Lamictal 5mg Chewabl Disprsbl Tabs

Manufacturer GLAXO SMITH KLINE Active Ingredient Lamotrigine Tablets for Oral Suspension(la MOE tri jeen) Pronunciation la MOE tri jeen
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.
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Drug Class
Anticonvulsant; Mood stabilizer
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Pharmacologic Class
Phenyltriazine derivative; Voltage-gated sodium channel blocker
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Pregnancy Category
Not available
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FDA Approved
Dec 1994
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lamotrigine is a medication used to treat certain types of seizures (epilepsy) and to help prevent extreme mood swings in adults with bipolar disorder. It works by stabilizing electrical activity in the brain. It's very important to start with a low dose and increase it very slowly over several weeks to months to reduce the risk of a serious skin rash.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food.

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 Safety Information

Do not change your dose or stop taking this medication without talking to your doctor, as this can increase your risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to do so slowly to minimize the risk of side effects. If you stop taking this medication and need to restart it, your doctor may prescribe a lower dose and gradually increase it.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and 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. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in a drug take-back program 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.
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Lifestyle & Tips

  • Take exactly as prescribed, do not stop suddenly without consulting your doctor.
  • Do not change your dose or how often you take it without your doctor's guidance.
  • Report any new skin rash immediately to your doctor, as it could be serious.
  • Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness or blurred vision.
  • If you are taking oral contraceptives, discuss with your doctor as lamotrigine can make them less effective and vice versa.
  • Avoid alcohol or other CNS depressants, as they can increase side effects like dizziness and drowsiness.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable, requires slow titration based on indication and concomitant medications.
Dose Range: 25 - 700 mg

Condition-Specific Dosing:

Epilepsy (monotherapy): Initial: 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks. Maintenance: 100-400 mg/day in 1-2 divided doses.
Epilepsy (with valproate): Initial: 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks. Maintenance: 100-200 mg/day in 1-2 divided doses.
Epilepsy (with enzyme-inducing AEDs without valproate): Initial: 50 mg once daily for 2 weeks, then 100 mg/day in 2 divided doses for 2 weeks. Maintenance: 300-500 mg/day in 2 divided doses.
Bipolar I Disorder (maintenance): Initial: 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then 100 mg once daily for 1 week. Target: 200 mg once daily (or 400 mg/day if with enzyme-inducing AEDs, or 100 mg/day if with valproate).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for children under 2 years.
Child: Dosing for epilepsy (2-12 years) is weight-based and depends on concomitant medications (e.g., 0.3-0.6 mg/kg/day initial, titrated up to 5-15 mg/kg/day maintenance).
Adolescent: Dosing for epilepsy (13-17 years) generally follows adult recommendations based on concomitant medications. Bipolar disorder maintenance not approved for this age group.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: Consider dose reduction in patients with significant renal impairment. Initial dose may be reduced by 25-50%.
Dialysis: Supplemental doses after dialysis are generally not required as only a small fraction is removed. Consider dose reduction in severe renal impairment.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Initial, escalation, and maintenance doses should be reduced by approximately 25%.
Severe: Initial, escalation, and maintenance doses should be reduced by approximately 50%.
Confidence: Medium

Pharmacology

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Mechanism of Action

Lamotrigine is a phenyltriazine derivative that is thought to exert its anticonvulsant and mood-stabilizing effects by inhibiting voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and modulating the release of excitatory neurotransmitters (e.g., glutamate and aspartate). It also has weak effects on voltage-gated calcium channels and may inhibit serotonin 5-HT3 receptors.
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Pharmacokinetics

Absorption:

Bioavailability: 98%
Tmax: 1-4 hours (oral)
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

Elimination:

HalfLife: Approximately 25-30 hours (monotherapy); significantly affected by concomitant medications (e.g., ~15 hours with enzyme inducers, ~59 hours with valproate).
Clearance: Approximately 30 mL/min (adults)
ExcretionRoute: Renal (approximately 94% as metabolites, 2% as unchanged drug)
Unchanged: Approximately 2%
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Pharmacodynamics

OnsetOfAction: Weeks (due to slow titration)
PeakEffect: Weeks to months (after reaching maintenance dose)
DurationOfAction: 24 hours (dosed once or twice daily)
Confidence: Medium

