Lamictal XR 25-50mg Titration Kt 28
WARNING: Severe skin reactions may happen with this drug. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands. The chance of a skin reaction is raised in children between 2 and 17 years old. It may also be raised if you take valproic acid or divalproex sodium with this drug, if you start taking this drug at too high of a dose, or if your dose is raised too fast. Skin reactions have also happened without any of these. Talk with your doctor.Most cases of skin reactions have happened within 2 to 8 weeks of starting this drug, but some show up after longer treatment like 6 months. Talk with the doctor.This drug is not approved for use in children younger than 13 years old. Talk with the doctor. @ COMMON USES: It is used to help control certain kinds of seizures.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant; Mood Stabilizer
Pharmacologic Class
Phenyltriazine derivative; Voltage-gated sodium channel blocker
Pregnancy Category
Not available (FDA has phased out letter categories; historically C/D depending on source/indication)
FDA Approved
Jul 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamictal XR is an extended-release medication used to treat certain types of seizures (epilepsy) and to help prevent mood swings in people with bipolar disorder. It works by stabilizing electrical activity in the brain. It's very important to take this medication exactly as prescribed, especially during the initial titration phase, to reduce the risk of a serious skin rash.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to 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're feeling well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
Do not alter the dose or stop taking this medication without consulting your doctor, as this may lead to seizures.
If you need to stop taking this medication, your doctor will instruct you on how to gradually discontinue it to minimize the risk of side effects.
If you've stopped taking this medication, consult your doctor before restarting, as you may need to begin with a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in a local drug take-back program.
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 get the most benefit from your medication, it's essential to 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're feeling well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
Do not alter the dose or stop taking this medication without consulting your doctor, as this may lead to seizures.
If you need to stop taking this medication, your doctor will instruct you on how to gradually discontinue it to minimize the risk of side effects.
If you've stopped taking this medication, consult your doctor before restarting, as you may need to begin with a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in a local drug take-back program.
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.
Lifestyle & Tips
- Take exactly as prescribed, do not crush, chew, or divide the extended-release tablets.
- Do not stop taking this medication suddenly, as it can lead to increased seizures or withdrawal symptoms. Any dose changes should be made under medical supervision.
- Report any new skin rash immediately to your doctor. This is a serious side effect.
- 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 may increase drowsiness or dizziness.
- Use caution when driving or operating machinery until you know how this medication affects you.
- 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.
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
Dosing & Administration
Adult Dosing
Standard Dose:
Titration is critical to minimize rash risk. Dosing varies significantly based on concomitant medications.
Dose Range:
25 - 600 mg
Condition-Specific Dosing:
Epilepsy (Adjunctive Therapy) - Not taking Valproate or Enzyme Inducers:
Weeks 1 & 2: 25 mg once daily; Weeks 3 & 4: 50 mg once daily; Week 5: 100 mg once daily; Week 6: 150 mg once daily; Week 7: 200 mg once daily. Subsequent dose increases up to 300-500 mg/day.
Epilepsy (Adjunctive Therapy) - Taking Valproate:
Weeks 1 & 2: 25 mg every other day; Weeks 3 & 4: 25 mg once daily; Week 5: 50 mg once daily; Week 6: 75 mg once daily; Week 7: 100 mg once daily. Subsequent dose increases up to 100-200 mg/day.
Epilepsy (Adjunctive Therapy) - Taking Enzyme Inducers (e.g., Carbamazepine, Phenytoin, Phenobarbital) and NOT Valproate:
Weeks 1 & 2: 50 mg once daily; Weeks 3 & 4: 100 mg once daily; Week 5: 200 mg once daily; Week 6: 300 mg once daily; Week 7: 400 mg once daily. Subsequent dose increases up to 400-600 mg/day.
Bipolar I Disorder (Maintenance) - Not taking Valproate or Enzyme Inducers:
Weeks 1 & 2: 25 mg once daily; Weeks 3 & 4: 50 mg once daily; Week 5: 100 mg once daily; Week 6: 200 mg once daily (target maintenance dose).
