Lamictal ODT 50-100mg Tb Kit Green
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 calming overactive nerve signals in the brain. It's very important to start with a low dose and slowly increase it over several weeks 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 to you and follow the instructions closely. You can take this medication with or without food.
Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well. To take the medication, place it on your tongue and let it dissolve. You don't need to drink water, and make sure not to swallow it whole. Also, avoid chewing, breaking, or crushing the medication.
Important Warnings
Do not change your dose or stop taking this medication without consulting your doctor, as this can lead to seizures. If you need to stop taking the medication, your doctor will instruct you on how to gradually stop it to minimize the risk of side effects. If you've stopped taking the medication and need to restart, your doctor may recommend starting with a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
To keep your medication effective, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe place, 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 local drug take-back programs.
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 get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food.
Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well. To take the medication, place it on your tongue and let it dissolve. You don't need to drink water, and make sure not to swallow it whole. Also, avoid chewing, breaking, or crushing the medication.
Important Warnings
Do not change your dose or stop taking this medication without consulting your doctor, as this can lead to seizures. If you need to stop taking the medication, your doctor will instruct you on how to gradually stop it to minimize the risk of side effects. If you've stopped taking the medication and need to restart, your doctor may recommend starting with a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
To keep your medication effective, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe place, 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 local drug take-back programs.
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.
Lifestyle & Tips
- Take exactly as prescribed, do not stop suddenly without consulting your doctor.
- Do not crush, chew, or break the orally disintegrating tablets; allow them to dissolve on the tongue and then swallow with or without water.
- Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Report any new skin rash immediately to your doctor, as this can be a sign of a serious side effect.
- Be aware of changes in mood or behavior, including suicidal thoughts, and report them to your doctor.
- If you are taking oral contraceptives, discuss with your doctor as your lamotrigine dose may need adjustment.
- Avoid alcohol or other CNS depressants, as they can increase drowsiness.
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 variable, requires slow titration. Initial dose typically 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then 100 mg daily for 1 week, then 200 mg daily. Dosing depends on concomitant medications (e.g., valproate, enzyme-inducing AEDs) and indication.
Dose Range:
25 - 700 mg
Condition-Specific Dosing:
Epilepsy (monotherapy):
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. Maintenance: 300-500 mg/day in 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-inducing AEDs without valproate):
Initial: 50 mg daily for 2 weeks, then 100 mg daily for 2 weeks. Maintenance: 300-500 mg/day in 2 divided doses.
Bipolar I Disorder (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 mg/day with valproate, or 300-400 mg/day with enzyme-inducing AEDs).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (generally not recommended for children <2 years due to increased risk of rash)
Child:
Dosing highly dependent on age, weight, and concomitant medications. Requires slow titration. E.g., for 2-12 years with valproate: 0.15 mg/kg/day for 2 weeks, then 0.3 mg/kg/day for 2 weeks, target 1-5 mg/kg/day. Max 200 mg/day.
Adolescent:
Similar to adult dosing, but may require lower initial doses and slower titration based on weight and concomitant medications.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
Consider reduced maintenance doses in patients with significant renal impairment.
Severe:
Consider reduced maintenance doses (e.g., 25% reduction) in patients with significant renal impairment (CrCl <30 mL/min).
Dialysis:
Supplemental doses after dialysis are generally not needed as only a small amount is removed. Monitor clinical response.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Reduce initial, escalation, and maintenance doses by approximately 25% in patients with moderate hepatic impairment (Child-Pugh B).
Severe:
Reduce initial, escalation, and maintenance doses by approximately 50% in patients with severe hepatic impairment (Child-Pugh C).
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% (oral)
Tmax:
1.4 to 4.8 hours (oral disintegrating tablets 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 reduced by enzyme-inducing AEDs (e.g., 13-14 hours with carbamazepine, phenytoin, phenobarbital) and significantly prolonged by valproate (e.g., 59-70 hours).
Clearance:
Highly variable based on concomitant medications.