Safety & Warnings

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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 risk of serious rash is increased with higher initial doses, exceeding recommended dose escalation, or concomitant use of valproate. 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.
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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 immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Shortness of breath, significant weight gain, or swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Changes in balance or coordination
Inability to control eye movements
Flu-like symptoms
Painful or irregular menstrual periods
Low blood cell counts, which can increase the risk of:
+ Infections (fever, chills, or sore throat)
+ Bleeding problems (unexplained bruising or bleeding)
+ Anemia (feeling extremely tired or weak)

An immune system disorder called hemophagocytic lymphohistiocytosis (HLH) has been associated with this medication. HLH can be life-threatening. Seek immediate medical attention if you experience:

Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance or coordination
Difficulty walking (new or worsening symptoms)

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild 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 help if they bother you or persist:

Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness or tremors
Sleep disturbances
Nose or throat irritation
Weight loss
Dry mouth
Back pain

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Any new skin rash (especially if blistering, peeling, or widespread)
  • Fever, swollen glands, facial swelling, or mouth sores
  • Difficulty breathing or swallowing
  • Yellowing of skin or eyes (jaundice)
  • Unusual bruising or bleeding
  • Severe headache, stiff neck, nausea, vomiting, sensitivity to light (signs of aseptic meningitis)
  • Worsening depression, suicidal thoughts, or unusual changes in behavior
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your overall health status, including any existing medical conditions

This 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.
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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, about your treatment. This will help ensure your safety and prevent potential interactions with other medications.

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 medication.

Monitoring and Lab Tests
Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor. Additionally, inform all your healthcare providers and laboratory 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 medications that may cause drowsiness, consult with your doctor.

Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. If you experience any new or worsening symptoms, such as depression, anxiety, restlessness, 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 problem called aseptic meningitis. If you experience symptoms such as headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.

Medication Verification
To ensure you receive the correct medication, always verify the product's appearance, shape, color, size, and labeling. If you notice any changes, consult with your pharmacist.

Heart Problems
If you have an abnormal heartbeat, heart failure, or other heart problems, discuss your condition with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with certain heart conditions.

Pediatric Use
When administering this medication to children, use caution, as the risk of certain side effects may be higher in pediatric patients.

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 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 Management
If your seizures change or worsen after starting this medication, consult with your doctor to adjust your treatment plan as needed.
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Overdose Information

Overdose Symptoms:

  • Dizziness
  • Ataxia (loss of coordination)
  • Nystagmus (involuntary eye movements)
  • Decreased consciousness
  • Seizures
  • Coma
  • Cardiac conduction abnormalities (e.g., QRS prolongation)

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. Gastric lavage or activated charcoal may be considered if ingestion is recent.

Drug Interactions

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Major Interactions

  • Valproate (increases lamotrigine levels significantly, requiring dose reduction)
  • Carbamazepine, Phenytoin, Phenobarbital, Primidone (decrease lamotrigine levels significantly, requiring dose increase)
  • Oral contraceptives (estrogen-containing) (decrease lamotrigine levels, requiring dose increase; lamotrigine may decrease contraceptive efficacy)
  • Rifampin (decreases lamotrigine levels)
  • Lopinavir/Ritonavir, Atazanavir/Ritonavir (decrease lamotrigine levels)
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Moderate Interactions

  • Acetaminophen (may slightly decrease lamotrigine levels with chronic high-dose use)
  • Folic acid inhibitors (e.g., trimethoprim) (theoretical interaction, monitor)
  • Risperidone (lamotrigine may decrease risperidone levels)
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Confidence Interactions

Monitoring

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Baseline Monitoring

Baseline skin assessment

Rationale: To identify any pre-existing skin conditions and establish a baseline for monitoring for serious rash.

Timing: Prior to initiation

Renal and hepatic function tests

Rationale: To assess baseline organ function, as dose adjustments may be needed in impairment.

Timing: Prior to initiation

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Routine Monitoring

Skin for rash (e.g., Stevens-Johnson Syndrome, TEN)

Frequency: Daily during titration, then regularly

Target: Absence of rash

Action Threshold: Any new rash, especially if severe, widespread, or accompanied by fever/systemic symptoms, requires immediate discontinuation.

Clinical efficacy (seizure frequency/mood stability)

Frequency: Regularly during titration and maintenance

Target: Reduction in seizure frequency or stabilization of mood

Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.

