Lamictal XR 300mg Tablets
WARNING: Severe skin reactions may happen with this drug. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands. The chance of a skin reaction is raised in children between 2 and 17 years old. It may also be raised if you take valproic acid or divalproex sodium with this drug, if you start taking this drug at too high of a dose, or if your dose is raised too fast. Skin reactions have also happened without any of these. Talk with your doctor.Most cases of skin reactions have happened within 2 to 8 weeks of starting this drug, but some show up after longer treatment like 6 months. Talk with the doctor.This drug is not approved for use in children younger than 13 years old. Talk with the doctor. @ COMMON USES: It is used to help control certain kinds of seizures.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant
Pharmacologic Class
Phenyltriazine derivative; Voltage-gated sodium channel blocker
Pregnancy Category
C
FDA Approved
Jul 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamictal XR is an extended-release medication used to help control certain types of seizures in adults with epilepsy. It works by stabilizing electrical activity in the brain. It's important to take it exactly as prescribed, especially during the beginning of treatment, to reduce the risk of serious skin rashes.
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 your 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 your dose or stop taking this medication without consulting your doctor, as this may lead to seizures.
If you need to stop taking this 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 this 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 your medication at room temperature, protected from light, and in a dry place. Avoid storing 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 by your pharmacist. Check with your pharmacist for guidance on the best disposal methods, and consider participating in local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
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 your 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 your dose or stop taking this medication without consulting your doctor, as this may lead to seizures.
If you need to stop taking this 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 this 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 your medication at room temperature, protected from light, and in a dry place. Avoid storing 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 by your pharmacist. Check with your pharmacist for guidance on the best disposal methods, and consider participating in local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
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 Lamictal XR once daily, at the same time each day, with or without food.
- Swallow tablets whole; do not chew, crush, or divide them.
- Do not stop taking this medication suddenly, as it can increase seizure frequency. Any dose changes should be made under medical supervision.
- Avoid activities requiring mental alertness, such as driving or operating machinery, until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Report any new or worsening rash immediately to your doctor. This is a serious side effect.
- Report any unusual mood changes, depression, or thoughts of self-harm to your doctor.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, herbal supplements, and oral contraceptives, as they can interact with Lamictal XR.
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:
Dosage must be individualized and titrated slowly due to risk of serious rash. For partial-onset seizures (adjunctive therapy): 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 150 mg once daily for 1 week, then 200 mg once daily. May increase by 100 mg/day weekly to maintenance. Maintenance dose typically 300-500 mg once daily.
Dose Range:
25 - 500 mg
Condition-Specific Dosing:
Concomitant Valproate:
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, then 100 mg once daily for 1 week, then 150 mg once daily. Maintenance dose typically 200-250 mg once daily.
Concomitant Enzyme-Inducing AEDs (e.g., Carbamazepine, Phenytoin, Phenobarbital) without Valproate:
Initial 50 mg once daily for 2 weeks, then 100 mg once daily for 2 weeks, then 200 mg once daily for 1 week, then 300 mg once daily for 1 week, then 400 mg once daily. Maintenance dose typically 400-600 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for Lamictal XR. Lamictal (immediate-release) is approved for children 2 years and older for certain indications, with specific weight-based dosing and titration.
Adolescent:
Dosing for adolescents (13-17 years) is generally similar to adult dosing, with careful titration based on concomitant medications.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required, but caution advised.
Moderate:
No specific dose adjustment required, but caution advised.
Severe:
Reduced maintenance doses may be effective for patients with significant renal impairment. Initial titration should follow standard guidelines, but subsequent dose increases should be based on clinical response and tolerability. Use with caution.
Dialysis:
Supplemental doses after dialysis are not required. Reduced maintenance doses may be effective. Use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
Initial, escalation, and maintenance doses should be reduced by approximately 25%.
Severe:
Initial, escalation, and maintenance doses should be reduced by approximately 50%.
Confidence:
High
Pharmacology
Mechanism of Action
Lamotrigine is an anticonvulsant believed to exert its effects by inhibiting voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and inhibiting the release of excitatory neurotransmitters (primarily glutamate and aspartate). It also has weak effects on voltage-gated calcium channels and may inhibit neuronal firing by other mechanisms.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 98% (oral)
Tmax:
Lamictal XR: 4-6 hours (range 3-10 hours)
FoodEffect:
Food does not significantly affect the rate or extent of absorption of Lamictal XR.
Distribution:
Vd:
0.97-1.22 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (single dose); can be significantly altered by concomitant medications (e.g., valproate increases half-life, enzyme inducers decrease half-life).
