Lamictal 200mg 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 extreme 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 slowly increase it over several weeks to months to reduce the risk of a serious skin rash.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
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 well.
Swallow the medication whole; do not chew, break, or crush it. If you have difficulty swallowing, consult with your doctor.
Important Safety Precautions
Do not change your dose or stop taking this medication without consulting your doctor, as this may cause seizures.
If you need to stop taking this medication, do not stop suddenly. Instead, gradually taper off the medication as directed by your doctor to minimize the risk of side effects.
If you have stopped taking this medication and need to restart, consult with your doctor. You may need to begin with a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult with your pharmacist for guidance on the best disposal method, and consider participating in a local drug take-back program.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next 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 a missed dose.
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
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 well.
Swallow the medication whole; do not chew, break, or crush it. If you have difficulty swallowing, consult with your doctor.
Important Safety Precautions
Do not change your dose or stop taking this medication without consulting your doctor, as this may cause seizures.
If you need to stop taking this medication, do not stop suddenly. Instead, gradually taper off the medication as directed by your doctor to minimize the risk of side effects.
If you have stopped taking this medication and need to restart, consult with your doctor. You may need to begin with a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult with your pharmacist for guidance on the best disposal method, and consider participating in a local drug take-back program.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next 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 a missed dose.
Lifestyle & Tips
- Take exactly as prescribed; do not stop abruptly without consulting your doctor, as this can cause seizures or worsening mood.
- Report any rash immediately to your doctor, especially if it's widespread, blistering, or accompanied by fever or flu-like symptoms.
- 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.
- If you are taking oral contraceptives, discuss with your doctor as they can affect lamotrigine levels.
- Avoid alcohol or other CNS depressants, as they can increase side effects like dizziness and drowsiness.
- Maintain regular follow-up appointments with your doctor to monitor your condition and medication effectiveness/safety.
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:
Initial titration varies significantly based on concomitant medications. For epilepsy (monotherapy): 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. For bipolar disorder (monotherapy): 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.
Dose Range:
10 - 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. Max: 500 mg/day.
epilepsy_adjunctive_with_valproate:
Initial: 25 mg every other day for 2 weeks, then 25 mg daily for 2 weeks, then 50 mg daily for 1 week. Max: 200 mg/day.
epilepsy_adjunctive_with_enzyme_inducers_without_valproate:
Initial: 50 mg daily for 2 weeks, then 100 mg daily (divided BID) for 2 weeks, then 200 mg daily (divided BID) for 1 week. Max: 700 mg/day.
bipolar_disorder_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. Max: 400 mg/day.
bipolar_disorder_with_valproate:
Initial: 25 mg every other day for 2 weeks, then 25 mg daily for 2 weeks, then 50 mg daily for 1 week. Max: 100 mg/day.
bipolar_disorder_with_enzyme_inducers_without_valproate:
Initial: 50 mg daily for 2 weeks, then 100 mg daily (divided BID) for 2 weeks, then 200 mg daily (divided BID) for 1 week. Max: 400 mg/day.
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 is weight-based and depends on concomitant medications. For epilepsy (2-12 years): Initial doses range from 0.3 mg/kg/day to 2 mg/kg/day, titrated slowly. Max doses range from 5-15 mg/kg/day depending on concomitant medications. Max 200-400 mg/day.
Adolescent:
Dosing generally follows adult guidelines for patients âĨ13 years of age.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Consider lower maintenance doses in patients with significant renal impairment.
Severe:
Consider lower maintenance doses in patients with significant renal impairment. Initial dose reduction by 25% for CrCl <30 mL/min. Subsequent dose adjustments should be based on clinical response.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed by hemodialysis. However, monitor clinical response.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Initial dose reduction by 50% for Child-Pugh Class B. Subsequent dose adjustments should be based on clinical response.
Severe:
Initial dose reduction by 75% for Child-Pugh Class C. Subsequent dose adjustments should be based on 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:
98%
Tmax:
1.4 to 4.8 hours (oral)
FoodEffect:
Food has no significant effect on the rate or extent of absorption.
Distribution:
Vd:
0.97 to 1.36 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); significantly affected by concomitant medications (e.g., ~15 hours with enzyme inducers, ~59 hours with valproate).
