Lamictal ODT 25-50mg Tb Kit Blue

Manufacturer GLAXO SMITH KLINE Active Ingredient Lamotrigine Orally Disintegrating Tablets(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 epilepsy (seizures) and bipolar disorder. It works by stabilizing electrical activity in the brain. The ODT (Orally Disintegrating Tablet) form dissolves quickly in your mouth.
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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 with your medication 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. To take the medication, place it on your tongue and let it dissolve. You don't need to drink water with it, and make sure not to swallow it whole. Also, avoid chewing, breaking, or crushing the medication.

Important Safety Information

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

Storing and Disposing of Your Medication

To keep your medication effective and safe, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications out of the reach of children and pets.

When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for the best way to dispose of your medication, or look into local drug take-back programs.

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, as this can cause withdrawal seizures or worsening of bipolar symptoms.
  • Report any rash immediately to your doctor, especially if accompanied by fever, swelling, or flu-like symptoms.
  • Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
  • Be aware that oral contraceptives can reduce the effectiveness of lamotrigine, and lamotrigine can reduce the effectiveness of oral contraceptives. Discuss contraception with your doctor.
  • Avoid alcohol, as it can increase side effects like dizziness and drowsiness.
  • Carry a medical alert card or wear a medical alert bracelet indicating you take lamotrigine.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized, requires slow titration to minimize rash risk. Initial dose typically 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then increased by 50-100 mg/day every 1-2 weeks. Maintenance dose varies by indication and concomitant medications.
Dose Range: 100 - 700 mg

Condition-Specific Dosing:

Epilepsy (monotherapy): 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then 100 mg daily for 1 week, then 200-400 mg daily (divided BID).
Epilepsy (with valproate): 25 mg every other day for 2 weeks, then 25 mg daily for 2 weeks, then 50 mg daily (divided BID). Maintenance 100-200 mg daily.
Epilepsy (with enzyme-inducing AEDs): 50 mg daily for 2 weeks, then 100 mg daily (divided BID) for 2 weeks, then 200 mg daily (divided BID) for 1 week, then 300-500 mg daily (divided BID).
Bipolar I Disorder (maintenance): 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 daily (up to 400 mg daily if needed).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for <2 years old. For 2-12 years, dosing is weight-based and depends on concomitant medications, requiring slow titration.
Child: 2-12 years: Initial dose 0.3-0.6 mg/kg/day depending on concomitant medications. Titration over several weeks to maintenance doses of 1-15 mg/kg/day (max 200-400 mg/day).
Adolescent: 13-17 years: Dosing generally follows adult recommendations for epilepsy. Not approved for bipolar disorder in this age group.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, but monitor for adverse effects.
Moderate: No specific adjustment needed, but monitor for adverse effects.
Severe: Consider lower initial and maintenance doses. Monitor clinical response and adverse effects.
Dialysis: Supplemental dose after dialysis is generally not required as lamotrigine is minimally dialyzed. Monitor clinical response.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Reduce initial, escalation, and maintenance doses by approximately 25%.
Severe: Reduce initial, escalation, and maintenance doses by approximately 50%.
Confidence: Medium

Pharmacology

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Mechanism of Action

Lamotrigine is a phenyltriazine derivative that inhibits voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and modulating the release of excitatory neurotransmitters (e.g., glutamate and aspartate). It also weakly inhibits voltage-gated calcium channels.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 98% (oral)
Tmax: 1.4 to 4.8 hours (oral disintegrating tablets may have slightly faster absorption)
FoodEffect: Food does not significantly affect the rate or extent of absorption.

