Lamotrigine Blue Starter Kit 25mg T
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 Antiepileptic
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 stabilize mood in people with bipolar disorder. It works by calming overactive nerve signals in the brain. It's very important to start this medication at a very low dose and increase it slowly over several weeks to months to reduce the risk of a serious skin rash.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to 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're feeling 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 discontinue it to minimize the risk of side effects.
If you've stopped taking the medication, consult your doctor before restarting, as you may need to begin with a lower dose and gradually increase 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 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's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
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 the medication as directed by your doctor or healthcare provider, even if you're feeling 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 discontinue it to minimize the risk of side effects.
If you've stopped taking the medication, consult your doctor before restarting, as you may need to begin with a lower dose and gradually increase 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 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's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take exactly as prescribed, do not stop suddenly without consulting your doctor, as this can cause seizures to worsen.
- Do not take more than the prescribed dose or increase the dose faster than instructed, as this increases the risk of serious skin rash.
- Be aware of the symptoms of a serious skin rash (e.g., fever, widespread rash, blistering, facial swelling, sore throat) and seek immediate medical attention if they occur.
- Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
- If you are taking oral contraceptives, inform your doctor as your lamotrigine dose may need to be adjusted.
- Avoid alcohol or other CNS depressants as they can increase drowsiness.
- Carry a medical alert card or wear a medical alert bracelet indicating you take lamotrigine, especially if you have epilepsy.
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:
Initial titration varies significantly based on concomitant medications. For monotherapy or with non-interacting AEDs: 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. Further increases by 100 mg/day weekly to maintenance.
Dose Range:
100 - 700 mg
Condition-Specific Dosing:
Monotherapy or with non-interacting AEDs:
Initial: 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then 100 mg once daily for 1 week, then 200 mg once daily. Maintenance: 200-400 mg/day (divided BID).
With Valproate (UGT inhibitor):
Initial: 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks, then 50 mg once daily for 1 week. Maintenance: 100-200 mg/day (divided BID).
With Enzyme-inducing AEDs (e.g., Carbamazepine, Phenytoin, Phenobarbital) without Valproate:
Initial: 50 mg once daily for 2 weeks, then 100 mg/day (divided BID) for 2 weeks, then 200 mg/day (divided BID) for 1 week. Maintenance: 300-500 mg/day (divided BID).
With Oral Contraceptives:
May require up to double the usual maintenance dose of lamotrigine.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy not established in patients <2 years of age for epilepsy, or <18 years for bipolar disorder).
Child:
Dosing for epilepsy (2-12 years) is weight-based and depends on concomitant medications, similar titration principles as adults. E.g., for monotherapy/non-interacting AEDs: 0.3 mg/kg/day for 2 weeks, then 0.6 mg/kg/day for 2 weeks, then 1.2 mg/kg/day for 1 week, then 2.4 mg/kg/day. Maintenance: 4.5-15 mg/kg/day (max 300 mg/day).
Adolescent:
Generally follows adult dosing guidelines for epilepsy (âĨ13 years) and bipolar disorder (âĨ18 years).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Reduced maintenance doses may be effective for patients with significant renal impairment; use with caution. Initial titration may follow standard guidelines, but subsequent dose increases should be based on clinical response.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed. Use with caution and monitor clinical response.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Initial, escalation, and maintenance doses should be reduced by approximately 25%.
Severe:
Initial, escalation, and maintenance doses should be reduced by approximately 50%. Use with caution and monitor clinical response.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that is thought to exert its anticonvulsant and mood-stabilizing effects by inhibiting voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and modulating the release of excitatory neurotransmitters (e.g., glutamate and aspartate). It also has weak effects on voltage-gated calcium channels and may inhibit serotonin 5-HT3 receptors.
Pharmacokinetics
Absorption:
Bioavailability:
98% (oral)
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 30 mL/min (adults)
ExcretionRoute:
Renal (approximately 94% as metabolites, 2% unchanged drug)
Unchanged:
Approximately 2%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration to minimize rash risk)
PeakEffect:
Weeks to months (after reaching maintenance dose)
DurationOfAction:
Not directly applicable due to chronic use and slow titration, but half-life dictates dosing frequency.
