Lamictal Blue Starter Kit 25mg
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
Category C
FDA Approved
Dec 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamotrigine is a medication used to treat certain types of seizures (epilepsy) and to help prevent mood swings in people with bipolar disorder. It works by stabilizing electrical activity in the brain. It's very important to start this medication at a very low dose and increase it slowly to reduce the risk of a serious skin rash.
How to Use This Medicine
Taking Your Medication
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.
It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you're feeling well. Swallow the medication whole; do not chew, break, or crush it. If you have difficulty swallowing, consult your doctor.
Important Warnings
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, your doctor will instruct you on how to gradually stop it to minimize the risk of side effects. If you do stop taking this medication, you may need to restart it at a lower dose and gradually increase the dose under your doctor's guidance.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep 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. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
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.
It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you're feeling well. Swallow the medication whole; do not chew, break, or crush it. If you have difficulty swallowing, consult your doctor.
Important Warnings
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, your doctor will instruct you on how to gradually stop it to minimize the risk of side effects. If you do stop taking this medication, you may need to restart it at a lower dose and gradually increase the dose under your doctor's guidance.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep 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. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take exactly as prescribed, do not stop suddenly without consulting your doctor, as this can cause withdrawal seizures or worsening mood.
- Follow the slow dose titration schedule carefully to minimize the risk of serious skin rash.
- Report any new skin rash immediately to your doctor, especially if it's accompanied by fever, swollen glands, or facial swelling.
- Avoid alcohol or other CNS depressants, as they can increase side effects like dizziness and drowsiness.
- Be aware that lamotrigine can cause dizziness, drowsiness, or blurred vision, so avoid driving or operating machinery until you know how it affects you.
- If you are taking oral contraceptives, discuss this with your doctor as they can affect lamotrigine levels, and lamotrigine may affect contraceptive efficacy.
- Carry a medical alert card or wear a medical alert bracelet indicating you are taking lamotrigine.
Available Forms & Alternatives
Available Strengths:
- Lamictal 150mg Tablets
- Lamictal 200mg Tablets
- Lamictal 100mg Tablets
- Lamictal 25mg Tablets
- Lamictal 5mg Chewabl Disprsbl Tabs
- Lamictal 25mg Chewabl Disprsbl Tabs
- Lamictal Orange Strt Kit25mg/100mg
- Lamictal Blue Starter Kit 25mg
- Lamictal XR 25mg Tablets
- Lamictal XR 50mg Tablets
- Lamictal XR 100mg Tablets
- Lamictal XR 200mg Tablets
- Lamictal XR 25-50-100mg Titrtn Kit
- Lamictal XR 25-50mg Titration Kt 28
- Lamictal XR 50-100-200mg Titrtn Kit
- Lamictal ODT 25mg Tablets
- Lamictal ODT 50mg Tablets
- Lamictal ODT 100mg Tablets
- Lamictal ODT 200mg Tablets
- Lamictal ODT 25-50-100mg Tb Kt Orng
- Lamictal ODT 25-50mg Tb Kit Blue
- Lamictal ODT 50-100mg Tb Kit Green
- Lamictal Green Strt Kit 25mg/100mg
- Lamictal XR 300mg Tablets
- Lamictal XR 250mg Tablets
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized, requiring slow titration to minimize rash risk. Initial dosing depends on concomitant medications (e.g., valproate, enzyme-inducing AEDs). For monotherapy or with non-interacting AEDs: Initial 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then increase by 50 mg/day every 1-2 weeks. Maintenance: 100-400 mg/day in 1-2 divided doses.
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
Epilepsy (monotherapy):
Initial 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then increase by 50 mg/day every 1-2 weeks. Maintenance: 225-375 mg/day in 2 divided doses.
Epilepsy (adjunctive therapy with valproate):
Initial 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks, then increase by 25-50 mg/day every 1-2 weeks. Maintenance: 100-200 mg/day in 1-2 divided doses.
Epilepsy (adjunctive therapy with enzyme-inducing AEDs without valproate):
Initial 50 mg once daily for 2 weeks, then 100 mg/day in 2 divided doses for 2 weeks, then increase by 100 mg/day every 1-2 weeks. Maintenance: 300-500 mg/day in 2 divided doses.
