Naproxen Sodium 220mg Tablets

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:

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, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding 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.
Other Serious Symptoms: Shortness of breath, sudden significant weight gain, or swelling in the arms or legs, chest pain or pressure, rapid heartbeat, weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Additional Concerns: Extreme fatigue or weakness, ringing in the ears, severe back pain, flu-like symptoms, or liver problems (indicated by dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin and eyes).
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or other serious reactions, which can 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.

Common Side Effects

Most people do not experience severe side effects, and many have no side effects or only minor ones. However, if you are bothered by any of the following side effects or if they persist, contact your doctor:

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

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or 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 drug, its components, or other substances, such as foods or medications. 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 medication like aspirin, or pemetrexed.
If you are having difficulty conceiving or 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 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 your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change 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 the dosage and duration of treatment. Taking more than the prescribed amount or using the 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 who already have this condition. This can 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 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 help 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.

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 drug may affect ovulation, potentially impacting fertility. However, this effect is reversible, and ovulation typically returns to normal once the medication is stopped. If you are planning to become pregnant or are concerned about fertility, discuss these issues with your doctor.

Breastfeeding mothers should inform their doctor, as they will need to discuss the potential risks and benefits of taking this medication while nursing their baby.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• Other NSAIDs (increased risk of GI bleeding and renal dysfunction)
• Ketorolac (additive toxicity)

• Anticoagulants (e.g., warfarin, heparin): Increased risk of bleeding.
• Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of GI bleeding.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Diuretics (e.g., furosemide, hydrochlorothiazide): Reduced diuretic and antihypertensive effects; increased risk of renal impairment.
• ACE inhibitors/ARBs: Reduced antihypertensive effects; increased risk of renal impairment.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Cyclosporine/Tacrolimus: Increased risk of nephrotoxicity.

• Beta-blockers: Reduced antihypertensive effects.
• Hydantoins (e.g., phenytoin): Increased hydantoin levels.
• Sulfonylureas: Increased hypoglycemic effect.
• Probenecid: Increased naproxen plasma concentrations and half-life.
• Cholestyramine: Delayed naproxen absorption.
• Digoxin: Possible increase in digoxin levels.

• 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 impairment (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, difficulty breathing)
• Unexplained weight gain or edema

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

Naproxen is excreted in breast milk in small amounts. Generally considered compatible with breastfeeding, but use with caution, especially in preterm or jaundiced infants. Monitor infant for adverse effects.

Not recommended for children under 12 years of age without physician consultation due to limited safety and efficacy data in this age group for OTC use. Risk of Reye's syndrome is not associated with naproxen, but caution is still advised.

Elderly patients are at increased risk for serious adverse reactions, including gastrointestinal bleeding, ulceration, perforation, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor renal function and signs of GI bleeding closely.

• Naproxen sodium has a longer half-life than ibuprofen, allowing for less frequent dosing (every 8-12 hours vs. every 4-6 hours).
• Advise patients to take with food, milk, or antacids to minimize GI upset.
• Educate patients on the signs and symptoms of serious cardiovascular and GI adverse events, and when to seek immediate medical attention.
• Remind patients that OTC naproxen sodium is not for long-term chronic pain management without physician supervision.
• Caution against concomitant use with other NSAIDs (including aspirin for pain relief, but low-dose aspirin for cardiovascular protection may be continued under medical advice, with increased GI risk).

• Acetaminophen (e.g., Tylenol) for pain and fever (different mechanism, no anti-inflammatory effect, different side effect profile).
• Ibuprofen (another NSAID, shorter half-life, similar risks).
• Aspirin (another NSAID, antiplatelet effects, higher GI risk at analgesic doses).
• Topical NSAIDs (e.g., diclofenac gel) for localized pain, with lower systemic absorption.
• Non-pharmacological therapies (e.g., RICE - Rest, Ice, Compression, Elevation; physical therapy; heat/cold therapy).

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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 consumed, and the time it occurred.