Lamictal ODT 25mg 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 prevent mood swings in people with bipolar disorder. It works by stabilizing electrical activity in the brain. It's very important to start this medication at a very low dose and increase it slowly over several weeks to months 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 take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. To take the medication, place it on your tongue and let it dissolve completely. You don't need to drink water with it, and make sure not to swallow it whole, chew, break, or crush it.
Important Safety Precautions
Do not change your dosage or stop taking this medication without consulting your doctor first, 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 do stop taking the medication, you may need to restart at a lower dose and gradually increase it under your doctor's guidance.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom, and 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. You can also check with your pharmacist about potential 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. To take the medication, place it on your tongue and let it dissolve completely. You don't need to drink water with it, and make sure not to swallow it whole, chew, break, or crush it.
Important Safety Precautions
Do not change your dosage or stop taking this medication without consulting your doctor first, 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 do stop taking the medication, you may need to restart at a lower dose and gradually increase it under your doctor's guidance.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom, and 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. You can also check with your pharmacist about potential 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed, do not stop suddenly without consulting your doctor.
- Report any rash immediately to your doctor, even if it seems mild.
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how the medication affects you, as it can cause dizziness or drowsiness.
- Inform your doctor about all other medications, including over-the-counter drugs, herbal supplements, and especially hormonal birth control, as they can affect lamotrigine levels.
- Do not crush, chew, or split the orally disintegrating tablets; allow them to dissolve on the tongue and then swallow with or without water.
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, depends on indication and concomitant medications. Titration is critical to minimize rash risk.
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. Increase by 50-100 mg/day every 1-2 weeks. Maintenance: 225-375 mg/day in 2 divided doses.
Epilepsy (with valproate):
Initial: 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks. Increase by 25-50 mg/day every 1-2 weeks. Maintenance: 100-200 mg/day in 1-2 divided doses.
Epilepsy (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. Increase by 100 mg/day every 1-2 weeks. Maintenance: 300-500 mg/day in 2 divided doses.
Bipolar I Disorder (maintenance):
Initial: 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then 100 mg once daily for 1 week, then 200 mg once daily. Target dose: 200 mg/day. (Titration varies with concomitant medications, similar to epilepsy).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy not established in patients <2 years of age for epilepsy, or <18 years for bipolar disorder).
Child:
Dosing for epilepsy (2-12 years) is weight-based and depends on concomitant medications. Example (with valproate): Initial 0.15 mg/kg/day for 2 weeks, then 0.3 mg/kg/day for 2 weeks. Maintenance: 1-5 mg/kg/day. Max 200 mg/day. (Refer to specific guidelines for detailed pediatric dosing).
Adolescent:
Dosing for epilepsy (12-18 years) generally follows adult guidelines. For bipolar disorder, not indicated for patients <18 years.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Consider dose reduction in patients with significant renal impairment. Use with caution. No specific guidelines for initial dose, but maintenance doses may need reduction.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed. Use with caution and 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%. Use with caution and monitor clinical response.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that is thought to exert its anticonvulsant and mood-stabilizing effects by inhibiting voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and modulating the release of excitatory neurotransmitters (e.g., glutamate and aspartate). It also weakly inhibits voltage-gated calcium channels.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 98%
Tmax:
1 to 4 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 to 33 hours (monotherapy); significantly affected by concomitant medications (e.g., valproate increases half-life, enzyme inducers decrease half-life).