ExcretionRoute:
Renal (approximately 94% as metabolites, 6% unchanged)
Unchanged:
Approximately 6%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration)
PeakEffect:
Weeks to months (after reaching target dose)
DurationOfAction:
24 hours (dosed once or twice daily)
Safety & Warnings
BLACK BOX WARNING
Serious Skin Rashes: Lamotrigine can cause serious skin rashes requiring hospitalization and discontinuation of treatment. These include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). The incidence of these rashes, which have resulted in death, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 16 years) and 0.08% to 0.3% in adults. Risk factors include high initial doses, rapid dose escalation, and concomitant use of valproate. Benign rashes also occur, but it is not possible to predict which rashes will prove to be serious or life-threatening. Therefore, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related.
Side Effects
Serious 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 medical attention:
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
Changes in balance
Inability to control eye movements
Flu-like symptoms
Painful 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
+ 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
Changes in balance
Difficulty 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 side effects, contact your doctor 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 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 immediately or seek medical attention:
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
Changes in balance
Inability to control eye movements
Flu-like symptoms
Painful 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
+ 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
Changes in balance
Difficulty 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 side effects, contact your doctor 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 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 skin rash (especially if accompanied by fever, swollen glands, or flu-like symptoms)
- Swelling of the face, eyes, lips, or tongue
- Sore throat, mouth sores
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe fatigue or weakness
- Worsening depression, anxiety, or suicidal thoughts
- New or worsening seizures
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 allergic reaction you experienced, including any symptoms that occurred.
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 allergic reaction you experienced, including any symptoms that occurred.
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, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be sure to discuss any concerns with your doctor. Additionally, inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal thoughts or behaviors. 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 pre-existing 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 birth control methods may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may increase during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based methods may not be effective in preventing pregnancy while taking this medication. Use an alternative form of birth control, such as a condom.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult with your doctor to adjust your treatment plan.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be sure to discuss any concerns with your doctor. Additionally, inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal thoughts or behaviors. 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 pre-existing 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 birth control methods may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may increase during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based methods may not be effective in preventing pregnancy while taking this medication. Use an alternative form of birth control, such as a condom.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult with your doctor to adjust your treatment plan.
Overdose Information
Overdose Symptoms:
- Nystagmus (involuntary eye movements)
- Ataxia (loss of coordination)
- Impaired consciousness
- Seizures
- Coma
- Intraventricular conduction delay (ECG changes)
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US). Treatment is supportive; there is no specific antidote. Gastric lavage or activated charcoal may be considered if ingestion is recent.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels significantly, requiring dose reduction and increased rash risk)
- Oral Contraceptives (estrogen-containing; can decrease lamotrigine levels by up to 50%, requiring dose increase)
- Enzyme-inducing Antiepileptic Drugs (e.g., Carbamazepine, Phenytoin, Phenobarbital, Primidone; decrease lamotrigine levels, requiring dose increase)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/Ritonavir (decreases lamotrigine levels)
- Atazanavir/Ritonavir (decreases lamotrigine levels)
Moderate Interactions
- Paracetamol/Acetaminophen (high doses may slightly decrease lamotrigine levels)
- Risperidone (lamotrigine may decrease risperidone levels)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Bupropion (may increase lamotrigine levels)
Confidence Interactions
Monitoring
Baseline Monitoring
Renal and Hepatic Function Tests (BUN, Creatinine, ALT, AST, Bilirubin)
Rationale: To establish baseline function and guide dose adjustments in impaired patients.
Timing: Prior to initiation
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for rare but serious hematologic reactions (e.g., aplastic anemia, agranulocytosis).
Timing: Prior to initiation
Skin Examination
Rationale: To establish baseline skin condition and educate patient on rash monitoring.
Timing: Prior to initiation
Routine Monitoring
Clinical response (seizure frequency/severity, mood stability)
Frequency: Regularly during titration and maintenance
Target: Individualized
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or re-evaluation.
Adverse effects (especially rash, fever, lymphadenopathy, signs of DRESS/SJS/TEN)
Frequency: Daily during titration, then regularly
Target: Absence of severe rash or systemic hypersensitivity reactions
Action Threshold: Any new rash should be evaluated immediately; discontinue if severe or associated with systemic symptoms.
