Lamictal 150mg Tablets

Manufacturer GLAXO SMITH KLINE Active Ingredient Lamotrigine 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 certain types of seizures (epilepsy) and to help prevent extreme mood swings in people with bipolar disorder. It works by stabilizing electrical activity in the brain. It's very important to start this medication at a very low dose and increase it slowly 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 with your prescription 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 start feeling well. Swallow the medication whole; do not chew, break, or crush it. If you have difficulty swallowing, consult your doctor for guidance.

Important Warnings

Do not change your dose or stop taking this medication without consulting your doctor, as this may cause seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually reduce the dose 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. 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 way to dispose of medications, and consider participating in local drug take-back programs.

Missing 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 resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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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 talking to your doctor.
  • Avoid alcohol or other CNS depressants, as they can increase side effects like dizziness and drowsiness.
  • Be aware that oral contraceptives can affect lamotrigine levels; discuss with your doctor.
  • Carry a medical alert card or wear medical identification indicating you are taking lamotrigine.
  • Report any new or worsening skin rash immediately to your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable, requires slow titration. For epilepsy (adjunctive): Initial 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then increase by 50 mg/day every 1-2 weeks. Maintenance: 300-500 mg/day in 2 divided doses (without valproate or enzyme inducers). For bipolar I disorder (maintenance): Initial 25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then 100 mg daily for 1 week, then 200 mg daily. Maintenance: 200 mg/day (without valproate or enzyme inducers). Dosing must be adjusted based on concomitant medications (e.g., valproate, enzyme-inducing AEDs, oral contraceptives).
Dose Range: 25 - 700 mg

Condition-Specific Dosing:

concomitant_valproate: Initial 25 mg every other day for 2 weeks, then 25 mg daily for 2 weeks. Maintenance: 100-200 mg/day.
concomitant_enzyme_inducers: Initial 50 mg daily for 2 weeks, then 100 mg daily for 2 weeks. Maintenance: 300-500 mg/day (up to 700 mg/day in some cases).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Epilepsy (2-12 years, adjunctive): Dosing is weight-based and depends on concomitant medications. Initial doses are very low (e.g., 0.3 mg/kg/day with valproate). Titration is slow over several weeks. Maintenance: 1-15 mg/kg/day depending on co-medications.
Adolescent: Dosing similar to adults, but titration may be slower for younger adolescents. For epilepsy (13-17 years): Dosing similar to adults, adjusted for concomitant medications.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: Consider dose reduction in patients with significant renal impairment. Monitor clinical response.
Severe: Significant dose reduction (e.g., 25% reduction in maintenance dose) may be necessary. Monitor clinical response and adverse effects.
Dialysis: Supplemental doses after dialysis are generally not required as only a small fraction is removed. However, monitor clinical response and consider individualizing dose.

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%. Monitor for adverse effects.

Pharmacology

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Mechanism of Action

Lamotrigine is a phenyltriazine derivative that exerts its anticonvulsant and mood-stabilizing effects primarily by blocking voltage-sensitive sodium channels. This action stabilizes neuronal membranes and inhibits the release of excitatory neurotransmitters, particularly glutamate and aspartate. It also has weak effects on voltage-gated calcium channels and may modulate 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: 0.9-1.3 L/kg
ProteinBinding: Approximately 55%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 25-33 hours (monotherapy); significantly shorter with enzyme inducers (e.g., 13-14 hours) and longer with valproate (e.g., 59-70 hours).
Clearance: Approximately 30 mL/min (monotherapy)
ExcretionRoute: Renal (approximately 94% as metabolites, 2% as unchanged drug)
Unchanged: Approximately 2%
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Pharmacodynamics

OnsetOfAction: Weeks (due to slow titration required to minimize rash risk)
PeakEffect: Weeks to months (after reaching stable maintenance dose)
DurationOfAction: 24 hours (given twice daily dosing, but half-life supports once daily in some cases)
Note: Therapeutic effects are observed after reaching stable plasma concentrations, which takes several weeks due to the slow titration schedule.

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 incidence of these serious rashes is higher in pediatric patients than in adults. Other risk factors include coadministration with valproate, exceeding recommended initial doses, and exceeding recommended dose escalation. Benign rashes are also common, 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

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 emergency 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)

Additionally, a rare but potentially life-threatening immune system disorder called hemophagocytic lymphohistiocytosis (HLH) has been associated with this medication. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance or trouble walking (new or worsening)

Other Possible Side Effects

Most people do not experience significant side effects while taking this medication. However, some individuals may encounter mild or moderate side effects, including:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Difficulty sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain

If you experience any of these side effects or have concerns about other symptoms, contact your doctor for guidance. 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 it's widespread, blistering, or involves your mouth, eyes, or genitals.
  • Fever, swollen glands, or flu-like symptoms.
  • Swelling of your face, eyes, lips, or tongue.
  • Sore throat or mouth sores.
  • Unusual bruising or bleeding.
  • Yellowing of your skin or eyes (jaundice).
  • Dark urine.
  • Severe fatigue or weakness.
  • 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 complete medical history, including any health problems you have

This information will help your doctor determine whether it is safe for you to take this medication in combination with your other medications and health conditions. Never start, stop, or change 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 lab 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 (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 behaviors. Immediately contact your doctor if you experience any 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 condition 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
To ensure you have the correct medication, always verify the product's appearance, shape, color, size, and labeling. If you notice any changes, consult with your pharmacist.

Heart-Related Warnings
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 pre-existing heart conditions.

Pediatric Use
When administering this medication to children, use 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 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. Use an alternative form of birth control, such as a condom, while taking this medication.

