Dexamethasone Pho 4mg/ml Inj, 1ml

Manufacturer FRESENIUS KABI Active Ingredient Dexamethasone Injection Solution(deks a METH a sone) Pronunciation deks-a-METH-a-sone
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
Adrenal corticosteroid, Anti-inflammatory agent, Immunosuppressant
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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?

Dexamethasone is a type of steroid medicine that works by reducing inflammation (swelling and irritation) and calming down your body's immune system. It's used to treat many conditions, including severe allergies, asthma, arthritis, certain skin conditions, and some types of cancer. It can also help with swelling in the brain or to prevent nausea and vomiting from chemotherapy.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and follow all instructions provided. This medication is administered via injection.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Take exactly as prescribed; do not stop abruptly without consulting your doctor, as this can lead to serious withdrawal symptoms.
  • Take with food or milk to reduce stomach upset.
  • Avoid contact with people who are sick or have infections (e.g., chickenpox, measles) as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat, body aches) immediately.
  • Monitor blood sugar levels if you have diabetes, as this medication can increase them.
  • Limit sodium intake to help prevent fluid retention.
  • Ensure adequate calcium and vitamin D intake, especially with long-term use, to protect bone health.
  • Carry a steroid identification card or bracelet if on long-term therapy.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable depending on indication. Typical anti-inflammatory/immunosuppressive dose: 0.75-9 mg/day IV/IM, single or divided doses. Cerebral edema: Initial 10 mg IV, then 4 mg IM/IV every 6 hours. Antiemetic (chemotherapy-induced): 8-20 mg IV prior to chemotherapy. COVID-19: 6 mg IV/PO once daily for up to 10 days.
Dose Range: 0.75 - 20 mg

Condition-Specific Dosing:

Anti-inflammatory/Immunosuppressive: 0.75-9 mg/day IV/IM
Cerebral Edema: Initial 10 mg IV, then 4 mg IM/IV q6h
Chemotherapy-induced Nausea/Vomiting: 8-20 mg IV prior to chemotherapy
COVID-19: 6 mg IV/PO once daily for up to 10 days
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Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., bronchopulmonary dysplasia) may use 0.05-0.1 mg/kg/day in divided doses.
Infant: Anti-inflammatory/Immunosuppressive: 0.02-0.3 mg/kg/day or 0.6-9 mg/m2/day in 1-4 divided doses. Croup: 0.6 mg/kg IM/PO single dose (max 10 mg).
Child: Anti-inflammatory/Immunosuppressive: 0.02-0.3 mg/kg/day or 0.6-9 mg/m2/day in 1-4 divided doses. Croup: 0.6 mg/kg IM/PO single dose (max 10 mg).
Adolescent: Dosing similar to adult for specific indications, adjusted for weight/surface area if applicable.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required.
Dialysis: Not significantly dialyzable; no supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No specific dose adjustment, but use with caution.
Moderate: No specific dose adjustment, but use with caution; monitor for increased adverse effects.
Severe: No specific dose adjustment, but use with caution; monitor for increased adverse effects due to altered metabolism.

Pharmacology

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Mechanism of Action

Dexamethasone is a synthetic adrenocortical steroid that is approximately 25 times more potent than hydrocortisone and 5-10 times more potent than prednisone. It binds to specific intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus and modulates gene expression. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines). It also suppresses the immune system by inhibiting leukocyte migration, reducing lymphocyte activity, and decreasing antibody production.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV/IM); 80-90% (oral)
Tmax: 1-2 hours (oral)
FoodEffect: Food may slightly delay absorption but does not significantly affect extent of absorption.

Distribution:

Vd: 0.8 L/kg
ProteinBinding: Approximately 77% (primarily to albumin)
CnssPenetration: Yes (good penetration)

Elimination:

HalfLife: Plasma half-life: 3-4.5 hours; Biological half-life: 36-54 hours
Clearance: Approximately 2.8 mL/min/kg
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Rapid (IV); Anti-inflammatory effects may take hours to develop.
PeakEffect: Varies by indication; peak plasma levels within minutes (IV) to hours (oral).
DurationOfAction: Long (36-72 hours for biological effects due to prolonged tissue binding).

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 notice 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 low potassium levels: muscle pain or weakness, muscle cramps, or an abnormal heartbeat
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of adrenal gland problems: severe nausea and vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or belly, moon face, severe headache, or slow wound healing
Signs of high blood sugar: confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth
Abnormal heartbeat (fast, slow, or irregular)
Chest pain or pressure
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Changes in menstrual periods
Bone or joint pain
Muscle pain or weakness
Changes in vision
Changes in behavior or mood
Seizures
Unusual burning, numbness, or tingling sensations
Unexplained bruising or bleeding
Severe stomach pain
Black, tarry, or bloody stools, or vomiting blood or coffee ground-like material
Irritation at the injection site

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any others that bother you or don't go away, contact your doctor:

Nausea or vomiting
Trouble sleeping
Restlessness
Excessive sweating
Hair thinning
Headache
Dizziness, fatigue, or weakness
Weight gain
Increased appetite
* Hiccups

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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:

  • Signs of infection (fever, chills, severe sore throat, unusual body aches)
  • Severe stomach pain, black or tarry stools (signs of GI bleeding)
  • Unusual swelling of the face, hands, or ankles
  • Significant weight gain
  • Extreme fatigue or weakness
  • Blurred vision or eye pain
  • Severe mood changes (depression, anxiety, irritability, euphoria)
  • Increased thirst or urination (signs of high blood sugar)
  • Muscle weakness or cramps
  • Easy bruising or thinning skin
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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 affecting the eye
Stomach or bowel problems, including:
+ Diverticulitis
+ Ulcerative colitis
+ Ulcers
+ Recent bowel surgery

This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Be sure to inform your doctor and pharmacist about:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems, including those not listed above

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests, as directed by your doctor, are crucial to monitor your condition. Additionally, if you are taking this medication long-term, you may need to undergo eye pressure and bone density checks.

This medication can interfere with certain laboratory tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug. There is a risk of developing high blood pressure with medications like this one, so regular blood pressure checks, as advised by your doctor, are necessary.

This medication may also affect the results of allergy skin tests, so be sure to inform your doctor and laboratory workers that you are taking this medication. Long-term use of this medication may increase the risk of cataracts or glaucoma; discuss this with your doctor.

Prolonged use of this medication can lead to weak bones (osteoporosis), so talk to your doctor to determine if you are at higher risk or have any questions. You may need to reduce your salt intake and take potassium supplements; consult with your doctor about this. If you have diabetes, it is crucial to closely monitor your blood sugar levels.

Before consuming alcohol, discuss it with your doctor. Additionally, consult with your doctor before receiving any vaccinations, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

It is essential to be aware that chickenpox and measles can be severe or even fatal in individuals taking steroid medications like this one. Avoid close contact with people who have chickenpox or measles if you have not had these illnesses before. If you have been exposed to chickenpox or measles, inform your doctor immediately. Steroid medications, including this one, increase the risk of infection, which can be mild or severe, and even life-threatening. The risk of infection is higher with higher doses of steroids.

To minimize the risk of infection, wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and notify your doctor if you experience any signs of infection. Some infections, such as tuberculosis and hepatitis B, can reactivate in individuals taking medications like this one; inform your doctor if you have a history of these infections.

This medication can suppress the production of natural steroids in your body. If you experience fever, infection, surgery, or injury, inform your doctor, as your body's response to these stresses may be affected, and you may require additional steroid doses.

If you have been taking this medication for an extended period, consult with your doctor before stopping, as you may need to gradually taper off the medication. Inform your doctor 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.

Long-term use of this medication has been associated with an increased risk of Kaposi's sarcoma, a type of cancer; discuss this with your doctor. Patients with cancer may be at higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition; consult with your doctor about this.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. This medication can affect growth in children and adolescents; they may require regular growth checks. Inform your doctor if you have any concerns.

If you are allergic to sulfites, inform your doctor, as some products contain sulfites. Be aware that administering medications like this one into the spine (epidural) has been associated with severe health problems, including paralysis, loss of vision, stroke, and death. This medication is not approved for spinal administration; discuss this with your doctor.

This medication may lower sperm counts; if you have concerns, discuss this with your doctor. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks to you and your baby. If you took this medication during pregnancy, inform your baby's doctor.

It is crucial to follow your doctor's instructions and attend all scheduled appointments to ensure safe and effective use of this medication.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: fluid retention, hypertension, hyperglycemia, and electrolyte imbalances. Chronic overdose leads to Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, thin skin, muscle wasting).

What to Do:

There is no specific antidote. Treatment is supportive and symptomatic. In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • Live or live-attenuated vaccines (during immunosuppressive doses of dexamethasone)
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Major Interactions

  • CYP3A4 inducers (e.g., Phenytoin, Rifampin, Barbiturates, Carbamazepine, Ephedrine): May decrease dexamethasone levels and efficacy.
  • CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Erythromycin): May increase dexamethasone levels and risk of adverse effects.
  • NSAIDs (e.g., Ibuprofen, Naproxen): Increased risk of gastrointestinal ulceration and bleeding.
  • Anticoagulants (e.g., Warfarin): May alter anticoagulant effect (increase or decrease INR); monitor INR closely.
  • Diuretics (e.g., Thiazides, Loop diuretics): Increased risk of hypokalemia.
  • Antidiabetic agents (e.g., Insulin, Metformin): Dexamethasone can increase blood glucose, requiring dose adjustments of antidiabetics.
  • Cardiac Glycosides (e.g., Digoxin): Increased risk of digitalis toxicity due to hypokalemia.
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Moderate Interactions

  • Neuromuscular Blockers (e.g., Vecuronium, Pancuronium): Prolonged neuromuscular blockade, especially with high-dose corticosteroids.
  • Immunosuppressants (e.g., Cyclosporine): Increased blood levels of both drugs may occur; increased risk of seizures.
  • Fluoroquinolones (e.g., Ciprofloxacin): Increased risk of tendon rupture.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Blood Glucose

Rationale: Corticosteroids can induce hyperglycemia or worsen existing diabetes.

