Naproxen Sodium ER 375mg Tabs (24h)

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that exerts its anti-inflammatory, analgesic, and antipyretic effects by reversibly inhibiting cyclooxygenase (COX-1 and COX-2) enzymes. This inhibition leads to a reduction in the synthesis of prostaglandins, which are 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 immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of 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.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Chest pain or pressure, or a rapid heartbeat.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness.
Ringing in the ears.
Severe back pain.
Flu-like symptoms.
Liver problems: dark urine, fatigue, decreased appetite, nausea or stomach pain, pale-colored stools, vomiting, or yellowing of the skin or 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), and other serious reactions, which can affect internal organs and be life-threatening. Seek immediate medical help 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

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Stomach pain or heartburn.
Nausea or upset stomach.
Constipation.
Dizziness or headache.
* Drowsiness.

This is not an exhaustive list of possible side effects. If you have concerns 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. 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. 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 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.

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 this drug. There is a risk of developing high blood pressure with medications like this one, so your doctor may instruct 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 this medication 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. This drug may also increase your risk of bleeding, so it is essential to be cautious and avoid injury. 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, 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. 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 the following year compared to those not taking this medication.

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 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 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 with your doctor to discuss any potential risks to your baby.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• Ketorolac (concurrent use with 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.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Diuretics (e.g., furosemide, hydrochlorothiazide): Reduced natriuretic and diuretic effects, potential for renal impairment.
• ACE inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Pemetrexed: Increased pemetrexed toxicity (avoid in patients with renal impairment).

• Beta-blockers: Reduced antihypertensive effect.
• Cyclosporine: Increased risk of nephrotoxicity.
• Tacrolimus: Increased risk of nephrotoxicity.
• Digoxin: Increased digoxin plasma concentrations.
• Hydantoins (e.g., phenytoin): Increased hydantoin levels.
• Sulfonylureas: Increased hypoglycemic effect.
• Probenecid: Increased naproxen plasma concentrations and half-life.
• Cholestyramine: Can delay naproxen absorption.

• Antacids: Can delay naproxen absorption (minor effect).

• 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, hives, difficulty breathing, swelling of face/throat)
• Unexplained weight gain or edema
• Severe headache or vision changes

Avoid use after 20 weeks gestation due to risk of fetal renal dysfunction leading to oligohydramnios, and potential for premature closure of the fetal ductus arteriosus. Use during 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 in low concentrations. Generally considered compatible with breastfeeding, but monitor the infant for adverse effects (e.g., irritability, drowsiness, poor feeding). Use the lowest effective dose for the shortest duration.

Safety and efficacy of Naproxen Sodium ER 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 effects, including gastrointestinal bleeding, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration. Monitor renal function, blood pressure, and for signs of GI bleeding closely.

• Naproxen Sodium ER is designed for once-daily dosing, providing 24-hour pain and inflammation relief.
• Always take with food or milk to minimize GI upset, even with the ER formulation.
• Patients should be advised of the black box warnings regarding cardiovascular and gastrointestinal risks.
• Avoid concomitant use with other NSAIDs (including OTC ibuprofen or aspirin for pain) to prevent additive toxicity.
• Caution is advised in patients with a history of hypertension, heart failure, or renal impairment due to the risk of fluid retention and worsening conditions.
• Patients on anticoagulants or antiplatelet agents require careful monitoring for bleeding.

• Other NSAIDs (e.g., ibuprofen, celecoxib, meloxicam, diclofenac)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, with higher risk of side effects and dependence)
• Topical NSAIDs (e.g., diclofenac gel, for localized pain)
• Non-pharmacological therapies (e.g., RICE - Rest, Ice, Compression, Elevation; physical therapy, acupuncture)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, 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. 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 details about the overdose, including the substance taken, the amount, and the time it occurred.