Lamotrigine Orge Strt Kit25/100mg
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 adults with bipolar disorder. It works by stabilizing electrical activity in the brain.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
Do not alter the dose or stop taking the medication without consulting your doctor, as this may lead to seizures.
If you need to stop taking the medication, your doctor will instruct you on how to gradually taper off the dose to minimize the risk of side effects.
If you stop taking the medication and need to restart, your doctor may recommend starting at a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light and moisture.
Keep the medication in a dry place, away from the bathroom.
Store all medications in a safe location, 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 by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in local drug take-back programs.
What to Do If You Miss a Dose
Take the missed dose as soon as you remember.
If it is 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 a missed dose.
To get the most benefit from your medication, 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 the medication as directed by your doctor or healthcare provider, even if you start to feel well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
Do not alter the dose or stop taking the medication without consulting your doctor, as this may lead to seizures.
If you need to stop taking the medication, your doctor will instruct you on how to gradually taper off the dose to minimize the risk of side effects.
If you stop taking the medication and need to restart, your doctor may recommend starting at a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light and moisture.
Keep the medication in a dry place, away from the bathroom.
Store all medications in a safe location, 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 by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in local drug take-back programs.
What to Do If You Miss a Dose
Take the missed dose as soon as you remember.
If it is 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 a missed dose.
Lifestyle & Tips
- Take exactly as prescribed, do not stop suddenly without consulting your doctor, as this can cause serious problems like increased seizures.
- Report any new skin rash immediately to your doctor, as this can be a sign of a serious, life-threatening reaction.
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how this medication affects you, as it can cause dizziness or drowsiness.
- If you are a woman of childbearing potential, discuss contraception and pregnancy planning with your doctor, as lamotrigine levels can change during pregnancy and with oral contraceptive use.
- Avoid alcohol or other CNS depressants, as they can increase side effects like dizziness and drowsiness.
Available Forms & Alternatives
Available Strengths:
- Lamotrigine 150mg Tablets
- Lamotrigine 200mg Tablets
- Lamotrigine 25mg Tablets
- Lamotrigine 100mg Tablets
- Lamotrigine 25mg Chew/disprsbl Tab
- Lamotrigine 5mg Chew/disprsbl Tab
- Lamotrigine ER 50mg Tablets
- Lamotrigine ER 200mg Tablets
- Lamotrigine ER 100mg Tablets
- Lamotrigine 300mg ER Tablets
- Lamotrigine ER 25mg Tablets
- Lamotrigine ODT 25mg Tablets
- Lamotrigine ODT 50mg Tablets
- Lamotrigine Orge Strt Kit25/100mg
- Lamotrigine Blue Starter Kit 25mg T
- Lamotrigine Green Str Kit 25/100mg
- Lamotrigine ODT 100mg Tablets
- Lamotrigine ODT 200mg Tablets
- Lamotrigine ER 250mg Tablets
- Lamotrigine ODT 25-50-100mg Tb Kit
Dosing & Administration
Adult Dosing
Standard Dose:
Maintenance dose typically 100-400 mg/day, divided into 1-2 doses. Titration is critical and depends on concomitant medications.
Dose Range:
100 - 400 mg
Condition-Specific Dosing:
epilepsy_monotherapy:
25 mg/day for 2 weeks, then 50 mg/day for 2 weeks, then increase by 50-100 mg/day every 1-2 weeks to maintenance of 225-375 mg/day.
epilepsy_with_valproate:
12.5 mg/day (or 25 mg every other day) for 2 weeks, then 25 mg/day for 2 weeks, then increase by 25-50 mg/day every 1-2 weeks to maintenance of 100-200 mg/day.
epilepsy_with_enzyme_inducers:
50 mg/day for 2 weeks, then 100 mg/day for 2 weeks, then increase by 100 mg/day every 1-2 weeks to maintenance of 300-500 mg/day (up to 700 mg/day).
bipolar_disorder:
25 mg/day for 2 weeks, then 50 mg/day for 2 weeks, then 100 mg/day for 1 week, then 200 mg/day. Doses adjusted based on concomitant medications similar to epilepsy.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Dosing is weight-based and highly dependent on concomitant medications (e.g., 0.3-0.6 mg/kg/day initially with valproate, 2 mg/kg/day initially with enzyme inducers). Titration is slow and gradual.
Adolescent:
Dosing similar to adults, but titration may be slower for younger adolescents.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
Consider lower maintenance doses, especially if significant concomitant medications are used.
Severe:
Reduce maintenance dose by 25-50%. Careful monitoring is required.
Dialysis:
Supplemental doses after dialysis are generally not needed as only a small fraction is removed. Consider lower maintenance doses.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Reduce initial, escalation, and maintenance doses by 25%.
Severe:
Reduce initial, escalation, and maintenance doses by 50%. Careful monitoring is required.