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 (uncontrolled 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. Treatment is supportive; there is no specific antidote.

Drug Interactions

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Major Interactions

  • Valproate (increases lamotrigine levels, increases risk of serious rash)
  • Carbamazepine (decreases lamotrigine levels)
  • Phenytoin (decreases lamotrigine levels)
  • Phenobarbital (decreases lamotrigine levels)
  • Primidone (decreases lamotrigine levels)
  • Oral contraceptives containing estrogen (e.g., ethinyl estradiol) (decrease lamotrigine levels)
  • Rifampin (decreases lamotrigine levels)
  • Lopinavir/ritonavir (decreases lamotrigine levels)
  • Atazanavir/ritonavir (decreases lamotrigine levels)
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Moderate Interactions

  • Risperidone (lamotrigine may decrease risperidone levels)
  • Olanzapine (lamotrigine may decrease olanzapine levels)
  • Bupropion (lamotrigine may increase bupropion levels, theoretical seizure risk)
  • Paroxetine (lamotrigine may increase paroxetine levels)
  • Sertraline (lamotrigine may increase sertraline levels)
  • Folic acid (may decrease lamotrigine levels, though clinical significance is debated)
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Minor Interactions

  • Acetaminophen (may slightly decrease lamotrigine levels with chronic high doses)

Monitoring

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Baseline Monitoring

Skin assessment

Rationale: To establish baseline for potential serious rash (SJS/TEN).

Timing: Prior to initiation.

Renal and hepatic function tests (e.g., BUN, creatinine, LFTs)

Rationale: To guide initial dosing and identify patients requiring dose adjustments.

Timing: Prior to initiation.

Complete blood count (CBC)

Rationale: To establish baseline for potential hematologic abnormalities (rare).

Timing: Prior to initiation.

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Routine Monitoring

Skin assessment

Frequency: Daily during titration, then regularly.

Target: Absence of new rash.

Action Threshold: Any new rash, especially widespread, blistering, or involving mucous membranes, requires immediate discontinuation and medical evaluation.

Seizure frequency/mood stability

Frequency: Regularly, at each follow-up visit.

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, nausea)

Frequency: Regularly, at each follow-up visit.

Target: Tolerable side effect profile.

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

Lamotrigine plasma levels (therapeutic drug monitoring)

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

Target: Typically 3-14 mcg/mL for epilepsy, but clinical response is paramount.

Action Threshold: Levels outside expected range, especially if correlated with clinical symptoms or lack of efficacy, may warrant dose adjustment.

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Symptom Monitoring

  • New or worsening skin rash (especially blistering, peeling, or involving mucous membranes)
  • Fever
  • Swollen lymph nodes
  • Swelling of the face, eyes, lips, or tongue
  • Sore throat
  • Mouth sores
  • Unusual bruising or bleeding
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Severe fatigue
  • Worsening depression or suicidal thoughts/behavior
  • New or worsening seizures
  • Dizziness, ataxia, blurred vision, diplopia

Special Patient Groups

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Pregnancy

Lamotrigine crosses the placenta. While older classification was Category C, newer data from registries suggest it is generally considered one of the safer AEDs during pregnancy for seizure control, but risks are still present. Folic acid supplementation (at least 4 mg/day) is strongly recommended for women of childbearing potential and during pregnancy to reduce the risk of neural tube defects associated with AED use.

Trimester-Specific Risks:

First Trimester: Small increased risk of oral clefts (cleft lip/palate) has been reported in some studies, though overall risk is low and debated. Risk of major congenital malformations is generally considered lower than with some other AEDs.
Second Trimester: Continued monitoring of lamotrigine levels may be necessary as clearance can increase during pregnancy, potentially leading to decreased drug levels and loss of seizure control.
Third Trimester: Clearance may continue to increase. Monitor for signs of withdrawal in the neonate if maternal levels are high at delivery, though this is rare for lamotrigine.
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Lactation

Lamotrigine is excreted into breast milk. The relative infant dose (RID) can be significant (up to 30-50%). Monitor breastfed infants for adverse effects such as rash, drowsiness, poor feeding, and apnea. Weigh benefits of breastfeeding against potential risks.

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

Higher incidence of serious rash (SJS/TEN) compared to adults, especially in children under 16 years. Dosing is weight-based and requires very careful, slow titration. Not recommended for children under 2 years for epilepsy due to lack of data and increased rash risk. Not approved for bipolar disorder in pediatric patients.

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Geriatric Use

No specific dose adjustments are generally needed based on age alone, but older adults may have reduced renal or hepatic function, requiring dose adjustments. Start with lower doses and titrate slowly due to potential for increased sensitivity to adverse effects (e.g., dizziness, ataxia).

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. Patients must be educated on this.
  • Concomitant valproate significantly increases lamotrigine levels, requiring a much slower and lower initial titration.
  • Concomitant enzyme-inducing AEDs (e.g., carbamazepine, phenytoin) significantly decrease lamotrigine levels, requiring a faster and higher initial titration.
  • Oral contraceptives containing estrogen can significantly decrease lamotrigine levels, potentially leading to loss of seizure control or mood stability. Dose adjustments may be needed.
  • Lamotrigine is often preferred in women of childbearing potential due to a relatively favorable safety profile in pregnancy compared to some other AEDs, but folic acid supplementation is crucial.
  • Patients should be advised to report any rash immediately and discontinue the drug unless the rash is clearly not drug-related.
  • Lamotrigine is effective for both partial and generalized seizures, including Lennox-Gastaut syndrome, and for maintenance treatment of bipolar I disorder.
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Alternative Therapies

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

Average Cost: Check current 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 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 about the overdose, including the medication taken, the quantity, and the time it occurred.