Naproxen 375mg Tablets

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that exerts its anti-inflammatory, analgesic, and antipyretic effects by reversibly inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (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:

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.
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 significant 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, significant weight gain, or swelling in the arms or legs.
Cardiovascular Concerns: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological Symptoms: Difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
General Concerns: Extreme fatigue or weakness, ringing in the ears, severe back pain, or flu-like symptoms.
Liver Problems: Dark urine, fatigue, decreased appetite, stomach upset or 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: These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can affect internal organs and be life-threatening. Seek immediate medical attention 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

While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:

Stomach pain or heartburn
Upset stomach
Constipation
Dizziness or headache
Drowsiness

If these or any other side effects bother you or persist, consult your doctor for guidance. Not all possible side effects are listed here. If you have concerns about side effects, discuss them with 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 to ensure safe treatment:

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.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A history of asthma triggered by salicylate medications, such as aspirin, or NSAIDs.
Certain health conditions, including:
+ Gastrointestinal (GI) bleeding or kidney problems.
+ Heart failure (weak heart) or a recent heart attack.
Concurrent use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
Difficulty getting pregnant or ongoing fertility evaluations.
* Pregnancy, planned pregnancy, or pregnancy during treatment. 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 under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

To ensure your safety, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments and health issues. Never start, stop, or adjust the dosage 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 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 cautious and 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 with pre-existing heart failure. This may 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 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 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 interference)
• Other NSAIDs (increased risk of adverse effects)
• Ketorolac (increased risk of adverse effects)
• Advanced renal disease

• Anticoagulants (e.g., Warfarin, Dabigatran, Rivaroxaban): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel, Ticagrelor): Increased risk of bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
• Diuretics (e.g., Furosemide, Hydrochlorothiazide): Reduced diuretic and antihypertensive effect, increased risk of renal impairment.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Cyclosporine/Tacrolimus: Increased risk of nephrotoxicity.
• Digoxin: Increased digoxin plasma concentrations (less common but possible).

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

• Antacids: May delay absorption but not extent.

• Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of fluid retention/edema (swelling in ankles, feet, hands)
• Unusual weight gain
• Shortness of breath or chest pain (signs of cardiovascular events)
• Changes in urination (decreased urine output, dark urine)
• Yellowing of skin or eyes (jaundice)
• Unusual bruising or bleeding
• Persistent headache or dizziness
• Severe skin rash or blistering

Avoid use during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the newborn. 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.

Naproxen is excreted into breast milk in small amounts. While generally considered compatible with breastfeeding by some sources, caution is advised, especially with long-term use or high doses. Monitor the infant for adverse effects such as drowsiness, poor feeding, or gastrointestinal upset.

Not recommended for children under 2 years of age. For children ≥2 years with juvenile idiopathic arthritis, specific dosing guidelines apply. Use in children should be carefully weighed against risks, especially regarding renal and GI effects. Avoid in children with dehydration or hypovolemia.

Elderly patients are at increased risk for serious adverse effects, particularly gastrointestinal bleeding, ulceration, perforation, and renal impairment. Use the lowest effective dose for the shortest duration. Monitor renal function, blood pressure, and for signs of GI bleeding more frequently.

• Naproxen has a longer half-life than ibuprofen, allowing for twice-daily dosing, which can improve adherence for chronic conditions.
• Naproxen sodium (e.g., Aleve) is absorbed faster than naproxen base, leading to quicker pain relief, but the overall efficacy and duration are similar.
• Always advise patients to take naproxen with food, milk, or antacids to minimize gastrointestinal upset.
• Educate patients on the signs of GI bleeding and cardiovascular events, as these are serious potential side effects.
• 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 for pain) to prevent additive toxicity.
• Naproxen can interfere with the antiplatelet effect of low-dose aspirin; if both are necessary, naproxen should be taken at least 30 minutes after or 8 hours before immediate-release aspirin.

• Other NSAIDs (e.g., Ibuprofen, Diclofenac, Meloxicam, Celecoxib)
• 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)
• Corticosteroids (for severe inflammation, short-term use)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions like RA
• Physical therapy, RICE (Rest, Ice, Compression, Elevation) for musculoskeletal injuries

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. 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 provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill. 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 details about the medication taken, the amount, and the time it occurred.