Celecoxib 200mg Capsules

Manufacturer GREENSTONE Active Ingredient Celecoxib Capsules(se le KOKS ib) Pronunciation se le KOKS ib
WARNING: This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using this drug and may be greater with higher doses or long-term use. Do not use this drug right before or after bypass heart surgery.This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. @ COMMON USES: It is used to ease pain and swelling. It is used to treat arthritis.It is used to ease painful period (menstrual) cycles.It is used to treat ankylosing spondylitis.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Nonsteroidal Anti-inflammatory Drug (NSAID)
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Pharmacologic Class
Cyclooxygenase-2 (COX-2) Selective Inhibitor
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Pregnancy Category
Not available
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FDA Approved
Dec 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Celecoxib is a medicine called a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking a specific enzyme in your body called COX-2, which helps reduce pain, swelling, and fever. It's often used to treat conditions like arthritis, menstrual pain, and other types of acute pain.
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How to Use This Medicine

Taking Your Medication

To take this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food. Always take it with a full glass of water.

If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce. However, do not chew the mixture. The applesauce should be at room temperature, not warm. Do not mix the medication with any other liquids or foods. After mixing, take the dose immediately or store it in the refrigerator for up to 6 hours.

Storing and Disposing of Your Medication

Store this 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. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

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 the missed one.
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Lifestyle & Tips

  • Take with food or milk if stomach upset occurs.
  • Avoid alcohol, as it can increase the risk of stomach problems.
  • Do not take other NSAIDs (like ibuprofen, naproxen) or aspirin (unless directed by your doctor) while taking celecoxib, as this can increase side effects.
  • Stay hydrated, especially if you have kidney problems.
  • Report any signs of bleeding (black stools, vomiting blood) or heart problems (chest pain, shortness of breath) immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: 200 mg once daily or 100 mg twice daily for osteoarthritis; 100-200 mg twice daily for rheumatoid arthritis; 400 mg initially, then 200 mg if needed on first day, then 200 mg twice daily for acute pain/dysmenorrhea; 400 mg once daily for ankylosing spondylitis
Dose Range: 100 - 400 mg

Condition-Specific Dosing:

osteoarthritis: 200 mg once daily or 100 mg twice daily
rheumatoidArthritis: 100-200 mg twice daily
acutePain: 400 mg initially, then 200 mg if needed on first day, then 200 mg twice daily
dysmenorrhea: 400 mg initially, then 200 mg if needed on first day, then 200 mg twice daily
ankylosingSpondylitis: 400 mg once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Juvenile Idiopathic Arthritis (JIA): 10-25 kg: 50 mg twice daily; >25 kg: 100 mg twice daily
Adolescent: Juvenile Idiopathic Arthritis (JIA): 10-25 kg: 50 mg twice daily; >25 kg: 100 mg twice daily
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: Use with caution, monitor renal function
Severe: Not recommended (CrCl < 30 mL/min)
Dialysis: Not recommended

Hepatic Impairment:

Mild: No adjustment needed (Child-Pugh Class A)
Moderate: Reduce dose by 50% (Child-Pugh Class B); maximum 200 mg/day
Severe: Not recommended (Child-Pugh Class C)

Pharmacology

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Mechanism of Action

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that selectively inhibits cyclooxygenase-2 (COX-2). COX-2 is induced by inflammatory stimuli and is responsible for the synthesis of prostaglandins, which are mediators of pain, inflammation, and fever. By selectively inhibiting COX-2, celecoxib reduces prostaglandin synthesis, thereby alleviating symptoms of inflammation and pain, while theoretically sparing COX-1 mediated functions (e.g., gastric protection, platelet aggregation) to a greater extent than non-selective NSAIDs.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (well-absorbed)
Tmax: 3 hours
FoodEffect: Food (high-fat meal) delays Tmax by 1-2 hours and increases AUC by 10-20%.

