Lamotrigine 25mg Chew/disprsbl Tab
WARNING: Severe skin reactions may happen with this drug. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands. The chance of a skin reaction is raised in children between 2 and 17 years old. It may also be raised if you take valproic acid or divalproex sodium with this drug, if you start taking this drug at too high of a dose, or if your dose is raised too fast. Skin reactions have also happened without any of these. Talk with your doctor.Most cases of skin reactions have happened within 2 to 8 weeks of starting this drug, but some show up after longer treatment like 6 months. Talk with the doctor. @ COMMON USES: It is used to help control certain kinds of seizures.It is used to treat bipolar disorder.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant; Mood Stabilizer
Pharmacologic Class
Phenyltriazine derivative; Voltage-gated sodium channel blocker
Pregnancy Category
Not available
FDA Approved
Dec 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamotrigine is a medication used to treat certain types of seizures (epilepsy) and to help stabilize mood in people with bipolar disorder. It works by calming overactive nerve signals in the brain.
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. You can swallow the tablet whole, chew it, or mix it with water or fruit juice. If you choose to chew the tablet, be sure to drink a little water or fruit juice to help with swallowing.
If you need to break up the tablet, you can do so by adding a liquid to cover the tablet in a glass or spoon. Wait at least 1 minute for the tablet to break up completely, then mix and drink.
Important Warnings
Do not change your dose or stop taking this medication without consulting your doctor, as this can increase the risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to do so gradually to minimize the risk of side effects. If you stop taking this medication and need to restart it, your doctor may recommend starting with 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. 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 properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. You can also check with your pharmacist about drug take-back programs in your area.
What to Do If You Miss 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 return to 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. You can swallow the tablet whole, chew it, or mix it with water or fruit juice. If you choose to chew the tablet, be sure to drink a little water or fruit juice to help with swallowing.
If you need to break up the tablet, you can do so by adding a liquid to cover the tablet in a glass or spoon. Wait at least 1 minute for the tablet to break up completely, then mix and drink.
Important Warnings
Do not change your dose or stop taking this medication without consulting your doctor, as this can increase the risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to do so gradually to minimize the risk of side effects. If you stop taking this medication and need to restart it, your doctor may recommend starting with 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. 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 properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. You can also check with your pharmacist about drug take-back programs in your area.
What to Do If You Miss 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 return to 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 abruptly without consulting your doctor.
- Report any new skin rash immediately to your doctor, as it could be serious.
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Do not crush, chew, or split extended-release tablets. Chewable/dispersible tablets can be chewed or dissolved in a small amount of water.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.
- Carry a medical alert card or wear a medical alert bracelet indicating you take lamotrigine.
- Discuss all other medications, including over-the-counter drugs, herbal supplements, and oral contraceptives, with your doctor, as they can interact with lamotrigine.
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 individualized, slow titration required. For epilepsy monotherapy: Initial 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then increase by 50-100 mg/day every 1-2 weeks to maintenance (100-400 mg/day). For bipolar disorder: Initial 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then 100 mg daily for 1 week, then 200 mg daily. Dosing varies significantly with concomitant medications.
Dose Range:
25 - 700 mg
Condition-Specific Dosing:
epilepsy_monotherapy:
100-400 mg/day
epilepsy_with_valproate:
25-200 mg/day
epilepsy_with_enzyme_inducers:
300-700 mg/day
bipolar_disorder:
200 mg/day (up to 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 is weight-based and depends on concomitant medications. For epilepsy (2-12 years): Initial 0.3-0.6 mg/kg/day for 2 weeks, then titrated up. Max 15 mg/kg/day (up to 400 mg/day). Higher risk of rash in this age group.
Adolescent:
Similar to adult dosing, but titration may be slower for younger adolescents. For bipolar disorder, not approved for <18 years.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
Consider dose reduction in patients with significant renal impairment. Monitor clinical response.
Severe:
Significant dose reduction may be necessary (e.g., 25% of usual dose). Monitor clinical response and adverse effects.
Dialysis:
Supplemental dose after dialysis is generally not needed as only a small fraction is removed. Monitor clinical response.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Initial dose and subsequent dose escalations should be reduced by approximately 50%.
