Lamotrigine ODT 100mg Tablets

Manufacturer DR.REDDY'S LABORATORIES 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 certain types of seizures (epilepsy) and to help stabilize mood in people with bipolar disorder. It works by affecting certain chemicals and electrical signals 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 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. To take the medication, place it on your tongue and let it dissolve. You don't need to drink water with it. Do not swallow the medication whole, and avoid chewing, breaking, or crushing it.

Important Warnings

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 taper off the dose to minimize potential side effects. If you've stopped taking the medication and need to restart, your doctor may recommend starting with a lower dose and gradually increasing it.

Storing and Disposing of Your Medication

To keep your medication effective, store it at room temperature, away from light and moisture. Avoid storing it in a bathroom. Keep all medications in a safe place, 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. Check with your pharmacist for guidance on the best way to dispose of your medication, 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. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing 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 abruptly without consulting your doctor, as this can cause withdrawal seizures or worsening of mood.
  • Follow the slow titration schedule carefully to minimize the risk of serious skin rash.
  • Avoid alcohol or other CNS depressants, as they can increase drowsiness.
  • Be aware of potential dizziness or drowsiness, especially when starting or changing doses; avoid driving or operating machinery until you know how the medication affects you.
  • For ODT, place the tablet on your tongue and allow it to dissolve. Do not chew or crush. You can take it with or without water.
  • 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. If you miss multiple doses, contact your doctor as you may need to restart titration.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

Epilepsy (Adjunctive Therapy, with enzyme-inducing AEDs, NOT valproate): Initial: 50 mg/day for weeks 1-2, then 100 mg/day for weeks 3-4. Maintenance: 300-500 mg/day in 2 divided doses.
Epilepsy (Adjunctive Therapy, with valproate): Initial: 25 mg every other day for weeks 1-2, then 25 mg/day for weeks 3-4. Maintenance: 100-200 mg/day in 1-2 divided doses.
Epilepsy (Monotherapy, converting from enzyme-inducing AEDs): Initial: 50 mg/day for weeks 1-2, then 100 mg/day for weeks 3-4. Maintenance: 250-300 mg/day in 2 divided doses.
Bipolar I Disorder (Maintenance): Initial: 25 mg/day for weeks 1-2, then 50 mg/day for weeks 3-4, then 100 mg/day for week 5. Target: 200 mg/day (some patients may require 100-400 mg/day). Dosing adjusted if on valproate or enzyme inducers.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Epilepsy (adjunctive therapy, 2-12 years): Dosing is weight-based and depends on concomitant medications (e.g., with enzyme-inducing AEDs: initial 0.6 mg/kg/day, maintenance 5-15 mg/kg/day; with valproate: initial 0.15 mg/kg/day, maintenance 1-5 mg/kg/day).
Adolescent: Epilepsy (13-17 years): Dosing similar to adult recommendations for epilepsy.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: Consider reduced maintenance doses in patients with significant renal impairment.
Severe: Consider reduced maintenance doses (e.g., 25% reduction) in patients with significant renal impairment (CrCl <30 mL/min).
Dialysis: Supplemental doses after dialysis are generally not required, but monitor clinical response. Lamotrigine is partially dialyzable.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Initial, escalation, and maintenance doses should be reduced by approximately 25% in patients with moderate hepatic impairment (Child-Pugh Class B).
Severe: Initial, escalation, and maintenance doses should be reduced by approximately 50% in patients with severe hepatic impairment (Child-Pugh Class C).
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.
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Pharmacokinetics

Absorption:

Bioavailability: 98%
Tmax: 1-4 hours (oral tablets); ODT may be slightly faster but clinically insignificant.
FoodEffect: Food does not significantly affect the rate or extent of absorption.