Distribution:

Vd: Approximately 400 L
ProteinBinding: Approximately 97% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 11 hours
Clearance: Not available
ExcretionRoute: Fecal (57%), Urinary (27%)
Unchanged: Less than 3% (feces and urine)
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Pharmacodynamics

OnsetOfAction: Within 60 minutes (for acute pain)
PeakEffect: 2-4 hours
DurationOfAction: Up to 24 hours (dose-dependent)

Safety & Warnings

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BLACK BOX WARNING

CARDIOVASCULAR THROMBOTIC EVENTS: NSAIDs, including celecoxib, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. GASTROINTESTINAL RISK: NSAIDs, including celecoxib, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
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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 immediate medical attention:

Allergic reactions: 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. In rare cases, allergic reactions can be life-threatening.
Bleeding: Vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrolled bleeding.
Kidney problems: Inability to urinate, changes in urine output, blood in the urine, or sudden significant weight gain.
High potassium levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
High blood pressure: Severe headache or dizziness, fainting, or changes in vision.
Respiratory issues: Shortness of breath, sudden significant weight gain, or swelling in the arms or legs.
Cardiovascular concerns: Chest pain or pressure.
Neurological symptoms: Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
General weakness: Feeling extremely tired or weak.
Flu-like symptoms.
Liver problems: Dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin and eyes. Liver problems can be fatal, so seek medical help immediately if you experience these symptoms.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions can occur, potentially affecting internal organs and being life-threatening. Seek medical help right away if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:

Constipation, diarrhea, stomach pain, nausea, or vomiting.
Heartburn.
Gas.
Dizziness or headache.
Common cold symptoms.
Nose or throat irritation.

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

  • Chest pain, shortness of breath, sudden weakness or numbness on one side of the body, slurred speech (signs of heart attack or stroke)
  • Severe stomach pain, black or tarry stools, vomiting blood (signs of stomach bleeding)
  • Sudden weight gain, swelling in your arms or legs (signs of fluid retention or heart problems)
  • Skin rash, blistering, peeling skin, fever, sore throat (signs of severe skin reaction)
  • Yellowing of skin or eyes, dark urine, nausea, vomiting, unusual tiredness (signs of liver problems)
  • Decreased urination, swelling in feet or ankles (signs of kidney problems)
  • Allergic reactions like hives, difficulty breathing, swelling of face/lips/tongue/throat
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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:
+ Allergy to this medication or any of its components
+ Allergy to other medications, foods, or substances, and the symptoms you experienced
+ Allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
+ Sulfa allergy
If you have ever had:
+ Nasal polyps or swelling of the mouth, face, lips, tongue, or throat
+ Unusual hoarseness or trouble breathing after taking aspirin or NSAIDs
If you have any of the following health conditions:
+ Dehydration
+ Gastrointestinal (GI) bleeding
+ Heart failure (weak heart)
+ Kidney disease
+ Liver disease
+ Recent heart attack
If you are experiencing fertility issues or undergoing fertility testing
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. It is crucial to note that:
+ This medication may harm an unborn baby if taken at 20 weeks or later in pregnancy
+ If you are between 20 to 30 weeks pregnant, only take this medication if your doctor has instructed you to do so
+ Do not take this medication if you are more than 30 weeks pregnant
If you are currently taking any other NSAID, a salicylate drug like aspirin, or pemetrexed

To ensure your safety, it is vital to inform your doctor and pharmacist about:

All medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins
Any health problems you have

Do not start, stop, or change the dose of any medication without consulting your doctor to confirm that it is safe to do so. This list is not exhaustive, and your doctor and pharmacist need to be aware of all your medications and health conditions to provide proper guidance.
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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. If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition.

You should also have your blood pressure checked regularly, as medications like this one can cause high blood pressure. Your doctor will advise you on how often to have your blood pressure checked.