Distribution:

Vd: 0.97 to 1.36 L/kg
ProteinBinding: Approximately 55%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 25-33 hours (can vary significantly with concomitant medications: ~15 hours with enzyme inducers, ~59 hours with valproate)
Clearance: Approximately 30 mL/min (adults)
ExcretionRoute: Renal (approximately 94% as metabolites, 6% as unchanged drug)
Unchanged: Approximately 6%
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Pharmacodynamics

OnsetOfAction: Gradual (due to slow titration)
PeakEffect: Not acutely defined for chronic therapy; therapeutic effects are observed after reaching stable maintenance doses.
DurationOfAction: Dependent on half-life; effects persist as long as drug levels are maintained.
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

Serious Skin Rashes: Lamotrigine can cause serious skin rashes requiring hospitalization and discontinuation of treatment, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The incidence of these rashes, which can be fatal, is approximately 0.3% to 0.8% in pediatric patients (2-16 years) and 0.08% to 0.3% in adults. Risk factors include concomitant use of valproate, exceeding recommended initial doses or dose escalation, and age (pediatric patients are at higher risk).
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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 immediately or seek medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful periods
Changes in menstrual cycle, including spotting or bleeding between periods

Low Blood Cell Counts

This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:

Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak

Immune System Problem (Hemophagocytic Lymphohistiocytosis)

In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor immediately:

Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Difficulty walking

Other Side Effects

Most people do not experience serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor if they bother you or do not go away:

Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain

Reporting Side Effects

If you have questions about side effects or experience any symptoms that concern you, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Any new or worsening skin rash
  • 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 behavior or mood (e.g., agitation, aggression, panic attacks, restlessness, irritability, impulsivity, hypomania, mania)
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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, 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 existing health problems

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.
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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, that you are using this drug.

Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.

Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be sure to discuss any concerns with your doctor. Additionally, inform all your healthcare providers and 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 using prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.

Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal ideation. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.

Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.

Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult with your pharmacist.

Heart-Related Warnings
If you have a history of abnormal heart rhythms, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heartbeats can occur in individuals with certain heart conditions, which may lead to sudden death.

Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.

Interactions with Birth Control
Birth control pills and other hormone-based contraceptives 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 contraceptives may be less effective in preventing pregnancy when taking this medication. Use an alternative form of birth control, such as a condom.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.

Seizure-Specific Warnings
If your seizures change or worsen after starting this medication, consult with your doctor.
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Overdose Information

Overdose Symptoms:

  • Nystagmus (involuntary eye movements)
  • Ataxia (loss of coordination)
  • Impaired consciousness
  • Seizures
  • Coma
  • QRS prolongation (cardiac conduction delay)

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is generally 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, increases rash risk)
  • Oral Contraceptives (estrogen-containing, decrease lamotrigine levels)
  • Carbamazepine (decreases lamotrigine levels, increases risk of CNS side effects)
  • Phenytoin (decreases lamotrigine levels)
  • Phenobarbital (decreases lamotrigine levels)
  • Primidone (decreases lamotrigine levels)
  • Rifampin (decreases lamotrigine levels)
  • Lopinavir/Ritonavir (decreases lamotrigine levels)
  • Atazanavir/Ritonavir (decreases lamotrigine levels)
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Moderate Interactions

  • Acetaminophen (may slightly decrease lamotrigine levels with chronic high doses)
  • Risperidone (lamotrigine may decrease risperidone levels)
  • Olanzapine (lamotrigine may decrease olanzapine levels)
  • Bupropion (may increase lamotrigine levels, monitor for toxicity)
  • Sertraline (may increase lamotrigine levels, monitor for toxicity)
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Confidence Interactions

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To establish baseline and monitor for rare hematologic abnormalities.

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: To establish baseline and monitor for rare hepatic dysfunction.

Timing: Prior to initiation

Renal Function Tests (Creatinine, BUN)

Rationale: To establish baseline and guide dosing in renal impairment.

Timing: Prior to initiation

Skin Examination

Rationale: To establish baseline skin condition and educate patient on rash monitoring.