Clearance:
Approximately 30 mL/min (adults)
ExcretionRoute:
Renal (approximately 94% as metabolites, 2% unchanged)
Unchanged:
Approximately 2%
Pharmacodynamics
OnsetOfAction:
Gradual, due to slow titration required to minimize rash risk. Therapeutic effects may take weeks to months to achieve.
PeakEffect:
Not directly applicable due to slow titration and chronic use. Steady-state concentrations are achieved after approximately 5-7 half-lives.
DurationOfAction:
Sustained release formulation provides once-daily dosing.
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 rashes, which have been reported in approximately 0.3% to 0.8% of pediatric patients (2 to 16 years of age) and 0.08% to 0.3% of adults, is greater in pediatric patients than in adults. The risk of serious rash is increased by coadministration with valproate, exceeding the recommended initial dose, or exceeding the recommended dose escalation. 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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or 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 or irregular menstrual periods
Low blood cell counts, which can increase the risk of:
+ Infections (fever, chills, or sore throat)
+ Bleeding problems (unexplained bruising or bleeding)
+ Anemia (feeling extremely tired or weak)
Additionally, an immune system disorder called hemophagocytic lymphohistiocytosis (HLH) has been reported with this medication. HLH can be life-threatening. Seek immediate medical attention if you experience:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems or difficulty walking (new or worsening symptoms)
Other Possible Side Effects
Most people taking this medication will not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
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
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or 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 or irregular menstrual periods
Low blood cell counts, which can increase the risk of:
+ Infections (fever, chills, or sore throat)
+ Bleeding problems (unexplained bruising or bleeding)
+ Anemia (feeling extremely tired or weak)
Additionally, an immune system disorder called hemophagocytic lymphohistiocytosis (HLH) has been reported with this medication. HLH can be life-threatening. Seek immediate medical attention if you experience:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems or difficulty walking (new or worsening symptoms)
Other Possible Side Effects
Most people taking this medication will not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
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
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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
- Signs of meningitis (headache, fever, stiff neck, nausea, vomiting, sensitivity to light)
- Signs of HLH (persistent fever, rash, enlarged lymph nodes, liver, or spleen, neurological symptoms)
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 overall health status, including any existing medical conditions
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, 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 overall health status, including any existing medical conditions
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as advised by your doctor. Be sure to discuss your test results with your doctor. Additionally, inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab tests.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or using prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal thoughts or behaviors. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or packaging, consult with your pharmacist.
Heart-Related Warnings
If you have an abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with pre-existing heart conditions.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
Interactions with Birth Control
Birth control pills and other hormone-based 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 minimize the risk of pregnancy.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult with your doctor to adjust your treatment plan as needed.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as advised by your doctor. Be sure to discuss your test results with your doctor. Additionally, inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab tests.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or using prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal thoughts or behaviors. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or packaging, consult with your pharmacist.
Heart-Related Warnings
If you have an abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with pre-existing heart conditions.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
Interactions with Birth Control
Birth control pills and other hormone-based 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 minimize the risk of pregnancy.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult with your doctor to adjust your treatment plan as needed.
Overdose Information
Overdose Symptoms:
- Nystagmus (involuntary eye movements)
- Ataxia (loss of coordination)
- Impaired consciousness
- Seizures
- Coma
- Cardiac conduction abnormalities (e.g., QRS prolongation)
What to Do:
Seek immediate medical attention or call Poison Control (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, increases risk of serious rash)
- Carbamazepine (decreases lamotrigine levels)
- Phenytoin (decreases lamotrigine levels)
- Phenobarbital (decreases lamotrigine levels)
- Primidone (decreases lamotrigine levels)
- Oral Contraceptives (estrogen-containing) (decrease lamotrigine levels)
- Rifampin (decreases lamotrigine levels)
- Lopinavir/Ritonavir (decreases lamotrigine levels)
- Atazanavir/Ritonavir (decreases lamotrigine levels)
Moderate Interactions
- Paracetamol (Acetaminophen) (may decrease lamotrigine levels with chronic high-dose use)
- Risperidone (lamotrigine may decrease risperidone levels)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Aripiprazole (lamotrigine may decrease aripiprazole levels)
- Lithium (potential for neurotoxicity, monitor for adverse effects)
- Zidovudine (lamotrigine may increase zidovudine levels)
Minor Interactions
- Folic acid (may slightly decrease lamotrigine levels)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for blood dyscrasias (e.g., aplastic anemia, agranulocytosis, 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 hepatic impairment, though routine monitoring is not typically recommended unless symptoms arise.
Timing: Prior to initiation
Renal Function Tests (RFTs)
Rationale: To establish baseline, especially in patients with pre-existing renal impairment.
