Lamictal ODT 25-50-100mg Tb Kt Orng
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 prevent extreme mood swings in people with bipolar disorder. It works by stabilizing electrical activity in the brain. It's very important to start with 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, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication 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 feeling well. To take the 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 Safety Information
Do not change your dose or stop taking this medication without consulting your doctor, as this could lead to seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually reduce the dose to minimize the risk of 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, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, 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 drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. 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, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication 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 feeling well. To take the 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 Safety Information
Do not change your dose or stop taking this medication without consulting your doctor, as this could lead to seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually reduce the dose to minimize the risk of 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, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, 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 drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. 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 suddenly without consulting your doctor.
- Do not take more than the prescribed dose or increase the dose faster than instructed.
- Report any rash immediately to your doctor, even if it seems mild.
- Be aware of potential dizziness, drowsiness, or blurred vision, especially when starting or changing doses. Avoid driving or operating machinery until you know how it affects you.
- Avoid alcohol or other CNS depressants, as they can worsen side effects.
- If you are taking birth control pills, inform your doctor as they can affect lamotrigine levels.
- Carry a medical alert card or wear a medical alert bracelet indicating you are taking lamotrigine, especially if used for 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
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized, slow titration required. Initial dose 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then increase by 50-100 mg every 1-2 weeks. Maintenance dose varies by indication and concomitant medications (e.g., 100-400 mg/day for epilepsy, 200 mg/day for bipolar maintenance).
Dose Range:
25 - 700 mg
Condition-Specific Dosing:
epilepsy_monotherapy:
Initial: 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks. Maintenance: 100-400 mg/day in 1-2 divided doses.
epilepsy_with_valproate:
Initial: 25 mg every other day for 2 weeks, then 25 mg daily for 2 weeks. Maintenance: 100-200 mg/day in 1-2 divided doses.
epilepsy_with_enzyme_inducers:
Initial: 50 mg daily for 2 weeks, then 100 mg daily in 2 divided doses for 2 weeks. Maintenance: 300-500 mg/day in 2 divided doses.
bipolar_maintenance:
Initial: 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then 100 mg daily for 1 week, then 200 mg daily. Target dose 200 mg/day (or 100-400 mg/day depending on concomitant medications).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for general use. Dosing for Lennox-Gastaut syndrome in children ≥2 years.
Child:
Dosing varies significantly by age (2-12 years vs. >12 years) and concomitant medications. Requires careful, slow titration. For children 2-12 years, initial doses range from 0.3 mg/kg/day to 2 mg/kg/day depending on concomitant AEDs, titrated to maintenance doses of 1-15 mg/kg/day.
Adolescent:
For adolescents >12 years, dosing generally follows adult guidelines, with careful titration.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, but monitor for adverse effects.
Moderate:
No specific adjustment needed, but monitor for adverse effects.
Severe:
Consider a reduction in maintenance dose for patients with significant renal impairment (CrCl <30 mL/min). Monitor for adverse effects.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed. Monitor for 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 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). It is thought to achieve this by selectively blocking voltage-sensitive sodium channels, thereby inhibiting sustained repetitive firing of neurons and preventing the generation of action potentials.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1.4 to 4.8 hours (oral tablets)
FoodEffect:
Not significantly affected by food.
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., ~70 hours with valproate, ~15 hours with enzyme inducers).
Clearance:
Approximately 30 mL/min/kg (adults, monotherapy)
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 10% (unchanged drug in urine)
Pharmacodynamics
OnsetOfAction:
Gradual (due to slow titration)
PeakEffect:
Weeks to months (after reaching stable maintenance dose)
DurationOfAction:
24 hours (dosed once or twice daily)
Safety & Warnings
BLACK BOX WARNING
Serious Skin Rashes: Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). The incidence of these rashes, which have resulted in death, is approximately 0.3% to 0.8% in pediatric patients (2 to 16 years of age) and 0.08% to 0.3% in adults. Risk factors include concomitant use of valproate, exceeding recommended initial doses, and rapid dose escalation. Benign rashes also occur, but it is not possible to predict which rashes will prove to be serious. Therefore, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring.