Severe:
Initial dose and subsequent dose escalations should be reduced by approximately 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 blocking voltage-sensitive sodium channels. This action stabilizes neuronal membranes and modulates the release of excitatory neurotransmitters, particularly glutamate and aspartate, thereby preventing repetitive neuronal firing and propagation of seizure activity. It also has weak effects on calcium channels and serotonin receptors.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1.4-4.8 hours (oral)
FoodEffect:
Minimal effect on rate or extent of absorption.
Distribution:
Vd:
0.97-1.36 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
25-33 hours (monotherapy); significantly affected by concomitant medications (e.g., 13-15 hours with enzyme inducers, 59-70 hours with valproate)
Clearance:
Approximately 30 mL/min (monotherapy)
ExcretionRoute:
Renal (primarily as glucuronide conjugates)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration to minimize rash risk)
PeakEffect:
Weeks (after reaching 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) and toxic epidermal necrolysis (TEN), which can result in death. The incidence of these serious rashes is greater in pediatric patients than in adults. Additional risk factors include concomitant use with valproate, exceeding the recommended initial dose of lamotrigine, and exceeding the recommended dose escalation for lamotrigine. Benign rashes also occur, but it is not possible to predict reliably which rashes will prove to be serious. Therefore, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you 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
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, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem (Hemophagocytic Lymphohistiocytosis)
In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Difficulty walking
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor 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
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, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem (Hemophagocytic Lymphohistiocytosis)
In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Difficulty walking
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor 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 blistering, widespread, or involving mouth/eyes/genitals)
- Fever, swollen glands, or facial swelling (signs of hypersensitivity reaction)
- Sore throat, mouth sores, or eye irritation
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe muscle pain or weakness
- New or worsening depression, anxiety, or suicidal thoughts/behaviors
- Changes in behavior (e.g., agitation, aggression, restlessness, panic attacks)
- 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 complete medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be 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 taking 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 labeling, 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 this population.
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 not be effective in preventing pregnancy while taking this medication. Use an alternative form of birth control, such as a condom.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure-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 taking 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 labeling, 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 this population.
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 not be effective in preventing pregnancy while taking this medication. Use an alternative form of birth control, such as a condom.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure-Specific Warnings
If your seizures change or worsen after starting this medication, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Nystagmus (involuntary eye movements)
- Ataxia (loss of coordination)
- Impaired consciousness
- Seizures
- Coma
- QRS prolongation (cardiac effects)
What to Do:
Seek immediate medical attention. Call 911 or 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 (significantly increases lamotrigine levels, requiring dose reduction)
- Carbamazepine (significantly decreases lamotrigine levels, requiring dose increase)
- Phenytoin (significantly decreases lamotrigine levels, requiring dose increase)
- Phenobarbital (significantly decreases lamotrigine levels, requiring dose increase)
- Primidone (significantly decreases lamotrigine levels, requiring dose increase)
- Estrogen-containing oral contraceptives (can decrease lamotrigine levels, requiring dose increase)
Moderate Interactions
- Rifampin (decreases lamotrigine levels)
- Lopinavir/Ritonavir (decreases lamotrigine levels)
- Atazanavir/Ritonavir (decreases lamotrigine levels)
- Risperidone (lamotrigine may decrease risperidone levels)
- Paroxetine (lamotrigine may decrease paroxetine levels)
- Sertraline (lamotrigine may decrease sertraline levels)
Minor Interactions
- Acetaminophen (may slightly decrease lamotrigine levels with chronic high-dose use)
- Bupropion (may slightly decrease lamotrigine levels)
Monitoring
Baseline Monitoring
Renal function (BUN, Creatinine)
Rationale: To establish baseline for potential dose adjustments in renal impairment.
Timing: Prior to initiation
Liver function (ALT, AST, Bilirubin)
Rationale: To establish baseline for potential dose adjustments in hepatic impairment and monitor for rare hepatic dysfunction.
Timing: Prior to initiation
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for rare blood dyscrasias (e.g., neutropenia, aplastic anemia).
Timing: Prior to initiation
Skin assessment
Rationale: To document baseline skin condition due to risk of serious rash.
Timing: Prior to initiation
Routine Monitoring
Skin integrity
Frequency: Daily during titration, then regularly
Target: Absence of new rash
Action Threshold: Any new rash (especially widespread, blistering, or involving mucous membranes) requires immediate discontinuation and medical evaluation.