Timing: Prior to initiation
Routine Monitoring
Clinical assessment for rash (e.g., Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis)
Frequency: Daily during titration, then regularly
Target: Absence of rash
Action Threshold: Any new rash should prompt immediate discontinuation of lamotrigine and medical evaluation.
Seizure frequency and severity
Frequency: Regularly (e.g., monthly initially, then every 3-6 months)
Target: Reduction or elimination of seizures
Action Threshold: Increased seizure frequency or severity may indicate need for dose adjustment or alternative therapy.
Adverse effects (e.g., dizziness, ataxia, blurred vision, headache, nausea, somnolence)
Frequency: Regularly, especially during titration and dose changes
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Mood and behavioral changes (e.g., depression, suicidal ideation)
Frequency: Regularly
Target: Stable mood
Action Threshold: New or worsening mood changes, especially suicidal thoughts, require immediate evaluation and intervention.
Symptom Monitoring
- Rash (any type, especially widespread or blistering)
- 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
- Unexplained weakness or fatigue
- Signs of aseptic meningitis (headache, fever, nausea, vomiting, stiff neck, rash, photophobia)
- Signs of Hemophagocytic Lymphohistiocytosis (HLH) (fever, rash, enlarged liver/spleen, lymphadenopathy, neurological symptoms)
Special Patient Groups
Pregnancy
Lamotrigine is classified as Pregnancy Category C. While animal studies show some developmental toxicity, human data from pregnancy registries suggest that lamotrigine monotherapy is not associated with a major increase in the risk of major congenital malformations compared to the general population. However, the risk of oral clefts has been debated. The decision to use lamotrigine during pregnancy should weigh the potential benefits against the risks, especially considering the risks of uncontrolled seizures to both mother and fetus. Dose adjustments may be necessary during pregnancy due to changes in lamotrigine clearance.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of oral clefts (though data are conflicting and overall risk appears low with monotherapy). Close monitoring of lamotrigine levels may be considered due to potential for decreased levels.
Second Trimester:
Clearance of lamotrigine may increase, potentially requiring dose adjustments to maintain therapeutic levels.
Third Trimester:
Clearance of lamotrigine may continue to increase. Monitor for seizure control and adjust dose as needed. Monitor infant for signs of lamotrigine toxicity post-delivery.
Lactation
Lamotrigine is excreted into breast milk. While some infants have shown no adverse effects, there are reports of adverse events such as apnea, drowsiness, and poor feeding in breastfed infants. The American Academy of Pediatrics considers lamotrigine to be compatible with breastfeeding, but caution is advised. Monitor breastfed infants for drowsiness, poor feeding, rash, and apnea. Consider therapeutic drug monitoring in the infant if concerns arise.
Infant Risk:
L3 (Moderately Safe - Limited controlled studies show no increase in adverse effects, or only minor non-serious adverse effects. Risk of adverse effects is possible, but unlikely.)
Pediatric Use
Lamictal XR is not approved for use in pediatric patients under 13 years of age. The immediate-release formulation (Lamictal) is approved for certain seizure types in children 2 years and older, with specific weight-based dosing and titration schedules. Children are at a higher risk of developing serious skin rashes compared to adults.
Geriatric Use
No specific dose adjustments are generally required based on age alone, but elderly patients may be more sensitive to the adverse effects of lamotrigine (e.g., dizziness, ataxia). Start with lower doses and titrate slowly, monitoring for adverse effects and drug interactions, especially in those with renal or hepatic impairment.
Clinical Information
Clinical Pearls
- Slow titration is paramount to minimize the risk of serious skin rash. Do not accelerate the titration schedule.
- Patients should be educated to report any rash immediately and discontinue the drug unless advised otherwise by a physician.
- Concomitant use of valproate significantly increases lamotrigine levels and the risk of rash, requiring a much slower titration schedule.
- Concomitant use of enzyme-inducing AEDs (e.g., carbamazepine, phenytoin) or oral contraceptives significantly decreases lamotrigine levels, often requiring higher doses.
- Lamotrigine XR is designed for once-daily dosing and should not be crushed or chewed.
- Consider therapeutic drug monitoring (TDM) in situations where drug interactions are suspected, during pregnancy, or if seizure control is suboptimal despite adequate dosing, or if toxicity is suspected.
Alternative Therapies
- Levetiracetam (Keppra)
- Topiramate (Topamax)
- Carbamazepine (Tegretol)
- Oxcarbazepine (Trileptal)
- Phenytoin (Dilantin)
- Valproate (Depakote)
- Zonisamide (Zonegran)
- Lacosamide (Vimpat)
- Perampanel (Fycompa)
Cost & Coverage
Average Cost:
$300 - $600 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic often Tier 1)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information 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, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.