Side Effects
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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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
Low Blood Cell Counts and Infections
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 (HLH)
In rare cases, this medication can cause a life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Difficulty walking (new or worsening)
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:
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 any questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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
+ 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
Low Blood Cell Counts and Infections
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 (HLH)
In rare cases, this medication can cause a life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Difficulty walking (new or worsening)
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:
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 any questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any new or worsening skin rash (especially if accompanied by fever, swollen glands, or facial swelling)
- Signs of allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Fever, sore throat, mouth sores, or other signs of infection
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe muscle pain or weakness
- New or worsening depression, anxiety, or other mood changes
- Thoughts of self-harm or suicide
- New or worsening seizures
- Severe dizziness or loss of coordination
- Blurred or double vision
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your 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 your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your 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 are necessary to monitor your condition. Follow your doctor's instructions for scheduling these tests. 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 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 behaviors. This risk may be higher in individuals with a history of suicidal thoughts or attempts. If you experience any 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 attempts, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
Medication Verification
To avoid mix-ups, always verify that you have the correct medication. Check the shape, color, size, and labeling of your medication. If you notice any changes, consult your pharmacist.
Heart Problems
If you have a history of abnormal heart rhythms, heart failure, or other heart conditions, discuss your treatment with your doctor. Abnormal heart rhythms can increase the risk of sudden death in individuals with pre-existing heart conditions.
Pediatric Use
When using this medication in children, it is essential to exercise caution, as the risk of certain side effects may be higher in this population.
Birth Control and Hormone Interactions
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. Inform 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 contraceptives may be less effective in preventing pregnancy. Use an alternative form of birth control, such as a condom, while taking this medication.
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 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 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 behaviors. This risk may be higher in individuals with a history of suicidal thoughts or attempts. If you experience any 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 attempts, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
Medication Verification
To avoid mix-ups, always verify that you have the correct medication. Check the shape, color, size, and labeling of your medication. If you notice any changes, consult your pharmacist.
Heart Problems
If you have a history of abnormal heart rhythms, heart failure, or other heart conditions, discuss your treatment with your doctor. Abnormal heart rhythms can increase the risk of sudden death in individuals with pre-existing heart conditions.
Pediatric Use
When using this medication in children, it is essential to exercise caution, as the risk of certain side effects may be higher in this population.
Birth Control and Hormone Interactions
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. Inform 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 contraceptives may be less effective in preventing pregnancy. Use an alternative form of birth control, such as a condom, while taking this medication.
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:
- Nystagmus (involuntary eye movements)
- Ataxia (loss of coordination)
- Impaired consciousness
- Grand mal seizures
- Coma
- Intraventricular conduction delay (widened QRS on ECG)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is 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, increases risk of rash)
- Estrogen-containing oral contraceptives (decrease lamotrigine levels)
- Rifampin (decreases lamotrigine levels)
- Carbamazepine (decreases lamotrigine levels, but also can increase carbamazepine epoxide levels)
- Phenytoin, Phenobarbital, Primidone (decrease lamotrigine levels)
Moderate Interactions
- Lopinavir/Ritonavir (decreases lamotrigine levels)
- Atazanavir/Ritonavir (decreases lamotrigine levels)
- Paracetamol/Acetaminophen (may decrease lamotrigine levels with chronic high-dose use)
Monitoring
Baseline Monitoring
Renal function (BUN, Creatinine)
Rationale: To assess baseline kidney function, especially important for dose adjustments in severe impairment.
Timing: Prior to initiation
Hepatic function (ALT, AST, Bilirubin)
Rationale: To assess baseline liver function, important for dose adjustments in hepatic impairment.
Timing: Prior to initiation
Complete Blood Count (CBC)
Rationale: To establish baseline, although significant hematologic abnormalities are rare.