Before consuming alcohol, discuss the potential risks with your doctor. If you smoke, talk to your doctor about the potential interactions with this medication. Additionally, if you have asthma, consult with your doctor, as you may be more sensitive to this drug.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended dose can increase your chances of experiencing adverse effects. Furthermore, do not take this medication for longer than the duration specified by your doctor.

As this medication can affect blood clotting, you may be more prone to bleeding. To reduce the risk of injury, be cautious and use a soft toothbrush and an electric razor.

The use of medications like this one can increase the risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss these potential risks with your doctor.

In people who have recently experienced a heart attack, the use of medications like this one can increase the risk of another heart attack and heart-related death. Additionally, individuals taking this medication after a first heart attack may have a higher risk of death within the following year compared to those not taking this medication. Talk to your doctor about these potential risks.

If you are taking aspirin to prevent a heart attack, consult with your doctor about the potential interactions with this medication.

Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like this medication may affect ovulation, which can impact fertility. However, this effect is reversible when the medication is stopped. Discuss the potential risks with your doctor.

If you are breastfeeding, inform your doctor, as they will need to assess the potential risks to your baby.

When administering this medication to children, use caution, as there is a risk of disseminated intravascular coagulation (DIC), a blood disorder, in children with juvenile rheumatoid arthritis (JRA). Consult with your doctor to discuss the potential risks and benefits.
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Overdose Information

Overdose Symptoms:

  • Lethargy
  • Drowsiness
  • Nausea
  • Vomiting
  • Epigastric pain
  • GI bleeding
  • Rarely: hypertension, acute renal failure, respiratory depression, coma

What to Do:

There is no specific antidote. Management is supportive and symptomatic. Consider emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or an osmotic cathartic in symptomatic patients seen within 4 hours of ingestion or following a large overdose. Call 1-800-222-1222 (Poison Control Center).

Drug Interactions

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Contraindicated Interactions

  • Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
  • History of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs
  • Known hypersensitivity to celecoxib or sulfonamides
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Major Interactions

  • Warfarin (increased bleeding risk)
  • Lithium (increased lithium levels)
  • Methotrexate (increased methotrexate toxicity)
  • Pemetrexed (increased pemetrexed toxicity)
  • Fluconazole (increased celecoxib levels)
  • ACE inhibitors/ARBs (reduced antihypertensive effect, increased renal impairment risk)
  • Diuretics (reduced diuretic effect, increased renal impairment risk)
  • Other NSAIDs or aspirin (increased GI and renal adverse effects)
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Moderate Interactions

  • Cyclosporine (increased nephrotoxicity)
  • Tacrolimus (increased nephrotoxicity)
  • Dextromethorphan (increased dextromethorphan levels)
  • Beta-blockers (reduced antihypertensive effect)
  • SSRIs/SNRIs (increased bleeding risk)
  • Corticosteroids (increased GI bleeding risk)
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Minor Interactions

  • Antacids (may decrease celecoxib absorption, but not clinically significant)

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To establish baseline and monitor for anemia or other hematologic abnormalities, especially with long-term use.

Timing: Prior to initiation

Renal Function (BUN, Creatinine, eGFR)

Rationale: To assess baseline renal function, as NSAIDs can cause renal impairment.

Timing: Prior to initiation

Liver Function Tests (ALT, AST)

Rationale: To assess baseline hepatic function, as NSAIDs can cause liver injury.

Timing: Prior to initiation

Blood Pressure (BP)

Rationale: To establish baseline, as NSAIDs can cause new onset hypertension or worsen pre-existing hypertension.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during the initial weeks of treatment and with dose changes

Target: Individualized, typically <130/80 mmHg

Action Threshold: Significant increase from baseline or sustained hypertension; consider dose reduction or alternative therapy.

Renal Function (BUN, Creatinine, eGFR)

Frequency: Periodically, especially in patients at risk for renal impairment (e.g., elderly, heart failure, diuretic use, pre-existing renal dysfunction)

Target: Within normal limits, stable

Action Threshold: Significant increase in creatinine or decrease in eGFR; consider dose reduction, discontinuation, or alternative therapy.