Bipolar I Disorder (Maintenance) - Taking Valproate:
Weeks 1 & 2: 25 mg every other day; Weeks 3 & 4: 25 mg once daily; Week 5: 50 mg once daily; Week 6: 100 mg once daily (target maintenance dose).
Bipolar I Disorder (Maintenance) - Taking Enzyme Inducers (e.g., Carbamazepine, Phenytoin, Phenobarbital) and NOT Valproate:
Weeks 1 & 2: 50 mg once daily; Weeks 3 & 4: 100 mg once daily; Week 5: 200 mg once daily; Week 6: 300 mg once daily; Week 7: 400 mg once daily (target maintenance dose).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for XR formulation. Immediate-release lamotrigine is used in children for epilepsy.
Adolescent:
Dosing for adolescents (âĨ13 years) is generally similar to adult dosing for epilepsy and bipolar disorder, following the same titration schedules based on concomitant medications.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
Consider dose reduction in patients with significant renal impairment (CrCl < 30 mL/min). Initial dose reduction by 25% to 50% may be considered, with careful monitoring.
Dialysis:
Supplemental doses after dialysis are generally not needed as only a small fraction is removed. Consider dose reduction in patients with ESRD, with careful monitoring.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
Initial, escalation, and maintenance doses should be reduced by approximately 25%.
Severe:
Initial, escalation, and maintenance doses should be reduced by approximately 50%. Careful monitoring is essential.
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 inhibiting the release of excitatory neurotransmitters (primarily glutamate and aspartate). It also has weak effects on voltage-gated calcium channels and may modulate serotonin 5-HT3 receptors.
Pharmacokinetics
Absorption:
Bioavailability:
98% (oral)
Tmax:
4-6 hours (immediate-release); 4-12 hours (extended-release)
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
0.97-1.36 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes (readily crosses the blood-brain barrier)
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); significantly reduced by enzyme inducers (e.g., 13-14 hours) and significantly prolonged by valproate (e.g., 59-70 hours).
Clearance:
Approximately 30 mL/min (monotherapy); highly variable based on concomitant medications.
ExcretionRoute:
Renal (approximately 94% as metabolites, 2% unchanged)
Unchanged:
Approximately 2%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration to minimize rash risk)
PeakEffect:
Weeks to months (after reaching maintenance dose)
DurationOfAction:
24 hours (for XR formulation, allowing once-daily dosing)
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Serious skin rashes requiring hospitalization and discontinuation of treatment have been reported, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The incidence of these rashes, which have resulted in deaths, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 16 years) and 0.08% to 0.3% in adults. The risk of serious rash is increased by coadministration with valproate, exceeding the recommended initial dose, or exceeding the recommended dose escalation.
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, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem: Hemophagocytic Lymphohistiocytosis (HLH)
This medication can cause a rare but life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking (new or worsening)
Other Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
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 or concerns about side effects, 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, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem: Hemophagocytic Lymphohistiocytosis (HLH)
This medication can cause a rare but life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking (new or worsening)
Other Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
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 or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any new skin rash (especially blistering, peeling, or widespread)
- Fever, swollen glands, or flu-like symptoms
- Sore throat or mouth sores
- Swelling in your face or around your eyes
- Unusual bruising or bleeding
- Yellowing of your skin or eyes (jaundice)
- Dark urine or severe fatigue (signs of liver problems)
- New or worsening depression, anxiety, or agitation
- Thoughts of harming yourself or others
- Changes in behavior or mood not typical for you
- Worsening of seizures
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 your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your overall health status, including any existing medical conditions
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your overall health status, including any existing medical conditions
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
General Information
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Avoid driving and other activities that require alertness until you understand how this medication affects you.
It may take several weeks to experience the full effects of this medication.
Regular blood tests will be necessary, as directed by your doctor. Discuss any concerns or questions with your doctor.
This medication may interfere with certain laboratory tests. Notify all your healthcare providers and laboratory personnel that you are taking this medication.