Bipolar I Disorder (maintenance):
Similar titration as epilepsy, depending on concomitant medications. Target maintenance: 200 mg/day (with valproate: 100 mg/day; with enzyme-inducing AEDs: 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 for epilepsy (2-16 years) is weight-based and depends on concomitant medications. Titration is slow and individualized. E.g., for adjunctive therapy with valproate (2-12 years): Initial 0.15 mg/kg/day for 2 weeks, then 0.3 mg/kg/day for 2 weeks, then increase by 0.3 mg/kg/day every 1-2 weeks. Maintenance: 1-5 mg/kg/day (max 200 mg/day).
Adolescent:
Dosing for epilepsy (13-16 years) generally follows adult guidelines, but titration should be cautious. Not indicated for bipolar disorder in adolescents <18 years.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
Consider lower maintenance doses, especially if significant renal impairment (CrCl <30 mL/min).
Severe:
Consider lower maintenance doses (e.g., 25% reduction in maintenance dose for CrCl <30 mL/min).
Dialysis:
Supplemental doses after dialysis are generally not needed as only a small amount is removed. Monitor clinical response.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Initial dose and subsequent dose escalations should be reduced by 50%.
Severe:
Initial dose and subsequent dose escalations should be reduced by 75%. Monitor closely for adverse effects.
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:
Approximately 98%
Tmax:
1.4 to 4.8 hours (oral)
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
0.97 to 1.36 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); significantly affected by concomitant medications (e.g., ~15 hours with enzyme-inducing AEDs, ~59 hours with valproate).
Clearance:
Approximately 30 mL/min/kg (monotherapy)
ExcretionRoute:
Renal (approximately 94% as metabolites, 2% as unchanged drug)
Unchanged:
Approximately 2%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration required)
PeakEffect:
Weeks to months (after reaching stable maintenance dose)
DurationOfAction:
Related to half-life; effects persist as long as drug levels 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 (2-16 years) and 0.08% to 0.3% in adults. Risk factors include concomitant use of valproate, exceeding recommended initial doses, and rapid dose escalation. Benign rashes also occur, but it is not possible to predict which rashes will prove to be serious. Therefore, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, 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: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or significant weight gain.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Shortness of breath, significant weight gain, or swelling in the arms or legs.
Severe muscle pain or weakness.
Severe joint pain or swelling.
Changes in vision.
Chest pain or pressure.
Abnormal heartbeat (fast, slow, or irregular).
Severe dizziness or fainting.
Balance problems.
Uncontrolled eye movements.
Flu-like symptoms.
Painful menstrual periods.
Changes in menstrual cycle, including spotting or bleeding between periods.
Low Blood Cell Counts
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: fever, chills, or 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 right away:
Fever.
Swollen glands.
Rash.
Seizures.
Confusion or decreased alertness.
Balance problems.
Difficulty walking (new or worsening).
Other Side Effects
Most people taking this medication do not experience serious side effects, but some may occur. If you experience any of the following side effects and they bother you or do not go away, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness.
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Shakiness.
Sleep disturbances.
Nose or throat irritation.
Weight loss.
Dry mouth.
* Back pain.
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, 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: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or significant weight gain.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Shortness of breath, significant weight gain, or swelling in the arms or legs.
Severe muscle pain or weakness.
Severe joint pain or swelling.
Changes in vision.
Chest pain or pressure.
Abnormal heartbeat (fast, slow, or irregular).
Severe dizziness or fainting.
Balance problems.
Uncontrolled eye movements.
Flu-like symptoms.
Painful menstrual periods.
Changes in menstrual cycle, including spotting or bleeding between periods.
Low Blood Cell Counts
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: fever, chills, or 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 right away:
Fever.
Swollen glands.
Rash.
Seizures.
Confusion or decreased alertness.
Balance problems.
Difficulty walking (new or worsening).
Other Side Effects
Most people taking this medication do not experience serious side effects, but some may occur. If you experience any of the following side effects and they bother you or do not go away, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness.
