Lamotrigine ODT 50mg Tablets
WARNING: Severe skin reactions may happen with this drug. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands. The chance of a skin reaction is raised in children between 2 and 17 years old. It may also be raised if you take valproic acid or divalproex sodium with this drug, if you start taking this drug at too high of a dose, or if your dose is raised too fast. Skin reactions have also happened without any of these. Talk with your doctor.Most cases of skin reactions have happened within 2 to 8 weeks of starting this drug, but some show up after longer treatment like 6 months. Talk with the doctor. @ COMMON USES: It is used to help control certain kinds of seizures.It is used to treat bipolar disorder.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant; Mood Stabilizer
Pharmacologic Class
Phenyltriazine derivative; Voltage-gated sodium channel blocker
Pregnancy Category
Not available
FDA Approved
Jul 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamotrigine is a medication used to treat certain types of seizures (epilepsy) and to help prevent extreme mood swings in people with bipolar disorder. It works by calming overactive nerve signals in the brain. The ODT (Orally Disintegrating Tablet) form dissolves quickly in your mouth, making it easier to take.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, unless your doctor or healthcare provider advises you to stop.
To take this medication:
Place it on your tongue and let it dissolve. You don't need water.
Do not swallow it whole, chew, break, or crush it.
Important Warnings
Do not change your dose or stop taking this medication without talking to 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 stop taking this medication and need to restart it, your doctor may prescribe a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications by throwing them away. 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 disposing of medications, and consider participating in a drug take-back program in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and take the next one at the scheduled time.
* Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, unless your doctor or healthcare provider advises you to stop.
To take this medication:
Place it on your tongue and let it dissolve. You don't need water.
Do not swallow it whole, chew, break, or crush it.
Important Warnings
Do not change your dose or stop taking this medication without talking to 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 stop taking this medication and need to restart it, your doctor may prescribe a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications by throwing them away. 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 disposing of medications, and consider participating in a drug take-back program in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and take the next one at the scheduled time.
* Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take exactly as prescribed, do not stop taking abruptly, as this can cause serious problems like increased seizures or withdrawal symptoms.
- Do not take a higher dose or increase your dose faster than prescribed, as this significantly increases the risk of a serious skin rash.
- Report any new skin rash immediately to your doctor, especially if it's widespread, blistering, or accompanied by fever, swollen glands, or facial swelling.
- Be aware of potential changes in mood or behavior, including suicidal thoughts, and report them to your doctor.
- Avoid alcohol or other CNS depressants, as they can increase side effects like dizziness and drowsiness.
- If you are a woman of childbearing potential, discuss contraception with your doctor, as lamotrigine can interact with oral contraceptives, and pregnancy planning is important.
- Do not crush, chew, or split the ODT tablet. Allow it to dissolve completely on your tongue and then swallow with or without water.
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:
Highly variable due to titration and concomitant medications. Initial dose typically 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then increase by 50-100 mg/day every 1-2 weeks. Maintenance dose ranges from 100-400 mg/day, divided once or twice daily.
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
Epilepsy (adjunctive therapy):
100-400 mg/day (divided BID)
Bipolar I Disorder (maintenance):
100-400 mg/day (once daily or divided BID)
Epilepsy (monotherapy):
250-300 mg/day (once daily or divided BID)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy not established in patients <2 years of age)
Child:
Dosing is weight-based and depends on concomitant medications (e.g., valproate, enzyme-inducing AEDs). Typically starts at 0.3-0.6 mg/kg/day and titrated up. For children 2-12 years with epilepsy, maintenance doses can range from 1-15 mg/kg/day (max 400 mg/day).
Adolescent:
Similar to adult dosing, but may start with lower initial doses and slower titration, especially if on interacting medications.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
Consider dose reduction in patients with significant renal impairment. Monitor clinical response.
Severe:
Consider dose reduction in patients with significant renal impairment. Monitor clinical response.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed. Monitor clinical response and adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
Reduce initial, escalation, and maintenance doses by approximately 25%.
Severe:
Reduce initial, escalation, and maintenance doses by approximately 50%.
Confidence:
Medium
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that is thought to exert its anticonvulsant and mood-stabilizing effects by inhibiting voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and modulating the release of excitatory neurotransmitters (e.g., glutamate and aspartate). It also has weak effects on voltage-gated calcium channels.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 98% (oral)
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 inducers, ~59 hours with valproate).
