Lamotrigine 25mg Tablets

Lamotrigine is a phenyltriazine derivative that stabilizes neuronal membranes and inhibits the release of excitatory neurotransmitters (primarily glutamate and aspartate). It achieves this by blocking voltage-sensitive sodium channels, thereby inhibiting sustained repetitive firing of neurons. It also weakly inhibits voltage-gated calcium channels.

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, and many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention 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 any side effects, 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.

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 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.

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, this medication may interfere with certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug.

Interactions with Other Substances
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.

Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal thoughts or actions. Immediately contact your doctor if you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes. 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. Seek medical attention immediately if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.

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

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

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 be less effective in preventing pregnancy when taking this medication. Use an alternative form of birth control, such as a condom, to prevent pregnancy.

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.

• Valproate (valproic acid, divalproex sodium): Significantly decreases lamotrigine clearance, increasing lamotrigine levels and risk of serious rash. Requires significant lamotrigine dose reduction.
• Carbamazepine, Phenytoin, Phenobarbital, Primidone: Significantly increase lamotrigine clearance, decreasing lamotrigine levels. Requires significant lamotrigine dose increase.
• Oral Contraceptives (containing estrogen): May decrease lamotrigine levels by up to 50%. Requires lamotrigine dose adjustment. Breakthrough seizures or loss of mood stability may occur.
• Rifampin: Significantly increases lamotrigine clearance, decreasing lamotrigine levels.
• Lopinavir/ritonavir, Atazanavir/ritonavir: May decrease lamotrigine levels.

• Risperidone: May increase lamotrigine levels (mechanism unclear).
• Paroxetine, Sertraline: May increase lamotrigine levels (weak inhibition of glucuronidation).
• Topiramate: May increase lamotrigine levels (mechanism unclear).
• Ethanol: May increase CNS depression.

• Acetaminophen: High doses may slightly decrease lamotrigine levels (glucuronidation competition).

• Skin rash (any type, especially widespread, blistering, or involving mucous membranes)
• Fever
• Swollen lymph nodes
• Swelling of face, eyes, lips, tongue
• Sore throat
• Mouth sores
• Unusual bruising or bleeding
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Severe fatigue
• Dizziness
• Ataxia (lack of coordination)
• Blurred or double vision
• Headache
• Nausea/vomiting
• Insomnia
• Tremor
• Changes in mood or behavior (e.g., depression, suicidal thoughts, aggression, agitation)

Use during pregnancy should be carefully considered. While classified as Category C, data from pregnancy registries suggest that the risk of major congenital malformations with lamotrigine monotherapy is relatively low (around 1-3%), similar to the general population. However, higher risks may be associated with polytherapy, especially with valproate. Folic acid supplementation is generally recommended for women of childbearing potential taking AEDs.

Lamotrigine is excreted into breast milk. While generally considered compatible with breastfeeding by some experts (L3), infant monitoring for adverse effects (e.g., rash, drowsiness, poor feeding, apnea) is recommended, especially in neonates or if high doses are used. Infant serum levels can be significant.

Safety and efficacy for bipolar disorder not established in patients under 18 years. For epilepsy, approved for children ≥2 years. Dosing is complex and weight-based, requiring careful titration due to higher risk of serious rash in younger children.

No specific dose adjustments are generally needed based on age alone, 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, requiring dose adjustments based on those impairments. Start low and titrate slowly.

• The most critical aspect of lamotrigine therapy is slow dose titration to minimize the risk of serious skin rash. Never accelerate the titration schedule.
• Concomitant valproate significantly increases lamotrigine levels, requiring a much slower and lower lamotrigine titration. Concomitant enzyme-inducing AEDs (e.g., carbamazepine, phenytoin) significantly decrease lamotrigine levels, requiring a faster and higher lamotrigine titration.
• Patients should be educated to report any rash immediately. While most rashes are benign, it's impossible to distinguish serious from benign rashes early on, so discontinuation is often recommended.
• Lamotrigine is effective for both focal and generalized seizures, including Lennox-Gastaut syndrome, and is a first-line mood stabilizer for bipolar depression.
• Therapeutic drug monitoring (TDM) is not routinely required but can be useful in specific situations (e.g., suspected non-adherence, drug interactions, pregnancy, renal/hepatic impairment, treatment failure, toxicity).

• For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Phenytoin, Topiramate, Oxcarbazepine, Zonisamide, Gabapentin, Pregabalin.
• For Bipolar Disorder (Mood Stabilizers): Lithium, Valproate (divalproex), Carbamazepine, Atypical Antipsychotics (e.g., Quetiapine, Olanzapine, Lurasidone, Cariprazine).

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, a patient fact sheet that provides important information. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.