Adverse effects (e.g., dizziness, ataxia, blurred vision, headache)

Frequency: Regularly, especially during titration

Target: Tolerable side effect profile

Action Threshold: Intolerable side effects may require dose reduction or discontinuation.

Lamotrigine serum concentrations (therapeutic drug monitoring)

Frequency: Not routinely recommended, but may be useful in specific situations (e.g., suspected toxicity, lack of efficacy, significant drug interactions, renal/hepatic impairment, pregnancy)

Target: Not well-defined, but often 3-14 mcg/mL for epilepsy

Action Threshold: Levels outside expected range for clinical response or toxicity.

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Symptom Monitoring

  • Skin rash (any type, especially blistering, peeling, or widespread)
  • Fever, swollen lymph nodes, facial swelling
  • Sore throat, mouth sores, eye irritation
  • Unusual bruising or bleeding
  • Signs of liver problems (e.g., yellowing skin/eyes, dark urine, severe stomach pain)
  • Signs of aseptic meningitis (e.g., headache, fever, nausea, vomiting, stiff neck, sensitivity to light)
  • Worsening depression, suicidal thoughts or behavior, unusual changes in mood or behavior

Special Patient Groups

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Pregnancy

Lamotrigine crosses the placenta. While older classification was Category C, current data suggest it is not associated with a major increase in overall major congenital malformations. However, some studies suggest a possible increased risk of oral clefts, particularly with first-trimester exposure, though this risk is debated and may be small. Benefits of seizure control often outweigh potential risks. Dose adjustments may be needed during pregnancy due to altered pharmacokinetics.

Trimester-Specific Risks:

First Trimester: Possible small increased risk of oral clefts (e.g., cleft lip/palate), though data are conflicting and risk is likely low. Monitor lamotrigine levels as they may decrease due to increased clearance.
Second Trimester: Clearance may continue to increase, potentially requiring dose adjustments to maintain therapeutic levels.
Third Trimester: Clearance may continue to increase. Monitor for potential withdrawal symptoms in neonate if maternal levels are high at delivery.
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Lactation

Lamotrigine is excreted into breast milk. The amount transferred to the infant can be significant, potentially leading to detectable serum levels and adverse effects (e.g., rash, apnea, drowsiness) in the infant. Monitoring the infant for adverse effects is recommended. Benefits of breastfeeding should be weighed against potential risks.

Infant Risk: L3 (Moderately Safe) - Monitor infant for drowsiness, poor feeding, rash, and apnea. Consider therapeutic drug monitoring in the infant if concerns arise.
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Pediatric Use

Approved for epilepsy in children â‰Ĩ2 years. Dosing is weight-based and highly dependent on concomitant medications. Risk of serious rash is higher in children than adults. Not approved for bipolar disorder in pediatric patients.

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Geriatric Use

No specific dose adjustments are generally required based on age alone, but dose titration should be cautious due to potential for decreased renal/hepatic function and increased sensitivity to adverse effects. Start low and titrate slowly.

Clinical Information

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Clinical Pearls

  • The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rash. Adherence to the recommended titration is paramount.
  • Concomitant medications significantly impact lamotrigine levels: valproate increases levels (requiring lower lamotrigine doses), while enzyme-inducing AEDs (carbamazepine, phenytoin, phenobarbital) and estrogen-containing oral contraceptives decrease levels (requiring higher lamotrigine doses).
  • Patients should be educated to report any rash immediately. While most rashes are benign, distinguishing them from serious ones (SJS/TEN) early is difficult, and discontinuation is usually recommended.
  • Lamotrigine can cause aseptic meningitis, though rare. Symptoms include headache, fever, nausea, vomiting, stiff neck, and sensitivity to light. Discontinuation usually leads to resolution.
  • Chewable dispersible tablets can be swallowed whole, chewed, or dispersed in a small amount of water or diluted fruit juice.
  • For bipolar disorder, lamotrigine is primarily used for maintenance treatment to prevent depressive episodes, with less efficacy for acute mania or depression.
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Alternative Therapies

  • For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Phenytoin, Topiramate, Oxcarbazepine, Zonisamide, Gabapentin, Pregabalin.
  • For Bipolar Disorder (Mood Stabilizers): Lithium, Valproate, Carbamazepine, Quetiapine, Olanzapine, Aripiprazole, Lurasidone.
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Cost & Coverage

Average Cost: Varies widely by dose and quantity per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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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 provides crucial information about its use. 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, don't hesitate 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 details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.