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 has weak effects on voltage-gated calcium channels.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1.4-4.8 hours (oral)
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
0.97-1.36 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 0.3-0.4 mL/min/kg (monotherapy)
ExcretionRoute:
Renal (approximately 94% of dose, primarily as glucuronide conjugates)
Unchanged:
Approximately 10% (renal)
Pharmacodynamics
OnsetOfAction:
Not acutely measurable for therapeutic effect; requires slow titration to achieve steady-state concentrations and clinical effect.
PeakEffect:
Achieved at steady-state concentrations, typically after several weeks of titration.
DurationOfAction:
Related to half-life; effects persist as long as therapeutic concentrations are maintained.
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 (aged 2 to 16 years) and 0.08% to 0.3% in adults. The risk of serious rash is increased by coadministration with valproate, exceeding recommended initial doses or dose escalation, and in patients with a history of allergy or rash to other antiepileptic drugs. Benign rashes are also common, but it is not possible to predict which rashes will prove to be serious. Therefore, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
This medication can cause low blood cell counts, which can increase the risk of bleeding, infection, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem (Hemophagocytic Lymphohistiocytosis)
This medication can cause a rare but life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor right away:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Trouble walking (new or worsening)
Other Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to contact your doctor if you experience any of the following:
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
If you have any questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
This medication can cause low blood cell counts, which can increase the risk of bleeding, infection, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem (Hemophagocytic Lymphohistiocytosis)
This medication can cause a rare but life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor right away:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Trouble walking (new or worsening)
Other Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to contact your doctor if you experience any of the following:
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
If you have any questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any new skin rash (especially blistering, peeling, or widespread)
- 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)
- Dark urine
- Severe muscle pain or weakness
- Worsening seizures or new types of seizures
- Changes in mood or behavior (e.g., new or worsening depression, anxiety, agitation, suicidal thoughts)
- Vision changes (e.g., double vision, blurred vision)
- Severe headache with stiff neck, nausea, vomiting, sensitivity to light, and fever (signs of aseptic meningitis)
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
* Your complete medical history, including any health problems you have
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 change 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, 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
* Your complete medical history, including any health problems you have
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 change 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 using prescription or over-the-counter (OTC) drugs 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 ideation. 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 Problems
If you have an abnormal heartbeat, heart failure, or other heart conditions, discuss the risks with your doctor. Abnormal heart rhythms can occur in people with certain heart problems, which may lead to sudden death.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
Birth Control and Hormone Interactions
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. 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 contraceptives may be less effective in preventing pregnancy when 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 with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult with your doctor.
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 using prescription or over-the-counter (OTC) drugs 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 ideation. 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 Problems
If you have an abnormal heartbeat, heart failure, or other heart conditions, discuss the risks with your doctor. Abnormal heart rhythms can occur in people with certain heart problems, which may lead to sudden death.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
Birth Control and Hormone Interactions
Birth control pills and other hormone-based contraceptives may affect the levels of this medication in your body. 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 contraceptives may be less effective in preventing pregnancy when 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 with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Nystagmus (involuntary eye movements)
- Ataxia (loss of coordination)
- Impaired consciousness
- Grand mal seizures
- Coma
- Intraventricular conduction delay (ECG changes)
What to Do:
Seek immediate medical attention or call 911. Contact a poison control center (1-800-222-1222). Management is supportive, including gastric lavage, activated charcoal, and close monitoring of vital signs and cardiac function.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels significantly, increasing risk of rash)
- Carbamazepine (decreases lamotrigine levels)
- Phenytoin (decreases lamotrigine levels)
- Phenobarbital (decreases lamotrigine levels)
- Primidone (decreases lamotrigine levels)
- Oral Contraceptives (estrogen-containing) (decrease lamotrigine levels significantly)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/Ritonavir (decreases lamotrigine levels)
- Atazanavir/Ritonavir (decreases lamotrigine levels)
Moderate Interactions
- Acetaminophen (may slightly decrease lamotrigine levels with chronic high-dose use)
- Risperidone (lamotrigine may decrease risperidone levels)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Bupropion (may slightly increase lamotrigine levels)
- Sertraline (may slightly increase lamotrigine levels)
Monitoring
Baseline Monitoring
Renal function (BUN, Creatinine)
Rationale: To assess baseline kidney function, especially important for dose adjustments in impairment.
Timing: Prior to initiation
Hepatic function (ALT, AST, Bilirubin)
Rationale: To assess baseline liver function, important for dose adjustments in impairment and monitoring for rare hepatotoxicity.
Timing: Prior to initiation
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for rare hematologic abnormalities (e.g., neutropenia, aplastic anemia).
Timing: Prior to initiation
Routine Monitoring
Clinical efficacy (seizure frequency/severity, mood stability)
Frequency: Regularly during titration and maintenance
Target: Optimal control with minimal side effects
Action Threshold: Inadequate control or intolerable side effects warrant dose adjustment or alternative therapy.