Clearance:
Approximately 30 mL/min (adults)
ExcretionRoute:
Renal (approximately 94% of dose)
Unchanged:
Approximately 8% (renal excretion)
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration)
PeakEffect:
Weeks to months (after reaching maintenance dose)
DurationOfAction:
24 hours (with once or twice daily 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 (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 or life-threatening. 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 immediately or seek emergency medical attention:
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 urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Shortness of breath, significant 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 menstrual periods or changes in menstrual cycle (including spotting or bleeding between cycles)
Additionally, this medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, seek medical attention immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems or difficulty walking (new or worsening symptoms)
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 discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or do not resolve on their own:
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
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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 urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Shortness of breath, significant 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 menstrual periods or changes in menstrual cycle (including spotting or bleeding between cycles)
Additionally, this medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, seek medical attention immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems or difficulty walking (new or worsening symptoms)
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 discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or do not resolve on their own:
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
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any new skin rash (red spots, blisters, peeling skin)
- Fever, swollen glands, or flu-like symptoms
- Swelling of the face, eyes, lips, or tongue
- Sore throat or mouth sores
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Severe muscle pain or weakness
- Changes in vision (e.g., double vision, blurred vision)
- Increased seizures or worsening mood symptoms
- Thoughts of self-harm or suicide
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be aware that this medication may interfere with certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. Immediately contact your doctor if you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes. 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. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult with your pharmacist.
Heart-Related Warnings
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 using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
Interactions with Birth Control
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may 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 when taking this medication. Use an alternative form of birth control, such as a condom, to minimize the risk of pregnancy.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure-Specific Warnings
If your seizures change or worsen after starting this medication, consult with your doctor to adjust your treatment plan as needed.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be aware that this medication may interfere with certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. Immediately contact your doctor if you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes. 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. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult with your pharmacist.
Heart-Related Warnings
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 using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
Interactions with Birth Control
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may 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 when taking this medication. Use an alternative form of birth control, such as a condom, to minimize the risk of pregnancy.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure-Specific Warnings
If your seizures change or worsen after starting this medication, consult with your doctor to adjust your treatment plan as needed.
Overdose Information
Overdose Symptoms:
- Nystagmus (involuntary eye movements)
- Ataxia (loss of coordination)
- Impaired consciousness
- Seizures
- Coma
- QRS prolongation (cardiac effects)
What to Do:
Seek immediate medical attention or call Poison Control (1-800-222-1222). Treatment is supportive; there is no specific antidote. Hemodialysis is not effective in removing lamotrigine.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels, increasing risk of rash)
- Carbamazepine, Phenytoin, Phenobarbital, Primidone (decrease lamotrigine levels)
- Oral Contraceptives (estrogen-containing, decrease lamotrigine levels)
- Rifampin (decreases lamotrigine levels)
- 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)
- Bupropion (may increase lamotrigine levels)
Confidence Interactions
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To establish baseline for rash monitoring due to risk of serious dermatologic reactions.
Timing: Prior to initiation
Concomitant medications review
Rationale: To determine appropriate initial dosing and titration schedule based on drug interactions.
Timing: Prior to initiation
Liver function tests (LFTs)
Rationale: Although not routinely required, consider in patients with pre-existing hepatic impairment or risk factors.
Timing: Prior to initiation (if indicated)
Renal function tests (RFTs)
Rationale: Although not routinely required, consider in patients with pre-existing renal impairment or risk factors.
Timing: Prior to initiation (if indicated)
Routine Monitoring
Skin for rash
Frequency: Daily during titration, then regularly
Target: Absence of new rash
Action Threshold: Any new rash, especially widespread, blistering, or associated with fever/lymphadenopathy, requires immediate medical evaluation and potential discontinuation.
Seizure frequency/Mood stability
Frequency: Regularly (e.g., at follow-up visits)
Target: Reduction in seizure frequency or stabilization of mood
Action Threshold: Lack of efficacy may warrant dose adjustment or alternative therapy.
Signs/symptoms of hypersensitivity reaction (e.g., fever, lymphadenopathy, facial swelling, liver dysfunction, blood dyscrasias)
Frequency: Regularly, especially during titration
Target: Absence of symptoms
Action Threshold: Any signs/symptoms require immediate medical evaluation and potential discontinuation.
Complete Blood Count (CBC) with differential
Frequency: Not routinely required, but consider if signs of blood dyscrasias (e.g., unexplained bruising, infection) develop.
