Lamictal Orange Strt Kit25mg/100mg
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. It's very important to start this medication at a low dose and increase it very slowly to reduce the risk of a serious skin rash.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. 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 trouble swallowing, consult your doctor for guidance.
Do not change your dose or stop taking this medication without talking to 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 gradually stop it to minimize the risk of side effects.
If you stop taking this medication and need to restart it, 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 moisture.
Keep your medication in a dry place, away from the bathroom.
Store all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about potential 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.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed one.
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 trouble swallowing, consult your doctor for guidance.
Do not change your dose or stop taking this medication without talking to 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 gradually stop it to minimize the risk of side effects.
If you stop taking this medication and need to restart it, 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 moisture.
Keep your medication in a dry place, away from the bathroom.
Store all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about potential 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.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take exactly as prescribed, do not stop abruptly without consulting your doctor.
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how the medication affects you, as it can cause dizziness or drowsiness.
- Report any new or worsening rash immediately to your doctor.
- Avoid alcohol or other CNS depressants, as they can increase side effects like dizziness and drowsiness.
- If you are taking oral contraceptives, discuss with your doctor as they can affect lamotrigine levels and vice versa.
- Maintain good hydration.
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:
Initial titration varies significantly based on concomitant medications. For patients not taking valproate or enzyme-inducing AEDs, initial dose is typically 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then increase by 50 mg/day every 1-2 weeks. Maintenance: 100-400 mg/day in 1-2 divided doses.
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
epilepsy_monotherapy:
Initial: 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then 100 mg daily for 1 week, then 200 mg daily. May increase to 300-500 mg/day.
epilepsy_with_valproate:
Initial: 25 mg every other day for 2 weeks, then 25 mg daily for 2 weeks. Maintenance: 100-200 mg/day.
epilepsy_with_enzyme_inducers_without_valproate:
Initial: 50 mg daily for 2 weeks, then 100 mg daily in 2 divided doses for 2 weeks. Maintenance: 300-500 mg/day in 2 divided doses.
bipolar_disorder_maintenance:
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. Target dose: 200 mg/day (or 100 mg/day with valproate, 300-400 mg/day with enzyme inducers).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy not established in children <2 years for epilepsy, or <18 years for bipolar disorder).
Child:
Dosing for epilepsy (2-12 years) is weight-based and highly dependent on concomitant medications. Example (with valproate): 0.15 mg/kg/day for 2 weeks, then 0.3 mg/kg/day for 2 weeks, then increase by 0.3 mg/kg/day every 1-2 weeks. Max 1-5 mg/kg/day. (Orange Strt Kit 25mg/100mg is for specific titration steps, often for older children/adults).
Adolescent:
Generally follows adult dosing guidelines for epilepsy (âĨ12 years) and bipolar disorder (âĨ18 years).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
Consider dose reduction in patients with significant renal impairment.
Severe:
Consider dose reduction in patients with significant renal impairment. Initial dose reduction by 25% for CrCl <30 mL/min. Subsequent dose adjustments should be based on clinical response.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed by hemodialysis. However, close monitoring is advised.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Initial dose reduction by 50% for Child-Pugh Class B. Subsequent dose adjustments should be based on clinical response.
Severe:
Initial dose reduction by 75% for Child-Pugh Class C. Subsequent dose adjustments should be based on clinical response.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that inhibits voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and inhibiting the release of excitatory neurotransmitters (e.g., glutamate and aspartate). It also has weak inhibitory effects on voltage-gated calcium channels. This action is thought to prevent repetitive neuronal firing and reduce synaptic glutamate release, contributing to its anticonvulsant and mood-stabilizing effects.