Clearance:
Approximately 30 mL/min (monotherapy)
ExcretionRoute:
Renal (approximately 94% as metabolites, 2% as unchanged drug)
Unchanged:
Approximately 2%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration to minimize rash risk)
PeakEffect:
Weeks to months (after reaching therapeutic maintenance dose)
DurationOfAction:
24 hours (dosed once or twice daily)
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 to 16 years of age) and 0.08% to 0.3% in adults. Risk factors include high initial doses, rapid dose escalation, and co-administration with valproate. 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
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 or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Changes in balance
Uncontrolled eye movements
Flu-like symptoms
Painful periods
Changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts and Infections
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as:
+ Fever
+ Chills
+ Sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem: Hemophagocytic Lymphohistiocytosis (HLH)
This medication can cause a rare but life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or experience any symptoms that concern you, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Changes in balance
Uncontrolled eye movements
Flu-like symptoms
Painful periods
Changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts and Infections
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as:
+ Fever
+ Chills
+ Sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem: Hemophagocytic Lymphohistiocytosis (HLH)
This medication can cause a rare but life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or experience any symptoms that concern you, 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 severe, blistering, or widespread)
- Fever, swollen glands, or facial swelling (signs of DRESS syndrome)
- Sore throat, mouth sores, or unusual bruising/bleeding (signs of blood problems)
- Yellowing of skin or eyes, dark urine, severe fatigue (signs of liver problems)
- Worsening depression, anxiety, agitation, or new suicidal thoughts/behaviors
- New or worsening seizures
- Severe dizziness, blurred vision, or unsteadiness
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 health problems, as these may affect the safety and efficacy of the medication
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the medication is used effectively and safely.
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 health problems, as these may affect the safety and efficacy of the medication
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the medication is used effectively and safely.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be sure to discuss any concerns with your doctor. Additionally, inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or using prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal thoughts or behaviors. Immediately contact your doctor if you experience any 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 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 certain heart conditions.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in pediatric patients.
Interactions with Birth Control
Birth control pills and other hormone-based birth control methods may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based methods may be less effective in preventing pregnancy when taking this medication. Use an alternative form of birth control, such as a condom, to 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-Specific Warnings
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 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. Immediately contact your doctor if you experience any 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 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 certain heart conditions.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in pediatric patients.
Interactions with Birth Control
Birth control pills and other hormone-based birth control methods may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based methods may be less effective in preventing pregnancy when taking this medication. Use an alternative form of birth control, such as a condom, to 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-Specific Warnings
If your seizures change or worsen after starting this medication, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Ataxia (loss of coordination)
- Nystagmus (involuntary eye movements)
- Increased seizures
- Decreased consciousness
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive; there is no specific antidote.
Drug Interactions
Major Interactions
- Valproate (valproic acid, divalproex sodium): Significantly increases lamotrigine levels (inhibits glucuronidation), requiring substantial lamotrigine dose reduction and slower titration.
- Carbamazepine, Phenytoin, Phenobarbital, Primidone: Significantly decrease lamotrigine levels (induce glucuronidation), requiring higher lamotrigine doses and faster titration.
- Oral Contraceptives (containing estrogen): Can significantly decrease lamotrigine levels, potentially leading to loss of seizure control or mood stabilization. Dose adjustments may be needed.
Moderate Interactions
- Rifampin: Decreases lamotrigine levels.
- Lopinavir/Ritonavir, Atazanavir/Ritonavir: May decrease lamotrigine levels.
- Risperidone: Co-administration may increase risperidone levels and decrease lamotrigine levels.
- Paroxetine, Sertraline: May slightly increase lamotrigine levels.
Minor Interactions
- Acetaminophen: May slightly decrease lamotrigine levels with chronic high-dose use.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for rare blood dyscrasias (e.g., neutropenia, aplastic anemia).
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for rare hepatic dysfunction.
Timing: Prior to initiation
Renal Function Tests (Creatinine, BUN)
Rationale: To establish baseline, especially if renal impairment is suspected.
Timing: Prior to initiation
Skin Examination
Rationale: To establish baseline and educate patient on rash monitoring.