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) and toxic epidermal necrolysis (TEN), which can result in death. The incidence of these serious rashes is greater in pediatric patients than in adults. Other risk factors include concomitant use with valproate, exceeding recommended initial doses, and rapid dose escalation. Benign rashes also occur, but it is not possible to predict which rashes will prove to be serious. Therefore, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring.
Side Effects
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 experience 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
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 immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Trouble walking (new or worsening)
Other Side Effects
Most people do not experience serious side effects, and many people have only minor side effects. However, if you experience any of the following side effects and they bother you or do not go away, contact your doctor:
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 want to report a side effect, 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 experience 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
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 immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Trouble walking (new or worsening)
Other Side Effects
Most people do not experience serious side effects, and many people have only minor side effects. However, if you experience any of the following side effects and they bother you or do not go away, contact your doctor:
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 want to report a side effect, 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 it's widespread, blistering, or accompanied by fever, swollen glands, or facial swelling.
- Signs of allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
- Signs of liver problems: nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
- Signs of aseptic meningitis: headache, fever, nausea, vomiting, stiff neck, increased sensitivity to light.
- Signs of blood problems: fever, chills, sore throat, swollen gums, painful mouth sores, skin sores, pale skin, easy bruising or bleeding.
- Changes in mood or behavior: new or worsening depression, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggression, restlessness, hyperactivity (mentally or physically), increased suicidal thoughts or actions.
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 safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have or have had
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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 safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have or have had
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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 inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult 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 increase the risk of sudden death in individuals with certain heart problems.
Pediatric Use
When administering this medication to children, use 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 be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy when taking this medication. Use an alternative form of birth control, such as a condom.
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.
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 inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult 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 increase the risk of sudden death in individuals with certain heart problems.
Pediatric Use
When administering this medication to children, use 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 be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy when taking this medication. Use an alternative form of birth control, such as a condom.
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.
Overdose Information
Overdose Symptoms:
- Dizziness
- Drowsiness
- Blurred vision
- Lack of coordination
- Nystagmus (uncontrolled eye movements)
- Increased seizures
- Coma
What to Do:
Seek immediate emergency medical attention or call the Poison Help line at 1-800-222-1222. There is no specific antidote; treatment is supportive.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels, increases risk of serious rash)
- Carbamazepine, Phenytoin, Phenobarbital, Primidone (decrease lamotrigine levels)
- Oral Contraceptives (estrogen-containing) (decrease lamotrigine levels)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/Ritonavir, Atazanavir/Ritonavir (decrease lamotrigine levels)
Moderate Interactions
- Acetaminophen (may slightly decrease lamotrigine levels with chronic high doses)
- Risperidone (lamotrigine may decrease risperidone levels)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Bupropion (lamotrigine may increase bupropion levels)
- Folic acid inhibitors (e.g., methotrexate, trimethoprim) - theoretical concern for additive folate antagonism, but not well-established clinically.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for potential hematologic abnormalities (e.g., neutropenia, aplastic anemia, HLH), though routine monitoring is not typically recommended unless symptoms arise.
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for potential hepatic impairment, especially in patients with pre-existing liver disease.
Timing: Prior to initiation
Renal Function Tests (RFTs)
Rationale: To establish baseline and guide dosing in patients with severe renal impairment.
Timing: Prior to initiation
Skin assessment
Rationale: To document baseline skin condition and educate patient on rash symptoms.
Timing: Prior to initiation
Routine Monitoring
Clinical monitoring for rash (e.g., Stevens-Johnson Syndrome, TEN)
Frequency: Daily during titration, then regularly
Target: Absence of rash
Action Threshold: Any new rash should prompt immediate discontinuation and medical evaluation.
Clinical monitoring for signs of hypersensitivity syndrome (DRESS)
Frequency: Regularly, especially during first 8 weeks
Target: Absence of fever, lymphadenopathy, facial edema, liver dysfunction, eosinophilia
Action Threshold: Any signs should prompt immediate discontinuation and medical evaluation.
Clinical monitoring for signs of aseptic meningitis
Frequency: Regularly
Target: Absence of headache, fever, nausea, vomiting, nuchal rigidity, photophobia
Action Threshold: Any signs should prompt immediate discontinuation and medical evaluation.
Clinical monitoring for signs of Hemophagocytic Lymphohistiocytosis (HLH)
Frequency: Regularly
Target: Absence of fever, rash, hepatosplenomegaly, lymphadenopathy, cytopenias
Action Threshold: Any signs should prompt immediate discontinuation and medical evaluation.
