Naproxen 500mg Tablets

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic, anti-inflammatory, and antipyretic activities. Its mechanism of action is believed to be due to the reversible inhibition of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, which results in decreased synthesis of prostaglandins, key mediators of inflammation, pain, and fever.

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 Reaction: 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, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises, 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, fainting, numbness, tingling, or shortness of breath.
High Blood Pressure: Severe headache, 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, pressure, or rapid heartbeat.
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 Symptoms: Extreme fatigue, weakness, ringing in the ears, severe back pain, or flu-like symptoms.
Liver Problems: Dark urine, tiredness, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin and eyes. (Note: Liver problems can be life-threatening and have occurred with similar medications.)
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or other serious reactions, which can be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Most people taking this medication do not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Stomach pain or heartburn
Upset stomach
Constipation
Dizziness or headache
Drowsiness

This is not an exhaustive list of possible side effects. If you have concerns or questions 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. Be sure to 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 ever experienced asthma triggered by a salicylate medication, such as aspirin, or an NSAID.
If you have a history of gastrointestinal (GI) bleeding or kidney problems.
If you have heart failure (a weak heart) or have recently had a heart attack.
If you are currently taking any other NSAID, a salicylate drug like aspirin, or pemetrexed.
If you are having difficulty getting pregnant or are 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 after 20 weeks of pregnancy. If you are between 20 and 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.

To ensure your safety, it is vital to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.

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.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and lab personnel that you are taking this drug. There is a risk of developing high blood pressure with medications like this one, so your doctor may advise you to have your blood pressure checked regularly.

Before consuming alcohol, discuss the potential risks with your doctor. If you smoke, talk to your doctor about the possible effects on your health. It is vital to follow your doctor's instructions regarding dosage and duration of treatment. Taking more than the prescribed amount or using this medication for longer than recommended may increase your risk of severe side effects.

If you have asthma, consult your doctor, as you may be more sensitive to this medication. Additionally, this drug may affect your blood's ability to clot, making you more prone to bleeding. To minimize this risk, be careful to avoid injuries, use a soft toothbrush, and consider using an electric razor.

The use of medications like this one may increase the risk of heart failure, particularly in people who already have this condition. This can lead to a higher chance of heart attack, hospitalization for heart failure, and death. 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 type of medication. In fact, studies have shown that individuals taking drugs like this one after a first heart attack were more likely to die within a year compared to those not taking these medications.

If you are taking aspirin to prevent heart attacks, consult your doctor about potential interactions. If you are on a low-sodium or sodium-free diet, inform your doctor, as some formulations of this medication may contain sodium.

Older adults (60 years or 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 drug may affect ovulation, potentially impacting fertility. However, this effect is reversible when the medication is stopped. If you are breastfeeding, discuss the potential risks to your baby with your doctor.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• Severe renal impairment
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

• Anticoagulants (e.g., Warfarin, Heparin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of bleeding.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Cyclosporine: Increased nephrotoxicity.
• Tacrolimus: Increased nephrotoxicity.
• Diuretics (e.g., Furosemide, Thiazides): Reduced natriuretic effect, potential for renal impairment.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
• Digoxin: Increased digoxin plasma concentrations.
• Pemetrexed: Increased pemetrexed toxicity (avoid in patients with renal impairment).

• Beta-blockers: Reduced antihypertensive effect.
• Hydantoins (e.g., Phenytoin): Increased hydantoin levels.
• Sulfonylureas: Increased hypoglycemic effect.
• Probenecid: Increased naproxen plasma concentrations and half-life.
• Cholestyramine: May delay naproxen absorption.
• Antacids: May delay naproxen absorption.

• Not available

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

Avoid use during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and potential for renal dysfunction in the fetus, leading to oligohydramnios. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus, and at the lowest effective dose for the shortest duration possible.

Naproxen is excreted in breast milk in small amounts. The American Academy of Pediatrics considers naproxen to be compatible with breastfeeding. However, due to its long half-life, there is a theoretical risk of accumulation in the infant. Monitor the infant for adverse effects such as drowsiness, poor feeding, or gastrointestinal upset.

Not recommended for children under 2 years of age. For Juvenile Idiopathic Arthritis (JIA), dosing is weight-based (10 mg/kg/day in two divided doses, max 1000 mg/day). Use with caution and monitor for adverse effects, especially GI and renal.

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

• Naproxen has a longer half-life than ibuprofen, allowing for twice-daily dosing, which can improve adherence for chronic conditions.
• Always advise patients to take naproxen with food, milk, or antacids to minimize GI upset.
• Educate patients on the signs and symptoms of GI bleeding and cardiovascular events, emphasizing the black box warnings.
• Consider a proton pump inhibitor (PPI) or H2 blocker for patients at high risk of GI complications (e.g., history of ulcers, concomitant corticosteroid or anticoagulant use).
• Caution patients about the potential for fluid retention and elevated blood pressure, especially those with pre-existing cardiovascular conditions.
• Naproxen can interfere with low-dose aspirin's antiplatelet effect if taken concurrently. Advise patients to take naproxen at least 30 minutes after or 8 hours before immediate-release aspirin.

• Other NSAIDs (e.g., Ibuprofen, Diclofenac, Celecoxib)
• 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 rheumatoid arthritis (e.g., Methotrexate, Biologics)
• Topical NSAIDs (e.g., Diclofenac gel) for localized pain with less systemic exposure.

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 valuable resource 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, we encourage you to discuss them 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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.