Celecoxib 400mg Capsules

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that selectively inhibits cyclooxygenase-2 (COX-2). COX-2 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 exerting anti-inflammatory, analgesic, and antipyretic effects, while theoretically sparing COX-1 mediated functions (e.g., gastric protection, platelet aggregation) to a greater extent than non-selective NSAIDs.

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:

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. 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 Issues: Chest pain or pressure.
Neurological Issues: Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
General Weakness: Feeling extremely tired or weak.
Flu-like Symptoms: Unusual fatigue, fever, or body aches.
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 it's essential to seek medical help right away if you experience any of these symptoms.
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe reactions can occur, potentially affecting internal organs. Seek medical help immediately 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

While many people may not experience side effects or only have mild ones, it's essential to be aware of the following potential side effects:

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

If any of these side effects bother you or persist, contact your doctor for guidance. This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice and guidance on managing side effects.

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. Describe the allergic reaction and its symptoms.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A sulfa allergy.
A history of nasal polyps or swelling of the mouth, face, lips, tongue, or throat, unusual hoarseness, or trouble breathing after taking aspirin or NSAIDs.
Certain health conditions, including:
+ Dehydration
+ Gastrointestinal (GI) bleeding
+ Heart failure (weak heart)
+ Kidney disease
+ Liver disease
Recent heart attack.
Fertility issues or if you are undergoing fertility evaluation.
Pregnancy, planned pregnancy, or pregnancy during treatment. This medication 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 under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

Additionally, inform your doctor about:

Concurrent use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
All prescription and over-the-counter (OTC) medications, natural products, and vitamins you are taking.

It is crucial to review your entire medication regimen and health history with your doctor and pharmacist to ensure safe treatment. Do not initiate, stop, or adjust the dose 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.

High blood pressure is a potential side effect of this medication. Follow your doctor's instructions for checking your blood pressure regularly. Additionally, discuss your alcohol consumption with your doctor before drinking. If you smoke, talk to your doctor about the potential risks. Patients with asthma should also consult their doctor, as they may be more sensitive to this medication.

Adhere to the prescribed dosage and do not exceed the recommended amount, as this may increase your risk of severe side effects. Do not take this medication for longer than your doctor has instructed.

As this medication may affect your blood's ability to clot, you may bleed more easily. To minimize the risk of injury, be cautious and use a soft toothbrush and an electric razor.

The use of this medication may 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 this medication after a first heart attack were more likely to die within the following year compared to those not taking this medication. If you are taking aspirin to prevent heart attacks, consult your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Women of childbearing age should be aware that 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, consult your doctor to discuss any potential risks to your baby. When administering this medication to children, use caution, as there is a risk of disseminated intravascular coagulation (DIC) in children with juvenile rheumatoid arthritis (JRA). Consult your doctor to discuss the potential risks and benefits.

• Warfarin (increased bleeding risk, monitor INR closely)
• Lithium (increased lithium plasma concentrations, monitor lithium levels)
• Methotrexate (increased methotrexate plasma concentrations, monitor for toxicity)
• ACE Inhibitors/Angiotensin Receptor Blockers (ARBs) (reduced antihypertensive effect, increased risk of renal impairment)
• Diuretics (e.g., Furosemide, Thiazides) (reduced natriuretic and diuretic effects)
• Pemetrexed (increased pemetrexed toxicity in patients with renal impairment)

• Fluconazole (CYP2C9 inhibitor, significantly increases celecoxib plasma concentrations; reduce celecoxib dose by 50%)
• Rifampin (CYP2C9 inducer, may decrease celecoxib plasma concentrations)
• Dextromethorphan (CYP2D6 substrate, celecoxib is a moderate CYP2D6 inhibitor, may increase dextromethorphan levels)
• Antacids (may reduce celecoxib absorption, separate administration)
• Aspirin (increased risk of GI adverse events, celecoxib does not substitute for aspirin in CV prophylaxis)

• Not many clinically significant minor interactions reported.

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe stomach pain)
• Signs of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of liver injury (e.g., jaundice, dark urine, fatigue, flu-like symptoms)
• Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet)
• Skin reactions (e.g., rash, blistering, peeling skin)
• Unusual bruising or bleeding
• Swelling (edema)

Use of NSAIDs, including celecoxib, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios. Therefore, celecoxib is contraindicated in the third trimester. Use in the first and second trimesters should only be considered if the potential benefit justifies the potential risk to the fetus.

Low levels of celecoxib are excreted into breast milk. While the risk to a nursing infant appears low, use with caution. Monitor the infant for potential adverse effects such as gastrointestinal upset (e.g., diarrhea, vomiting) or rash.

Approved for Juvenile Idiopathic Arthritis (JIA) in children 2 years of age and older. Dosing is weight-based. Safety and efficacy in children younger than 2 years have not been established.

Elderly patients are at increased risk for serious adverse events associated with NSAIDs, including gastrointestinal bleeding, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration necessary. Monitor closely for adverse effects.

• Celecoxib is a selective COX-2 inhibitor, which theoretically offers a lower risk of serious GI adverse events compared to non-selective NSAIDs, but this risk is still present and can be serious.
• Despite its COX-2 selectivity, celecoxib carries a black box warning for cardiovascular thrombotic events (MI, stroke) and serious GI adverse events (bleeding, ulceration, perforation).
• Celecoxib is not a substitute for aspirin for cardiovascular prophylaxis. Patients requiring aspirin for antiplatelet effect should continue aspirin therapy.
• Consider co-administration with a proton pump inhibitor (PPI) or misoprostol for patients at high risk of GI complications (e.g., history of ulcer, concomitant corticosteroid or anticoagulant use).
• Monitor blood pressure regularly, as NSAIDs can cause new-onset hypertension or worsen existing hypertension.
• Avoid use in patients with severe heart failure, advanced renal disease, or severe hepatic impairment.
• Patients with a history of aspirin-sensitive asthma should not take celecoxib due to the risk of bronchospasm.

• Other NSAIDs (e.g., ibuprofen, naproxen, diclofenac, meloxicam)
• Acetaminophen (for pain and fever, but not inflammation)
• Opioid analgesics (for severe pain, short-term use)
• Corticosteroids (for severe inflammation, short-term use)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions like rheumatoid arthritis (e.g., methotrexate, biologics)
• Topical NSAIDs (e.g., diclofenac gel) for localized pain
• Physical therapy, exercise, heat/cold therapy, acupuncture (non-pharmacological approaches)

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 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 seeking help, be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.