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Shakiness.
Sleep disturbances.
Nose or throat irritation.
Weight loss.
Dry mouth.
* Back pain.
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 skin rash (especially blistering, peeling, or widespread)
- Fever, swollen glands, or facial swelling (signs of a serious allergic reaction)
- Sore throat, mouth sores, or unusual bruising/bleeding (signs of blood problems)
- Yellowing of skin or eyes (jaundice), dark urine (signs of liver problems)
- Worsening depression, new or worsening suicidal thoughts or behaviors
- Unusual changes in mood or behavior (e.g., agitation, aggression, panic attacks)
- Severe muscle pain or weakness
- Vision changes (e.g., double vision, blurred vision)
- Severe dizziness or loss of coordination
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 medical history, including any health problems you have
This 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 medical history, including any health problems you have
This 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
Your doctor will require you to have regular blood work done. Be sure to follow their instructions and 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 shape, color, size, or labeling of your medication, 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 heartbeats can increase the risk of sudden death in individuals with certain heart problems.
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 be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy when taking this medication. Use an alternative form of birth control, such as a condom, to prevent 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.
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
Your doctor will require you to have regular blood work done. Be sure to follow their instructions and 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 shape, color, size, or labeling of your medication, 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 heartbeats can increase the risk of sudden death in individuals with certain heart problems.
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 be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy when taking this medication. Use an alternative form of birth control, such as a condom, to prevent 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.
Overdose Information
Overdose Symptoms:
- Nystagmus (involuntary eye movements)
- Ataxia (loss of coordination)
- Impaired consciousness
- Seizures
- Coma
- QRS prolongation (cardiac conduction abnormality)
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. Gastric lavage or activated charcoal may be considered if ingestion is recent.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels, requiring significant dose reduction of lamotrigine and increased risk of rash)
- Carbamazepine, Phenytoin, Phenobarbital, Primidone (decrease lamotrigine levels, requiring increased lamotrigine dose)
- Estrogen-containing oral contraceptives (decrease lamotrigine levels, requiring increased lamotrigine dose; lamotrigine may also decrease contraceptive efficacy)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/ritonavir (decreases lamotrigine levels)
- Atazanavir/ritonavir (decreases lamotrigine levels)
Moderate Interactions
- Paracetamol/Acetaminophen (may slightly decrease lamotrigine levels with chronic high-dose use)
- Risperidone (lamotrigine may decrease risperidone levels)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Lithium (potential for additive CNS effects, monitor for toxicity)
Minor Interactions
- Bupropion (may slightly increase lamotrigine levels)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for rare but serious hematologic reactions (e.g., blood dyscrasias).
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for rare but serious hepatic dysfunction.
Timing: Prior to initiation
Renal Function Tests (Creatinine, BUN)
Rationale: To establish baseline and guide dose adjustments in renal impairment.
Timing: Prior to initiation
Skin Assessment
Rationale: To document baseline skin condition and educate patient on rash symptoms, given the risk of serious dermatologic reactions.
Timing: Prior to initiation
Routine Monitoring
Skin Assessment
Frequency: Daily during titration, then regularly
Target: Absence of new rash, especially maculopapular or blistering
Action Threshold: Any new rash, especially if accompanied by fever, lymphadenopathy, facial swelling, or other systemic symptoms, requires immediate discontinuation and medical evaluation.
Seizure Frequency/Severity (for epilepsy)
Frequency: Regularly (e.g., monthly initially, then every 3-6 months)
Target: Reduction in seizure frequency/severity
Action Threshold: Worsening seizures or inadequate control may require dose adjustment or alternative therapy.
Mood Stability (for bipolar disorder)
Frequency: Regularly (e.g., monthly initially, then every 3-6 months)
Target: Stabilization of mood, reduction in mood episodes
Action Threshold: Worsening mood symptoms (depression, mania, mixed states) or inadequate control may require dose adjustment or alternative therapy.
Suicidal Ideation/Behavior
Frequency: Regularly, especially during initial therapy or dose changes
Target: Absence of suicidal thoughts or behaviors
Action Threshold: Any emergence or worsening of suicidal thoughts or behaviors requires immediate clinical assessment and intervention.