Timing: Prior to initiation

Serum Electrolytes (especially Potassium)

Rationale: Risk of hypokalemia due to mineralocorticoid effects.

Timing: Prior to initiation

Weight

Rationale: Fluid retention and weight gain are common side effects.

Timing: Prior to initiation

Signs of Infection

Rationale: Corticosteroids can mask signs of infection.

Timing: Prior to initiation

Bone Mineral Density (BMD)

Rationale: For long-term therapy, to assess osteoporosis risk.

Timing: Prior to initiation (if long-term therapy anticipated)

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Routine Monitoring

Blood Pressure (BP)

Frequency: Daily to weekly, then periodically

Target: Individualized, aim for normotensive

Action Threshold: Sustained elevation requiring intervention

Blood Glucose

Frequency: Daily to weekly, then periodically (more frequently in diabetics)

Target: Individualized, aim for euglycemia

Action Threshold: Persistent hyperglycemia requiring intervention

Serum Electrolytes (especially Potassium)

Frequency: Weekly initially, then periodically (especially with concomitant diuretics)

Target: Within normal limits

Action Threshold: Hypokalemia requiring supplementation

Weight

Frequency: Weekly

Target: Stable or as desired

Action Threshold: Significant, unexplained weight gain

Signs/Symptoms of Infection

Frequency: Continuously

Target: Absence of fever, localized pain, redness, swelling

Action Threshold: Presence of new or worsening signs of infection

Growth (Pediatric Patients)

Frequency: Periodically (e.g., every 3-6 months)

Target: Normal growth velocity for age

Action Threshold: Growth retardation

Ophthalmic Exam (for long-term use)

Frequency: Annually

Target: Absence of cataracts or glaucoma

Action Threshold: Development of cataracts or increased intraocular pressure

Adrenal Function (after withdrawal)

Frequency: As clinically indicated during and after tapering

Target: Normal cortisol response

Action Threshold: Signs/symptoms of adrenal insufficiency

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Symptom Monitoring

  • Fever
  • Sore throat
  • Unusual fatigue or weakness
  • Increased thirst or urination
  • Blurred vision
  • Swelling of ankles or feet
  • Unusual weight gain
  • Muscle weakness or pain
  • Mood changes (irritability, depression, euphoria)
  • Sleep disturbances
  • Stomach pain
  • Black, tarry stools
  • Easy bruising or thinning skin
  • Slow wound healing

Special Patient Groups

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Pregnancy

Dexamethasone is classified as Pregnancy Category C. Animal studies have shown adverse effects on the fetus, and there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Prolonged or repeated use during pregnancy may lead to fetal adrenal suppression, requiring monitoring of the neonate.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of oral clefts, though data are conflicting and overall risk is low.
Second Trimester: Risk of fetal growth restriction and adrenal suppression with prolonged use.
Third Trimester: Risk of fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism.
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Lactation

Dexamethasone is excreted into breast milk. The amount transferred is generally low, but potential for adverse effects on the infant (e.g., growth suppression, interference with endogenous corticosteroid production) exists, especially with high doses or prolonged use. The decision to breastfeed should consider the benefit of the drug to the mother, the risk of infant exposure, and the risk of untreated maternal condition. Short-term, low-dose use is generally considered compatible with breastfeeding, but caution is advised with higher doses or long-term therapy.

Infant Risk: L3 (Moderately Safe) for short-term, low-dose; L4 (Possibly Hazardous) for high-dose or long-term use. Monitor infant for signs of adrenal suppression (e.g., poor weight gain, irritability).
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Pediatric Use

Children are more susceptible to growth retardation and adrenal suppression with long-term corticosteroid therapy. Careful monitoring of growth and development is essential. Alternate-day therapy may reduce some adverse effects. Increased risk of intracranial hypertension in children.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects such as osteoporosis, hypertension, diabetes, fluid retention, and cataracts. Use the lowest effective dose for the shortest duration possible. Close monitoring for adverse effects is recommended.

Clinical Information

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Clinical Pearls

  • Dexamethasone has a long biological half-life (36-54 hours), allowing for once-daily dosing or alternate-day therapy for many indications.
  • Due to its potent glucocorticoid activity and minimal mineralocorticoid effects, it is often preferred when fluid retention is undesirable.
  • Abrupt discontinuation after prolonged therapy can lead to adrenal insufficiency; always taper the dose gradually.
  • Can mask signs and symptoms of infection, making diagnosis challenging.
  • The sodium phosphate ester formulation allows for rapid onset of action via IV/IM administration.
  • Patients on long-term therapy should be advised to carry a steroid identification card.
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Alternative Therapies

  • Other systemic corticosteroids (e.g., Prednisone, Methylprednisolone, Hydrocortisone)
  • NSAIDs (for inflammatory conditions, if appropriate)
  • Specific immunosuppressants (e.g., Methotrexate, Azathioprine, Biologics) depending on the underlying autoimmune or inflammatory condition.
  • Antihistamines (for allergic reactions)
  • Bronchodilators (for asthma exacerbations)
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Cost & Coverage

Average Cost: Highly variable, typically low per vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your prescription medications with others, and do not take medications prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional or pharmacist, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure prompt and effective treatment.