Distribution:

Vd: 0.97-1.22 L/kg
ProteinBinding: Approximately 55%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 25-33 hours (monotherapy); significantly affected by concomitant medications (e.g., ~15 hours with enzyme inducers, ~59 hours with valproate).
Clearance: Approximately 30 mL/min (monotherapy)
ExcretionRoute: Renal (approximately 90% as glucuronide metabolites, 10% as unchanged drug)
Unchanged: Approximately 10%
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Pharmacodynamics

OnsetOfAction: Gradual (due to slow titration to minimize rash risk)
PeakEffect: Not directly applicable due to slow titration and chronic use; therapeutic effects are observed over weeks.
DurationOfAction: Dependent on half-life, typically allows for once or twice daily dosing.

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), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). The incidence of these rashes, which have resulted in deaths, is approximately 0.3% to 0.8% in pediatric patients (2-17 years) and 0.08% to 0.3% in adults. The risk of serious rash is increased by coadministration with valproate, exceeding recommended initial doses, or exceeding the recommended dose escalation.
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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 experience 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
Inability to control eye movements
Flu-like symptoms
Painful periods
Changes in menstrual cycle, including spotting or bleeding between cycles

Low Blood Cell Counts

This medication can cause low blood cell counts, which can increase the risk of bleeding, infection, 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)

This medication can cause a rare but potentially life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor right away:

Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Changes in balance
Difficulty walking

Other Side Effects

Most people do not experience serious side effects, but some may occur. If you experience any of the following side effects, 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 side effects not listed here, 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 skin rash, especially if it's blistering, peeling, or accompanied by fever, swollen glands, or facial swelling. Seek immediate medical attention.
  • Signs of allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
  • Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain, nausea, vomiting.
  • Signs of blood problems: unusual bruising or bleeding, pale skin, unusual tiredness, fever, chills, body aches, flu-like symptoms.
  • New or worsening depression, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggression, restlessness, hyperactivity (mentally or physically), or thoughts about suicide or hurting yourself.
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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 symptoms you experienced as a result of the allergy.
If you are currently taking dofetilide, as this may interact with the medication.

Additionally, to ensure safe treatment, 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 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 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 performing tasks 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 your test results with your doctor. Additionally, inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab tests.

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 behaviors. 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 problem 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 Problems
If you have an abnormal heartbeat, heart failure, or other heart problems, discuss this with your doctor, as abnormal heartbeats can increase the risk of 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.

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.
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Overdose Information

Overdose Symptoms:

  • Dizziness
  • Ataxia (loss of coordination)
  • Nystagmus (uncontrolled eye movements)
  • Increased seizures
  • Decreased consciousness
  • Coma

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Management 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, Phenytoin, Phenobarbital, Primidone (decrease lamotrigine levels)
  • Estrogen-containing oral contraceptives (decrease lamotrigine levels)
  • Rifampin (decreases lamotrigine levels)
  • Lopinavir/ritonavir, Atazanavir/ritonavir (decrease lamotrigine levels)
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Moderate Interactions

  • Risperidone (lamotrigine may decrease risperidone levels)
  • Paroxetine, Sertraline (may decrease lamotrigine levels)
  • Ethanol (additive CNS depression)
  • Other CNS depressants (additive CNS depression)

Monitoring

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Baseline Monitoring

Renal and Hepatic Function

Rationale: To establish baseline function, especially if impairment is suspected, as dose adjustments may be needed.

Timing: Prior to initiation

Complete Blood Count (CBC)

Rationale: To establish baseline, though blood dyscrasias are rare.

Timing: Prior to initiation

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Routine Monitoring

Skin for Rash

Frequency: Daily, especially during titration and first 8 weeks of therapy

Target: Absence of rash

Action Threshold: Any new rash should prompt immediate discontinuation and medical evaluation due to risk of SJS/TEN.

Signs/Symptoms of Hypersensitivity Syndrome

Frequency: Regularly, especially during initial therapy

Target: Absence of fever, lymphadenopathy, facial edema, hepatic dysfunction, coagulopathy, multiorgan failure.

Action Threshold: Any signs/symptoms should prompt immediate discontinuation and medical evaluation.

Mood and Behavior Changes (especially suicidal ideation)

Frequency: Regularly, especially during initial therapy and dose adjustments

Target: Stable mood, absence of suicidal thoughts or behaviors

Action Threshold: Report any new or worsening depression, suicidal thoughts, or unusual changes in mood/behavior immediately.

