Prednisolone ODT 15mg Tablets

Manufacturer PRASCO Active Ingredient Prednisolone Orally Disintegrating Tablets(pred NISS oh lone) Pronunciation pred-NISS-oh-lone
It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.
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Drug Class
Corticosteroid
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Prednisolone is a type of steroid medicine that works like a natural hormone your body makes. It helps reduce inflammation (swelling and redness) and calm down an overactive immune system. It's used for many conditions like allergies, asthma, arthritis, and certain skin conditions.
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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.

If you take this medication once a day, take it in the morning.
Take your medication with food to help your body absorb it properly.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.

Handling and Taking Your Medication

Do not remove your medication from the blister pack until you are ready to take it.
Take your medication immediately after opening the blister pack. Do not store the removed medication for later use.
When opening the blister pack, do not push the tablet through the foil. Instead, use dry hands to carefully remove the tablet from the foil.
Place the tablet on your tongue and let it dissolve. You do not need to drink water with it. Do not swallow the tablet whole, and avoid chewing, breaking, or crushing it.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the 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 your medication, 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, with food.
If it is 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 to make up for a missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed, usually with food or milk to reduce stomach upset.
  • Do not stop taking this medicine suddenly, especially if you've been on it for more than a few days. Your doctor will tell you how to slowly reduce the dose to prevent withdrawal symptoms.
  • Avoid contact with people who are sick, especially with chickenpox or measles, as your immune system may be weakened.
  • Report any signs of infection (fever, chills, sore throat) immediately.
  • Limit salt intake to help prevent fluid retention and high blood pressure.
  • Monitor blood sugar if you have diabetes, as this medicine can raise blood sugar levels.
  • Ensure adequate calcium and vitamin D intake, and discuss bone health with your doctor, especially for long-term use.
  • Carry a steroid warning card if on long-term therapy, indicating you are taking a corticosteroid.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable, depends on indication. Typical initial dose for many inflammatory conditions: 5-60 mg/day, often tapered.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

Allergic reactions: 20-60 mg/day, tapered over 5-10 days
Asthma (acute exacerbation): 40-60 mg/day for 3-10 days
Rheumatic disorders: 5-60 mg/day, adjusted based on response
Multiple Sclerosis (acute exacerbation): 200 mg/day for 7 days, then 80 mg every other day for 1 month
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions may warrant use under specialist guidance (e.g., congenital adrenal hyperplasia).
Infant: Dosing is weight-based and indication-specific. E.g., 0.5-2 mg/kg/day in divided doses for inflammatory conditions.
Child: Dosing is weight-based and indication-specific. E.g., 0.5-2 mg/kg/day (max 60 mg/day) for inflammatory/immunosuppressive conditions.
Adolescent: Similar to adult dosing, adjusted for weight and indication.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.
Dialysis: Prednisolone is not significantly removed by hemodialysis. No supplemental dose needed.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Consider dose reduction, monitor for increased side effects due to impaired metabolism.
Severe: Significant dose reduction may be necessary; monitor closely for adverse effects. Prednisolone is primarily metabolized by the liver.

Pharmacology

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Mechanism of Action

Prednisolone is a synthetic glucocorticoid. It exerts its effects by binding to intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex then modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortin) and inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, prostaglandins, leukotrienes). It suppresses immune responses by inhibiting the function of lymphocytes and macrophages, reducing capillary permeability, and stabilizing lysosomal membranes.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 70-90% (oral)
Tmax: 1-2 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: 0.22-0.7 L/kg
ProteinBinding: Approximately 70-90% (concentration-dependent, primarily to albumin and corticosteroid-binding globulin)
CnssPenetration: Limited, but sufficient to produce CNS effects (e.g., mood changes, insomnia).

Elimination:

HalfLife: 2-4 hours (plasma half-life); 18-36 hours (biological half-life)
Clearance: Not readily available as a single rate, varies with metabolism.
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <5% (renal)
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Pharmacodynamics

OnsetOfAction: Hours to days (for full therapeutic effect, depending on indication)
PeakEffect: Variable, depends on indication and duration of therapy.
DurationOfAction: 18-36 hours (biological effect, allowing for once-daily or alternate-day dosing)

Safety & Warnings

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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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Signs of adrenal gland weakness: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of pancreatitis: severe abdominal pain, severe back pain, or severe nausea and vomiting
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Purple, red, blue, brown, or black skin lesions or mouth sores
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Menstrual changes
Bone or joint pain
Vision changes
New or worsening mental, mood, or behavioral changes
Seizures
Unusual burning, numbness, or tingling sensations
Unexplained bruising or bleeding
Abdominal swelling
Severe stomach pain
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
New or worsening muscle weakness
Fluid retention, swelling, weight gain, or breathing difficulties

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or persist:

Upset stomach
Increased appetite
Weight gain
Sleep disturbances
Restlessness
Excessive sweating
Headache
Fatigue or weakness

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:

  • Severe stomach pain, black or tarry stools (signs of GI bleeding)
  • Unusual swelling in hands, ankles, or feet (fluid retention)
  • Sudden weight gain
  • Blurred vision or eye pain
  • Extreme mood changes (depression, anxiety, euphoria)
  • Increased thirst or urination (high blood sugar)
  • Muscle weakness or severe fatigue
  • Signs of infection (fever, chills, persistent cough, painful urination)
  • Difficulty sleeping
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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 conditions to ensure safe treatment:

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.
The presence of any infection, including bacterial, viral, or fungal infections, as well as specific conditions like:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Any other type of infection
Nerve problems in the eye, as this medication may affect your vision or interact with existing eye conditions.
Recent or upcoming administration of the smallpox vaccine, as this may interact with the medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you are taking this medication long-term, your doctor may recommend regular blood tests, weight checks, and other laboratory tests to monitor your health. You may also need to have your eye pressure and bone density checked regularly.

High Blood Pressure

Drugs like this one can cause high blood pressure. Your doctor will monitor your blood pressure regularly, so it is crucial to follow their instructions.

Allergy Skin Tests

This medication may affect the results of allergy skin tests. Be sure to inform your doctor and laboratory personnel that you are taking this medication.

Long-term Use and Eye Problems

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this risk with your doctor.

Osteoporosis

Prolonged use of this medication may also increase the risk of osteoporosis (weak bones). Talk to your doctor to determine if you are at higher risk or if you have any questions.

Dietary Changes and Potassium Supplements

You may need to reduce your salt intake and take potassium supplements while taking this medication. Consult with your doctor for personalized advice.

Diabetes Management

If you have diabetes, it is crucial to monitor your blood sugar levels closely while taking this medication.

Alcohol Consumption and Vaccinations

Before consuming alcohol or receiving any vaccinations, discuss the potential risks with your doctor. Some vaccines may not be effective or may increase the risk of infection when taken with this medication.

Infection Risks

Steroid medications like this one can increase the risk of infection, which can be severe or even life-threatening. Avoid close contact with people who have infections, colds, or flu, and wash your hands frequently. Inform your doctor immediately if you notice any signs of infection.

Reactivation of Infections

In some cases, this medication can reactivate latent infections, such as tuberculosis or hepatitis B. Inform your doctor if you have a history of these infections.

Adrenal Insufficiency

This medication may lower your body's natural steroid production. If you experience stress, such as a fever, infection, surgery, or injury, consult with your doctor, as you may need additional oral steroids. Carry a warning card indicating that you may require extra steroids in emergency situations.

Stopping the Medication

Do not stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to stop taking this medication, your doctor will guide you on how to taper off slowly.

Missed Doses or Recently Stopped Medication

If you have missed a dose or recently stopped taking this medication and experience symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform your doctor promptly.

Kaposi's Sarcoma

Long-term use of this medication has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this risk with your doctor.

Age-Related Considerations

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Effects on Growth and Fertility

This medication may affect growth in children and adolescents, so regular growth checks may be necessary. Additionally, it may lower sperm counts in some individuals. If you have concerns, discuss them with your doctor.

Pregnancy and Breastfeeding

This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or are breastfeeding, inform your doctor immediately. If you used this medication during pregnancy, be sure to inform your baby's doctor.

Post-Pregnancy Care

If you took this medication during pregnancy, inform your baby's doctor to ensure proper care and monitoring.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare and usually does not cause life-threatening problems.
  • Symptoms may include: nausea, vomiting, stomach upset, fluid retention, high blood pressure, and temporary mood changes.

What to Do:

Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention. Treatment is generally supportive; no specific antidote.

Drug Interactions

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Major Interactions

  • Live attenuated vaccines (increased risk of infection)
  • Mifepristone (antagonizes corticosteroid effect)
  • Desmopressin (increased risk of hyponatremia)
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Moderate Interactions

  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Diuretics (thiazide and loop) (increased risk of hypokalemia)
  • Anticoagulants (warfarin) (may alter anticoagulant effect, monitor INR)
  • Antidiabetics (insulin, oral hypoglycemics) (may increase blood glucose, requiring dose adjustment)
  • CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital, carbamazepine) (decreased prednisolone levels)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) (increased prednisolone levels)
  • Digoxin (increased risk of toxicity with hypokalemia)
  • Cyclosporine (increased levels of both drugs, increased risk of seizures)
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Minor Interactions

  • Antacids (may reduce absorption, separate administration)
  • Cholestyramine (may reduce absorption, separate administration)

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To assess baseline white blood cell count (leukocytosis is common with corticosteroids), hemoglobin, and platelets.

Timing: Prior to initiation of therapy.

Serum Electrolytes (Na, K, Cl, CO2)

Rationale: To assess baseline electrolyte balance, particularly potassium, due to risk of hypokalemia.

Timing: Prior to initiation of therapy.

Blood Glucose (Fasting or HbA1c)

Rationale: To assess baseline glucose control, as corticosteroids can induce hyperglycemia.

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: To assess baseline blood pressure, as corticosteroids can cause hypertension.

Timing: Prior to initiation of therapy.

Weight

Rationale: To establish baseline weight, as corticosteroids can cause fluid retention and weight gain.

