Naproxen Sod 500mg CR Tablets

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. Its mechanism of action, like that of other NSAIDs, is believed 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 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 immediately or seek emergency 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, numbness or 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 or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological Issues: Difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Extreme Fatigue: Feeling very tired or weak.
Other Symptoms: Ringing in the ears, severe back pain, or flu-like symptoms.

Liver Problems: This medication can cause liver damage, which may be fatal. If you experience any of the following symptoms, contact your doctor immediately: dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin and eyes.

Severe Skin Reactions: This medication can cause life-threatening skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions. If you notice any of the following symptoms, seek medical help right away: 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 Side Effects

Most people do not experience severe side effects, but some may occur. If you notice any of the following symptoms, contact your doctor if they bother you or do not go away:

Stomach pain or heartburn
Upset stomach
Constipation
Dizziness or headache
* Drowsiness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 another NSAID, a salicylate medication like aspirin, or pemetrexed.
If you are having difficulty getting pregnant or undergoing fertility testing.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. 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.

Additionally, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Share information about your health problems to ensure it is safe 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.

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.

This medication may interfere with certain laboratory tests, so be sure to notify all your healthcare providers and lab personnel that you are taking it. There is a risk of developing high blood pressure with this type of medication, 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 potential interactions between smoking and 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 may increase your risk of severe side effects.

If you have asthma, consult with 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 injury, 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 heart failure. This may lead to a higher risk 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 be at a higher risk of heart attack and heart-related death when taking this type of medication. In fact, studies have shown that people taking drugs like this one after a first heart attack were more likely to die in the following year compared to those not taking these medications.

If you are taking aspirin to prevent heart attacks, consult with 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 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. If you are breastfeeding, discuss the potential risks to your baby with your doctor.

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

• Anticoagulants (e.g., Warfarin, Heparin, Dabigatran, Rivaroxaban): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel, Ticagrelor): Increased risk of bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Diuretics (e.g., Furosemide, Thiazides): Reduced natriuretic and antihypertensive effects, potential for renal impairment.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
• Cyclosporine: Increased nephrotoxicity.
• Tacrolimus: Increased nephrotoxicity.

• Beta-blockers: Reduced antihypertensive effect.
• Hydantoins (e.g., Phenytoin): Increased plasma concentrations of hydantoins.
• Sulfonylureas: Increased hypoglycemic effect.
• Probenecid: Increased naproxen plasma concentrations and half-life.
• Cholestyramine: May delay naproxen absorption.
• Corticosteroids: Increased risk of GI ulceration and bleeding.

• Antacids: May delay absorption but generally not clinically significant.

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs 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)
• Signs of liver injury (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Unexplained weight gain or edema
• New onset or worsening hypertension
• Severe skin reactions (e.g., rash, blistering, peeling skin)

Use should be avoided during pregnancy, especially in the third trimester, due to potential risks to the fetus (e.g., premature closure of the ductus arteriosus, renal dysfunction). Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.

Naproxen is excreted in breast milk in small amounts. While the amount is generally considered low, potential adverse effects on the infant are possible. Use with caution, or consider alternative analgesics, especially for long-term use or in preterm infants.

Safety and effectiveness of naproxen modified-release tablets have not been established in pediatric patients under 18 years of age. Immediate-release naproxen formulations may be used in children for specific conditions under medical supervision.

Elderly patients are at increased risk for serious adverse reactions to NSAIDs, including gastrointestinal bleeding, ulceration, and perforation, as well as renal impairment and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects.

• Naproxen sodium CR is designed for once-daily dosing, which can improve patient adherence compared to multiple daily doses of immediate-release formulations.
• Always advise patients to take NSAIDs with food or milk to minimize GI upset, even with CR formulations.
• Educate patients about the black box warnings, particularly the signs of GI bleeding and cardiovascular events, and when to seek immediate medical attention.
• Consider proton pump inhibitors (PPIs) or H2-receptor antagonists for patients at high risk of GI complications (e.g., history of ulcers, concomitant corticosteroid or anticoagulant use).
• Regular monitoring of blood pressure, renal function, and CBC is crucial, especially in elderly patients or those on long-term therapy.
• Avoid concomitant use with other NSAIDs, including over-the-counter products, to prevent additive toxicity.
• Patients with a history of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs should not take naproxen due to the risk of severe, potentially fatal, anaphylactoid reactions.

• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Other NSAIDs (e.g., Ibuprofen, Celecoxib, Diclofenac, Meloxicam)
• Topical NSAIDs (e.g., Diclofenac gel, for localized pain)
• Corticosteroids (for severe inflammation, short-term use)
• Opioid analgesics (for severe pain, short-term use, with caution)
• Non-pharmacological therapies (e.g., RICE - Rest, Ice, Compression, Elevation; physical therapy, acupuncture, massage)

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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.