Timing: Prior to initiation
Routine Monitoring
Skin Examination
Frequency: Regularly, especially during titration and with any new symptoms.
Target: Absence of rash, particularly severe or widespread rash.
Action Threshold: Any new rash, especially if accompanied by fever, lymphadenopathy, facial swelling, or systemic symptoms, requires immediate medical evaluation and potential discontinuation.
Clinical Efficacy (seizure frequency/mood stability)
Frequency: Regularly, at each follow-up visit.
Target: Reduction in seizure frequency or stabilization of mood symptoms.
Action Threshold: Worsening symptoms, lack of efficacy, or intolerable side effects may require dose adjustment or alternative therapy.
Adverse Effects (e.g., dizziness, ataxia, blurred vision, headache, nausea)
Frequency: Regularly, at each follow-up visit.
Target: Tolerable side effect profile.
Action Threshold: Intolerable side effects may require dose adjustment or discontinuation.
Suicidal Ideation/Behavior
Frequency: Regularly, at each follow-up visit, especially during initial therapy or dose changes.
Target: Absence of new or worsening suicidal thoughts or behaviors.
Action Threshold: Any report of suicidal ideation requires immediate assessment and intervention.
Symptom Monitoring
- Skin rash (especially widespread, blistering, or painful)
- Fever
- Swollen lymph nodes
- Facial swelling
- Sore throat
- Mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe fatigue
- Worsening depression or mood changes
- New or worsening suicidal thoughts or behavior
- Unusual changes in behavior or thinking
- New or worsening seizures
Special Patient Groups
Pregnancy
Lamotrigine crosses the placenta. While older data suggested a potential increased risk of oral clefts, more recent and larger studies have not consistently confirmed this. However, there is still a potential for other adverse outcomes. The decision to use lamotrigine during pregnancy should be made after careful consideration of risks versus benefits, especially given the risks of uncontrolled seizures or mood disorders during pregnancy. Pregnancy registries are available.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of oral clefts (though debated by recent data) and other major congenital malformations. Risk is generally considered low but not zero.
Second Trimester:
Generally considered safer than first trimester for organogenesis, but continued exposure.
Third Trimester:
Continued exposure; potential for withdrawal symptoms in neonate if discontinued abruptly before delivery.
Lactation
Lamotrigine is excreted into breast milk. Infant serum concentrations can be significant. Monitor breastfed infants for adverse effects such as rash, apnea, drowsiness, and poor feeding. The benefits of breastfeeding should be weighed against the potential risks to the infant.
Infant Risk:
Moderate (L3 - Moderately Safe). Monitor infant for rash, drowsiness, poor feeding, and apnea. Consider therapeutic drug monitoring in the infant if concerns arise.
Pediatric Use
Approved for adjunctive treatment of partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients 2 years and older. Dosing is weight-based and highly dependent on concomitant medications. Higher incidence of serious rash in pediatric patients compared to adults.
Geriatric Use
No specific dose adjustments are generally required based on age alone, but older 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 low and titrate slowly, monitoring closely for adverse effects.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rashes. Adherence to this schedule is paramount.
- Patients must be educated to report any rash immediately, as it could be a sign of a life-threatening reaction (SJS/TEN/DRESS).
- Drug interactions, especially with valproate (increases lamotrigine levels) and enzyme-inducing AEDs/oral contraceptives (decrease lamotrigine levels), significantly impact dosing and titration schedules.
- Lamotrigine ODT can be taken with or without water. It should be allowed to dissolve completely on the tongue.
- Therapeutic drug monitoring (TDM) is not routinely recommended but can be useful in specific situations, such as suspected non-adherence, drug interactions, renal/hepatic impairment, or lack of efficacy/toxicity at usual doses.
Alternative Therapies
- Other Antiepileptic Drugs (AEDs): Levetiracetam, Carbamazepine, Oxcarbazepine, Valproate, Topiramate, Gabapentin, Pregabalin, Phenytoin, Zonisamide, Lacosamide, Rufinamide, Clobazam.
- Other Mood Stabilizers (for Bipolar Disorder): Lithium, Valproate, Carbamazepine, Atypical Antipsychotics (e.g., Quetiapine, Olanzapine, Aripiprazole).
Cost & Coverage
Average Cost:
$30 - $150 per 30 tablets (generic 50mg ODT)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.