Pharmacokinetics
Absorption:
Bioavailability:
98% (oral)
Tmax:
1.4-4.8 hours (oral)
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
0.97-1.3 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:
0.3-0.5 mL/min/kg
ExcretionRoute:
Renal (approximately 94% of dose)
Unchanged:
Approximately 2% (renal)
Pharmacodynamics
OnsetOfAction:
Gradual (due to titration schedule)
PeakEffect:
Weeks to months (after reaching maintenance dose)
DurationOfAction:
Dependent on half-life, typically once or twice 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 be fatal. The incidence of these serious rashes is higher in pediatric patients than in adults. Other risk factors include concomitant use with valproate, exceeding recommended initial doses, and rapid dose escalation. Benign rashes also occur, but it is not possible to predict which rashes will prove to be serious or life-threatening. Therefore, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, 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 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 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, 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 periods or changes in menstrual cycle, including spotting or bleeding between cycles
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 (new or worsening)
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Sleep disturbances
Nose or throat irritation
Weight loss
Dry mouth
Back pain
Reporting Side Effects
If you have questions about side effects or want to report a side effect, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects 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 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 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, 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 periods or changes in menstrual cycle, including spotting or bleeding between cycles
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 (new or worsening)
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Sleep disturbances
Nose or throat irritation
Weight loss
Dry mouth
Back pain
Reporting Side Effects
If you have questions about side effects or want to report a side effect, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any new skin rash, especially if it spreads, blisters, or involves the mouth, eyes, or genitals.
- 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 or weakness.
- New or worsening depression, anxiety, or suicidal thoughts/behavior.
- Changes in vision (blurred or double vision).
- Severe dizziness or loss of coordination.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
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 existing health problems
This information will help your doctor determine whether it is safe to take this medication with your other medications and health conditions. Do not 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
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 existing health problems
This information will help your doctor determine whether it is safe to take this medication with your other medications and health conditions. Do not 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.
To ensure your safety, 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.
Regular blood tests are necessary, as directed by your doctor. Be aware that this medication may interfere with certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug.
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.
As with other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. Monitor your mood and behavior, and immediately report any new or worsening symptoms, such as depression, anxiety, restlessness, irritability, panic attacks, or other changes in mood or behavior, to your doctor. If you experience suicidal thoughts or actions, seek medical attention right away.
This medication may also 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.
To avoid medication errors, always verify that you have the correct product, and check with your pharmacist if you notice any changes in the drug's appearance, shape, color, size, or labeling.
If you have a history of abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor, as this medication may increase the risk of abnormal heartbeats, which can lead to sudden death.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
If you are using birth control pills or other hormone-based birth control methods, be aware that they may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control, as the risk of side effects may be increased during the week when the pills are not active. Additionally, birth control pills and other hormone-based methods may not be effective in preventing pregnancy while taking this medication, so consider using alternative forms of birth control, such as condoms.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Specific Considerations for Seizure Treatment
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.
To ensure your safety, 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.
Regular blood tests are necessary, as directed by your doctor. Be aware that this medication may interfere with certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug.
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.
As with other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. Monitor your mood and behavior, and immediately report any new or worsening symptoms, such as depression, anxiety, restlessness, irritability, panic attacks, or other changes in mood or behavior, to your doctor. If you experience suicidal thoughts or actions, seek medical attention right away.
This medication may also 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.
To avoid medication errors, always verify that you have the correct product, and check with your pharmacist if you notice any changes in the drug's appearance, shape, color, size, or labeling.
If you have a history of abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor, as this medication may increase the risk of abnormal heartbeats, which can lead to sudden death.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
If you are using birth control pills or other hormone-based birth control methods, be aware that they may affect the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control, as the risk of side effects may be increased during the week when the pills are not active. Additionally, birth control pills and other hormone-based methods may not be effective in preventing pregnancy while taking this medication, so consider using alternative forms of birth control, such as condoms.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Specific Considerations for Seizure Treatment
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:
- 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 (increases lamotrigine levels, increasing risk of 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
- Risperidone (lamotrigine may decrease risperidone levels)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Paroxetine (lamotrigine may increase paroxetine levels)
- Sertraline (lamotrigine may increase sertraline levels)
- Folic acid antagonists (e.g., methotrexate, trimethoprim; theoretical interaction due to lamotrigine's weak dihydrofolate reductase inhibition)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for potential hematologic abnormalities (rare).
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for potential hepatic dysfunction (rare).
Timing: Prior to initiation
Renal Function Tests (RFTs)
Rationale: To establish baseline, especially if renal impairment is suspected.
Timing: Prior to initiation
Routine Monitoring
Skin examination
Frequency: Regularly, especially during titration and first 8 weeks of therapy
Target: Absence of rash
Action Threshold: Any new rash should prompt immediate evaluation and potential discontinuation.