Timing: Prior to initiation of therapy.

Bone Mineral Density (BMD)

Rationale: For patients anticipated to be on long-term therapy (>3 months) to assess baseline bone health due to risk of osteoporosis.

Timing: Prior to initiation of long-term therapy.

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Routine Monitoring

Blood Pressure

Frequency: Regularly, especially during initial therapy and dose changes (e.g., weekly to monthly).

Target: <130/80 mmHg (or patient-specific target)

Action Threshold: Sustained elevation above target; consider antihypertensive therapy or dose adjustment.

Blood Glucose

Frequency: Weekly to monthly, or more frequently in diabetics. HbA1c every 3-6 months for long-term therapy.

Target: Fasting <100 mg/dL; HbA1c <7%

Action Threshold: Persistent hyperglycemia; consider antidiabetic medication or dose adjustment.

Serum Electrolytes (especially Potassium)

Frequency: Periodically, especially with concomitant diuretic use or high doses (e.g., monthly).

Target: K: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia; consider potassium supplementation or dose adjustment.

Weight

Frequency: Monthly.

Target: Stable weight

Action Threshold: Significant or rapid weight gain; assess for fluid retention or increased appetite.

Ophthalmologic Exam (for long-term use)

Frequency: Annually for patients on prolonged therapy (>6 months).

Target: No cataracts or glaucoma

Action Threshold: Development of cataracts or increased intraocular pressure; refer to ophthalmologist.

Bone Mineral Density (BMD)

Frequency: Every 1-2 years for patients on prolonged therapy.

Target: Stable BMD, T-score >-2.5

Action Threshold: Significant bone loss or osteoporosis; consider bisphosphonates or other bone-sparing agents.

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Symptom Monitoring

  • Signs of infection (fever, chills, sore throat, unusual fatigue, non-healing wounds)
  • Gastrointestinal symptoms (abdominal pain, black/tarry stools, heartburn)
  • Mood changes (irritability, anxiety, depression, euphoria)
  • Sleep disturbances (insomnia)
  • Fluid retention (swelling in ankles/feet, sudden weight gain)
  • Muscle weakness or pain
  • Skin changes (thinning, bruising, acne)
  • Visual disturbances
  • Symptoms of adrenal insufficiency upon withdrawal (fatigue, weakness, nausea, vomiting, hypotension, joint/muscle pain)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids cross the placenta. Observational studies suggest a possible increased risk of oral clefts with first-trimester use, though data are inconsistent. Fetal growth restriction and adrenal suppression in the neonate have been reported with prolonged or high-dose use.

Trimester-Specific Risks:

First Trimester: Possible increased risk of oral clefts (controversial data).
Second Trimester: Generally considered safer than first or third, but still monitor for fetal growth.
Third Trimester: Risk of fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism.
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Lactation

L3 (Moderately safe). Prednisolone is excreted into breast milk in small amounts. Low doses (e.g., <20 mg/day) are generally considered compatible with breastfeeding. For higher doses, consider waiting 4 hours after the dose before breastfeeding to minimize infant exposure.

Infant Risk: Low risk of adverse effects with typical doses. Monitor infant for signs of adrenal suppression (e.g., poor weight gain, irritability) or other side effects, though unlikely.
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Pediatric Use

Long-term use in children can cause growth retardation, delayed weight gain, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Monitor growth and development closely. Alternate-day therapy may minimize growth suppression. Increased risk of intracranial hypertension in children.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects, including osteoporosis, fluid retention, hypertension, diabetes, and skin thinning. Use the lowest effective dose for the shortest duration possible. Monitor closely for side effects.

Clinical Information

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Clinical Pearls

  • Prednisolone ODT (Orally Disintegrating Tablet) is useful for patients who have difficulty swallowing pills, such as children or elderly patients.
  • Always advise patients not to stop prednisolone suddenly, especially after prolonged use, due to the risk of adrenal insufficiency. A gradual tapering schedule is essential.
  • Administer with food or milk to minimize gastrointestinal upset.
  • Patients on long-term corticosteroid therapy should be monitored for bone density, blood glucose, blood pressure, and signs of infection.
  • Consider prophylactic measures for osteoporosis (calcium, vitamin D, bisphosphonates) in patients on long-term therapy.
  • Immunosuppression is a significant risk; advise patients to avoid exposure to infections and report any signs of illness promptly.
  • Mood changes (euphoria, depression, anxiety) are common side effects and should be discussed with patients and caregivers.
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Alternative Therapies

  • Other systemic corticosteroids (e.g., prednisone, methylprednisolone, dexamethasone, hydrocortisone)
  • Non-steroidal anti-inflammatory drugs (NSAIDs) for inflammatory conditions (less potent, different side effect profile)
  • Disease-modifying antirheumatic drugs (DMARDs) or biologics for chronic inflammatory/autoimmune conditions (e.g., methotrexate, adalimumab, etanercept)
  • Immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil) for severe autoimmune conditions (often used as steroid-sparing agents)
  • Antihistamines for allergic reactions (less potent)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (15mg ODT)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, 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.