Clearance:
Approximately 30 mL/min (monotherapy)
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 10% (unchanged drug in urine)
Pharmacodynamics
OnsetOfAction:
Slow (due to required titration to minimize rash risk); therapeutic effects may take several weeks to months to achieve.
PeakEffect:
Not directly measurable for therapeutic effect; plasma concentrations peak within hours of a single dose.
DurationOfAction:
Plasma half-life dictates dosing frequency (once or twice daily).
Safety & Warnings
BLACK BOX WARNING
Serious skin rashes requiring hospitalization and discontinuation of treatment have been reported, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The incidence of these rashes, which have resulted in deaths, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 16 years) and 0.08% to 0.3% in adults. Risk factors include high initial doses, rapid dose escalation, and concomitant use of valproate.
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 or seek medical attention immediately:
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)
This medication can cause a rare but 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, and many side effects are mild and temporary. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or experience any side effects not listed here, 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
+ 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)
This medication can cause a rare but 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, and many side effects are mild and temporary. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or experience any side effects not listed here, 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
- Fever, swollen glands, facial swelling, sore throat, mouth sores
- Unusual bruising or bleeding
- Signs of infection
- Worsening depression, new or worsening thoughts of self-harm or suicide
- Severe dizziness, unsteadiness, or problems with coordination
- Blurred or double vision
- Severe nausea or vomiting
- Yellowing of skin or eyes (jaundice)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure 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
* Any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure 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
* Any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm 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 using prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal thoughts or behaviors. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
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 birth control methods may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based methods may be less effective in preventing pregnancy when taking this medication. Use 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 Management
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 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 using prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal thoughts or behaviors. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
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 birth control methods may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based methods may be less effective in preventing pregnancy when taking this medication. Use 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 Management
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:
- Ataxia (lack of coordination)
- Nystagmus (involuntary eye movements)
- Increased seizures
- Decreased consciousness
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive; there is no specific antidote.
Drug Interactions
Major Interactions
- Valproate (valproic acid, divalproex sodium): Significantly increases lamotrigine levels, increasing risk of serious rash. Requires significant lamotrigine dose reduction.
- Estrogen-containing oral contraceptives: May decrease lamotrigine levels, potentially leading to loss of seizure control or mood stabilization. Requires lamotrigine dose increase.
- Rifampin: Significantly decreases lamotrigine levels. Requires lamotrigine dose increase.
- Carbamazepine, Phenytoin, Phenobarbital, Primidone: May decrease lamotrigine levels. Requires lamotrigine dose increase.
Moderate Interactions
- Lopinavir/ritonavir: May decrease lamotrigine levels.
- Atazanavir/ritonavir: May decrease lamotrigine levels.
- Risperidone: May increase lamotrigine levels (less common, but reported).
- Paracetamol (acetaminophen): High doses may slightly decrease lamotrigine levels.
Monitoring
Baseline Monitoring
Renal and Hepatic Function (BUN, Cr, LFTs)
Rationale: To establish baseline function and guide initial dosing, especially in patients with pre-existing impairment.
Timing: Prior to initiation
Complete Blood Count (CBC) with differential
Rationale: Although rare, blood dyscrasias (e.g., neutropenia, aplastic anemia) have been reported. Establishes baseline.
Timing: Prior to initiation
Skin examination
Rationale: To document any pre-existing skin conditions, given the risk of serious rash.
Timing: Prior to initiation
Routine Monitoring
Clinical response (seizure frequency/severity, mood stability)
Frequency: Regularly during titration and maintenance, typically every 2-4 weeks during titration, then every 3-6 months or as clinically indicated.
Target: Optimal seizure control with minimal side effects; stable mood.
Action Threshold: Worsening symptoms, inadequate response, or intolerable side effects warrant dose adjustment or re-evaluation.
Adverse effects (especially rash, dizziness, ataxia, headache, nausea)
Frequency: Daily during initial titration, then regularly at each visit.
Target: Absence or mild, tolerable side effects.
Action Threshold: Any sign of serious rash (e.g., fever, facial swelling, lymphadenopathy, mucosal involvement) requires immediate discontinuation. Intolerable side effects require dose adjustment or discontinuation.
Suicidal ideation/behavior
Frequency: Regularly, especially during initial therapy and dose changes.
Target: Absence of suicidal thoughts or behaviors.
Action Threshold: Any new or worsening suicidal ideation requires immediate clinical assessment and intervention.