Adverse effects (especially skin rash)
Frequency: Daily during titration, then regularly
Target: Absence of rash or other serious hypersensitivity reactions
Action Threshold: Any new rash should prompt immediate discontinuation and medical evaluation.
Mental status and behavioral changes
Frequency: Regularly
Target: Stable mood, absence of suicidal ideation or unusual behavior
Action Threshold: Worsening depression, suicidal thoughts, or unusual behavioral changes require immediate assessment.
Lamotrigine plasma concentrations (therapeutic drug monitoring)
Frequency: Not routinely recommended, but may be useful in specific situations (e.g., suspected non-adherence, drug interactions, renal/hepatic impairment, pregnancy, or lack of efficacy/toxicity at expected doses).
Target: Typically 3-14 mcg/mL (varies by lab and indication)
Action Threshold: Levels outside therapeutic range may warrant dose adjustment or investigation of adherence/interactions.
Symptom Monitoring
- Skin rash (any type, especially blistering or widespread)
- Fever
- Swollen lymph nodes
- Swelling of face, eyes, lips, or tongue
- Sore throat
- Mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe muscle pain or weakness
- Worsening seizures
- Changes in mood or behavior (e.g., depression, anxiety, agitation, suicidal thoughts)
- Vision changes (e.g., double vision, blurred vision)
Special Patient Groups
Pregnancy
Lamotrigine crosses the placenta. While generally considered one of the safer antiepileptic drugs during pregnancy, it is associated with a small increased risk of oral clefts (cleft lip/palate) when exposed in the first trimester, particularly at higher doses. However, the risk of untreated epilepsy or bipolar disorder to both mother and fetus often outweighs the risks of medication. Levels of lamotrigine can decrease significantly during pregnancy, requiring dose adjustments. Folic acid supplementation is recommended for all women of childbearing potential taking antiepileptic drugs.
Trimester-Specific Risks:
First Trimester:
Small increased risk of oral clefts (cleft lip/palate). Close monitoring of lamotrigine levels and dose adjustment may be necessary due to increased clearance.
Second Trimester:
Continued monitoring of lamotrigine levels and dose adjustment as clearance may continue to increase.
Third Trimester:
Continued monitoring of lamotrigine levels. Levels may rapidly increase postpartum, requiring dose reduction.
Lactation
Lamotrigine is excreted into breast milk. While generally considered compatible with breastfeeding, infant monitoring for adverse effects (e.g., rash, drowsiness, poor feeding, apnea) is recommended, especially in the first few weeks of life. The infant's serum lamotrigine levels can be significant.
Infant Risk:
L3 (Moderate risk - monitor infant for drowsiness, rash, poor feeding, apnea. Consider therapeutic drug monitoring in the infant if concerns arise).
Pediatric Use
Approved for partial seizures, generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients âĨ2 years of age. Dosing is weight-based and complex, requiring careful titration based on concomitant medications. Higher incidence of serious rash in pediatric patients compared to adults.
Geriatric Use
No specific dose adjustments are generally required based solely on age, but older patients may be more sensitive to adverse effects (e.g., dizziness, ataxia). Start with lower doses and titrate slowly, monitoring for side effects.
Clinical Information
Clinical Pearls
- Slow titration is paramount to minimize the risk of serious skin rash. Never accelerate the titration schedule.
- Patients should be educated to report any rash immediately and discontinue the medication unless instructed otherwise by a healthcare professional.
- Lamotrigine levels are significantly affected by concomitant medications, especially valproate (increases levels) and enzyme-inducing antiepileptic drugs or oral contraceptives (decrease levels). Dose adjustments are crucial when starting or stopping these interacting medications.
- Consider therapeutic drug monitoring (TDM) in situations of suspected non-adherence, drug interactions, renal/hepatic impairment, pregnancy, or when efficacy/toxicity is not as expected.
- Lamotrigine can cause aseptic meningitis, a rare but serious adverse effect. Patients presenting with symptoms of meningitis should be evaluated for this possibility.
- For women on oral contraceptives, consider using a higher dose of lamotrigine or alternative contraception, as estrogen can significantly reduce lamotrigine levels, potentially leading to loss of seizure control or mood stabilization.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Phenytoin, Topiramate, Oxcarbazepine, Zonisamide, Gabapentin, Pregabalin, Lacosamide, Rufinamide, Clobazam, Perampanel, Cannabidiol.
- For Bipolar Disorder: Lithium, Valproate, Carbamazepine, Olanzapine, Quetiapine, Lurasidone, Asenapine, Cariprazine.
Cost & Coverage
Average Cost:
Varies widely by dosage and quantity per 30 tablets
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 provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. 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. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.