Timing: Prior to initiation

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Routine Monitoring

Clinical response (seizure frequency/severity, mood stability)

Frequency: Regularly during titration and maintenance

Target: Individualized

Action Threshold: Lack of efficacy or worsening symptoms

Adverse effects (especially rash, CNS effects, suicidal ideation)

Frequency: Regularly, especially during titration and dose changes

Target: Absence of severe adverse effects

Action Threshold: Appearance of rash, fever, lymphadenopathy, facial swelling, or worsening mood/behavioral changes

Skin Examination

Frequency: At each visit, especially during titration

Target: Absence of new or worsening rash

Action Threshold: Any new rash, particularly if accompanied by systemic symptoms

Therapeutic Drug Monitoring (TDM)

Frequency: Not routinely recommended, but may be considered in cases of suspected non-adherence, drug interactions, or treatment failure.

Target: Not well-established, but some sources suggest 3-14 mcg/mL for epilepsy.

Action Threshold: Levels outside expected range, or clinical signs of toxicity/inefficacy.

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Symptom Monitoring

  • Skin rash (especially blistering, peeling, or widespread)
  • Fever
  • Swollen lymph glands
  • Swelling of the face or tongue
  • Sore throat
  • Mouth sores
  • Unusual bruising or bleeding
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Severe muscle pain or weakness
  • New or worsening depression
  • Anxiety
  • Agitation
  • Restlessness
  • Panic attacks
  • Insomnia
  • Irritability
  • Hostility
  • Aggressiveness
  • Impulsivity
  • Akathisia (restlessness)
  • Hypomania/mania
  • Other unusual changes in behavior or mood
  • Suicidal thoughts or behavior

Special Patient Groups

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Pregnancy

Use during pregnancy should be carefully considered, weighing the potential risks to the fetus against the benefits of seizure control or mood stabilization for the mother. Lamotrigine is excreted into breast milk.

Trimester-Specific Risks:

First Trimester: Increased risk of oral clefts (e.g., cleft lip/palate) has been reported in some studies, particularly with higher doses or polytherapy, but overall absolute risk is low and debated. Data from pregnancy registries suggest the risk is not significantly increased compared to the general population.
Second Trimester: No specific increased risks reported.
Third Trimester: No specific increased risks reported.
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Lactation

Lamotrigine is excreted into breast milk. Monitor breastfed infants for adverse effects such as rash, apnea, drowsiness, and poor feeding. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for lamotrigine, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

Infant Risk: L3 (Moderate risk - monitor infant for drowsiness, poor feeding, rash, apnea).
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Pediatric Use

Approved for partial seizures, generalized tonic-clonic seizures, and Lennox-Gastaut syndrome in patients β‰₯2 years of age. Dosing is weight-based and complex, requiring careful titration. Higher risk of serious rash in pediatric patients compared to adults.

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Geriatric Use

Start with lower doses and titrate slowly, as elderly patients may be more sensitive to adverse effects (e.g., dizziness, ataxia). Monitor renal and hepatic function.

Clinical Information

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Clinical Pearls

  • The most critical aspect of lamotrigine therapy is slow titration to minimize the risk of serious skin rash. Do not accelerate the titration schedule.
  • Patients should be educated to report any rash immediately, regardless of how mild it appears, and to discontinue the drug if a rash develops unless clearly not drug-related.
  • Concomitant use of valproate significantly increases lamotrigine levels and the risk of rash, requiring a much slower and lower initial dosing schedule for lamotrigine.
  • Estrogen-containing oral contraceptives can significantly decrease lamotrigine levels, potentially leading to loss of seizure control or mood stabilization. Dose adjustments may be necessary.
  • Lamotrigine ODT can be taken with or without water. It should be placed on the tongue and allowed to dissolve, then swallowed with saliva. Do not chew or crush.
  • Therapeutic drug monitoring is not routinely recommended but can be useful in cases of suspected non-adherence, drug interactions, or treatment failure.
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Alternative Therapies

  • Valproate (Divalproex sodium)
  • Carbamazepine
  • Oxcarbazepine
  • Levetiracetam
  • Topiramate
  • Gabapentin
  • Pregabalin
  • Phenytoin
  • Lithium
  • Quetiapine
  • Olanzapine
  • Aripiprazole
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Cost & Coverage

Average Cost: Varies widely, typically $50-$300+ per 30 tablets (generic)
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 is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the amount taken and the time it occurred.