Timing: Prior to initiation
Routine Monitoring
Clinical response (seizure control, mood stability)
Frequency: Regularly during titration and maintenance
Target: Individualized
Action Threshold: Lack of efficacy or worsening symptoms
Adverse effects (especially rash, dizziness, ataxia, blurred vision, headache)
Frequency: Regularly, especially during titration
Target: Absence of severe or intolerable side effects
Action Threshold: Appearance of severe rash, signs of hypersensitivity, or intolerable side effects
Suicidal ideation/behavior
Frequency: Regularly, especially at initiation and dose changes
Target: Absence of suicidal thoughts or behaviors
Action Threshold: Any report or observation of suicidal ideation or behavior
Lamotrigine serum concentrations (therapeutic drug monitoring)
Frequency: Not routinely recommended, but may be useful in specific situations (e.g., suspected non-adherence, drug interactions, renal/hepatic impairment, pregnancy, toxicity, or lack of efficacy).
Target: Typically 2-20 mcg/mL (varies by lab and indication)
Action Threshold: Levels outside therapeutic range, or symptoms of toxicity/lack of efficacy despite adequate dosing.
Symptom Monitoring
- Skin rash (any type, especially severe 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
- Agitation
- Restlessness
- Panic attacks
- Insomnia
- Irritability
- Hostility
- Aggressiveness
- Impulsivity
- Akathisia (psychomotor restlessness)
- Hypomania
- Mania
- Thoughts about self-harm or suicide
- New or worsening seizures
- Dizziness
- Ataxia (loss of coordination)
- Blurred vision
- Diplopia (double vision)
- Headache
- Nausea
- Vomiting
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus. Lamotrigine crosses the placenta. Data from pregnancy registries suggest an increased risk of oral clefts (cleft lip/palate) in infants exposed to lamotrigine during the first trimester, though the absolute risk is low and debated. Monitor lamotrigine levels during pregnancy as they may decrease, requiring dose adjustments.
Trimester-Specific Risks:
First Trimester:
Potential increased risk of oral clefts (cleft lip/palate).
Second Trimester:
Potential for decreased lamotrigine levels due to increased clearance.
Third Trimester:
Potential for decreased lamotrigine levels due to increased clearance. Monitor infant for withdrawal symptoms or adverse effects post-delivery.
Lactation
Lamotrigine is excreted into breast milk. Monitor breastfed infants for adverse effects such as rash, sedation, poor feeding, and poor weight gain. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for lamotrigine, and any potential adverse effects on the breastfed infant from lamotrigine or from the underlying maternal condition.
Infant Risk:
L3 (Moderate risk). Potential for rash, sedation, poor feeding, and poor weight gain in the infant. Monitor closely.
Pediatric Use
Higher risk of serious skin rash (SJS/TEN) compared to adults, especially in children under 16 years. Dosing is weight-based and highly dependent on concomitant medications. Careful, slow titration is crucial. Approved for Lennox-Gastaut syndrome and partial seizures in children ≥2 years.
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 susceptibility to adverse effects like dizziness and ataxia.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rash. Patients must be educated on this.
- Concomitant valproate significantly increases lamotrigine levels, requiring a much slower and lower initial titration. Conversely, enzyme-inducing AEDs (e.g., carbamazepine, phenytoin) decrease lamotrigine levels, requiring faster and higher titration.
- Oral disintegrating tablets (ODT) can be dispersed in a small amount of water or chewed/dissolved on the tongue. Do not crush or chew regular tablets.
- Patients should be advised to report any rash immediately, as it can be life-threatening. However, not all rashes are serious, and some benign rashes may occur.
- Lamotrigine is effective for both seizure control and mood stabilization in bipolar disorder, making it a valuable option for patients with comorbid conditions.
- Monitor for signs of aseptic meningitis (headache, fever, nausea, vomiting, stiff neck, rash, photophobia, myalgia, chills, altered consciousness) and Hemophagocytic Lymphohistiocytosis (HLH) (fever, rash, lymphadenopathy, hepatosplenomegaly, hematologic abnormalities).
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Phenytoin, Oxcarbazepine, Topiramate, Zonisamide, Gabapentin, Pregabalin.
- For Bipolar Disorder (Maintenance): Lithium, Valproate, Carbamazepine, Quetiapine, Olanzapine, Aripiprazole.
Cost & Coverage
Average Cost:
Varies widely by strength and quantity, e.g., $50-$300+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred, to facilitate prompt and appropriate treatment.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred, to facilitate prompt and appropriate treatment.