Naproxen 750mg ER 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 inhibition of prostaglandin synthesis primarily through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This reduces the formation 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 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.
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 or upset, light-colored stools, vomiting, or yellow skin or eyes.

Severe Skin Reactions: This medication can cause life-threatening skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe reactions. 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 side effects or any other symptoms that bother you or do not go away, contact your doctor:

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 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 drugs, 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 disclose all of the following to your doctor and pharmacist:

All prescription and over-the-counter (OTC) medications.
Natural products and vitamins.
Existing health problems.

Verify that it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust 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 it is crucial to notify all your healthcare providers and lab personnel that you are taking this drug. Additionally, medications like this one have been associated with high blood pressure, 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, you should also talk to your doctor about the potential interactions. 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. This drug may also 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 has been linked to an increased 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 potential 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 the following year compared to those not taking these medications.

If you are taking aspirin to prevent heart attacks, consult your doctor about potential interactions. Additionally, 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 anti-inflammatory effect, due to increased GI risk)
• Other NSAIDs (due to increased risk of adverse effects)
• Ketorolac (due to increased risk of adverse effects)
• Furosemide (in patients with renal impairment, due to risk of acute renal failure)

• Anticoagulants (e.g., Warfarin, Heparin, DOACs): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel, Aspirin low-dose): Increased risk of bleeding.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Lithium: Increased lithium levels and toxicity.
• Methotrexate: Increased methotrexate levels and toxicity.
• ACE Inhibitors/ARBs: Increased risk of renal impairment and reduced antihypertensive effect.
• Diuretics (e.g., Thiazides, Loop diuretics): Reduced diuretic and antihypertensive effect, increased risk of renal impairment.
• Cyclosporine: Increased risk of nephrotoxicity.
• Tacrolimus: Increased risk of nephrotoxicity.

• Beta-blockers: Reduced antihypertensive effect.
• Hydantoins (e.g., Phenytoin): Increased phenytoin levels.
• Sulfonylureas: Increased hypoglycemic effect.
• Probenecid: Increased naproxen levels.
• Cholestyramine: Delayed naproxen absorption.
• Digoxin: Increased digoxin levels (monitor).

• Antacids: May delay absorption but not significantly affect extent.

• 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 renal dysfunction (decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of allergic reaction (rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing)
• Unexplained weight gain or edema
• Severe headache or stiff neck (aseptic meningitis, rare)

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 during 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. While generally considered compatible with breastfeeding by some experts (L3), caution is advised. Monitor the infant for adverse effects such as drowsiness, poor feeding, or gastrointestinal upset. Consider alternative NSAIDs with shorter half-lives or lower excretion into milk if possible.

Extended-release formulations are generally not recommended for pediatric patients due to lack of established safety and efficacy, and difficulty in dose adjustment. Immediate-release naproxen is used in pediatric patients for specific indications, but dosing must be carefully calculated by weight.

Elderly patients are at a significantly higher risk for serious adverse effects from NSAIDs, including gastrointestinal bleeding, cardiovascular thrombotic events, and renal impairment. Use the lowest effective dose for the shortest duration possible. Monitor renal function, blood pressure, and signs of GI bleeding closely.

• Naproxen ER 750mg is a once-daily formulation, which can improve patient adherence compared to multiple daily dosing of immediate-release naproxen.
• Always advise patients to take NSAIDs with food, milk, or antacids to minimize GI upset, although this does not eliminate the risk of serious GI events.
• Educate patients on the signs and symptoms of serious cardiovascular and gastrointestinal adverse events, and when to seek immediate medical attention.
• Consider a proton pump inhibitor (PPI) or H2-receptor antagonist for patients at high risk of GI complications (e.g., history of ulcer, concomitant corticosteroid or anticoagulant use, elderly).
• Avoid in patients with severe heart failure, advanced renal disease, or severe hepatic impairment.
• Be mindful of the 'NSAID triad' (asthma, nasal polyps, aspirin sensitivity) as naproxen can precipitate severe bronchospasm in these patients.
• The extended 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 when managing adverse effects or switching therapies.

• Other NSAIDs (e.g., Ibuprofen, Celecoxib, Meloxicam, Diclofenac)
• Acetaminophen (for pain and fever, without 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, with different side effect profile)
• Disease-modifying antirheumatic drugs (DMARDs) or biologics (for chronic inflammatory conditions like rheumatoid arthritis, as disease-modifying agents rather than symptomatic relief)

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, which provides crucial information 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 details about the overdose, including the substance taken, the amount, and the time it occurred.