Seizure frequency/severity (if for epilepsy)
Frequency: Regularly (e.g., monthly initially, then every 3-6 months)
Target: Reduction in seizure activity
Action Threshold: Increased seizure frequency or lack of efficacy may indicate need for dose adjustment or alternative therapy.
Mood stability (if for bipolar disorder)
Frequency: Regularly (e.g., monthly initially, then every 3-6 months)
Target: Stabilization of mood, reduction in depressive/manic episodes
Action Threshold: Worsening mood symptoms or lack of efficacy may indicate need for dose adjustment or alternative therapy.
Signs/symptoms of hypersensitivity reaction (fever, lymphadenopathy, facial edema)
Frequency: Regularly, especially during titration
Target: Absence of symptoms
Action Threshold: Presence of any symptoms requires immediate discontinuation and medical evaluation.
Suicidal ideation/behavior
Frequency: Regularly, especially during initial therapy and dose changes
Target: Absence of new or worsening suicidal thoughts/behaviors
Action Threshold: Report any new or worsening suicidal thoughts/behaviors immediately to a healthcare provider.
Symptom Monitoring
- Rash (any type, especially blistering, widespread, or involving mucous membranes)
- Fever
- Swollen lymph nodes
- Facial swelling
- Sore throat
- Mouth sores
- Eye irritation/redness
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe muscle pain
- Unexplained weakness or fatigue
- New or worsening depression
- Anxiety
- Agitation
- Restlessness
- Panic attacks
- Insomnia
- Irritability
- Hostility
- Aggressiveness
- Impulsivity
- Akathisia (psychomotor restlessness)
- Hypomania
- Mania
- Other unusual changes in behavior or mood
Special Patient Groups
Pregnancy
Lamotrigine is generally considered one of the safer antiepileptic drugs during pregnancy compared to some alternatives, but it is not without risk. Data from pregnancy registries suggest a low risk of major congenital malformations, but a slightly increased risk of oral clefts has been reported in some studies (though not consistently confirmed). Use during pregnancy should be carefully weighed against the risks of uncontrolled seizures or mood episodes. Folic acid supplementation is recommended for all women of childbearing potential taking AEDs.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of oral clefts (controversial, some studies suggest, others do not).
Second Trimester:
Generally considered lower risk for major malformations compared to first trimester.
Third Trimester:
No specific increased risk of malformations. Potential for withdrawal symptoms in neonate if discontinued abruptly.
Lactation
Lamotrigine is excreted into breast milk. Infant serum concentrations can be significant. Monitor breastfed infants for adverse effects such as rash, drowsiness, poor feeding, and apnea. Breastfeeding may be acceptable with careful monitoring, especially if the infant is full-term and healthy. Consult with a healthcare provider.
Infant Risk:
Low to moderate risk. Monitor for rash, drowsiness, poor feeding, apnea.
Pediatric Use
Higher incidence of serious skin rash (SJS/TEN) in pediatric patients compared to adults, especially those under 16 years of age. Dosing is weight-based and requires careful, slow titration. Not approved for bipolar disorder in patients under 18 years.
Geriatric Use
Start with lower doses and titrate slowly due to potential for decreased renal/hepatic function and increased sensitivity to adverse effects. Monitor for dizziness, ataxia, and rash.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rashes (SJS/TEN). Adherence to this schedule is paramount.
- Patients must be educated to report any rash immediately. Discontinuation is usually required at the first sign of rash unless clearly benign.
- Dose adjustments are crucial when co-administered with valproate (reduce lamotrigine dose) or enzyme-inducing AEDs (increase lamotrigine dose).
- Lamotrigine is effective for both focal and generalized seizures, and is a first-line agent for bipolar depression.
- While not routinely monitored, therapeutic drug monitoring may be useful in cases of suspected non-adherence, drug interactions, or toxicity.
- Abrupt discontinuation can precipitate seizures or mood destabilization; taper off gradually over at least 2 weeks unless rash or other serious adverse event necessitates immediate cessation.
Alternative Therapies
- For Epilepsy: Levetiracetam, Topiramate, Carbamazepine, Oxcarbazepine, Valproate, Phenytoin, Zonisamide, Gabapentin, Pregabalin.
- For Bipolar Disorder: Lithium, Quetiapine, Olanzapine, Lurasidone, Cariprazine, Valproate, Carbamazepine.
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (generic 25mg)
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 is a patient fact sheet that provides crucial information. 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 quantity, and the time it occurred.