Seizure Control (for epilepsy)

Frequency: Regularly, at follow-up visits

Target: Reduction in seizure frequency/severity

Action Threshold: Inadequate control may require dose adjustment or alternative therapy.

Mood Stability (for bipolar disorder)

Frequency: Regularly, at follow-up visits

Target: Stabilization of mood, reduction in mood episodes

Action Threshold: Inadequate control may require dose adjustment or alternative therapy.

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Symptom Monitoring

  • Skin rash (especially blistering, peeling, or widespread)
  • Fever
  • Swollen lymph nodes
  • Facial swelling
  • Sore throat
  • Mouth sores
  • Unusual bruising or bleeding
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Severe muscle pain
  • New or worsening depression
  • Suicidal thoughts or behavior
  • Anxiety, agitation, panic attacks
  • Insomnia
  • Irritability
  • Hostility, aggressiveness
  • Impulsivity
  • Mania or hypomania
  • Restlessness
  • Aseptic meningitis symptoms (headache, fever, nausea, vomiting, stiff neck, rash, photophobia)

Special Patient Groups

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Pregnancy

Lamotrigine crosses the placenta. While older data suggested a potential increased risk of oral clefts, more recent and larger studies have not consistently confirmed this. The overall risk of major congenital malformations appears to be low, but it is not zero. Use during pregnancy should be carefully weighed against the potential risks of uncontrolled seizures or mood episodes for the mother and fetus. Pregnancy exposure registries are available.

Trimester-Specific Risks:

First Trimester: Potential, but unconfirmed, increased risk of oral clefts. Risk of major congenital malformations generally low.
Second Trimester: Continued exposure, generally considered safer than first trimester for organogenesis.
Third Trimester: Continued exposure. Potential for withdrawal symptoms in neonate if discontinued abruptly before delivery. Monitor neonate for drowsiness, poor feeding.
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Lactation

Lamotrigine is excreted into breast milk. Infant serum concentrations can be significant. Monitor breastfed infants for adverse effects such as drowsiness, poor feeding, rash, and apnea. Weigh the benefits of breastfeeding against the potential risks to the infant.

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

Approved for adjunctive treatment of partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients 2 years and older. Dosing is weight-based and requires careful titration. Higher risk of serious rash in pediatric patients compared to adults.

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Geriatric Use

Use with caution. Start with lower doses and titrate slowly, as elderly patients may be more sensitive to adverse effects, particularly dizziness, ataxia, and rash. Monitor renal and hepatic function.

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 rashes (SJS/TEN). Adherence to this schedule is paramount.
  • Concomitant medications significantly impact lamotrigine levels and require specific dose adjustments (e.g., valproate increases levels, enzyme inducers decrease levels). Always verify the patient's full medication list.
  • Patients should be educated to report any rash immediately, regardless of how mild it appears, and to discontinue the medication if a rash develops, unless otherwise advised by a healthcare professional.
  • Lamotrigine ODT can be taken with or without water, making it convenient for patients who have difficulty swallowing pills.
  • While primarily known as an anticonvulsant, lamotrigine is a first-line maintenance treatment for bipolar I disorder, particularly for preventing depressive episodes.
  • No routine therapeutic drug monitoring is typically required, but it may be considered in cases of suspected non-adherence, drug interactions, or treatment failure.
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Alternative Therapies

  • Other Antiepileptic Drugs (AEDs): Levetiracetam, Carbamazepine, Valproate, Topiramate, Oxcarbazepine, Phenytoin, Gabapentin, Pregabalin, Zonisamide, Lacosamide, Brivaracetam.
  • Other Mood Stabilizers (for bipolar disorder): Lithium, Quetiapine, Olanzapine, Aripiprazole, Cariprazine, Lurasidone, Valproate, Carbamazepine.
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Cost & Coverage

Average Cost: Varies widely, typically $30-$150+ per 30 tablets (100mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or higher (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 or take someone else's medication. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.