Celecoxib 100mg Capsules

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. Its mechanism of action is believed to be due to inhibition of prostaglandin synthesis, primarily via selective inhibition of cyclooxygenase-2 (COX-2). COX-2 is induced by inflammatory stimuli and is responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Unlike non-selective NSAIDs, celecoxib has minimal inhibitory effect on COX-1 at therapeutic concentrations, which is involved in maintaining gastric mucosal integrity and platelet function.

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 uncontrollable bleeding.
Kidney problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
High potassium levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, 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 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 problems, drooping on one side of the face, or blurred vision.
Fatigue: Feeling extremely tired or weak.
Flu-like symptoms.
Liver problems: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes. Liver problems can be fatal, so seek medical help immediately if you experience any of these symptoms.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be 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 people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

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

This is not an exhaustive list of possible 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.

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. Describe the allergic reaction and its symptoms.
If you are allergic to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
If you have a sulfa allergy.
If you have experienced nasal polyps, swelling of the mouth, face, lips, tongue, or throat, unusual hoarseness, or breathing difficulties after taking aspirin or NSAIDs.
If you have any of the following health conditions: dehydration, gastrointestinal (GI) bleeding, heart failure (weak heart), kidney disease, or liver disease.
If you have recently had a heart attack.
If you are having trouble conceiving or undergoing fertility testing.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. This drug may harm an unborn baby if taken after 20 weeks of pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication if your doctor advises you to do so. Do not take this medication if you are more than 30 weeks pregnant.

Additionally, inform your doctor if you are taking:

Any other NSAID
A salicylate drug, such as aspirin
* Pemetrexed

This is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or modify the dosage of any medication without consulting your doctor.

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 long-term, 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.

It is crucial to follow your doctor's instructions regarding the dosage and duration of treatment. Taking more than the prescribed amount or using this medication for longer than recommended can increase your risk of severe side effects.

Be cautious when using this medication, as it may affect your blood's ability to clot, making you more prone to bleeding. To minimize this risk, use a soft toothbrush and an electric razor, and avoid injuries.

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 risks with your doctor.

Furthermore, people who have had a recent heart attack may have a higher risk of heart attack and heart-related death when taking this medication. In fact, studies have shown that individuals taking drugs like this one after a first heart attack were more likely to die within the year following the heart attack compared to those not taking this type of medication. Talk to your doctor about these potential risks.

If you are taking aspirin to prevent heart attacks, 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.

Women of childbearing age should be aware that NSAIDs like this medication may affect ovulation, potentially impacting fertility. However, this effect is reversible when the medication is stopped. Discuss any concerns 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, especially in those with juvenile rheumatoid arthritis (JRA), as there is a risk of a rare blood disorder called disseminated intravascular coagulation (DIC). Consult with your doctor to discuss the potential risks and benefits.

• 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, sulfonamides, or any component of the formulation

• Warfarin (increased risk of bleeding)
• ACE inhibitors/ARBs (reduced antihypertensive effect, increased risk of renal impairment)
• Diuretics (reduced natriuretic and antihypertensive effect)
• Lithium (increased lithium plasma levels)
• Methotrexate (increased methotrexate plasma levels and toxicity)
• Pemetrexed (increased pemetrexed toxicity)
• Fluconazole (CYP2C9 inhibitor, significantly increases celecoxib plasma levels)

• Dextromethorphan (CYP2D6 substrate, celecoxib is a weak inhibitor)
• Antacids (may decrease celecoxib absorption)
• Aspirin (increased risk of GI adverse events, no additional CV benefit)
• Other NSAIDs (increased risk of GI and other adverse events)
• Corticosteroids (increased risk of GI ulceration/bleeding)
• SSRIs/SNRIs (increased risk of GI bleeding)
• Cyclosporine (increased nephrotoxicity)

• Not available

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Symptoms of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal impairment (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Symptoms of liver injury (e.g., nausea, fatigue, lethargy, itching, jaundice, right upper quadrant tenderness, flu-like symptoms)
• Signs of allergic reactions (e.g., rash, hives, itching, swelling of face/lips/tongue/throat, difficulty breathing)
• Symptoms of fluid retention (e.g., swelling, weight gain)
• New onset or worsening hypertension

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

Celecoxib is excreted in breast milk in low concentrations. The American Academy of Pediatrics considers celecoxib to be compatible with breastfeeding. However, due to the potential for serious adverse reactions in breastfed infants (e.g., cardiovascular, renal effects), caution is advised, especially in preterm infants or those with underlying conditions. Monitor the infant for adverse effects.

Approved for Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older. Dosing is weight-based. Safety and efficacy in other pediatric conditions or in children younger than 2 years have not been established. Use with caution and monitor for adverse effects, similar to adults.

Elderly patients are at greater risk for serious adverse events from NSAIDs, including celecoxib, particularly gastrointestinal bleeding, cardiovascular thrombotic events, and renal impairment. Use the lowest effective dose for the shortest duration possible. Monitor renal function, blood pressure, and for signs of GI bleeding more frequently.

• Celecoxib is a COX-2 selective NSAID, which theoretically offers a lower risk of GI side effects compared to non-selective NSAIDs, but it still carries a Black Box Warning for GI bleeding and ulceration.
• Despite COX-2 selectivity, celecoxib carries a similar cardiovascular thrombotic risk to non-selective NSAIDs. It is contraindicated in the peri-operative setting of CABG surgery.
• Patients with a history of sulfonamide allergy should generally avoid celecoxib due to its sulfonamide moiety, although cross-reactivity is not definitively established.
• Always use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Monitor blood pressure, renal function, and signs of GI or CV adverse events, especially in high-risk populations (elderly, pre-existing conditions).

• Other NSAIDs (e.g., ibuprofen, naproxen, diclofenac, meloxicam)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, with higher risk of side effects and dependence)
• Corticosteroids (for severe inflammation, with different side effect profile)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions like RA/AS
• Topical analgesics (e.g., topical NSAIDs, capsaicin, lidocaine)
• Non-pharmacological therapies (e.g., physical therapy, exercise, heat/cold therapy, acupuncture, massage)

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 and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information about its use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.

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 detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.