Target: Normal ranges
Action Threshold: Abnormalities may indicate serious adverse reactions (e.g., HLH, aplastic anemia).
Symptom Monitoring
- Skin rash (any type, especially blistering or widespread)
- Fever
- Swollen lymph nodes
- Swelling of face or lips
- Sore throat or mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Unusual tiredness or weakness
- Muscle aches or joint pain
- Signs of infection (e.g., fever, chills)
- Changes in vision (e.g., double vision, blurred vision)
- Dizziness or unsteadiness
- Headache
- Nausea or vomiting
- Changes in mood or behavior (e.g., depression, aggression, suicidal thoughts)
Special Patient Groups
Pregnancy
Lamotrigine is generally considered one of the safer antiepileptic drugs during pregnancy, but it is not without risk. There is a potential for increased risk of oral clefts, particularly with higher doses or polytherapy. Patients should be enrolled in a pregnancy registry (e.g., North American Antiepileptic Drug Pregnancy Registry). Dose adjustments may be needed during pregnancy due to changes in lamotrigine clearance.
Trimester-Specific Risks:
First Trimester:
Potential increased risk of oral clefts (cleft lip/palate), though absolute risk is low and data are conflicting. Risk of major congenital malformations is generally considered comparable to the general population or slightly elevated.
Second Trimester:
Clearance of lamotrigine may increase, potentially leading to decreased drug levels and loss of seizure control. Close monitoring of lamotrigine levels and dose adjustments may be necessary.
Third Trimester:
Clearance continues to increase. Monitoring and dose adjustments may be needed. Levels typically return to pre-pregnancy levels postpartum, requiring dose reduction to avoid toxicity.
Lactation
Lamotrigine is excreted into breast milk. While generally considered compatible with breastfeeding, infants should be monitored for adverse effects such as rash, drowsiness, poor feeding, and apnea. The American Academy of Pediatrics considers it compatible with breastfeeding.
Infant Risk:
L3 (Moderately safe). Monitor infant for rash, sedation, poor feeding, and apnea. Serum levels in breastfed infants are generally low, but individual variability exists.
Pediatric Use
Safety and efficacy for epilepsy not established in patients <2 years of age. For bipolar disorder, not indicated for patients <18 years of age. Pediatric patients (especially <16 years) have a higher risk of serious rash compared to adults. Dosing is weight-based and complex, requiring careful titration based on concomitant medications.
Geriatric Use
No specific dose adjustments are generally required based on age alone, but elderly patients may have reduced renal or hepatic function, which could necessitate dose adjustments. Start with lower doses and titrate slowly, monitoring for adverse effects.
Clinical Information
Clinical Pearls
- Slow titration is paramount to minimize the risk of serious skin rash. Never accelerate the titration schedule.
- Patients must be educated to report any rash immediately, regardless of appearance, and to discontinue the drug only under medical supervision.
- Concomitant valproate significantly increases lamotrigine levels, requiring a much slower and lower initial dose.
- Concomitant enzyme-inducing AEDs (e.g., carbamazepine, phenytoin) or oral contraceptives significantly decrease lamotrigine levels, requiring a faster and higher titration.
- Lamotrigine levels can fluctuate significantly during pregnancy and postpartum, requiring close monitoring and dose adjustments.
- Lamotrigine ODT can be taken with or without water; it dissolves rapidly on the tongue.
- Beyond rash, other serious adverse reactions include aseptic meningitis and hemophagocytic lymphohistiocytosis (HLH); educate patients on associated symptoms.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Phenytoin, Topiramate, Oxcarbazepine, Zonisamide, Gabapentin, Pregabalin.
- For Bipolar Disorder (Mood Stabilizers): Lithium, Valproate, Carbamazepine, Quetiapine, Olanzapine, Aripiprazole, Lurasidone.
Cost & Coverage
Average Cost:
$100 - $300 per 30 tablets (25mg ODT)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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 refill your prescription. If you have any questions or concerns about this medication, consult 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.