Clinical response (seizure frequency/mood stability)
Frequency: Regularly, especially during dose titration
Target: Optimal seizure control or mood stabilization with minimal side effects
Action Threshold: Lack of efficacy or intolerable side effects may require dose adjustment or discontinuation.
Adverse effects (e.g., dizziness, ataxia, blurred vision, headache, nausea)
Frequency: Regularly, especially during dose titration
Target: Minimal to tolerable
Action Threshold: Persistent or severe side effects may require dose adjustment or discontinuation.
Lamotrigine serum concentrations (Therapeutic Drug Monitoring - TDM)
Frequency: Not routinely recommended for all patients, but useful in specific situations (e.g., suspected non-adherence, drug interactions, renal/hepatic impairment, pregnancy, or lack of response/toxicity at expected doses).
Target: Typically 3-14 mcg/mL (for epilepsy), but clinical response is paramount.
Action Threshold: Levels outside range, especially if correlated with clinical symptoms, may warrant dose adjustment.
Symptom Monitoring
- Rash (especially widespread, blistering, or involving mucous membranes)
- 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 of depression or suicidal thoughts/behavior
- New or worsening seizures
- Dizziness
- Ataxia (loss of coordination)
- Blurred or double vision
- Headache
- Nausea/vomiting
Special Patient Groups
Pregnancy
Use during pregnancy should be carefully considered, weighing potential benefits against risks. Lamotrigine crosses the placenta. Data from pregnancy registries suggest a low but increased risk of oral clefts (cleft lip/palate) when exposed during the first trimester, though this risk is debated and may be similar to the general population or other AEDs. Folic acid supplementation is recommended for women of childbearing potential.
Trimester-Specific Risks:
First Trimester:
Potential, though debated, increased risk of oral clefts. Close monitoring of lamotrigine levels may be needed due to increased clearance during pregnancy.
Second Trimester:
Increased lamotrigine clearance may continue, requiring dose adjustments.
Third Trimester:
Increased lamotrigine clearance may continue. Monitor for withdrawal symptoms in neonate if mother was on high doses.
Lactation
Lamotrigine is excreted into breast milk. While generally considered compatible with breastfeeding with careful monitoring, some infants may experience adverse effects (e.g., rash, apnea, drowsiness, poor feeding). Monitor infant for rash, sedation, and adequate weight gain. Therapeutic drug monitoring in the infant may be considered.
Infant Risk:
L3 (Moderately Safe - Limited controlled studies show no adverse effects, or only minor non-serious adverse effects. Risk of adverse effects is possible, but unlikely.)
Pediatric Use
Safety and efficacy for epilepsy not established in children <2 years. Safety and efficacy for bipolar disorder not established in children <18 years. Pediatric patients, especially those <16 years, have a higher risk of serious rash. Careful titration is crucial.
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.
Clinical Information
Clinical Pearls
- The 'Orange Strt Kit' is designed to guide patients through the initial titration phase, which is critical to minimize the risk of serious rash. Emphasize strict adherence to the titration schedule.
- Serious rash (SJS/TEN) is the most significant adverse effect; educate patients to report any rash immediately.
- Dose adjustments are frequently required when lamotrigine is co-administered with other antiepileptic drugs (AEDs), especially valproate (increases lamotrigine levels) and enzyme-inducing AEDs like carbamazepine, phenytoin, phenobarbital (decrease lamotrigine levels).
- Oral contraceptives containing estrogen can significantly decrease lamotrigine levels, potentially leading to loss of seizure control or mood stabilization. Patients should be counseled on this interaction.
- Abrupt discontinuation can precipitate seizures or worsen mood symptoms; always taper off gradually under medical supervision.
- Lamotrigine is often preferred in women of childbearing potential due to a relatively lower risk of major congenital malformations compared to some other AEDs, though careful counseling is still necessary.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Phenytoin, Oxcarbazepine, Topiramate, Zonisamide, Gabapentin, Pregabalin, Lacosamide, Rufinamide, Clobazam, Perampanel, Brivaracetam.
- For Bipolar Disorder (Maintenance): Lithium, Valproate, Quetiapine, Olanzapine, Aripiprazole, Cariprazine, Lurasidone.
Cost & Coverage
Average Cost:
Varies widely by pharmacy and dosage form (e.g., $50-$300+ for 30 tablets of generic, higher for brand) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
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 valuable resource 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.