e.g., Olanzapine, Quetiapine, Aripiprazole, Lurasidone, Cariprazine).
Cost & Coverage
Average Cost:
Varies widely by pharmacy and dosage form (e.g., $50-$300+ for 30 tablets of 100mg ODT) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic); Tier 3 or higher (for brand)
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 crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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 substance taken, the amount, and the time it occurred.