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this medication may rarely increase the risk of suicidal thoughts or behaviors. This risk may be higher 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, or irritability
+ Panic attacks
+ Changes in mood or behavior
If you experience any suicidal thoughts or behaviors, contact your doctor right away.
Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis.
Seek medical attention immediately if you experience any of the following symptoms:
+ Headache
+ Fever
+ Chills
+ Severe nausea or vomiting
+ Stiff neck
+ Rash
+ Sensitivity to light
+ Drowsiness
+ Confusion
Medication Safety
Always verify that you have the correct medication, as some medications 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 Problems
If you have a history of abnormal heart rhythms, heart failure, or other heart problems, discuss this with your doctor.
Abnormal heart rhythms can occur in individuals with certain heart conditions, which may increase the risk of sudden death.
Pediatric Use
If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children.
Birth Control and Hormone Interactions
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 when taking birth control pills during the week when the pills are not active. Discuss this with your doctor.
Birth control pills and other hormone-based birth control methods may not be effective in preventing pregnancy while taking this medication. Use an additional 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 Management
* If your seizures change or worsen after starting this medication, consult with your doctor.
General Information
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Avoid driving and other activities that require alertness until you understand how this medication affects you.
It may take several weeks to experience the full effects of this medication.
Regular blood tests will be necessary, as directed by your doctor. Discuss any concerns or questions with your doctor.
This medication may interfere with certain laboratory tests. Notify all your healthcare providers and laboratory personnel that you are taking this medication.
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this medication may rarely increase the risk of suicidal thoughts or behaviors. This risk may be higher 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, or irritability
+ Panic attacks
+ Changes in mood or behavior
If you experience any suicidal thoughts or behaviors, contact your doctor right away.
Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis.
Seek medical attention immediately if you experience any of the following symptoms:
+ Headache
+ Fever
+ Chills
+ Severe nausea or vomiting
+ Stiff neck
+ Rash
+ Sensitivity to light
+ Drowsiness
+ Confusion
Medication Safety
Always verify that you have the correct medication, as some medications 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 Problems
If you have a history of abnormal heart rhythms, heart failure, or other heart problems, discuss this with your doctor.
Abnormal heart rhythms can occur in individuals with certain heart conditions, which may increase the risk of sudden death.
Pediatric Use
If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children.
Birth Control and Hormone Interactions
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 when taking birth control pills during the week when the pills are not active. Discuss this with your doctor.
Birth control pills and other hormone-based birth control methods may not be effective in preventing pregnancy while taking this medication. Use an additional 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 Management
* If your seizures change or worsen after starting this medication, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Dizziness
- Ataxia (loss of coordination)
- Nystagmus (involuntary eye movements)
- Decreased consciousness
- Coma
- Seizures
- Cardiac conduction abnormalities (e.g., QRS prolongation)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. There is no specific antidote; treatment is supportive.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels significantly, requiring dose reduction)
- Carbamazepine (decreases lamotrigine levels, requiring dose increase)
- Phenytoin (decreases lamotrigine levels, requiring dose increase)
- Phenobarbital (decreases lamotrigine levels, requiring dose increase)
- Primidone (decreases lamotrigine levels, requiring dose increase)
- Estrogen-containing oral contraceptives (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)
- Olanzapine (lamotrigine may decrease olanzapine levels)
- Bupropion (may increase lamotrigine levels)
Monitoring
Baseline Monitoring
Skin examination
Rationale: To establish baseline for early detection of serious rash (SJS/TEN).
Timing: Prior to initiation
Renal and Hepatic function tests (e.g., BUN, Cr, ALT, AST, bilirubin)
Rationale: To assess baseline organ function, especially if impairment is suspected or for dose adjustment.
Timing: Prior to initiation
Complete Blood Count (CBC) with differential
Rationale: To establish baseline for rare but serious hematologic reactions.
Timing: Prior to initiation
Routine Monitoring
Skin examination
Frequency: Regularly, especially during titration and first 8 weeks of therapy, and with any dose increase.