Suicidal ideation/behavior
Frequency: Regularly, especially during initial therapy or dose changes
Target: Absence of suicidal thoughts or behaviors
Action Threshold: Report any new or worsening suicidal thoughts or behaviors immediately.
Drug levels (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)
Target: Typically 3-14 mcg/mL (epilepsy), 2-10 mcg/mL (bipolar), but highly individualized.
Action Threshold: Levels outside target range or unexpected levels may prompt dose adjustment or investigation of adherence/interactions.
Symptom Monitoring
- Skin rash (any type, 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 fatigue or weakness
- New or worsening depression, anxiety, or irritability
- Panic attacks
- Insomnia
- Agitation or restlessness
- Aggressiveness, anger, or violence
- Other unusual changes in behavior or mood
- Suicidal thoughts or attempts
Special Patient Groups
Pregnancy
Use during pregnancy should be carefully considered, weighing potential benefits against risks. Lamotrigine crosses the placenta. While some studies suggest a small increased risk of oral clefts, overall risk is low and often outweighed by the risk of uncontrolled seizures for the mother and fetus. Folic acid supplementation is recommended for all women of childbearing potential on AEDs.
Trimester-Specific Risks:
First Trimester:
Small increased risk of oral clefts (e.g., cleft lip/palate) reported in some studies, particularly with higher doses or polytherapy. However, data are conflicting, and overall absolute risk is low.
Second Trimester:
Generally considered safer than first trimester for initiation, but continued monitoring of drug levels may be needed as clearance can increase.
Third Trimester:
Clearance may increase, potentially leading to lower lamotrigine levels and increased seizure risk. Levels should be monitored, and dose adjustments may be necessary. Monitor neonate for potential withdrawal symptoms or adverse effects.
Lactation
Lamotrigine is excreted into breast milk. While generally considered compatible with breastfeeding, monitor the infant for adverse effects such as rash, drowsiness, poor feeding, or apnea. Infant serum levels can be significant. L3 (Moderately Safe) to L4 (Potentially Hazardous) depending on source and infant monitoring.
Infant Risk:
Potential for rash, drowsiness, poor feeding, apnea. Monitor infant closely.
Pediatric Use
Increased risk of serious skin rash (SJS/TEN) in children under 16 years compared to adults, especially in those under 2 years. Use in children under 2 years is generally not recommended for epilepsy and not established for bipolar disorder. Dosing requires careful, slow titration based on age, weight, and concomitant medications.
Geriatric Use
No specific dose adjustments are typically required based on age alone, but older patients may be more sensitive to adverse effects (e.g., dizziness, ataxia) and may have age-related renal or hepatic impairment requiring dose adjustment. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rashes. Patients must be educated on this.
- Concomitant valproate significantly increases lamotrigine levels, requiring a much slower and lower initial lamotrigine dose.
- Concomitant enzyme-inducing AEDs (e.g., carbamazepine, phenytoin, phenobarbital) significantly decrease lamotrigine levels, requiring a faster and higher initial lamotrigine dose.
- Oral contraceptives containing estrogen can significantly decrease lamotrigine levels, potentially leading to loss of seizure control or mood stabilization. Dose adjustments may be needed when starting or stopping oral contraceptives.
- Patients should be advised to report any rash immediately. Discontinuation is usually warranted unless the rash is clearly benign and unrelated to the drug.
- Lamotrigine is effective for both focal and generalized seizures, and is a first-line agent for bipolar depression.
- Therapeutic drug monitoring is not routinely recommended but can be useful in cases of suspected non-adherence, drug interactions, pregnancy, or toxicity.
Alternative Therapies
- Other Antiepileptic Drugs (e.g., Levetiracetam, Carbamazepine, Valproate, Phenytoin, Topiramate, Oxcarbazepine, Gabapentin, Pregabalin)
- Other Mood Stabilizers (e.g., Lithium, Valproate, Carbamazepine, Atypical Antipsychotics)
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 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.