Naproxen Sod 500mg ER Tablets

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic, anti-inflammatory, and antipyretic activities. Its mechanism of action is thought to be due to the inhibition of prostaglandin synthesis, primarily through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This reduces the formation of prostaglandin precursors, which are involved in pain, inflammation, 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, 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.
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, 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 weight gain, or swelling in the arms or legs.
Cardiovascular Issues: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological Issues: Trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
General Symptoms: Extreme fatigue or weakness, ringing in the ears, severe back pain, or 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 life-threatening, so seek medical help immediately if you experience any of these symptoms.
Severe Skin Reactions: These can include 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; 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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

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, contact 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 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, planning to become pregnant, or become pregnant while taking this medication. This drug may harm an unborn baby if taken at 20 weeks or later in 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.

Additionally, it is crucial to discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure that 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 the 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. This drug may also increase your risk of bleeding, so be cautious and avoid injuries. To minimize this risk, use a soft toothbrush and an electric razor.

The use of medications like this one 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. Additionally, 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 people taking this type of medication after a first heart attack were more likely to die within a 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 your doctor about the 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.

If you are 60 years 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, which can impact 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 you will need to discuss the potential risks to your baby.

• Aspirin (high-dose, for antiplatelet effect, due to increased GI risk)
• Other NSAIDs (due to increased risk of adverse effects)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin, Heparin) - increased bleeding risk
• Antiplatelet agents (e.g., Clopidogrel, Aspirin low-dose) - increased bleeding risk
• SSRIs/SNRIs - increased GI bleeding risk
• Lithium - increased lithium levels and toxicity
• Methotrexate - increased methotrexate levels and toxicity
• Diuretics (e.g., Furosemide, Thiazides) - reduced diuretic and antihypertensive effects, increased renal toxicity risk
• ACE Inhibitors/ARBs - reduced antihypertensive effect, increased risk of renal impairment
• Cyclosporine - increased nephrotoxicity
• Tacrolimus - increased nephrotoxicity
• Pemetrexed - increased myelosuppression, renal, and GI toxicity (avoid in patients with CrCl < 80 mL/min)

• Beta-blockers - reduced antihypertensive effect
• Hydantoins (e.g., Phenytoin) - increased phenytoin levels
• Sulfonylureas - increased hypoglycemic effect
• Probenecid - increased naproxen levels
• Cholestyramine - delayed naproxen absorption
• Corticosteroids - increased GI ulceration/bleeding risk

• Antacids - may delay absorption but not extent

• 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 body, slurred speech)
• Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Symptoms of liver injury (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Unexplained weight gain or edema
• Skin rash or blistering
• Vision changes

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

Naproxen is excreted into breast milk. While levels are generally low, the American Academy of Pediatrics considers it usually compatible with breastfeeding. However, due to the long half-life and potential for adverse effects in the infant (e.g., bleeding, renal effects), use with caution, especially in neonates or if high doses are used. Monitor infant for adverse effects.

The extended-release formulation is generally not recommended for pediatric patients. Safety and efficacy have not been established in children under 18 years of age for this formulation. Immediate-release naproxen is used in pediatric patients for certain conditions, but with specific dosing guidelines.

Elderly patients are at increased risk for serious adverse effects from NSAIDs, including gastrointestinal bleeding, cardiovascular 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 closely.

• Naproxen ER is dosed once daily, which can improve patient adherence compared to multiple daily dosing of immediate-release formulations.
• Always advise patients to take naproxen with food, milk, or antacids to minimize GI upset, despite the ER formulation.
• Educate patients about the black box warnings for cardiovascular and GI risks, and symptoms to watch for.
• 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).
• Avoid concomitant use with other NSAIDs, including OTC ibuprofen or aspirin (unless low-dose aspirin for cardioprotection, in which case separate dosing by at least 30 minutes before or 8 hours after naproxen).
• The long half-life of naproxen means that it takes longer to reach steady state and also longer for drug levels to decline after discontinuation, which is important for managing adverse effects or drug interactions.

• Other NSAIDs (e.g., Ibuprofen, Diclofenac, Celecoxib)
• Acetaminophen (for pain/fever without inflammation)
• Opioid analgesics (for severe pain, short-term use)
• Corticosteroids (for severe inflammation)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions (e.g., Methotrexate, biologics)
• Topical analgesics (e.g., topical NSAIDs, capsaicin, lidocaine patches)
• Physical therapy, heat/cold therapy, exercise

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. It is important 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 guidance.

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.