Lamotrigine plasma levels (Therapeutic Drug Monitoring - TDM)
Frequency: Not routinely recommended, but may be useful in specific situations (e.g., suspected non-adherence, drug interactions, renal/hepatic impairment, pregnancy, unexplained toxicity or lack of efficacy).
Target: Generally 3-14 mcg/mL for epilepsy, 2-10 mcg/mL for bipolar disorder (ranges are highly variable and should be interpreted clinically).
Action Threshold: Levels outside expected range, especially if correlated with clinical symptoms or lack of efficacy, may warrant dose adjustment.
Symptom Monitoring
- Skin rash (especially widespread, blistering, or accompanied by fever, facial swelling, sore throat, swollen lymph nodes)
- Worsening seizures or new seizure types
- Changes in mood or behavior (e.g., depression, anxiety, agitation, suicidal thoughts)
- Dizziness, unsteadiness, blurred vision, double vision
- Headache
- Nausea, vomiting
- Fever, flu-like symptoms
- Unusual bleeding or bruising, signs of infection (rare blood dyscrasias)
- Signs of multi-organ hypersensitivity reaction (DRESS syndrome): fever, rash, lymphadenopathy, facial swelling, liver/kidney involvement
Special Patient Groups
Pregnancy
Lamotrigine crosses the placenta. While older data suggested a potential increased risk of oral clefts, more recent and larger studies have not consistently confirmed this. However, the risk of major congenital malformations cannot be entirely excluded. Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus. Monotherapy is generally preferred over polytherapy if possible. Folic acid supplementation is recommended for all women of childbearing potential taking antiepileptic drugs.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, particularly oral clefts, though data are conflicting and risk may be small or absent.
Second Trimester:
Generally considered lower risk for structural malformations compared to first trimester.
Third Trimester:
No specific risks identified, but monitoring of maternal lamotrigine levels may be considered as clearance can increase during pregnancy, potentially leading to decreased drug levels and loss of seizure control.
Lactation
Lamotrigine is excreted into breast milk. Infant serum concentrations can be significant. Monitor breastfed infants for adverse effects such as rash, apnea, drowsiness, and poor feeding. Weigh the benefits of breastfeeding against the potential risks to the infant. Therapeutic drug monitoring in the infant may be considered.
Infant Risk:
Moderate risk (L3). Potential for drowsiness, poor feeding, rash, and apnea in the infant. Monitor closely.
Pediatric Use
Increased risk of serious rash (SJS/TEN) in pediatric patients compared to adults. Dosing is weight-based and requires careful titration. Not approved for bipolar disorder in patients under 18 years or for epilepsy in patients under 2 years.
Geriatric Use
Start with lower doses and titrate slowly due to potential for decreased renal/hepatic function and increased sensitivity to adverse effects. Monitor for dizziness, ataxia, and cognitive side effects.
Clinical Information
Clinical Pearls
- **Slow Titration is CRITICAL:** The most important aspect of lamotrigine therapy is the slow, gradual dose escalation to minimize the risk of serious skin rashes (SJS/TEN). Do not accelerate the titration schedule.
- **Rash Awareness:** Educate patients thoroughly about the signs and symptoms of a serious rash and the need for immediate medical attention if one develops. Discontinue at the first sign of a rash unless it is clearly not drug-related.
- **Drug Interactions:** Be highly aware of interactions, especially with valproate (requires significant dose reduction of lamotrigine) and estrogen-containing oral contraceptives (may require lamotrigine dose increase).
- **Cognitive Profile:** Lamotrigine is often considered to have a more favorable cognitive side effect profile compared to some other antiepileptic drugs.
- **Mood Stabilizer:** While an antiepileptic, it's also a first-line mood stabilizer for bipolar depression, but not for acute mania.
- **Abrupt Discontinuation:** Avoid abrupt discontinuation, as this can precipitate seizures or worsen mood symptoms. Taper gradually over at least 2 weeks unless a serious rash occurs.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Oxcarbazepine, Valproate, Topiramate, Phenytoin, Zonisamide, Gabapentin, Pregabalin, Lacosamide.
- For Bipolar Disorder (Mood Stabilizers): Lithium, Valproate, Carbamazepine, Quetiapine, Olanzapine, Lurasidone, Cariprazine.
Cost & Coverage
Average Cost:
Varies widely, typically $30-$200+ 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's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.