Celecoxib 50mg 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 spares COX-1, which is constitutively expressed and involved in maintaining gastrointestinal mucosal integrity and platelet function.

Urgent Side Effects: Seek Medical Help Immediately

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 right away:

Allergic reactions: Rash, hives, itching, redness, swelling, blistering, or peeling skin with or without fever; wheezing; tightness in the chest or throat; difficulty breathing, swallowing, or speaking; 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; coffee ground-like vomit; blood in the urine; black, red, or tarry stools; gum bleeding; 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 changes, facial drooping, or blurred vision.
General weakness: 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 affect internal organs and be life-threatening. Seek medical help right away if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; mouth, throat, nose, eye, genital, or skin sores; 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:

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, consult 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 can also provide medical advice 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 and allergies before starting this medication:

Any known allergies to this drug, its components, or other substances, including foods and medications. Describe the allergic reaction and its symptoms.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
Sulfa allergies.
A history of nasal polyps or swelling of the mouth, face, lips, tongue, or throat, unusual hoarseness, or breathing difficulties when 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 ongoing fertility evaluation.

Pregnancy and Breastfeeding Considerations:

If you are pregnant, plan to become pregnant, or become pregnant while taking this medication, inform your doctor. This medication may harm an unborn baby if taken after 20 weeks of pregnancy.
Between 20 to 30 weeks of pregnancy, 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.

Medication Interactions:

Inform your doctor if you are taking any other NSAID, a salicylate drug like aspirin, or pemetrexed.
This is not an exhaustive list of interacting medications and health conditions.

Sharing Your Medical History and Current Medications:

Provide your doctor and pharmacist with a comprehensive list of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Discuss all your health problems with your doctor.
Ensure it is safe to take this medication with your existing medications and health conditions.
Do not start, stop, or change 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.

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 it with your doctor, as it may interact with your medication. If you smoke, talk to your doctor about the potential risks. Additionally, if you have asthma, consult your doctor, as you may be more sensitive to this medication.

It is crucial to follow your doctor's instructions regarding dosage and duration of treatment. Taking more than the prescribed amount or using it 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 this with your doctor.

People who have had a recent heart attack and are taking medications like this one may have a higher risk of heart attack and heart-related death. Additionally, research has shown that individuals taking this type of medication after a first heart attack were more likely to die within a year compared to those not taking it. Talk to your doctor about these risks.

If you are taking aspirin to prevent heart attacks, inform your doctor, as this may affect your treatment plan.

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 NSAIDs like this medication may affect ovulation, potentially impacting fertility. However, this effect is reversible when the medication is stopped. Discuss this 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 it with caution, especially in those with juvenile rheumatoid arthritis (JRA), as there is a risk of a rare blood condition called disseminated intravascular coagulation (DIC). Your doctor will help you weigh the benefits and risks of using this medication in children.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Warfarin and other oral anticoagulants (increased bleeding risk)
• Lithium (increased lithium levels and toxicity)
• Methotrexate (increased methotrexate levels and toxicity)
• ACE inhibitors/ARBs (reduced antihypertensive effect, increased renal impairment risk)
• Diuretics (reduced diuretic and antihypertensive effect, increased renal impairment risk)
• Fluconazole (significant increase in celecoxib plasma concentrations)
• Pemetrexed (increased pemetrexed exposure and toxicity)
• Cyclosporine (increased nephrotoxicity)

• Dextromethorphan (increased dextromethorphan exposure)
• Beta-blockers (reduced antihypertensive effect)
• SSRIs/SNRIs (increased bleeding risk)
• Corticosteroids (increased GI ulceration/bleeding risk)
• Antiplatelet agents (e.g., aspirin, clopidogrel) (increased bleeding risk)
• Digoxin (increased digoxin levels)

• Antacids (may reduce absorption, but not clinically significant)

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

Avoid use during pregnancy, especially during the third trimester due to the risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension of the newborn. 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 human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother and the potential adverse effects on the infant. L3 (Moderately Safe) per Hale's Lactation Risk Category, but caution is advised.

Approved for Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older. Dosing is weight-based. Safety and efficacy in children younger than 2 years have not been established. Increased risk of adverse events in children with systemic onset JIA.

Elderly patients are at a greater risk for serious cardiovascular, gastrointestinal, and renal adverse events. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects.

• Celecoxib is a COX-2 selective NSAID, which may offer a lower risk of serious GI adverse events compared to non-selective NSAIDs, but it still carries these risks, especially at higher doses or in susceptible patients.
• Despite COX-2 selectivity, celecoxib carries a Black Box Warning for cardiovascular thrombotic events, similar to non-selective NSAIDs. This risk is dose- and duration-dependent.
• Always use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Patients with a history of cardiovascular disease, hypertension, or renal impairment require careful monitoring.
• Advise patients to report any signs of GI bleeding, cardiovascular events, or allergic reactions immediately.
• Celecoxib is contraindicated in patients with a history of aspirin-sensitive asthma or other NSAID-induced allergic reactions.
• The 50mg capsule strength is less common but can be useful for dose titration or for patients requiring lower doses, especially in the elderly or those with mild-moderate hepatic impairment.

• Other NSAIDs (e.g., ibuprofen, naproxen, diclofenac, meloxicam)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, different mechanism, higher risk profile)
• Topical NSAIDs (e.g., diclofenac gel)
• Corticosteroids (for severe inflammation, different mechanism, significant side effects)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions (e.g., methotrexate, biologics)
• Physical therapy, exercise, heat/cold therapy (non-pharmacological)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.