Adverse Effects (e.g., dizziness, ataxia, blurred vision, nausea)
Frequency: Regularly, especially during titration
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Symptom Monitoring
- Skin rash (any type, especially blistering, peeling, 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 muscle pain
- Unexplained weakness or fatigue
- Worsening depression or mood changes
- New or worsening suicidal thoughts or behaviors
- Agitation, hostility, anxiety
- Panic attacks
- Insomnia
- Restlessness
- Irritability
- Aggressiveness
- Unusual changes in behavior
Special Patient Groups
Pregnancy
Lamotrigine is a Category C drug. While data from pregnancy registries suggest that the overall risk of major congenital malformations is not significantly increased compared to the general population, there is a potential for a slightly increased risk of oral clefts (cleft lip/palate) when exposed during the first trimester. The decision to use lamotrigine during pregnancy should weigh the potential benefits against the risks, considering the risks of uncontrolled seizures or mood episodes to both mother and fetus. Enrollment in a pregnancy registry (e.g., North American Antiepileptic Drug Pregnancy Registry) is recommended.
Trimester-Specific Risks:
First Trimester:
Potential slightly increased risk of oral clefts (cleft lip/palate).
Second Trimester:
No specific increased risk identified.
Third Trimester:
No specific increased risk identified. Monitor neonate for potential withdrawal symptoms if mother was on high doses.
Lactation
Lamotrigine is excreted into breast milk. Infant serum concentrations can be significant (up to 50% of maternal levels). While many infants are unaffected, monitor breastfed infants for adverse effects such as rash, drowsiness, poor feeding, and apnea. Weigh the benefits of breastfeeding against the potential risks to the infant. Therapeutic drug monitoring of infant levels may be considered.
Infant Risk:
L3 (Moderate risk) - Monitor infant for rash, sedation, poor feeding, and apnea. Consider alternative if infant is premature or has underlying health issues.
Pediatric Use
Safety and efficacy for epilepsy are established in patients 2 years and older. Not indicated for bipolar disorder in patients under 18 years. Pediatric patients (especially those 2-16 years) have a higher incidence of serious skin rashes compared to adults. Close monitoring and strict adherence to slow titration schedules are crucial. Dosing is weight-based and highly dependent on concomitant medications.
Geriatric Use
Use with caution in elderly patients, as they may be more sensitive to the effects of lamotrigine and may have age-related decreases in renal or hepatic function. Start with lower doses and titrate slowly. Monitor for adverse effects, especially dizziness and ataxia, which can increase fall risk.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rashes. Patients must be educated thoroughly on this.
- Concomitant valproate significantly increases lamotrigine levels, requiring a much slower and lower lamotrigine titration. Conversely, enzyme-inducing AEDs (e.g., carbamazepine, phenytoin) significantly decrease lamotrigine levels, requiring faster and higher titration.
- Oral contraceptives can decrease lamotrigine levels, potentially leading to loss of seizure control or mood stabilization. Dose adjustments may be needed when starting or stopping oral contraceptives.
- Lamotrigine is often preferred in women of childbearing potential due to a relatively lower risk of major congenital malformations compared to some other AEDs, though the oral cleft risk should be discussed.
- While therapeutic drug monitoring (TDM) is not routinely recommended for lamotrigine, it can be useful in specific situations, such as suspected non-adherence, drug interactions, renal/hepatic impairment, or when clinical response is suboptimal despite appropriate dosing.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Phenytoin, Topiramate, Oxcarbazepine, Zonisamide, Gabapentin, Pregabalin, Lacosamide, Rufinamide, Clobazam, Perampanel, Brivaracetam.
- For Bipolar Disorder (Mood Stabilizers): Lithium, Valproate, Carbamazepine, Olanzapine, Quetiapine, Lurasidone, Cariprazine, Asenapine, Risperidone, Aripiprazole.
Cost & Coverage
Average Cost:
$10 - $50 (generic 25mg, 30 tablets) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Generic formulations are typically covered as Tier 1 or Tier 2 by most insurance plans. Brand-name Lamictal may be Tier 3 or higher.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.