Therapeutic Drug Monitoring (TDM) - Lamotrigine levels
Frequency: Not routinely recommended unless clinical suspicion of toxicity, non-adherence, or significant drug interactions (e.g., with oral contraceptives, enzyme inducers/inhibitors).
Target: Epilepsy: 3-14 mcg/mL (variable, clinical correlation is key); Bipolar: 2-10 mcg/mL (less established)
Action Threshold: Levels outside range or clinical symptoms/lack of efficacy may warrant dose adjustment.
Mood and seizure frequency/severity
Frequency: Regularly (e.g., monthly initially, then quarterly)
Target: Improved mood stability, reduced seizure frequency/severity
Action Threshold: Worsening symptoms or lack of efficacy may warrant dose adjustment or alternative therapy.
Symptom Monitoring
- Skin rash (any type, especially blistering or widespread)
- Fever
- Swollen lymph nodes
- Facial swelling
- Sore throat
- Mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe fatigue
- Headache
- Nausea/vomiting
- Stiff neck
- Sensitivity to light
- Changes in mood or behavior (e.g., depression, suicidal thoughts, aggression, agitation)
- Worsening seizures
Special Patient Groups
Pregnancy
Lamotrigine is excreted into breast milk. The amount varies, and some infants may experience adverse effects. Monitor breastfed infants for rash, drowsiness, poor feeding, and apnea. Weigh potential benefits of breastfeeding against potential risks to the infant.
Trimester-Specific Risks:
First Trimester:
Data from pregnancy registries suggest a low risk of major congenital malformations (e.g., oral clefts) with lamotrigine monotherapy, lower than some other AEDs. However, no drug is risk-free. Discuss risks and benefits with a healthcare provider.
Second Trimester:
Not specifically associated with increased risk during this trimester beyond general pregnancy risks.
Third Trimester:
Not specifically associated with increased risk during this trimester beyond general pregnancy risks. Lamotrigine levels may decrease during pregnancy, requiring dose adjustments, and then increase postpartum.
Lactation
Lamotrigine is excreted into breast milk. The amount varies, and some infants may experience adverse effects. Monitor breastfed infants for rash, drowsiness, poor feeding, and apnea. Weigh potential benefits of breastfeeding against potential risks to the infant.
Infant Risk:
Low to moderate risk. Monitor for drowsiness, poor feeding, rash, and apnea. Therapeutic drug monitoring in the infant may be considered if concerns arise.
Pediatric Use
Safety and efficacy for epilepsy not established in patients younger than 2 years of age. Safety and efficacy for bipolar disorder not established in patients younger than 18 years of age. Pediatric patients (especially <16 years) have a higher risk of serious rash compared to adults. Dosing is weight-based and requires careful titration.
Geriatric Use
No specific dose adjustments are generally required based on age alone, but elderly 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 'Blue Starter Kit' is specifically designed for patients taking valproate, as valproate significantly increases lamotrigine levels, requiring a slower titration schedule to minimize rash risk.
- Strict adherence to the titration schedule is crucial to minimize the risk of serious skin rashes (SJS/TEN). Do not accelerate the dose increase.
- If lamotrigine is discontinued for more than 5 half-lives (e.g., 5 days for monotherapy, longer if on valproate), re-initiation should follow the initial titration schedule due to the risk of rash.
- Patients should be educated to report any rash immediately, as well as other signs of hypersensitivity (fever, swollen glands, facial swelling).
- Lamotrigine levels can be significantly affected by concomitant medications, particularly valproate (increases levels) and enzyme-inducing AEDs or oral contraceptives (decrease levels). Dose adjustments may be necessary.
- While primarily known for epilepsy and bipolar disorder, lamotrigine is sometimes used off-label for neuropathic pain or other mood disorders.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Oxcarbazepine, Valproate, Topiramate, Gabapentin, Phenytoin, Zonisamide, Lacosamide, Perampanel.
- For Bipolar Disorder (Mood Stabilization): Lithium, Valproate, Carbamazepine, Olanzapine, Quetiapine, Aripiprazole, Lurasidone.
Cost & Coverage
Average Cost:
Varies widely per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and avoid taking medication prescribed to someone else. This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.