Liver Function Tests (ALT, AST)

Frequency: Periodically, especially with long-term use or if symptoms of liver dysfunction develop

Target: Within normal limits

Action Threshold: Significant elevation (e.g., >3x ULN); discontinue celecoxib.

Signs/Symptoms of GI Bleeding

Frequency: Continuously (patient education)

Target: Absence of symptoms

Action Threshold: Black, tarry stools; coffee-ground emesis; severe abdominal pain; discontinue celecoxib and seek immediate medical attention.

Signs/Symptoms of Fluid Retention/Edema

Frequency: Continuously (patient education)

Target: Absence of symptoms

Action Threshold: Significant swelling, weight gain; consider dose adjustment or discontinuation.

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Symptom Monitoring

  • Abdominal pain
  • Indigestion
  • Nausea
  • Vomiting
  • Black or tarry stools
  • Coffee-ground vomit
  • Unusual bruising or bleeding
  • Swelling of ankles, feet, or hands (edema)
  • Shortness of breath
  • Chest pain
  • Weakness or numbness on one side of the body
  • Slurred speech
  • Sudden vision changes
  • Skin rash, blistering, or peeling
  • Flu-like symptoms (fever, sore throat, body aches)
  • Unexplained weight gain
  • Yellowing of skin or eyes (jaundice)
  • Dark urine

Special Patient Groups

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Pregnancy

Avoid use during the third trimester of pregnancy due to risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Use during the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, potential for increased risk of miscarriage or congenital malformations (though evidence is conflicting and not definitively established for all NSAIDs).
Second Trimester: Limited data, potential for fetal renal dysfunction and oligohydramnios (reduced amniotic fluid) with prolonged use.
Third Trimester: Contraindicated from 30 weeks gestation due to risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
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Lactation

Low levels of celecoxib are excreted into breast milk. The American Academy of Pediatrics considers celecoxib to be compatible with breastfeeding. However, caution is advised, especially in nursing infants with underlying conditions or if long-term use is anticipated.

Infant Risk: Low risk. Monitor infant for adverse effects such as gastrointestinal upset (diarrhea, vomiting) or rash.
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Pediatric Use

Approved for Juvenile Idiopathic Arthritis (JIA) in patients 2 years and older. Use with caution and at the lowest effective dose for the shortest duration. Increased risk of adverse events in children compared to adults for some NSAIDs, though celecoxib data in JIA is generally favorable.

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Geriatric Use

Elderly patients are at greater risk for serious cardiovascular, gastrointestinal, and renal adverse events. Use the lowest effective dose for the shortest duration. Monitor renal function, blood pressure, and signs of GI bleeding closely.

Clinical Information

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Clinical Pearls

  • Celecoxib is a COX-2 selective NSAID, which theoretically carries a lower risk of GI side effects compared to non-selective NSAIDs, but it still carries a significant GI risk, especially in high-risk patients.
  • Despite COX-2 selectivity, celecoxib carries a similar cardiovascular thrombotic risk to non-selective NSAIDs, and is contraindicated in the peri-operative setting of CABG surgery.
  • Patients with a history of sulfonamide allergy should avoid celecoxib due to its sulfonamide moiety.
  • Always use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
  • Advise patients to report any signs of fluid retention, chest pain, shortness of breath, or unusual bleeding/bruising immediately.
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Alternative Therapies

  • Other NSAIDs (e.g., ibuprofen, naproxen, diclofenac, meloxicam)
  • Acetaminophen
  • Opioid analgesics (for severe pain, short-term use)
  • Topical NSAIDs
  • Corticosteroids (for inflammatory conditions, short-term)
  • Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions like RA, AS, JIA (e.g., methotrexate, biologics)
  • Physical therapy
  • Non-pharmacological pain management strategies
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Cost & Coverage

Average Cost: Varies widely, typically $10-$100+ per 30 capsules (200mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or 4 (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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.