Target: Absence of new rash, particularly widespread, blistering, or painful rash.
Action Threshold: Discontinue immediately if rash develops, unless clearly not drug-related.
Clinical assessment of seizure control (for epilepsy) or mood stability (for bipolar disorder)
Frequency: At each clinical visit, especially during titration and dose adjustments.
Target: Reduction in seizure frequency/severity; stabilization of mood episodes.
Action Threshold: Consider dose adjustment or alternative therapy if inadequate response or worsening symptoms.
Monitoring for signs/symptoms of hypersensitivity syndrome (DRESS)
Frequency: Regularly, especially during the first 8 weeks.
Target: Absence of fever, lymphadenopathy, facial edema, liver dysfunction, eosinophilia.
Action Threshold: Discontinue immediately if suspected.
Monitoring for suicidal ideation/behavior
Frequency: Regularly, especially at initiation and with dose changes.
Target: Absence of new or worsening suicidal thoughts or behaviors.
Action Threshold: Immediate clinical evaluation and intervention if observed.
Symptom Monitoring
- Skin rash (especially blistering, widespread, 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
- New or worsening depression
- Suicidal thoughts or behavior
- Unusual changes in mood or behavior
- Worsening seizures
Special Patient Groups
Pregnancy
Lamotrigine crosses the placenta. While data suggest a low risk of major congenital malformations with monotherapy, particularly at lower doses, there is a potential for increased risk of oral clefts (cleft lip/palate) when used in the first trimester, though this risk is debated and may be small. The decision to use during pregnancy should weigh the potential risks to the fetus against the risks of uncontrolled seizures or mood episodes to the mother. Folate supplementation is generally recommended for women of childbearing potential taking antiepileptic drugs.
Trimester-Specific Risks:
First Trimester:
Potential small increased risk of oral clefts; close monitoring and risk-benefit discussion are crucial.
Second Trimester:
Generally considered lower risk for structural malformations compared to first trimester.
Third Trimester:
No specific increased risk of malformations; however, lamotrigine levels may decrease during pregnancy, requiring dose adjustments, and may increase postpartum.
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. The benefits of breastfeeding should be weighed against the potential risks to the infant.
Infant Risk:
L3 (Moderately Safe) - Monitor infant for rash, sedation, poor feeding, and apnea. Consider therapeutic drug monitoring in the infant if concerns arise.
Pediatric Use
Lamictal XR is approved for adjunctive treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients 13 years and older. The titration schedule is crucial due to the increased risk of serious rash in younger children (under 16 years) compared to adults. Immediate-release lamotrigine is used in younger children.
Geriatric Use
No specific dose adjustments are generally required based solely on age, but elderly patients may be more sensitive to adverse effects (e.g., dizziness, ataxia) and may have age-related decreases in renal or hepatic function, necessitating careful monitoring and potential dose adjustments. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Slow titration is paramount to minimize the risk of serious skin rash (SJS/TEN). Do not accelerate the titration schedule.
- The titration schedule is highly dependent on concomitant medications, especially valproate (which increases lamotrigine levels) and enzyme-inducing AEDs (which decrease lamotrigine levels).
- Patients should be educated to report any rash immediately and discontinue the drug unless the rash is clearly not drug-related.
- Lamotrigine XR is taken once daily. Tablets should be swallowed whole and not crushed, chewed, or divided.
- While therapeutic drug monitoring is not routinely recommended, it can be useful in cases of suspected non-adherence, drug interactions, or inadequate response/toxicity.
- Consider folate supplementation for women of childbearing potential due to potential risks with antiepileptic drugs during pregnancy.
Alternative Therapies
- Other antiepileptic drugs (e.g., Levetiracetam, Carbamazepine, Valproate, Oxcarbazepine, Topiramate, Gabapentin, Pregabalin)
- Other mood stabilizers (e.g., Lithium, Valproate, Carbamazepine, Atypical Antipsychotics)
Cost & Coverage
Average Cost:
$200 - $600+ per 30 tablets (XR, varying strengths)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand); Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.